qanastek/EMEA-V3 huggingface dataset:
The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
34 L- inċidenza ta ’ fratturi kkalkulata kienet ta ’ 1. 9 fratturi kull 100 sena ta ’ pazjent f’ nisa kkurati b’ pioglitazone u 1. 1 fratturi kull 100 sena ta ’ pazjent f’ nisa kkurati bi prodott ta ’ paragun.
Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Ħuwa rrappurtat li l- għotja ta ’ piogltazone flimkien ma ’ rifampicin (induttur taċ- ċitokromju P450 2C8) twassal għal tnaqqis ta ’ 54% fl- AUC ta ’ pioglitazone.
33 phenylbutazone, azapropazon and oxyfenbutazone insulin and oral antidiabetic products metformin salicylates and p-amino-salicylic acid anabolic steroids and male sex hormones chloramphenicol coumarin anticoagulants fenfluramine fibrates ACE inhibitors fluoxetine allopurinol sympatholytics cyclo-, tro-and iphosphamides sulphinpyrazone certain long-acting sulphonamides tetracyclines MAO-inhibitors quinolone antibiotics probenecid miconazol pentoxyfylline (high dose parenteral) tritoqualine fluconazole
phenylbutazone, azapropazon u oxyfenbutazone insulina u prodotti anti- dijabetiċi orali metformin salicylates u p- amino- salicylic acid sterojdi anaboliċi u ormoni sesswali ta ’ l- irġiel chloramphenicol coumarin anticoagulants fenfluramine fibrates inibituri ACE fluoxetine allopurinol sympatholytics cyclo -, tro - u iphosphamides sulphinpyrazone ċertu sulphonamides li jaħdmu fit- tul tetracyclines inibituri MAO anti- bijotiċi quinolone probenecid miconazol pentoxyfylline (doża għolja mogħtija b’ mod parenterali) tritoqualine fluconazole
Under the influence of sympatholytic active substances such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
36 Taħt l- influwenza ta ’ sustanzi attivi simpatolitiċi bħal imblukkaturi beta, clonidine, guanethidine u reserpine, is- sinjali ta ’ kontra- regolazzjoni adrinerġika għall- ipogliċemija jistgħu jkunu mnaqqsa jew assenti.
34 Sulphonylurea-derivatives like glimepiride pass into the breast milk.
Derivati ta ’ sulphonylurea bħal glimepiride jgħaddu fil- ħalib tas- sider.
General disorders and administration site conditions Uncommon:
37 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Mhux komuni: għejja
35 Renal and urinary disorders Uncommon:
Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni: glikosurja, proteina fl- awrina
Additional information on the individual active substances of the fixed dose combination
38 Tagħrif ieħor dwar is- sustanzi attivi individwali tat- taħlita ta ’ doża fissa
36 Immune system disorders Very rare:
Disturbi fis- sistema immuni Rari ħafna:
Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, agranulocytopenia, agranulocytosis, haemolytic anemia and pancyto-penia may occur.
Tromboċitopenija, leukopenija, eriroċitopenija, agranuloċitopenija, agranuloċitosi, anemija emolitika u panċito- penija moderata għal severa jistgħu jseħħu.
These are in general reversible upon discontinuation of medication.
Ġeneralment dawn huma riversibbli mal- waqfien tal- medikazzjoni.
A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
39 Twettqet analiżi ta ’ tagħrif miġbur ta ’ rapporti ta ’ avvennimenti avversi ta ’ fratturi fl- għadam minn provi kliniċi randomised, ikkontrollati b’ paragun, u double blind b’ aktar minn 8100 pazjent fil- gruppi kkurati b’ pioglitazone u 7400 pazjent fil- gruppi kkurrati bi prodott paragun li damu sa 3. 5 snin.
37 Treatment of overdosage of Tandemact primarily consists of preventing absorption of glimepiride by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium-sulphate (laxative).
Kura ta ’ doża eċċessiva ta ’ Tandemact tikkonsisti primarjament minn impediment ta ’ l- assorbiment ta ’ glimepiride billi jiġi ndott ir- remettar u wara jinxtorob ilma jew luminata b’ faħam attivat (assorbent) u sodium- sulphate (lassattiv).
Pioglitazone
40 Pioglitazone
38 The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
L- effett ta ’ pioglitazone (45 mg monoterapija vs. plaċebo) kien studjat fi prova żgħira ta ’ 18- il ġimgħa f’ pazjenti bid- dijabete tat- tip 2.
Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Kważi nofs il- pazjenti kellhom infart 41 mijokardijaku minn qabel u madwar 20% kellhom puplesija minn qabel.
39 Glimepiride increases the activity of the glycosyl-phosphatidylinositol-specific phospholipase C which may be correlated with the induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Glimepiride iżid l- attività ta ’ phospholipase C sepċifiku għal glycosyl- phosphatidylinositol li tista ’ tiġi kkorrelata mal- lipoġenesi u glikoġnesi indotta f’ ċellolli iżolati tax- xaħam u tal- muskoli.
5.2 Pharmacokinetic properties
42 5. 2 Tagħrif farmakokinetiku
40 Elimination:
Eliminazzjoni:
Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Wara għotja ta ’ pioglitazone radjutikketjat mill- ħalq lill- bniedem, it- tikkettjar miġbur kien l- aktar fil - feċi (55%) u f’ ammont inqas fl- awrina (45%).
Patients with renal impairment:
43 Pazjenti b’ indeboliment renali:
After a single dose of radiolabeled glimepiride, 58% of the radioactivity was recovered in the urine, and 35% in the faeces.
Wara doża waħda ta ’ glimepiride radjulabiljat, 58% tar- radjuattività kienet irkuprata fl- awrina, u 35% fil- feċi.
41 5.3 Preclinical safety data
44 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
42 6.4 Special precautions for storage
45 6. 4 Prekawzjonijiet speċjali għall- ħażna
Aluminium/ aluminim blisters; packs of 14, 28, 30, 50, 90 or 98 tablets.
Aluminju/ folji tal- aluminju; pakketti ta ’ 14, 28, 30, 50, 90 jew 98 pillola.
Takeda Italia Farmaceutici S. p. A Via Crosa 86, 28065 Cerano (NO) Italy
Takeda Italia Farmaceutici S. p. A Via Crosa 86, 28065 Cerano (NO) L- Italja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 7.0 presented in Module 1.8.1 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 7. 0, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, hija implimentata u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application, and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq jwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem fil- verżjoni tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) ta ’ Mejju 2007, ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq, u kull aġġornament sussegwenti ta ’ RMP miftiehem miċ - CHMP.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
48 • Fi żmien 60 ġurnata wara li tintlaħaq mira ta ’ mportanza (farmakoviġilanza jew tnaqqis ta ’ riskju) • Mat- talba ta ’ l- EMEA
Tandemact 30 mg/ 2 mg tablets
Tandemact 30 mg/ 2 mg pilloli
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride.
Kull pillola fiha 30 mg pioglitazone (bħala hydrochloride) u 2 mg glimepiride.
Contains lactose monohydrate.
Fih lattosju monohydrate.
14 tablets 28tablets 30 tablets 50 tablets 90 tablets 98 tablets
14- il pillola 28 pillola 30 pillola 50 pillola 90 pillola 98 pillola
EU/ 1/ 06/ 366/ 017 14 tablets EU/ 1/ 06/ 366/ 018 28 tablets EU/ 1/ 06/ 366/ 019 30 tablets EU/ 1/ 06/ 366/ 020 50 tablets EU/ 1/ 06/ 366/ 021 90 tablets EU/ 1/ 06/ 366/ 022 98 tablets
EU/ 1/ 06/ 366/ 017 14- il pillola EU/ 1/ 06/ 366/ 018 28 pillola EU/ 1/ 06/ 366/ 019 30 pillola EU/ 1/ 06/ 366/ 020 50 pillola EU/ 1/ 06/ 366/ 021 90 pillola EU/ 1/ 06/ 366/ 022 98 pillola
Tandemact 30 mg/ 4 mg tablets
Tandemact 30 mg/ 4 mg pilloli
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Kull pillola fiha 30 mg pioglitazone (bħala hydrochloride) u 4 mg glimepiride.
EU/ 1/ 06/ 366/ 005 14 tablets EU/ 1/ 06/ 366/ 006 28 tablets EU/ 1/ 06/ 366/ 007 30 tablets EU/ 1/ 06/ 366/ 008 50 tablets EU/ 1/ 06/ 366/ 009 90 tablets EU/ 1/ 06/ 366/ 010 98 tablets
EU/ 1/ 06/ 366/ 005 14- il pillola EU/ 1/ 06/ 366/ 006 28 pillola EU/ 1/ 06/ 366/ 007 30 pillola EU/ 1/ 06/ 366/ 008 50 pillola EU/ 1/ 06/ 366/ 009 90 pillola EU/ 1/ 06/ 366/ 010 98 pillola
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Tandemact 45 mg/ 4 mg tablets
Tandemact 45 mg/ 4 mg pilloli
Each tablet contains 45 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Kull pillola fiha 45 mg pioglitazone (bħala hydrochloride) u 4 mg glimepiride.
14 tablets 28 tablets 30 tablets 50 tablets 90 tablets 98 tablets 5.
14- il pillola 28 pillola 30 pillola 50 pillola 90 pillola 98 pillola
EU/ 1/ 06/ 366/ 011 14 tablets EU/ 1/ 06/ 366/ 012 28 tablets EU/ 1/ 06/ 366/ 013 30 tablets EU/ 1/ 06/ 366/ 014 50 tablets EU/ 1/ 06/ 366/ 015 90 tablets EU/ 1/ 06/ 366/ 016 98 tablets
EU/ 1/ 06/ 366/ 011 14- il pillola EU/ 1/ 06/ 366/ 012 28 pillola EU/ 1/ 06/ 366/ 013 30 pillola EU/ 1/ 06/ 366/ 014 50 pillola EU/ 1/ 06/ 366/ 015 90 pillola EU/ 1/ 06/ 366/ 016 98 pillola
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
57 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Tandemact 30 mg/ 2 mg tablets
Pilloli Tandemact 30 mg/ 2 mg
Expiry date:
Data ta ’ meta jiskadi:
Batch number:
Numru tal- lott:
ABBREVIATIONS FOR DAYS OF THE WEEK (PACK SIZES OF 14, 28, AND 98 TABLETS ONLY)
TQASSIR GĦALL- ĠRANET TAL- ĠIMGĦA (DAQSIJIET TAL- PAKKETT TA ’ 14, 28, U 98 PILLOLA BISS)
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
58 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Tandemact 30 mg/ 4 mg tablets
Pilloli Tandemact 30 mg/ 4 mg
Tandemact 45 mg/ 4 mg tablets
Pilloli Tandemact 45 mg/ 4 mg
57 PACKAGE LEAFLET:
61 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Tandemact 30 mg/ 2 mg tablets
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA Pilloli Tandemact 30 mg/ 2 mg
Pioglitazone / glimepiride
Pioglitazone / glimepiride
What Tandemact is and what it is used for 2.
X’ inhu Tandemact u għalxiex jintuża 2.
Before you take Tandemact 3.
Qabel ma tieħu Tandemact 3.
How to take Tandemact 4.
Kif għandek tieħu Tandemact 4.
Storing Tandemact 6.
Kif taħżen Tandemact 6.
WHAT TANDEMACT IS AND WHAT IT IS USED FOR
X’ INHU TANDEMACT U GĦALXIEX JINTUŻA
Tandemact is used for the treatment of type 2 (non-insulin dependent) diabetes mellitus.
Tandemact jintuża għall- kura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
This is the diabetes that usually develops in adulthood.
Din hija d - dijabete li ġeneralment tiżviluppa fi stat adult.
Tandemact helps control the level of sugar in your blood when you have type 2 diabetes by increasing the amount of insulin available and helping your body make better use of it.
Tandemact jgħin jikkontrolla l- livell ta ’ żokkor fid- demm tiegħek meta jkollok dijabete tat- tip 2 billi jżid l- ammont ta ’ l- insulina disponibbli u jgħin lill- ġismek jagħmel użu aħjar minnha.
BEFORE YOU TAKE TANDEMACT
QABEL MA TIEĦU TANDEMACT
Do not take Tandemact:
Tieħux pilloli Tandemact:
- If you are allergic (hypersensitive) to pioglitazone, glimepiride, other sulphonylureas or
- Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal pioglitazone, sulphonylureas oħra
sulphonamides, or any of the other ingredients of Tandemact.
jew sulphonamides jew sustanzi oħra ta ’ Tandemact.
- If you have severe problems with your kidneys.
- Jekk għandek problema serji bil- kliewi tiegħek.
- If you have insulin dependent diabetes (Type 1).
- Jekk għandek dijabete dipendenti mill- insulina (Tip I).
- If you are pregnant.
- Jekk inti tqila.
Take special care with Tandemact:
Oqgħod attent ħafna b’ pilloli Tandemact:
- If you are planning to become pregnant.
- Jekk qed tippjana li toħroġ tqila.
- If you are already taking other medicines for the treatment of diabetes.
- Jekk qed tieħu diġà pilloli oħra biex tikkura d- dijabete.
58 Taking other medicines:
62 Meta tieħu mediċini oħra:
This is because some medicines can weaken or strengthen the effect of Tandemact on the level of sugar in your blood.
Dan minħabba li ċertu mediċini jistgħu jdgħajjfu jew isaħħu l- effett ta ’ Tandemact fuq il- livell ta ’ żokkor fid- demm tiegħek.
Do not take Tandemact if you are pregnant or breast-feeding.
Tieħux Tandemact jekk inti tqila jew qed tredda ’.
Tell your doctor if you are, you think you might be or are planning to become pregnant, or if you are planning to breast-feed your baby.
Għid lit- tabib tiegħek jekk inti, taħseb li inti jew qed tippjana biex toħroġ tqila, jew jekk qed tippjana li tredda ’ t- tarbija tiegħek.
Alertness and reaction time may be impaired due to low or high blood sugar due to glimepiride, especially when beginning or after altering treatment or when Tandemact is not taken regularly.
L- viġilanza u l- ħin ta ’ reazzjoni jistgħu jiġu mnaqqsa minħabba żokkor fid- demm baxx jew għoli minħabba glimepiride, speċjalment fil- bidu jew wara tibdil tal- kura jew meta Tandemact ma jitteħidx regolarment.
This may affect your ability to drive or operate machinery.
Dan jista ’ jaffettwa l- ħila tiegħek li ssuq jew li tħaddem magni.
Important information about some of the ingredients of Tandemact:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ pilloli Tandemact:
This medicinal product contains lactose monohydrate.
Dan il- prodott mediċinali fih lattosju monohydrate.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Tandemact.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi żokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu Tandemact.
HOW TO TAKE TANDEMACT
KIF GĦANDEK TIEĦU TANDEMACT
Always take Tandemact exactly as your doctor has told you.
Dejjem għandek tieħu Tandemact skond il- parir tat- tabib.
The usual dose is one tablet taken once daily shortly before or with the first main meal.
Id- doża li ssoltu tingħata hija pillola kuljum ftit qabel jew ma ’ l- ewwel ikla prinċipali.
Tablets should be swallowed whole with some liquid.
Il- pilloli għandhom jinbelgħu sħaħ ma ’ ftit likwidu.
If you have the impression that the effect of Tandemact is too weak, talk to your doctor.
Jekk għandek l- impressjoni li l- effett ta ’ Tandemact huwa dgħajjef wisq, kellem lit- tabib tiegħek.
If you are following a special diet for diabetes, you should continue with this while you are taking Tandemact.
Jekk qed issegwi dieta speċjali għad- dijabete, għandek tkompli biha waqt li qed tieħu Tandemact.
Your doctor will ask you to have blood tests periodically during treatment with Tandemact.
It- tabib tiegħek se jitolbok tagħmel testijiet tad- demm kull tant żmien waqt il- kura b’ Tandemact.
If you take more Tandemact than you should:
Jekk tieħu pilloli Tandemact aktar milli suppost:
If you forget to take Tandemact:
Jekk tinsa tieħu pilloli Tandemact:
Try to take Tandemact daily as prescribed.
Ipprova ħu Tandemact kuljum kif preskritt.
If you stop taking Tandemact:
63 Jekk tieqaf tieħu Tandemact:
Do not stop taking Tandemact without first discussing it with your doctor or pharmacist.
Tieqafx tieħu Tandemact qabel ma tiddiskuti dan mat- tabib jew l- ispiżjar tiegħek.
Like all medicines, Tandemact can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Tandemact jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some patients experienced the following side effects whilst taking pioglitazone and sulphonylureas, including glimepiride:
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li kienu qed jieħdu pioglitazone u sulphonylureas, inkluż glimepiride:
- localised swelling (oedema)
- nefħa lokalizzata (edema)
- upper respiratory tract infection
- infezzjoni fl- apparat respiratorju ta ’ fuq
- numbness
- tnemnim
- sinusitis
- sinożite
- sweating
- għaraq
- decreased blood sugar
- tnaqqis taż- żokkor fid- demm
- sugar in urine
- żokkor fl- awrina
- proteins in urine
- proteini fl- awrina
- increased appetite
- żieda fl- aptit
- allergic reactions including allergic shock
- reazzjonijiet allerġiċi inkluż xokk allerġiku
- nausea, vomiting and diarrhoea
- tqalliħ, remettar u dijarrea.
Blurred vision due to swelling (or fluid) in the back of the eye has been reported.
Kienet irrappurtata vista mċajpra minħabba nefħa (jew fluwidu) fil- part ta ’ wara tal- għajn.
If you experience these symptoms for the first time or if they get worse talk to your doctor as soon as possible.
Jekk tesperjenza dawn is- sintomi għal l- ewwel darba jew jekk imorru għall- għar kellem lit- tabib tiegħek malajr kemm jista ’ jkun.
It is important to know what symptoms to expect when hypoglycaemia (low blood sugar) occurs.
Huwa mportanti li tkun taf x’ sintomi għandek tistenna meta jkun hemm ipogliċemija (żokkor fid- demm baxx).
Ask your doctor or pharmacist for more information if you are not sure how to recognise this.
Saqsi lit- tabib jew lill- ispiżjar tiegħek għal aktar informazzjoni jekk mintix ċert/ a kif tagħraf dan.
The symptoms may include cold sweat, tiredness, headache, rapid heartbeat, hunger pangs, irritability, nervousness or nausea.
Is- sintomi jistgħu jinkludu ixoqq għaraq kiesaħ għalik, għejja, uġigħ ta ’ ras, qalb tħabbat b’ rata mgħaġġla, attakki ta ’ ġuħ, irritabilità, tħossok nervuż jew tqalliħ.
Tell your doctor if you notice such symptoms.
Għid lit - tabib tiegħek jekk tinnota sintomi bħal dawn.
Lowering of the Hb level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme Glucose-6-phosphodehydrogenase.
Jista ’ jkun hemm tnaqqis fil- livell ta ’ Hb u tkissir taċ- ċelluli l- ħomor tad- demm (anemija emolitika) f’ pazjenti li m’ għandhomx l- enżima Glucose- 6- phosphodehydrogenase
STORING TANDEMACT
KIF TAĦŻEN TANDEMACT
Do not use Tandemact after the expiry date which is stated on the carton and blister.
Tużax Tandemact wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq il- folja.
Ask you pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għankekx bżonn.
What Tandemact contains:
X’ fih Tandemact:
The active substances are pioglitazone and glimepiride.
Is- sustanzi attivi huma pioglitazone u glimepiride.
Each tablet contains 30 mg pioglitazone (as hydrochloride) and 2 mg glimepiride.
Kull pillola fiha 30 mg pioglitazone (bħala hydrochloride) u 2 mg glimepiride.
The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate and polysorbate 80.
Is- sustanzi l- oħra huma cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lattosju monohydrate, magnesium stearate u polysorbate 80.
What Tandemact looks like and contents of the pack:
Id- Dehra tal- prodott u d- daqs tal- pakkett:
The tablets are white to off-white, round, convex and embossed ‘ 4833 G’ on one face and 30/ 2 on the other.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, konvessi u mmarkati b ’ ‘ 4833 G ’ fuq naħa u b’ 30/ 2 fuq in- naħa l- oħra.
The tablets are supplied in blister packs containing either 14, 28, 30, 50, 90 or 98 tablets.
Il- pilloli huma disponibbli f’ pakketti tal- folja li fihom 14, 28, 30, 50, 90 jew 98 pillola.
Takeda Italia Farmaceutici S. p. A., Via Crosa, 86, 28065 Cerano (NO), Italy.
Takeda Italia Farmaceutici S. p. A., Via Crosa, 86, 28065 Cerano (NO), L- Italja.
Eesti Takeda Global R & D Centre (Europe) Tel: +44 (0)20 3116 8000
65 Eesti Österreich Takeda Global R & D Centre (Europe) Tel: +44 (0) 20 3116 8000
Polska Takeda Global R & D Centre (Europe) Tel.: +44 (0)20 3116 8000
Polska Takeda Global R & D Centre (Europe) Tel.: +44 (0) 20 3116 80005000
INFORMATION FOR THE USER Tandemact 30 mg/ 4 mg tablets
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA Pilloli Tandemact 30 mg/ 4 mg
63 Taking other medicines:
67 Meta tieħu mediċini oħra:
If you stop taking Tandemact:
68 Jekk tieqaf tieħu Tandemact:
Each tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
Kull pillola fiha 30 mg pioglitazone (bħala hydrochloride) u 4 mg glimepiride.
The tablets are white to off-white, round, convex and embossed ‘ 4833 G’ on one face and 30/ 4 on the other.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, konvessi u mmarkati b ’ ‘ 4833 G ’ fuq naħa u b’ 30/ 4 fuq in- naħa l- oħra.
Eesti Takeda Global R & D Centre (Europe) Tel: +44 (0)20 3116 8000
Eesti Takeda Global R & D Centre (Europe)
INFORMATION FOR THE USER Tandemact 45 mg/ 4 mg tablets
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA Pilloli Tandemact 45 mg/ 4 mg
68 Taking other medicines:
72 Meta tieħu mediċini oħra:
If you stop taking Tandemact:
73 Jekk tieqaf tieħu Tandemact:
Each tablet contains 45 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
Kull pillola fiha 45 mg pioglitazone (bħala hydrochloride) u 4 mg glimepiride.
The tablets are white to off-white, round, flat and embossed ‘ 4833 G’ on one face and ‘ 45/ 4’ on the other.
Il- pilloli huma bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b ’ ‘ 4833 G ’ fuq naħa u b’ 45/ 4 fuq in - naħa l- oħra.
The tablets are supplied in blister packs containing either 14, 28, 30, 50, 90, or 98 tablets.
Il- pilloli huma disponibbli f’ pakketti tal- folja li fihom 14, 28, 30, 50, 90 jew 98 pillola.
Eesti Takeda Global R & D Centre (Europe) Tel: +44 (0)20 3116 8000
75 Eesti Österreich Takeda Global R & D Centre (Europe) Tel: +44 (0) 20 3116 8000
What is Tarceva?
X' inhu Tarceva?
Tarceva are white to pale yellow round tablets, which contain 25, 100 or 150 mg of the active substance erlotinib.
Tarceva huma pilloli tondi bojod ikanġu fl- isfar ċar, li fihom 25, 100 jew 150 mg tas- sustanza attiva erlotinib.
What is Tarceva used for?
Għal x' hiex jintuża Tarceva?
Tarceva is an anticancer medicine.
Tarceva hu mediċina ta 'kontra l- kanċer.
It is used to treat adult patients with the following diseases: • non-small cell lung cancer.
Jintuża biex jittratta pazjenti adulti li jbagħtu mill- mard li ġej: • kanċer tal- pulmun b ’ ċelloli li mhumiex żgħar.
Tarceva is used in advanced cancer or metastatic cancer (when cancer cells have spread from the original site to other parts of the body), when at least one previous chemotherapy treatment has failed.
Tarceva huwa wżat f' kanċer avvanzat jew f' kanċer metastatiku (meta ċ- ċelloli tal- kanċer ikunu nxterdu mis- sit oriġinali għal partijiet oħrajn tal- ġisem), meta għallinqas trattament wieħed ta 'kemjoterapija preċedenti ma jkunx ħadem.
Tarceva has not been shown to be effective in patients whose tumours are ‘ EGFR-negative’. ‘ EGFR-negative’ means that some receptors, the epidermal growth factor receptors (EGFR), cannot be detected on the surface of the cancer cells, or can only be detected in small quantities. • metastatic pancreatic cancer, in combination with gemcitabine (another anticancer medicine).
Tarceva ma ntweriex li huwa effettiv f' pazjenti li t- tumuri tagħhom huma ‘ EGFR - negattivi ’. ‘ EGFR- negattivi ’ ifisser li xi riċetturi, ir- riċetturi tal- fattur tat- tkabbir epidermali (EGFR) ma jkunux jistgħu jiġu osservati fuq il- wiċċ taċ- ċelloli b' kanċer, jew ikunu jistgħu jiġu osservati biss fi kwantitajiet żgħar. • kanċer tal- frixa metastatiku, f' kombinazzjoni ma 'gemcitabine (mediċina oħra kontra l- kanċer).
How is Tarceva used?
Kif jintuża Tarceva?
Treatment with Tarceva should be supervised by a doctor who has experience of the use of anticancer medicines.
Trattament b' Tarceva għandu jiġi sorveljat minn tabib b' esperjenza fl- użu ta 'mediċini kontra l- kanċer.
For lung cancer, the recommended daily dose of Tarceva is 150 mg.
Għal kanċer tal- pulmun, id- doża rakkomandata ta 'kuljum ta' Tarceva hija 150 mg.
For pancreatic cancer, it is 100 mg.
Għal kanċer tal - frixa, id- doża rakkomandata hija 100 mg.
Tarceva is taken at least one hour before or two hours after food.
Tarceva jittieħed għallinqas siegħa qabel u sagħtejn wara l - ikel.
If needed (for example because of side effects), the dose may be reduced in 50 mg steps.
Jekk meħtieġ (per eżempju minħabba l- effetti sekondarji), id- doża tista 'titnaqqas f' fażijiet ta' 50 mg.
Treatment of pancreatic cancer should be re-assessed after 4 to 8 weeks if no rash has developed.
Trattament ta 'kanċer tal- frixa għandu jiġi vvalutat mill- ġdid wara 4 sa 8 ġimgħat jekk ma jkun żviluppa ebda raxx.
Tarceva is not recommended for use in patients with severe liver or kidney disease.
Tarceva m' huwiex rakkomandat sabiex jintuża f' pazjenti b' mard sever tal- fwied jew tal- kliewi.
How does Tarceva work?
Kif jaħdem Tarceva?
The active substance in Tarceva, erlotinib, is an anti-cancer medicine that belongs to the group ‘ epidermal growth factor receptor (EGFR) inhibitors’.
Is- sustanza attiva f' Tarceva, erlotinib, hija mediċina kontra l- kanċer li tappartieni għall- grupp ‘ inibituri tar- riċettur tal- fattur tat- tkabbir epidermali ’ (EGFR).
Erlotinib blocks the epidermal growth factor receptors, which can be found on the surface of certain tumour cells.
Erlotinib jimblokka r- riċetturi tal- fattur tat- tkabbir epidermali, li jista 'jinstab fuq il- wiċċ ta' ċerti ċelloli ta 'tumuri.
As a result of this block, the tumour cell can no longer receive the messages needed for growth, progression and spreading (metastasis).
B' konsegwenza ta 'dan l- imblokk, iċ- ċelloli tat- tumuri ma jkunux jistgħu jirċievu aktar il- messaġġi meħtieġa għat- tkabbir, progress u tixrid (metastażi).
This helps Tarceva stop the cancer cells from growing and multiplying.
Dan jgħin lil Tarceva jwaqqaf iċ- ċelloli tal- kanċer milli jkomplu jikbru u jimmultiplikaw.
(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 How has Tarceva been studied?
(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 Kif ġie studjat Tarceva?
The effects of Tarceva were first tested in experimental models before being studied in humans.
L- effetti ta 'Tarceva għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil - bniedem.
The main study in non-small cell lung cancer involved 731 patients who had not responded to at least one previous chemotherapy treatment.
L- istudju prinċipali f' kanċer tal- pulmun taċ- ċelloli li mhumiex żgħar involva 731 pazjent li ma wieġbux għal mill- inqas trattament wieħed ta 'kemjoterapija preċedenti.
The main study in pancreatic cancer involved 569 patients with advanced, unresectable (unable to be removed by surgery) or metastatic pancreatic cancer, in combination with gemcitabine.
L- istudju ewlieni f' kanċer tal- frixa involva 569 pazjent b' kanċer avvanzat, li ma jistax jitneħħa b' kirurġija (unresectable) jew b' kanċer tal- frixa metastatiku, f' kombinazzjoni ma 'gemcitabine.
In both studies, Tarceva was compared with placebo (a dummy treatment) and the main measure of effectiveness was ‘ median survival’ (time until 50% of the patients were still alive).
Fiż- żewġ studji, Tarceva tqabbel ma 'plaċebo (trattament finta) u l- miżura ewlenija ta' l- effettività kienet ‘ is- sopravivenza medja ’ (żmien sakemm 50% tal- pazjenti kienu għadhom ħajjin).
What benefit has Tarceva shown during the studies?
X' benefiċċji ta 'Tarceva intwerew f' dawn l- istudji?
For lung cancer, the median survival for the Tarceva patients was 6.7 months, compared with 4.7 months for the patients treated with placebo.
Għal kanċer tal- pulmun, l- għajxien medju għall- pazjenti ta 'Tarceva kien ta' 6. 7 xhur, meta mqabbel ma '4. 7 xhur għall- pazjenti ttrattati bi plaċebo.
After 12 months, 31.2% of the patients taking erlotinib were still alive, compared with 21.5% of patients treated with placebo.
Wara 12- il xahar, 31. 2% tal- pazjenti li kienu qegħdin jieħdu erlotinib kienu għadhom ħajjin, meta mqabbla ma '21. 5% tal- pazjenti ttrattati bi plaċebo.
When looking at the results in patients who received Tarceva, and according to their tumour type, the survival figures were 8.6 months in patients who were ‘ EGFR-positive’ (those who had tumour cells that were shown to carry EGFR), compared with 5.0 months in patients who were EGFR-negative.
Meta wieħed iħares lejn ir- riżultati f' pazjenti li rċevew Tarceva, u skond it- tip ta 'tumur tagħhom, iċ- ċifri ta' sopravivenza kienu 8. 6 xhur f' pazjenti li kienu ‘ EGFR- pożittivi ’ (dawk li kellhom ċelloli ta 'tumur li ntwera li jġorru EGFR), meta mqabbla ma' 5. 0 xhur f' pazjenti li kienu EGFR- negattivi.
For metastatic pancreatic cancer, the mediansurvival in the patients treated with Tarceva was 5.9 months, compared to 5.1 months in those taking placebo.
Għal kanċer tal- frixa metastatiku, is- sopravivenza medja fil- pazjenti ttrattati b' Tarceva kienet ta '5. 9 xhur, meta mqabbla ma' 5. 1 xhur f' dawk jieħdu plaċebo.
However, there was no survival advantage for patients with advanced pancreatic cancer that had not spread beyond the pancreas.
Madankollu, ma kien hemm ebda vantaġġ fis - sopravivenza għal pazjenti b' kanċer tal- frixa avvanzat li ma nfirixx 'il hinn mill- frixa.
What is the risk associated with Tarceva?
X' inhu r- riskju assoċjat ma 'Tarceva?
In clinical studies, the most common side effects when taking Tarceva (seen in more than 1 patient in 10) were rash and diarrhoea.
L- iktar effetti sekondarji komuni bit- teħid ta 'Tarceva (li jidhru f' aktar minn pazjent 1 minn kull 10) huma raxx u dijarea.
Most of these were not serious and could be managed without treatment.
Ħafna minn dawn ma kinux serji u ma setgħux jiġu kkontrollati mingħajr trattament.
More serious rash and diarrhoea occurred in approximately 5-10% of Tarceva-treated patients and each side effect caused up to 1% of patients to stop treatment.
Raxx u dijarea aktar serji seħħew f' madwar 5- 10% tal- pazjenti ttrattati b' Tarceva u kull effett sekondarju ġiegħel lil sa 1% tal- pazjenti sabiex iwaqqfu t- trattament.
Patients with persistent and severe diarrhoea should contact their doctor, as they may be at risk of low blood potassium levels and kidney failure.
Pazjenti b' dijarea persistenti u severa għandhom jikkuntattjaw lit- tabib tagħhom, minħabba li jistgħu jkunu f' riskju ta 'livelli baxxi ta' potassju fid- demm u ħsara fil- kliewi.
They may need to be treated in hospital.
Jista 'jkollhom bżonn jiġu ttrattati l- isptar.
For the full list of side effects reported with Tarceva, please see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Tarceva, jekk jogħġbok ara l- Fuljett ta 'Tagħrif.
Tarceva should not be used in people who may be hypersensitive (allergic) to erlotinib or any of the other ingredients.
Tarceva m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal erlotinib jew għal xi sustanza oħra tiegħu.
It should be used with caution if the patient is taking other medicines, including warfarin (a medicine used to thin the blood), ketoconazole (to treat fungal infections), antibiotics (erythromycin, clarithromycin) or St.
Għandu jintuża b' attenzjoni jekk il- pazjent ikun qed jieħu mediċini oħra, inkluż warfarina (mediċina wżata biex traqqaq id- demm), ketoconazole (biex titratta infezzjonijiet fungali), antibijotiċi (erythromycin, clarithromycin) jew St.
John’ s wort (a herbal remedy).
John’ s wort (rimedju erbali).
Smoking should also be stopped as it could decrease the amount of medicine in the blood.
Ara l- Fuljett ta 'Tagħrif għad- dettalji kollha.
Why has Tarceva been approved?
Għaliex ġie approvat Tarceva?
The Committee for Medicinal products for Human Use (CHMP) concluded that Tarceva had shown that it is effective in the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen, although there was not enough justification for, or data on its use in patients whose tumours are EGFR-negative.
Il- Kumitat għall- prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li Tarceva wera li huwa effettiv fit- trattament ta 'pazjenti b' kanċer taċ- ċelloli tal- pulmun mhux żgħir li jkun avvanzat lokalment jew metastatiku wara li għallinqas reġimen wieħed tal- kemjoterapija preċedenti ma jkunx ħadem, għalkemm ma kienx hemm ġustifikazzjoni biżżejjed għal, jew tagħrif fuq l- użu tiegħu f' pazjenti li t- tumuri tagħhom huma EGFR- negattivi.
The committee decided that Tarceva’ s benefits are greater than its risks for these types of cancer, as well as for metastatic cancer of the pancreas.
Il- kumitat iddeċieda li l- benefiċċji ta 'Tarceva huma ikbar mir- riskji tiegħu għal dawk it- tipi ta' kanċer, kif ukoll għal kanċer metastatiku tal- frixa.
For pancreatic cancer, the committee concluded that doctors and patients should take the patient ’ s chances of survival into account when prescribing Tarceva.
Għal kanċer tal- frixa, il- kumitat ikkonkluda li t- tobba u l- pazjenti għandhom iqisu ċ- ċansijiet ta 'sopravivenza tal- pazjent meta jagħtu Tarceva.
The committee recommended that Tarceva be given marketing authorisation.
Il- Kumitat irrakkomanda li Tarceva jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Tarceva:
Tagħrif ieħor dwar Tarceva:
The European Commission granted a marketing authorisation valid throughout the European Union for Tarceva to Roche Registration Limited on 19 September 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Tarceva valida fl- Unjoni Ewropea kollha lil Roche Registration Limited fid- 19 ta 'Settembru 2005.
The full EPAR for Tarceva is available here.
L- EPAR sħiħ għal Tarceva huwa disponibbli minn hawnhekk.
This summary was last updated in 04-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' 04- 2007.
EU/ 1/ 05/ 311/ 001 EU/ 1/ 05/ 311/ 002 EU/ 1/ 05/ 311/ 003
EU/ 1/ 05/ 311/ 001 EU/ 1/ 05/ 311/ 002 EU/ 1/ 05/ 311/ 003
Tarceva Tarceva Tarceva
Tarceva Tarceva Tarceva
25 mg 100 mg 150 mg
25 mg 100 mg 150 mg
Film coated tablets Film coated tablets Film coated tablets
Pilloli miskija b’ rita Pilloli miskija b’ rita Pilloli miskija b’ rita
Blister (PVC/ Alu) Blister (PVC/ Alu) Blister (PVC/ Alu)
Folja (PVC/ Alu) Folja (PVC/ Alu) Folja (PVC/ Alu)
30 tablets 30 tablets 30 tablets
30 pillola 30 pillola 30 pillola
Tarceva 25 mg film-coated tablets
Tarceva 25 mg pilloli miksija b’ rita.
Tarceva 25 mg One film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride).
Tarceva 25 mg Pillola miksija b’ rita li fiha 25 mg erlotinib (bħala erlotinib hydrochloride)
Film-coated tablet White to yellowish, round, biconvex tablets with ‘ Tarceva 25’ and logo printed in brownish yellow on one side.
Pillola miksija b’ rita Pilloli bojod għal safranin, tondi, ibbuzzati fuq iż- żewġ naħat, b ’ ‘ Tarceva 25 ’ u logo stampati bl- isfar kannellin fuq naħa waħda.
Non-small cell lung cancer (NSCLC):
Kanċer tal- pulmun mhux taċ- ċellola żgħira (NSCLC):
Tarceva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Tarceva huwa indikat għall- kura ta ’ pazjenti b’ kanċer tal- pulmun mhux taċ- ċellola żgħira avvanzat lokalment jew li mmetastatizza, wara li falla imqar kors wieħed minn qabel ta ’ kemjoterapija.
When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
Meta jiġi preskritt Tarceva, wieħed irid jikkonsidra l- fatturi assoċjati ma ’ sopravivenza itwal.
No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with EGFR- negative tumours (see section 5.1).
Ma ntweriex benefiċċju ta ’ sopravivenza jew effetti oħra tal- kura relevanti klinikament f’ pazjenti b’ tumur negattivi għal EGFR (ara sezzjoni 5. 1).
Pancreatic cancer:
Kanċer tal- frixa:
Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.
Tarceva flimkien ma ’ gemcitabine huwa indikat għall- kura ta ’ pazjenti b’ kanċer metastatiku tal- frixa.
When prescribing Tarceva, factors associated with prolonged survival should be taken into account (see section 4.2 and 5.1).
Meta jiġi preskritt Tarceva, fatturi assoċjati ma ’ sopravivenza itwal għandhom jiġu kkunsidrati (ara sessjoni 4. 2 u 5. 1).
No survival advantage could be shown for patients with locally advanced disease.
Ma ntwera l- ebda vantaġġ ta ’ sopravivenza għall- pazjenti b’ marda avanzzata lokalment.
Tarceva treatment should be supervised by a physician experienced in the use of anticancer therapies.
Kura b’ Tarceva għandha tiġi sorveljata minn tabib b’ esperjenza fl- użu ta ’ terapiji kontra l- kanċer.
Non-small cell lung cancer:
Kanċer tal- pulmun mhux taċ- ċellola żgħira:
The recommended daily dose of Tarceva is 150 mg taken at least one hour before or two hours after the ingestion of food.
Id- doża rakkomandata ta ’ Tarceva hija ta ’ 150 mg mogħtija ta ’ l- inqas siegħa qabel jew sagħtejn wara l- ikel.
The recommended daily dose of Tarceva is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the summary of product characteristics of gemcitabine for the pancreatic cancer indication).
Id- doża rakkomandata ta ’ Tarceva hija ta ’ 100 mg mogħtija ta ’ l- inqas siegħa qabel jew sagħtejn wara l- ikel, flimkien ma ’ gemcitabine (ara s- sommarju tal- karatteristiċi tal- prodott ta ’ gemcitabine għall - indikazzjoni tal- kanċer tal- frixa).
In patients who do not develop rash within the first 4 – 8 weeks of treatment, further Tarceva treatment should be re-assessed (see section 5.1).
F’ pazjenti li ma jiżvilluppawx raxx fl- ewwel 4 – 8 ġimgħat ta ’ kura, aktar kura b’ Tarceva għandha tiġi assessjata mill- ġdid (ara sessjoni 5. 1).
2 When dose adjustment is necessary, reduce in 50 mg steps (see section 4.4).
2 Meta jkun hemm bżonn aġġustament tad- doża, naqqas bi kwantità ta ’ 50 mg kull darba (ara sezzjoni 4. 4.).
Tarceva is available in strengths of 25 mg, 100 mg and 150 mg.
Tarceva huwa disponibbli bħala pilloli b’ qawwiet ta ’ 25 mg, 100 mg u 150 mg.
Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see section 4.5).
L- użu flimkien ma ’ substrati u modulaturi ta ’ CYP3A4 jista ’ jinħtieġ aġġustament fid- doża (ara sezzjoni 4. 5).
Erlotinib is eliminated by hepatic metabolism and biliary excretion.
Erlotinib jiġi eliminat permezz ta ’ metaboliżmu fil- fwied u eskrezzjoni biljari.
Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7-9) compared with patients with adequate hepatic function, caution should be used when administering Tarceva to patients with hepatic impairment.
Għalkemm esponiment għal erlotinib kien simili f’ pazjenti b’ indeboliment moderat tal- funzjoni tal - fwied (punteġġ Child- Pugh 7- 9) meta mqabbel ma ’ pazjenti b’ funzjoni adegwata tal- fwied, għandha tintuża attenzjoni meta Tarceva jingħata lill- pazjenti b’ indeboliment tal- fwied.
Dose reduction or interruption of Tarceva should be considered if severe adverse reactions occur.
Tnaqqis jew twaqqif tad- doża ta ’ Tarceva għandha tiġi kkunsidrata jekk iseħħu reazzjonijiet avversi severi.
The safety and efficacy of erlotinib has not been studied in patients with severe hepatic impairment.
Is- sigurtà u l - effikaċja ta ’ erlotinib ma kienux studjati f’ pażjenti b’ indeboliment sever tal- fwied.
Use of Tarceva in patients with severe hepatic impairment is not recommended (see section 5.2).
L- użu ta ’ Tarceva f’ pazjenti b’ indeboliment sever tal- fwied mhux rakkomandat (ara sezzjoni 5. 2).
The safety and efficacy of erlotinib has not been studied in patients with renal impairment (serum creatinine concentration > 1.5 times the upper normal limit).
Is- sigurtà u l- effikaċja ta ’ erlotinib ma kienux studjati f’ pazjenti bi problemi tal - kliewi (konċentrazzjoni tal- krejatinina fis- serum > 1. 5 drabi l- għola livell normali).
Based on pharmacokinetic data no dose adjustments appear necessary in patients with mild or moderate renal impairment (see section 5.2).
Skond data farmakokinetika, ma jidhirx li hemm bżonn ta ’ aġġustament fid- doża f’ pazjenti b’ indeboliment ħafif għal moderat renali (ara sezzjoni 5. 2).
Use of Tarceva in patients with severe renal impairment is not recommended.
L- użu ta ’ Tarceva f’ pazjenti b ’ indeboliment sever renali mhux rakkomandat.
Paediatric use:
Użu fit- tfal:
The safety and efficacy of erlotinib has not been studied in patients under the age of 18 years.
Is- sigurtà u l- effikaċja ta ’ erlotinib ma kienux studjati f’ pazjenti taħt l- età ta ’ 18- il sena.
Use of Tarceva in paediatric patients is not recommended.
L- użu ta ’ Tarceva f’ pażjenti tfal mhux rakkomandat.
Smokers:
Dawk li jpejpu:
Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%.
It- tipjip ta ’ sigaretti ntwera li jnaqqas l- espożizzjoni għal erlotinib b’ 50- 60%.
The maximum tolerated dose of Tarceva in NSCLC patients who currently smoke cigarettes was 300 mg.
Id- doża massima ttollerata ta ’ Tarceva f’ pazjenti b’ NSCLC li jpejpu s- sigaretti kienet 300 mg.
Efficacy and long term safety of a dose higher than the recommended starting doses have not been established in patients who continue to smoke cigarettes (see sections 4.5 and 5.2).
L- effikaċja u s - sigurtà fit- tul ta ’ doża ogħla mid- dożi rrakkomandati tal- bidu ma kienux stabbiliti f’ pazjenti li jkomplu jpejpu s- sigaretti (ara sezzjonijiet 4. 5 u 5. 2).
Therefore, current smokers should be advised to stop smoking, as plasma concentrations of erlotinib in smokers as compared to non-smokers are reduced.
Għalhekk dawk li bħalissa qed ipejpu għandhom jiġu rrakkomandati biex jieqfu mit- tipjip, peress li l- konċentrazzjonijiet ta ’ erlotinib fil- plażma f’ dawk li jpejpu huma mnaqqsa meta mqabbla ma ’ dawk li ma jpejpux.
Severe hypersensitivity to erlotinib or to any of the excipients.
Sensittività eċċessiva qawwija għal erlotinib jew għal xi sustanzi mhux attivi.
Potent inducers of CYP3A4 may reduce the efficacy of erlotinib whereas potent inhibitors of CYP3A4 may lead to increased toxicity.
Indutturi qawwija ta ’ CYP3A4 jistgħu jnaqqsu l- effikaċja ta ’ erlotinib filwaqt li inibituri qawwija ta ’ CYP3A4 jistġħu jwasslu għal tossiċità miżjuda.
Concomitant treatment with these types of agents should be avoided (see section 4.5).
Kura flimkien ma ’ dawn it- tipi ta ’ aġenti trid tiġi evitata (ara sezzjoni 4. 5).
Current smokers should be advised to stop smoking, as plasma concentrations of erlotinib in smokers as compared to non-smokers are reduced.
Pażjenti li bħalissa jpejpu għandhom jiġu avżati sabiex jiefqu jpejpu, minħabba li l- konċetrazzjonijiet fil- plażma ta ’ erlotinib f’ pazjenti li jpejpu huma mnaqqsa meta mqabbla ma ’ dawk li ma jpejpux.
The degree of reduction is likely to be clinically significant (see section 4.5).
L - ammont ta ’ tnaqqis huwa probabbli li jkun klinikament sinnifikanti (ara sezzjoni 4. 5).
Cases of interstitial lung disease (ILD)-like events, including fatalities, have been reported uncommonly in patients receiving Tarceva for treatment of non-small cell lung cancer (NSCLC), pancreatic cancer or other advanced solid tumours.
Każijiet ta ’ episodji li jixbħu lill- marda interstizjali tal- pulmun (ILD), inkluż imwiet, ġew irrapurtati b’ mod mhux komuni f’ pazjenti li qed jingħataw Tarceva għall- kura ta ’ kanċer tal- pulmun mhux taċ - ċellola żgħira (NSCLC), kanċer tal- frixa jew tumuri solidi avvanzati oħra.
In the pivotal study BR.21 in NSCLC, the incidence of ILD (0.8%) was the same in both the placebo and Tarceva groups.
Fl- istudju kruċjali BR. 21 f’ NSCLC, l- inċidenża ta ’ ILD (0. 8%) kien l- istess kemm fil- ġrupp plaċebo kif ukoll dak ta ’ Tarceva.
In the pancreatic cancer study in combination with gemcitabine, the incidence of ILD-like events was 2.5% in the Tarceva plus gemcitabine group versus 0.4% in the placebo plus gemcitabine treated group.
Fl- istudju tal- kanċer tal- frixa flimkien ma ’ gemcitabine, l- inċidenza ta ’ episodji jixbħu lil ILD kienet ta ’ 2. 5% fil- grupp Tarceva flimkien ma ’ gemcitabine meta mqabbla ma ’ 0. 4% fil- grupp ikkurat bil - plaċebo flimkien ma ’ gemcitabine.
The overall incidence in Tarceva-treated patients from all studies (including uncontrolled studies and studies with concurrent chemotherapy) is approximately 0.6% compared to 0.2% in patients on placebo.
L- inċidenża totali f’ pazjenti kkurati b’ Tarceva mill- istudji kollha (inkluż studji mhux kontrollati u studji b’ kemjoterapija fl- istess ħin) hija ta ’ madwar 0. 6% meta mqabbel ma ’ 0. 2% f’ pazjenti fuq il- plaċebo.
Reported diagnoses in patients suspected of having ILD-like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome (ARDS), alveolitis, and lung infiltration.
Dijanjosi rrappurtati f’ pazjenti ssuspettati li għandhom episodji jixbħu lil ILD jinkudu pulmonite, pulmonite tar- radjazzjoni, pulmonite ta ’ l- ipersensittività, pulmonite ta ’ l- interstizju, mard tal- interstizju tal- pulmun, bronkolité obliterattiva, fibrosi pulmonari, Sindromu ta ’ Diffikultà Respiratorja Akuta (ARDS), alveolite u nfiltrazzjoni fil- pulmun.
Symptoms started from a few days to several months after initiating Tarceva therapy.
Is- sintomi bdew minn ftit ġranet sa diversi xhur wara li nbdiet il- kura b’ Tarceva.
Confounding or contributing factors such as concomitant or prior chemotherapy, prior radiotherapy, pre-existing parenchymal lung disease, metastatic lung disease, or pulmonary infections were frequent.
Fatturi li jikkonfondu jew jikkontribixxu bħal kemjoterapija fl- istess ħin jew minn qabel, radjuterapija minn qabel, mard tal -
3 In patients who develop acute onset of new and/ or progressive unexplained pulmonary symptoms such as dyspnoea, cough and fever, Tarceva therapy should be interrupted pending diagnostic evaluation.
3 parenkima tal- pulmun ġà eżistenti, mard metastatiku tal- pulmun, jew infezzjonijiet tal- pulmon, kienu frekwenti.
Patients treated concurrently with erlotinib and gemcitabine should be monitored carefully for the possibility to develop ILD-like toxicity.
Pazjenti kkurati fl- istess waqt b’ erlotinib u gemcitabine għandhom jiġu sorveljati b’ attenzjoni għall- possibilità li jiżvilluppaw tossiċità tixbaħ lil ILD.
If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment initiated as necessary (see section 4.8).
Jekk ILD hija ddijanjostikata, Tarceva għandu jitwaqqaf u kura xierqa tinbeda skond il- bżonn (ara sezzjoni 4. 8).
Diarrhoea has occurred in approximately 50% of patients on Tarceva and moderate or severe diarrhoea should be treated with e. g. loperamide.
Dijarea seħħet f’ madwar 50% tal- pazjenti fuq Tarceva u dijarea moderata jew qawwija għandha tiġi kkurata b ’ e. ż. loperamide.
In some cases dose reduction may be necessary.
F’ ċertu każijiet jista ’ jkun neċessarju li d- doża titnaqqas.
In the clinical studies doses were reduced by 50 mg steps.
Fi studji kliniċi id- doża kienet imnaqqsa bi kwantitajiet ta ’ 50 mg.
Dose reductions by 25 mg steps have not been investigated.
Tnaqqis tad- doża bi kwantitajiet ta ’ 25 mg ma ġewx investigati.