qanastek/EMEA-V3 huggingface dataset:
Individual CL/ F in the paediatric population was in the same range as individual adult data.
Analiżi farmakokinetika ta’ popolazzjoni li kienet tinkludi 96 pazjent pedjatriku li l- eta ’ tagħhom kienet bejn l- 10 u t- 18- il sena u li kienu jiżnu bejn il- 35 u l- 178 kg implikat medja tixtiebaħ ta ’ CL/ F bejn it- tfal u l- adulti.
CL/ F seemed to be independent of age, but increased with weight in the paediatric population.
CL/ F dehret li donnha kienet indipendenti mill- eta ’ iżda żdiedet mal- piż fil- popolazzjoni pedjatrika.
5.3 Preclinical safety data
11 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
Adverse effects observed in animal studies with possible relevance to clinical use were as follows:
Effetti mhux mixtieqa osservati fi studji fuq annimali b’ relevanza possibbli għal użu kliniku huma kif ġej:
11 In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
F’ mudell ta ’ annimal ittestjat għal polipożi familjali adenomatuża (FAP), il- kura b’ rosiglitazone b’ doża 200 iktar mid- doża farmakoloġikament attiva żiedet il- multipliċità ta ’ tumur fil- kolon.
Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.
Sodium starch glycollate (Type A) hypromellose microcrystalline cellulose lactose monohydrate magnesium stearate.
Film coating (Opadry pink OY-L-24802):
Rita tal- kisja (Opadry pink OY- L- 24802):
6.2 Incompatibilities
Hypromellose 6cP Titanium dioxide E171 Macrogol 3000 Lactose monohydrate Glycerol triacaetate Iron oxide red E172.
2 years.
6. 2 Inkompatibbilitajiet
6.5 Nature and contents of container
12 6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
Opaque blister packs (PVC/ aluminium).
Pakketti b’ folji blister opaki (PVC / aluminju).
56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets, unit dose pack.
56, 112, 168 jew 180 pilloli miksijin b’ rita jew 56 pillola miksijin b’ rita, pakkett ta ’ dożi individwali
Any unused product should be disposed of in accordance with local requirements.
L- ebda ħtiġijiet speċjali.
11 July 2000 Date of latest renewal:
11 ta ’ Lulju 2000 Data ta ’ l- aħħar tiġdid:
11 July 2005
11 ta ’ Lulju 2005
AVANDIA 4 mg film-coated tablets.
AVANDIA 4 mg pilloli miksijin b’ rita.
Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone.
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 4mg ta ’ rosiglitazone.
Excipient Contains lactose (approximately 105 mg).
Sustanza mhux attiva, Fih lattosju (bejn wieħed u ieħor 105 mg)
Orange film-coated tablets debossed with “ GSK” on one side and "4" on the other side.
Pilloli oranġjo miksija b’ rita li għandhom il- marka “ GSK ” imħaffra fuq naħa waħda u “ 2 ” fuq in- naħa l- oħra.
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:
Rosiglitazone hu indikat fit- trattament tad- dialbete mellitus tat- tip 2:
Rosiglitazone may be given once or twice a day.
14 Rosiglitazone jista ’ jingħata darba jew darbtejn kuljum.
14 Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly.
Anzjani (ara sezzjoni 4. 4 Retenzjoni ta ’ fluwidu u insuffiċjenza tal- qalb) Ma huwa meħtieġ l- ebda aġġustament tad- doża għall- anzjani.
− hepatic impairment
− indeboliment epatiku
Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure.
Insufficjenza tal- qalb kienet irrapuratata ukoll b’ mod aktar frekwenti f’ pazjenti bi storja ta ’ insuffiċjenza tal- qalb; edima u insuffiċjenza tal- qalb kienu rrapurtati wkoll b’ mod aktar frekwenti fl - anzjani, u f’ pazjenti b’ indeboliment ħafif jew moderat tal- kliewi.
Since NSAIDs and rosiglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
15 rosiglitazone huma assoċjati mar- ritenzjoni tal- fluwidu, it- teħid flimkien ta’ dawn jista ’ jżid ir- riskju ta ’ edima.
15 Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).
Iskemja Mijokardijaka L- informazzjoni disponibbli turi li kura b’ rosiglitazone tista ’ tkun assoċjata ma 'riskju akbar ta ’ eventi iskemiċi mijokardijiċi (ara sezzjoni 4. 8).
Anaemia Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
16 Anemija Waqt il- kura b’ rosiglitazone jista ’ jkun hemm tnaqqis fil- livell ta ’ l- emoglobina relatat mad- doża.
Hypoglycaemia Patients receiving rosiglitazone in combination therapy with a sulphonylurea or with insulin, may be at risk for dose-related hypoglycaemia.
Ipogliċemija Pazjenti li qed jirċievu rosiglitazone f’ terapija flimkien ma sulphonylurea jew ma ’ l- insulina jista ’ jkollhom ir- riskju ta ’ ipogliċemija relatata mad- doża.
16 Bone disorders In a long-term study an increased incidence of bone fractures (foot, hand and arm) was observed in female patients taking rosiglitazone as monotherapy (see section 4.8).
Mard ta ’ l- għadam Fi studju fit- tul ġiet osservata inċidenza akbar ta ’ ksur fl- għadam (fis- saqajn, fl- idejn u fid- dirgħajn) f’ pazjenti nisa li jkunu qed jieħdu rosiglitazone bħala monoterapija (ara sezzjoni 4. 8).
Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Għalkemm studji qabel l- użu kliniku wrew xi żbilanċi ormonali (ara s- sezzjoni 5. 3), ma ġew innotati l- ebda effetti mhux mixtieqa sinfikanti assoċjati ma ’ problemi mestruwali.
It cannot be excluded that other inducers (e. g. phenytoin, carbamazepine, phenobarbital, St John’ s wort) may also affect rosiglitazone exposure.
17 phenytoin, carbamazepine, phenobarbital, St John’ s wort) jistgħu wkoll ikollhom effett fuq l - esponiment għal rosiglitazone.
17 shown reproductive toxicity (see section 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva (ara s- sezzjoni 5. 3).
The incidence of heart failure on triple oral therapy was 1.4% in the main double blind study, compared to 0.4% for metformin plus 19 sulphonylurea dual therapy.
L- inċidenza ta ’ insuffiċjenza tal- qalb f’ terapija orali trippla kienet ta ’ 1. 4% fl- istudju double blind prinċipali, meta mqabbla ma ’ 0. 4% għal terapija doppja b’ metformin u sulphonylurea.
The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
L- inċidenza ta ’ insuffiċjenza tal- qalb f’ kombinazzjoni 19 ma ’ l- insulina (rosiglitazone miżjud ma ’ terapija b’ insulina stabbilita) kienet ta ’ 2. 4%, meta mqabbla ma ’ insulina waħedha, 1. 1%.
Three large long-term prospective randomised controlled clinical trials (mean duration 41 months; 14,067 patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk.
Tlett studji kliniċi kbar fuq tul ta ’ żmien twil, prospettivi, randomised u kontrollati (tul ta 'żmien medja ta ’ 41 xahar; 14, 067 pazjenti), li qabblu rosiglitazone ma ’ xi aġenti orali anti- dijabetiċi attivi jew plaċebo, ma kkonfermawx jew eskludew dan ir- riskju.
In their entirety, the available data on the risk of myocardial ischaemia are inconclusive.
Matulhom kollha, l- informazzjoni disponibbli fuq ir- riskju ta ’ iskemja mijokardijaka m’ hijiex konklussiva.
Rare cases of elevated liver enzymes and hepatocellular dysfunction cases a fatal outcome has been reported.
Każi rari ta ’ żjieda fl- enżimi tal- fwied u ħsara fil- funzjoni taċ- ċelloli tal- fwied kienu rappurtati.
In very rare
F’ każi rari ħafna kienu rrappurtati ukoll mwiet.
Rosiglitazone did not stimulate pancreatic insulin secretion or induce hypoglycaemia in rats and mice.
Rosiglitazone la stimola tnixxija ta ’ l- insulina mill- frixa u lanqas
The major metabolite (para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mouse.
Il- prodott ewlieni tal- metaboliżmu (sustanza tat- tip para - hydroxy- sulphate) b’ affinità għolja għas- sustanza umana PPARγ solubbli, wera qawwa relattivament għolja f’ analiżi dwar it- tolleranza għall- glukożju fi ġrieden smien.
21 Clinical trials data The glucose lowering effects observed with rosiglitazone are gradual in onset with near maximal reductions in fasting plasma glucose (FPG) evident following approximately 8 weeks of therapy.
Provi kliniċi l- effetti ta ’ tnaqqis fil- glukożju osservati b’ rosiglitazone huma gradwali fil- bidu b’ evidenza ta ’ riduzzjoni kważi massima fil- livell ta’ glukożju fil- plażma meta l- pazjent ikun sajjem (FPG), wara bejn wieħed u ieħor tmien ġimgħat ta ’ terapija.
Distribution The volume of distribution of rosiglitazone is approximately 14 litres in healthy volunteers.
22 Distribuzzjoni Il- volum tad- distribuzzjoni ta ’ rosiglitazone huwa madwar 14- il litru fil- voluntiera b’ saħħithom.
Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
L - irbit ta ’ rosiglitazone mal- proteini tal- plażma huwa għoli (madwar 99. 8%) u mhuwiex influwenzat mill- konċentrazzjoni jew mill- età.
22 sulphate and glucuronic acid.
Ir- rotot ewlenin ta ’ metaboliżmu huma N- demethylation u hydroxylation, segwiti permezz ta ’ konjugazzjoni bis- sulphate u glucuronic acid.
The contribution of the major metabolite (para-hydroxy-sulphate) to the overall anti-diabetic activity of rosiglitazone has not been fully elucidated in man and it cannot be ruled out that the metabolite may contribute to the activity.
Il- kontribut tal- prodott ewlieni tal- metaboliżmu (para - hydroxy- sulphate) fuq l- attività anti- ipergliċemika ġenerali ta ’ rosiglitazone għadu ma ġiex iċċarat għal kollox fil- bniedem u wieħed ma jistax jeskludi li l- prodott tal- metaboliżmu jista ’ jikkontribwixxi għal din l- attività.
Renal insufficiency:
23 Insuffiċjenza tal- kliewi:
23 In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
F’ mudell ta ’ annimal ittestjat għal polipożi familjali adenomatuża (FAP), il- kura b’ rosiglitazone b’ doża 200 iktar mid- doża farmakoloġikament attiva żiedet il- multipliċità ta ’ tumur fil- kolon.
Film coating (Opadry orange OY-L-23028):
Rita tal- kisja (Opadry oranġjo OY- L- 23028):
Hypromellose 6cP Titanium dioxide E171 Macrogol 3000 Purified talc Lactose monohydrate Glycerol triacetate Iron oxide red E172 Iron oxide yellow E172.
Hypromellose 6cP Titanium dioxide E171 Macrogol 3000 Purified talc Lactose monohydrate Glycerol triacaetate Iron oxide red E172 Iron oxide yellow E172.
Opaque blister packs (PVC/ aluminium).
Pakketti b’ folji blister opaki (PVC/ aluminju).
7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets, unit dose pack.
7, 28, 56, 84, 90 jew 112 pilloli miksijin b’ rita jew 56 pillola miksijin b’ rita, pakkett ta’ dożi individwali
AVANDIA 8 mg film-coated tablets.
AVANDIA 8 mg pilloli miksijin b’ rita.
Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone.
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 8 mg ta ’ rosiglitazone.
Excipient Contains lactose (approximately 209 mg).
Sustanza mhux attiva, Fih lattosju (bejn wieħed u ieħor 209 mg)
Red-brown film-coated tablets debossed with “ GSK” on one side and "8" on the other side.
Pilloli roża miksija b’ rita li għandhom il- marka “ GSK ” imħaffra fuq naħa waħda u “ 8 ” fuq in- naħa l - oħra.
Rosiglitazone may be given once or twice a day.
26 Rosiglitazone jista ’ jingħata darba jew darbtejn kuljum.
26 Elderly (see section 4.4 Fluid retention and cardiac failure) No dose adjustment is required in the elderly.
Anzjani (ara sezzjoni 4. 4 Retenzjoni ta ’ fluwidu u insuffiċjenza tal- qalb) Ma huwa meħtieġ l- ebda aġġustament tad- doża għall- anzjani.
Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Pazjenti ta 'fuq il- 75 sena għandhom jiġu trattati b’ kawtela minħabba l- esperjenza limitata f’ dan il- grupp ta ’ pazjenti.
Since NSAIDs and rosiglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
Billi l- NSAIDs u r - rosiglitazone huma assoċjati mar- ritenzjoni tal- fluwidu, it- teħid flimkien ta’ dawn jista ’ jżid ir- riskju ta ’ edima.
Combination with insulin An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
27 Għoti flimkien ma ’ l- insulina Inċidenza ogħla ta ’ insuffiċjenza tal- qalb ġiet osservata fi provi kliniċi meta rosiglitazone jintuża flimkien ma ’ l- insulina.
27 Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).
Iskemja Mijokardijaka L- informazzjoni disponibbli turi li kura b’ rosiglitazone tista ’ tkun assoċjata ma 'riskju akbar ta ’ eventi iskemiċi mijokardijaċi (ara sezzjoni 4. 8).
There are limited clinical trial data in patients with ischaemic heart disease and/ or peripheral arterial disease.
Hemm informazzjoni limitata minn studji kliniċi f’ pazjenti b’ mard iskemiku mijokardijaku u/ jew mard ta ’ l- arterji ta ’ l- idejn u s- saqajn.
Hypoglycaemia Patients receiving rosiglitazone in combination therapy with a sulphonylurea or with insulin, may be at risk for dose-related hypoglycaemia.
28 Ipogliċemija Pazjenti li qed jirċievu rosiglitazone f’ terapija flimkien ma sulphonylurea jew ma ’ l- insulina jista ’ jkollhom ir- riskju ta ’ ipogliċemija relatata mad- doża.
28 Bone disorders In a long-term study an increased incidence of bone fractures (foot, hand and arm) was observed in female patients taking rosiglitazone as monotherapy (see section 4.8).
Mard ta ’ l- għadam Fi studju fit- tul ġiet osservata inċidenza akbar ta ’ ksur fl- għadam (fis- saqajn, fl- idejn u fid- dirgħajn) f’ pazjenti nisa li jkunu qed jieħdu rosiglitazone bħala monoterapija (ara sezzjoni 4. 8).
Concomitant administration with the oral anti-diabetic agents metformin, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions with rosiglitazone.
29 Meta rosiglitazone ġie mogħti flimkien ma ’ l- aġenti anti- diabetiċi orali metformin, glibenclamide u acarbose ma ’ rriżultax li kien hemm xi interazzjonijiet farmakokinetiċi klinikament relevanti.
29 shown reproductive toxicity (see section 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva (ara s- sezzjoni 5. 3).
The incidence of heart failure on triple oral therapy was 1.4% in the main double blind study, compared to 0.4% for metformin plus 31 sulphonylurea dual therapy.
L- inċidenza ta ’ insuffiċjenza tal- qalb f’ terapija orali trippla kienet ta ’ 1. 4% fl- istudju double blind prinċipali, meta mqabbla ma ’ 0. 4% għal terapija doppja b’ metformin u sulphonylurea.
The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
L- inċidenza ta ’ insuffiċjenza tal- qalb f’ kombinazzjoni 31 ma ’ l- insulina (rosiglitazone miżjud ma ’ terapija b’ insulina stabbilita) kienet ta ’ 2. 4%, meta mqabbla ma ’ insulina waħedha, 1. 1%.
Three large long-term prospective randomised controlled clinical trials (mean duration 41 months; 14,067 patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk.
Fi studju estensiv ta ’ osservazzjoni li fih pazjenti kienu magħżulin tajjeb f’ linja ta ’ bażi, l- inċidenza ta ’ infart mijokardijaku endpoint b’ mod kompost u rivaskularizzazzjoni koronarja kienet ta ’ 17. 46 każi għal kull 1000 sena ħajja ta ’ persuna b’ terapija li fiha rosiglitazone u 17. 57 każi għal kull 1000 sena ħajja ta ’ persuna fil- każ ta ’ aġenti oħra anti- dijabetiċi [Hazard ratio 0. 93 (95% confidence interval 0. 80 – 1. 10)] Tlett studji kliniċi kbar fuq tul ta ’ żmien twil, prospettivi, randomised u kontrollati (tul ta 'żmien medja ta ’ 41 xahar; 14, 067 pazjenti), li qabblu rosiglitazone ma ’ xi aġenti orali anti- dijabetiċi attivi jew plaċebo, ma kkonfermawx jew eskludew dan ir- riskju.
33 Clinical trials data The glucose lowering effects observed with rosiglitazone are gradual in onset with near maximal reductions in fasting plasma glucose (FPG) evident following approximately 8 weeks of therapy.
Provi kliniċi l- effetti ta ’ tnaqqis fil- glukożju osservati b’ rosiglitazone huma gradwali fil- bidu b’ evidenza ta ’ riduzzjoni kważi massima fil- livell ta’ glukożju fil- plażma meta l- pazjent ikun sajjem (FPG), wara bejn wieħed u ieħor tmien ġimgħat ta ’ terapija.
Distribution The volume of distribution of rosiglitazone is approximately 14 litres in healthy volunteers.
34 Distribuzzjoni Il- volum tad- distribuzzjoni ta ’ rosiglitazone huwa madwar 14- il litru fil- voluntiera b’ saħħithom.
The contribution of the major metabolite (para-hydroxy-sulphate) to the overall anti-diabetic activity of rosiglitazone has not been fully elucidated in man and it cannot be
Il- kontribut tal- prodott ewlieni tal- metaboliżmu (para - hydroxy- sulphate) fuq l- attività anti- ipergliċemika ġenerali ta ’ rosiglitazone għadu ma ġiex iċċarat għal kollox fil- bniedem u wieħed ma jistax jeskludi li l- prodott tal- metaboliżmu jista ’ jikkontribwixxi għal din l- attività.
Renal insufficiency:
35 Insuffiċjenza tal- kliewi:
In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200
F’ mudell ta ’ annimal ittestjat għal polipożi familjali adenomatuża (FAP), il- kura b’ rosiglitazone b’ doża 200 iktar mid- doża farmakoloġikament attiva żiedet il- multipliċità ta ’ tumur fil- kolon.
Film coating (Opadry pink OY-L-24803):
Rita tal- kisja (Opadry pink OY- L- 24803):
Hypromellose 6cP Titanium dioxide E171 Macrogol 3000 Lactose monohydrate Glycerol triacetate Iron oxide red E172.
Hypromellose 6cP Titanium dioxide E171 Macrogol 3000 Lactose monohydrate Glycerol triacaetate Iron oxide red E172.
6.4 Special precautions for storage
36 6. 4 Prekawzjonijiet speċjali għall- ħażna
7, 28, 84, 90 or 112 film-coated tablets.
7, 28, 84, 90 jew 112 pilloli miksijin b’ rita.
Detailed information on this medicinal product is available on the website of the European Medicines Agency(EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: www. emea. europa. eu
Du Terras 53100 Mayenne France
Du terras 53100 Mayenne Franza
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spain
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spanja
Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit one additional 6 month Periodic Safety Update Report (PSUR) and thereafter yearly PSURs unless otherwise decided by the CHMP.
Wara t- tiġdid ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, d- Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq se jissottometti Rapport Perjodiku Aġġornat ta’ Sigurtà (Periodic Safety Update Report PSUR) addizjonali ta ’ sitt xhur u minn dak in- nhar Rapport Perjodiku Aġġornat ta ’ Sigurtà kull sena sakemm ma jiġix deċiz mod ieħor mis- CHMP
The Marketing Authorisation Holder commits to performing the pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jintrabat li jwettaq l- attivitajiet ta ’ Farmakoviġilanza kif dettaljat fil- Pjan ta ’ Farmakoviġilanza.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Pjan ta ’ l- Immaniġġjar tar- Riskju aġġornat għandu jiġi pprovdut skond il- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar - Riskju għall- prodotti mediċinali għall- użu uman
AVANDIA 2 mg film-coated tablets rosiglitazone
AVANDIA 2 mg pilloli miksijin b’ rita Rosiglitazone
Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 2 mg rosiglitazone
Contains lactose, see leaflet for further information
Fih il- lattożju, ara l- fuljett għal- aktar informazzjoni
56 film-coated tablets 112 film-coated tablets 168 film-coated tablets 180 film-coated tablets 56 film-coated tablets, unit dose pack
56 pillola miksijin b’ rita 112 pillola miksijin b’ rita 168 pillola miksijin b’ rita 180 pillola miksijin b’ rita 56 pillola miksijin b’ rita, pakkett b’ dożi individwali
For oral use Read the package leaflet before use Use only as directed by your doctor
Jittieħed mill- ħalq Aqra l- fuljett ta’ taghrif qabel l- użu Uża biss kif preskritt mit- tabib tiegħek
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
EU/ 1/ 00/ 137/ 002 EU/ 1/ 00/ 137/ 003 EU/ 1/ 00/ 137/ 013 EU/ 1/ 00/ 137/ 016 EU/ 1/ 00/ 137/ 004
EU/ 1/ 00/ 137/ 002 56 pillola EU/ 1/ 00/ 137/ 003 112 pillola EU/ 1/ 00/ 137/ 013 168 pillola EU/ 1/ 00/ 137/ 016 180 pillola EU/ 1/ 00/ 137/ 004 56 pillola f’ pakkett b’ dożi individwali
Medicinal product subject to medical prescription.
Prodott mediċinali li jingħata b’ riċetta tat- tabib.
INFORMATION IN BRAILLE
INFORMAZZJON BIL- BRAILLE
AVANDIA 2 mg tablets rosiglitazone
AVANDIA 2 mg pilloli rosiglitazone
AVANDIA 4 mg film-coated tablets rosiglitazone
AVANDIA 4 mg pilloli miksijin b’ rita Rosiglitazone
Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 4 mg rosiglitazone
7 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 112 film-coated tablets 56 film-coated tablets, unit dose pack
7 pilloli miksijin b’ rita 28 pillola miksijin b’ rita 56 pillola miksijin b’ rita 84 pillola miksijin b’ rita 90 pillola miksijin b’ rita 112 pillola miksijin b’ rita 56 pillola miksijin b’ rita, pakkett b’ dożi individwali
EU/ 1/ 00/ 137/ 005 EU/ 1/ 00/ 137/ 006 EU/ 1/ 00/ 137/ 007 EU/ 1/ 00/ 137/ 014 EU/ 1/ 00/ 137/ 017 EU/ 1/ 00/ 137/ 008 EU/ 1/ 00/ 137/ 009
EU/ 1/ 00/ 137/ 005 7 pilloli miksijin b’ rita EU/ 1/ 00/ 137/ 006 28 pillola miksijin b’ rita EU/ 1/ 00/ 137/ 007 56 pillola miksijin b’ rita EU/ 1/ 00/ 137/ 014 84 pillola miksijin b’ rita EU/ 1/ 00/ 137/ 017 90 pillola miksijin b’ rita EU/ 1/ 00/ 137/ 008 112 pillola miksijin b’ rita EU/ 1/ 00/ 137/ 009 56 pillola miksijin b’ rita, pakkett b’ dożi individwali
AVANDIA 4 mg tablets rosiglitazone
AVANDIA 4 mg pilloli rosiglitazone
AVANDIA 8 mg film-coated tablets rosiglitazone
AVANDIA 8mg pilloli miksijin b’ rita rosiglitazone
Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 8 mg rosiglitazone
7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 90 film-coated tablets 112 film-coated tablets
7 pilloli miksijin b’ rita 28 pillola miksijin b’ rita 84 pillola miksijin b’ rita 90 pillola miksijin b’ rita 112 pillola miksijin b’ rita
EU/ 1/ 00/ 137/ 010 EU/ 1/ 00/ 137/ 011 EU/ 1/ 00/ 137/ 015 EU/ 1/ 00/ 137/ 018 EU/ 1/ 00/ 137/ 012
EU/ 1/ 00/ 137/ 010 7 pilloli miksijin b’ rita EU/ 1/ 00/ 137/ 011 28 pillola miksijin b’ rita EU/ 1/ 00/ 137/ 015 84 pillola miksijin b’ rita EU/ 1/ 00/ 137/ 018 90 pillola miksijin b’ rita EU/ 1/ 00/ 137/ 012 112 pillola miksijin b’ rita
AVANDIA 8 mg tablets rosiglitazone
AVANDIA 8 mg pilloli rosiglitazone
INFORMATION FOR THE USER
51 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
AVANDIA 2 mg film-coated tablets AVANDIA 4 mg film-coated tablets AVANDIA 8 mg film-coated tablets rosiglitazone
AVANDIA 2mg pilloli miksijin b’ rita AVANDIA 4mg pilloli miksijin b’ rita AVANDIA 8mg pilloli miksijin b’ rita rosiglitazone
- If any of the side effects gets serious, or if you notice any side effects not listed in this
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek. − Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmija f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Avandia is and what it is used for 2.
X’ inhu Avandia u għalxiex jintuża 2.
Before you take Avandia 3.
Qabel ma tieħu Avandia 3.
How to take Avandia 4.
Kif għandek tieħu Avandia 4.
Possible side effects 5 How to store Avandia 6.
Kif taħżen Avandia 6.
WHAT AVANDIA IS AND WHAT IT IS USED FOR
X’ INHU AVANDIA U GĦALXIEX JINTUŻA
Avandia is used to treat type 2 diabetes.
Avandia jintuża biex jikkura dijabete tat- tip 2.
Avandia helps to reduce your blood sugar towards a normal level, by helping your body make better use of the insulin it produces.
Avandia jgħin biex inaqqas iz- zokkor fid- demm tiegħek għal livell normali billi jgħin lil ġismek jagħmel użu aħjar mill- insulina li jipproduċi.
Avandia can be used alone or in combination with other medicines to treat diabetes (such as metformin or a sulphonylurea).
Avandia jista ’ jintuża waħdu jew flimkien ma ’ mediċini oħra għad- dijabete (bħal metformin jew sulphonylurea).
BEFORE YOU TAKE AVANDIA
QABEL MA TIEĦU AVANDIA
To help manage your diabetes, it is important that you follow any diet and lifestyle advice from your doctor as well as taking Avandia.
Biex tgħin fl- imaniġġjar tad- dijabete tiegħek, huwa mportanti li ssegwi kull parir ta ’ dieta jew stil ta 'ħajja mingħand it- tabib tiegħek kif ukoll tieħu Avandia.
Don’ t take Avandia: • if you are allergic (hypersensitive) to rosiglitazone or any of the other ingredients of Avandia (listed in Section 6) • if you have had a heart attack or severe angina, that’ s being treated in hospital • if you have heart failure, or have had heart failure in the past • if you have liver disease • if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting) Check with your doctor if you think any of these apply to you.
ingredjenti l- oħra ta ’ Avandia (imniżżlin f’ Sezzjoni 6)
Don’ t take Avandia.
- jekk għandek mard tal- fwied
Take special care with Avandia
dardir jew rimettar)
Avandia is not recommended for people aged under 18, as the effectiveness in children has not been shown.
Tieħux Avandia.
52 If you have been diagnosed with angina (chest pain), or peripheral arterial disease (reduced blood flow to the legs):
52 Oqgħod attent ħafna b’ AVANDIA
Check with your doctor, as Avandia may not be suitable for you.
Iċċekkja mat- tabib tiegħek, għax Avandia jista ’ ma jkunx jgħodd għalik.
Conditions to look out for Avandia and other medicines for diabetes can make some existing conditions worse, or cause serious side effects.
Kundizzjonijiet li għandek toqgħod attent għalihom Avandia u mediċini oħra għad- dijabete jistgħu iġagħlu xi kondizzjonijiet eżistenti imorru għall- agħar, jew jikkawżaw effetti mhux mixtieqa serji.
You must look out for certain symptoms while you are taking Avandia, to reduce the risk of any problems.
Għandek toqgħod attent għal ċerti sintomi waqt li tkun qed tieħu Avandia, biex tnaqqas ir- riskju ta ’ xi problemi.
Ovulation may restart Women who are infertile due to a condition affecting their ovaries (such as Polycystic Ovarian Syndrome), may start ovulating again when they start taking Avandia.
Tista ’ terġa ’ tibda l- ovulazzjoni Nisa li huma infertili minħabba xi kundizzjoni li taffettwa l- ovarji tagħhom (bħal Sindromu Poliċestiku ta ’ l- Ovarji), jistgħu jerġgħu jibdew jovulaw meta jibdew jieħdu Avandia.
If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy (see ‘ Pregnancy and breast-feeding’ later in Section 2).
Jekk dan japplika għalik, uża kontraċezzjoni adattata biex tevita l- possibilita ’ ta ’ tqala mhux pjanata (ara ‘ Waqt li qed tieħu Avandia it- tabib tiegħek għandu bżonn ikun jaf ’ aktar ‘ il quddiem f’ Sezzjoni 2)
Certain medicines are especially likely to affect the amount of sugar in your blood: • gemfibrozil (used to lower cholesterol) • rifampicin (used to treat tuberculosis and other infections) Tell a doctor or pharmacist if you are taking any of these.
Ċerti mediċini għandhom speċjalment aktar possibilita ’ li jaffettwaw l- ammont ta ’ zokkor fid- demm tiegħek: • gemfibrozil (li jintuża biex ibaxxu l- kolesterol) • rifampicin (li jintuża jikkura t- tuberkulożi u nfezzjonijiet oħra) Għid lit- tabib jew lill- ispiżjar jekk tkun qed tieħu xi wieħed minn dawn.
Your blood sugar will be checked, and your dose of Avandia may need to be changed.
Ikun iċċekkjat il - livell ta ’ zokkor fid- demm tiegħek u d- doża tiegħek ta ’ Avandia jista ’ jkun hemm bżonn li tinbidel.
Pregnancy and breast-feeding • Avandia is not recommended during pregnancy.
Tqala u Treddigħ • Avandia m' huwiex rakkomandat waqt it- tqala.
If you are pregnant or could be pregnant, tell your doctor.
Jekk inti tqila jew tista ’ tkun tqila, għid lit - tabib tiegħek.
• Don’ t breast-feed while you are taking Avandia.
• Treddgħax waqt li tkun qed tieħu Avandia.
Driving and using machines This medicine should not affect your ability to drive or use machines.
Din il- mediċina m’ għandhiex ikollha effett fuq il- ħila tiegħek biex issuq jew tħaddem magni.
Avandia contains lactose Avandia tablets contain a small amount of lactose.
Avandia fiha l- lattożju Il- pilloli ta ’ Avandia fihom ammonti zgħar ta ’ lattożju.
HOW TO TAKE AVANDIA
KIF GĦANDEK TIEĦU AVANDIA
Always take Avandia tablets exactly as your doctor has told you.
Dejjem għandek tieħu il- pilloli ta ’ Avandia eżatt skond ma jkun qallek it- tabib tiegħek.
How much to take The usual starting dose is 4 mg a day.
Kemm tieħu Id- doża tal- bidu tas- soltu hija ta ’ 4mg kuljum.
This can be taken as one 4 mg tablet once a day, or as one 2 mg tablet taken twice a day.
Din tista ’ tittieħed bħala pillola waħda ta ’ 4mg darba kuljum, jew bħala pillola ta ’ 2mg waħda meħuda darbtejn kuljum.
The maximum dose is 8 mg of Avandia a day.
Id- doża massima hija ta '8mg ta' Avandia kuljum.
You can take Avandia with or without food.
Tista ’ tieħu Avandia jew ma ’ l- ikel jew fuq stonku vojt.
53 Take your tablets around the same time every day and follow any dietary advice that your doctor has given you.
Ħu l- pilloli tiegħek madwar l- istess ħin kuljum u segwi kull parir dijetitiku li jkun tak it- tabib tiegħek.
If you take more Avandia than you should If you accidentally take too many tablets, contact your doctor or pharmacist for advice.
Jekk tieħu aktar Avandia milli jmissek Jekk aċċidentalment tieħu ħafna pilloli, ikkuntatja lit- tabib jew lill- ispiżjar tiegħek għal parir.
If you forget to take Avandia Don’ t take extra tablets to make up for a missed dose.
Jekk tinsa tieħu Avandia Tieħux pilloli żejda biex tpatti għal doża li tkun tlift.
Don’ t stop taking Avandia Take Avandia for as long as your doctor recommends.
Tieqafx tieħu Avandia Ħu Avandia sakemm jirrikmandalek it- tabib tiegħek.
If you stop taking Avandia, your blood sugar will not be controlled, and you may become unwell.
Jekk tieqaf tieħu Avandia, iz- zokkor fid- demm tiegħek ma jkunx ikkontrollat, u tista ’ tkun ma tiflaħx.
Like all medicines, Avandia can cause side effects, but not everybody gets them.
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU Bħal kull mediċina oħra, Avandia jista ’ jkollu effetti sekondarji, għalkemm mhux kulħadd ikollu minnhom.
These are very rare in people taking Avandia.
Dawn huma rari ħafna f’ nies li jieħdu Avandia.
Stop taking Avandia.
Ieqaf ieħu Avandia.
Avandia can cause you to retain water (fluid retention) which leads to swelling and weight gain.
Avandia jista ’ jgiegħlek iżżomm l- ilma (ritenzjoni ta ’ fluwidu) li twassal għal nefħa u żieda fil- piż.
If you are taking Avandia with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level.
Jekk qed tieħu Avandia ma 'mediċini oħra għad- dijabete, huwa aktar possibli li z- zokkor fid- demm tiegħek jinżel taħt il- livell normali.
The severity can increase, leading to confusion and loss of consciousness.
Sintomi bikrin ta 'zokkor baxx fid- demm huma: • rogħda, għaraq, iħossok ħażin • nervożità, palpitazzjonijiet • ġuħ Is- severita ’ tista ’ żżid, u twassal għal konfużżjoni u telf ta' sensi.
Before you start taking Avandia you will have a blood sample taken to check your liver function.
Qabel ma tibda ’ tieħu Avandia jittieħidlek kampjun tad- demm biex tiċċekkja il - funzjoni tal- fwied tiegħek.
54 Eye problems:
Problemi fl- għajnejn:
Discuss with your doctor any concerns about your eyesight.
Ġraw każi ta ’ edema makulari ġodda jew li marru għall- agħar f’ okkażjonijiet rari f’ nies li jkunu fuq Avandia u mediċini simili. → Iddiskuti mat- tabib tiegħek kull inkwiet dwar il- vista tiegħek.
The chances of this happening may be higher in women taking Avandia for more than one year.
Il- possibilitajiet li jiġri dan jista ’ jkun aktar għoli f’ nisa li ilhom jieħdu rosiglitazone għal aktar minn sena.
Common side effects These may affect up to 1 in 10 people: • chest pain (angina) • broken bones • reduction in blood count (anaemia) • small increases in blood cholesterol, increased amount of fats in the blood • increased weight, increased appetite • constipation • swelling (oedema) due to water retention.
55 Dawn jistgħu jaffetwaw sa persuna waħda minn kull 10 • uġigħ fis- sider (anġina) • ksur ta ’ għadam • tnaqqis fin- numru ta ’ ċelluli fid- demm (anemija) • żidiet żgħar tal- kolesterol fid- demm, żieda fl- ammont ta ’ xaħmijiet fid- demm. • żjieda fil- piż, żjieda fl- aptit • stitikezza • zokkor aktar baxx fid- demm minn normal (ipoglikemja) • nefħa (edema) minħabba ritenzjoni ta ’ ilma
Rare side effects These may affect up to 1 in 1,000 people: • fluid in the lungs (pulmonary oedema) causing breathlessness • heart failure • swelling of the retina at the back of the eye (macular oedema) • liver doesn’ t function as well as it should (increase in liver enzymes).
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa wieħed 1 minn kull 1, 000 persuna • fluwidu fil- pulmun (edema pulmonari) li tikkawża qtugħ ta ’ nifs • falliment tal- qalb • nefħa fir- retina fuq wara ta ’ l- għajn (edema makulari) • il- fwied ma jiffunzjonax tajjeb kemm imissu (żieda fl- enżimi tal- fwied)
Very rare side effects These may affect up to 1 in 10,000 people: • allergic reactions • rapid and excessive weight gain caused by fluid retention.
Effetti sekondarji rari ħafna Dawn jistgħu jaffettwaw sa 1 minn kull 10, 000 persuna • reazzjonijiet allerġiċi • żieda rapida u eċċessiva fil- piż ikkawżata minn ritenzjoni ta ’ fluwidu
HOW TO STORE AVANDIA
KIF TAĦŻEN AVANDIA
Do not use Avandia after the expiry date shown on the pack.
Tużax Avandia wara d- data ta ’ skadenza li tidher fuq il- pakkett.
What Avandia contains The active substance is rosiglitazone.
X’ fih Avandia
Avandia tablets come in different strengths.
Il- pilloli ta ’ Avandia jiġu f’ dożi differenti.
2 mg, 4 mg or 8 mg rosiglitazone.
2mg, 4mg jew 8mg.
The other ingredients are: sodium starch glycollate (Type A), hypromellose, hypromellose 6cP, microcrystalline cellulose, lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 3000, glycerol triacetate and iron oxide red (E172).
Is- sustanzi l- oħra huma: sodium starch glycollate (Tip A), hypromellose, hypromellose 6cP, microcrystalline cellulose, lactose monohydrate, titanium dioxide (171), macrogol 3000, glycerol triacetate, u iron oxide red (E172).
The 4 mg tablet also contains purified talc and iron oxide yellow (E172).
Il- pillola ta ’ 4mg fiha wkoll purified talc u iron oxide yellow (E172).
What Avandia looks like and contents of the pack Avandia 2 mg tablets are pink and marked "GSK" on one side and "2" on the other.
56 Id- dehra ta ’ Avandia u l- kontenuti tal- pakkett Il- pilloli ta ’ Avandia 2mg huma roża, mmarkati "GSK" fuq naħa u "2" fuq l- oħra.
The tablets are provided in blister packs containing 56, 112, 168 or 180 film-coated tablets or 56 film-coated tablets in a unit dose pack.
Il- pilloli issibhom f’ pakki blister li fihom 56, 112, 168 jew 180 pillola miksijin b’ rita jew 56 pillola miksijin b’ rita f’ pakkett b’ doża unita.
Avandia 4 mg tablets are orange, marked "GSK" on one side and "4" on the other.
Il- pilloli ta ’ Avandia 4mg huma oranġjo, immarkati "GSK" fuq naħa waħda u "4" fuq l- oħra.
The tablets are provided in blister packs containing 7, 28, 56, 84, 90 or 112 film-coated tablets or 56 film-coated tablets in a unit dose pack.
Il- pilloli issibhom f’ pakki blister li fihom 7, 28, 56, 84, 90 jew 112 pillola miksijin b’ rita jew 56 pillola miksijin b’ rita f’ pakkett b’ doża unita.
Avandia 8 mg tablets are red-brown, marked "GSK" on one side and "8" on the other.
Il- pilloli ta ’ Avandia 8mg huma kannella fl- aħmar, immarkati "GSK" fuq naħa waħda u "8" fuq l - oħra.
The tablets are provided in blister packs containing 7, 28, 84, 90 or 112 film-coated tablets.
Il- pilloli issibhom f’ pakki blister li fihom 7, 28, 84,, 90 jew 112 pillola miksijin b’ rita.
Glaxo Wellcome Production, ZI du Terras, 53100 Mayenne, France.
Glaxo Wellcome Production, ZI du terras, 53100, Mayenne, Franza.
Glaxo Wellcome S. A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Glaxo Wellcome S. A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spanja.
56 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
57 Għall kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- AwtorizzazzjonI għat- tqegħid fis- Suq.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: www. emea. europa. eu
What is Avastin?
X’ inhu Avastin?
Avastin is a concentrate for solution for infusion (drip into a vein).
Avastin huwa konċentrat għal soluzzjoni għall- infużjoni (drip fil- vina).
It contains the active substance bevacizumab.
Huwa fih is- sustanza attiva bevacizumab.
What is Avastin used for?
Għal xiex jintuża Avastin?
Avastin is used with other anticancer medicines to treat: • metastatic cancer of the colon (part of the large intestine) or rectum, in combination with chemotherapy (anticancer medicines) that includes a ‘ fluoropyrimidine’ (such as 5-fluorouracil). ‘ Metastatic’ means that the cancer has spread to other parts of the body; • metastatic breast cancer in combination with paclitaxel; • advanced, metastatic or recurrent non-small cell lung cancer that is unresectable (cannot be removed by surgery alone) in patients whose cancer cells are not of the ‘ squamous ’ type, in combination with chemotherapy that includes a ‘ platinum-based ’ medicine; • advanced or metastatic kidney cancer, in combination with interferon alfa-2a.
Avastin jintuża ma ’ mediċini oħrajn ta ’ kontra l- kanċer biex jikkura: • kanċer metastatiku tal- kolon (parti mill- musrana l- kbira) jew tar- rektum, flimkien mal - kemjoterpaija (mediċini kontra l- kanċer) li tinkludi ‘ flworopirimidina ’ (bħal 5- fluorouracil). ‘ Metastatiku ’ jfisser li l- kanċer infirex għal partijiet oħra tal- ġisem; • kanċer tas- sider metastatiku, fejn jintuża flimkien ma ’ paclitaxel; • kanċer tal- pulmun mhux ta ’ ċellola żgħira li jkun avvanzat, metastatiku jew rikorrenti u li ma jistax jitneħħa bil- kirurġija waħedha f’ pazjenti li ċ- ċelloli tagħhom mhumiex tat- tip ‘ skwamużi ’, fejn jintuża flimkien mal- kemjoterapija li tkun tinkludi mediċina ‘ ibbażata fuq il- platinu ’. • kanċer avvanzat jew metastatiku tal- kliewi, f’ kumbinazzjoni ma ’ interferon alfa- 2a.
The medicine can only be obtained with a prescription.
Din il- mediċina tista ’ tinkiseb biss permezz ta ’ riċetta ta ’ tabib.
How is Avastin used?
Kif jintuża Avastin?
Avastin treatment should be supervised by a doctor who has experience in the use of cancer treatments.
It- trattament b’ Avastin għandu jkun sorveljata minn tabib li għandu esperjenza fl- użu ta ’ trattamenti kontra l- kanċer.
Avastin is given as an intravenous infusion.
Avastin jingħata bħala infużjoni intravenuża.
The treatment is continued until the disease progresses.
It- trattament jitkompla sakemm ma tiggrava l- marda.
The first infusion should last 90 minutes, but subsequent infusions may be given over a shorter period if the first infusion has been well tolerated.
L - ewwel infużjoni għandha ddum 90 minuta iżda l- infużjonijiet sussegwenti jistgħu jingħataw qabel jew wara l- għoti tal- mediċini kontra l- kanċer l- oħra, u jistgħu jingħataw fuq perjodu iqsar jekk l- ewwel infużjoni tkun ġiet ittollerata sewwa.
The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated.
Id- doża hija bejn 5 u 15 mg kull kilogramma tal- piż tal- piż tal - ġisem kull ġimagħtejn jew tliet ġimgħat, fejn jiddependi fuq it- tip ta ’ kanċer li jkun qed jiġi trattat.
See the Summary of Product Characteristics (also part of the EPAR) for more information.
Ara s- Sommarju tal- Karatteristiċi tal- Prodott (parti ukoll mill- EPAR) għal aktar tagħrif.
How does Avastin work?
Kif jaħdem Avastin?
The active substance in Avastin, bevacizumab, is a monoclonal antibody.
Is- sustanza attiva f’ Avastin, bevacizumab, huwa antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body or is circulating in the body.
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li ġie iddisinjat biex jagħraf u jorbot ma ’ struttura speċifika (imsejħa antiġenu) li tinsab fuq ċerti ċelloli fil- ġisem jew li tkun qed tiċċirkola fil- ġisem.
VEGF is a factor that circulates in the blood and makes blood vessels grow.
Bevacizumab ġie iddisinjat biex jorbot ma ’ fattur ta ’ l- iżvilupp ta ’ l- endotilju vaskulari (VEGF – Vascular endothelial growth factor).
Reproduction is authorised provided the source is acknowledged. the result, the cancer cells cannot develop their own blood supply, they are starved of oxygen and nutrients and this helps to slow down the growth of tumours.
Avastin iwaqqfu milli jkollu effett billi jorbot ma ’ VEGF.
How has Avastin been studied?
Kif ġie studjat Avastin?
In cancer of the colon or rectum, the effects of adding Avastin to combinations of anticancer medicines including a fluoropyrimidine have been studied in three main studies.
Avastin ġie studjat fuq 923 pazjent, fejn l- effetti taż- żieda ta ’ Avastin ma ’ kombinazzjonijiet ta ’ mediċini ta ’ kontra l- kanċer, inkluż flworopirimidina, ġew studjati fi tliet stiudji ewlenin.
The first two studies involved patients whose metastatic disease was being treated for the first time (‘ first-line’ treatment): the first study (923 patients) compared chemotherapy with and without Avastin, and the second (1,401 patients) compared adding Avastin with adding placebo (a dummy treatment).
L- ewwel żewġ studji involvew pazjenti li kienu qed jiġu trattati għall- ewwel darba għal- marda metastatika tagħhom (trattament ‘ primarju ’): l- ewwel studju (923 pazjent) ipparaguna l- kemjoterapija bi jew mingħajr Avastin, u t- tieni (1, 401 pazjent) ipparaguna ż- żieda ta ’ Avastin maż- żieda ta ’ plaċebo (trattament finta).
The third study involved 829 patients who had failed previous treatment including a fluoropyrimidine and irinotecan (another anticancer medicine).
It- tielet studju involva 829 pazjent li ma kienx ħadmilhom it- trattament preċedenti inklużi flworopirimidina u irinotekan (irinotecan) (mediċina oħra għal kontra l- kanċer).
In breast cancer, Avastin has been studied in 722 patients.
Fil- kanċer tas- sider, Avastin ġie studjat f’ 722 pazjent.
The study looked at the effectiveness of adding Avastin to treatment with paclitaxel.
L- istudju ħares lejn l- effikaċja taż- żieda ta ’ Avastin ma ’ kura b’ paclitaxel.
In lung cancer, Avastin has been studied in 878 patients.
F’ kanċer tal- pulmun, Avastin ġie studjat fi 878 pazjent.
The study compared the effectiveness of the combination of Avastin with platinum-based chemotherapy with that of chemotherapy alone.
L- istudju qabbel l- effikaċja ta ’ kombinazzjoni ta ’ Avastin u kemjoterapija bbażata fuq il- platinu ma ’ kemjoterpija waħedha.
In kidney cancer, Avastin has been studied in 649 patients with advanced or metastatic disease.
Fil- kanċer tal- kliewi, Avastin ġie studjat f’ 649 pazjent bil- marda avvanzata jew metastatika.
The study compared Avastin with placebo, both taken in combination with interferon alfa-2a.
L- istudju qabbel Avastin ma ’ plaċebo, fejn it- tnejn ittieħdu ma ’ interferon alfa- 2a.
In all of the studies, the main measure of effectiveness was either overall survival time or progression- free survival time (the time taken for the disease to get worse or for the patient to die).
Fl- istudji kollha, il- miżura prinċipali ta ’ effikaċja kienet jew sopravivenza globali jew żmien ta ’ ħajja bla progress tal- mard (iż- żmien li l- marda ssir agħar jew il- pazjent imut).
What benefit has Avastin shown during the studies?
X’ benefiċċju wera Avastin waqt l- istudji?
In cancer of the colon or rectum, the addition of Avastin prolonged survival time and progression-free survival time when added to fluoropyrimidine-containing chemotherapy.
Fil- kanċer tal- kolon jew tar- rektum, iż- żieda ta ’ Avastin tawlet iż- żmien ta ’ sopravivenza tal- pazjenti kif ukoll iż- żmien li fih il- marda ma tkunx qed tavvanza, meta tittieħed flimkien ma ’ kemjoterapija bil- flworopirimidina.
In the first study of previously untreated patients, adding Avastin increased survival times from an average of 15.6 to 20.3 months.
Fl- ewwel studju tal- pazjenti li ma kinux ħadu trattament qabel, iż- żieda ta ’ Avastin tawlet il- perjodu ta ’ sopravivenza minn medja ta ’ 15. 6 sa 20. 3 xhur.
In the second study, progression-free survival was 8.0 months in patients receiving placebo and 9.4 months in those receiving Avastin.
Fit- tieni studju, il- perjodu ta ’ sopravivenza fejn il- marda ma komplitx tiggrava kien ta ’ 8. 0 xhur f’ pazjenti li rċevew il- plaċebo u 9. 4 xhur f’ dawk li rċevew Avastin.
In previously-treated patients, adding Avastin increased survival time from 10.8 to 13.0 months.
F’ pazjenti li kienu diġà ħadu xi trattament, iż- żieda ta ’ Avastin tawlet il- perjodu ta ’ sopravivenza minn 10. 8 sa 13 - il xahar.
In breast cancer, the progression-free survival time was increased from 6.7 to 13.3 months in the patients receiving Avastin and paclitaxel compared with those receiving only paclitaxel.
Fil- kanċer tas- sider, il- perjodu ta ’ sopravivenza mingħajr ma l- marda bdiet tiggrava żdied minn 6. 7 għal 13. 3- il xhur f’ pazjenti li kienu qed jirċievu Avastin u paclitaxel meta mqabbla ma ’ dawk li kienu qed jirċievu paclitaxel biss.
In lung cancer, patients taking Avastin with paclitaxel and carboplatin survived for an average of 12.3 months, compared with 10.3 months for those taking paclitaxel and carboplatin alone.
F’ pazjenti b’ kanċer tal- pulmun, pazjenti li qed jieħdu Avastin ma ’ paclitaxel u karboplatina (carboplatin) issopravivew għal medja ta ’ 12. 3- xhur, meta mqabbla ma ’ 10. 3 xhur għal dawk li kienu qed jieħdu paclitaxel u karboplatina waħidhom.
In kidney cancer, adding Avastin to interferon alfa-2a increased the progression-free survival time from 5.4 to 10.2 months.
Fil- kanċer tal- kliewi, iż- żieda ta ’ Avastin ma ’ interferon alfa- 2a tawwal il- perjodu ta ’ sopravivenza mingħajr progressjoni tal- marda minn 5. 4 għal 10. 2 xhur.
What is the risk associated with Avastin?
X’ inhu r- riskju assoċjat ma ’ Avastin?