qanastek/EMEA-V3 huggingface dataset:
What is AVAMYS?
X’ inhu AVAMYS?
AVAMYS is a nasal spray that contains the active substance fluticasone furoate.
AVAMYS huwa sprej ta ’ l- imnieħer li fih is- sustanza attiva fluticasone furoate.
What is AVAMYS used for?
Għal x’ hiex jintuża AVAMYS?
AVAMYS is used to treat the symptoms of allergic rhinitis.
AVAMYS jintuża biex jikkura s- sintomi ta ’ rinite allerġika.
This is inflammation of the nasal passages caused by an allergy, resulting in runny nose, blocked nose, itching and sneezing.
Din hija infjammazzjoni tal- passaġġi ta ’ l- imnieħer ikkaġunata minn allerġija, li tirriżulta f’ imnieħer inixxi, imnieħer imblokkat, ħakk u għatis.
It is often accompanied by symptoms affecting the eyes, such as irritation, watering or redness.
Ta ’ spiss hija assoċjata ma ’ sintomi li jaffettwaw l- għajnejn, bħalma huma irritazzjoni, ħruġ ta ’ dmugħ jew ħmura.
AVAMYS is for use in adults and children aged six years and over.
AVAMYS huwa għal użu fl- adulti u fi tfal ta ’ età minn sitt snin ’ il fuq.
How is AVAMYS used?
Kif jintuża AVAMYS?
The recommended dose of AVAMYS for adults and adolescents aged 12 years and over is two sprays in each nostril once a day.
Id- doża irrikmandata ta’ AVAMYS għal adulti u adolexxenti ta ’ età ta ’ 12- il sena jew aktar hija żewġ sprejjaturi f’ kull minħar darba kuljum.
This can be reduced to one spray in each nostril once symptoms are controlled.
Din tista ’ tiġi mnaqqsa għal sprejjatura waħda f’ kull minħar ġaladarba s- sintomi jkunu kkontrollati.
For children between six and 12 years of age, the recommended dose is one spray in each nostril once a day, although this can be increased to two sprays if symptoms are not controlled.
Għal tfal bejn l- età ta ’ sitta u 12- il sena, id- doża irrikkmandata hija sprejattura waħda f’ kull minħar darba kuljum, għalkemm din tista ’ tiżdied għal żewġ sprejjaturi jekk is- sintomi ma jkunux ikkontrollati.
To get the most benefit from the medicine, it should be used regularly and at the same time every day.
Biex jittieħed l- akbar benefiċċju mill- mediċina, għandu jintuża regolarment u fl- istess ħin kuljum.
It usually starts to work from eight hours after the first spray, but it may take several days to get the maximum benefit.
Ġeneralment jibda jaħdem minn tmien sigħat wara l- ewwel sprejjatura, iżda jistgħu jgħaddu diversi jiem biex jinkiseb il- benefiċċju massimu.
AVAMYS should only be used for as long as the patient is exposed to the allergen, such as pollen, house dust mites or other animals.
AVAMYS għandu jintuża biss għal żmien twil biżżejjed sakemm il- pazjent huwa espost għall- allerġen, bħalma huwa polline, insetti mikroskopiċi fit- trabijiet tad- dar jew annimali oħra.
How does AVAMYS work?
Kif jaħdem AVAMYS?
The active substance in AVAMYS, fluticasone furoate, is a corticosteroid.
Is- sustanza attiva f’ AVAMYS, fluticasone furoate, hija korikosterojde.
It works in a similar way to naturally-occurring corticosteroid hormones, dampening down the activity of the immune system by attaching to receptors in various types of immune cell.
Taħdem b’ mod simili għal ormoni korikosterojdi li jinsabu b’ mod naturali, itaffu l- attività tas- sistema immunitarja billi jaqbdu ma ’ riċetturi f’ diversi tipi ta ’ ċelloli immuni.
This leads to a reduction the release of substances that are involved in the inflammation process, such as histamine, reducing the symptoms of allergy.
Dan iwassal għal tnaqqis fil- ħelsien ta ’ sustanzi li huma involuti fil- proċess ta ’ l- infjammazzjoni, bħalma hija ħistamin, u jnaqqas is- sintomi ta ’ allerġija.
How has AVAMYS been studied?
Kif ġie studjat AVAMYS?
The effects of AVAMYS were first tested in experimental models before being studied in humans.
L- effetti ta’ AVAMYS kienu l- ewwel ittestjati f’ mudelli esperimentali qabel ma ġew studjati fil - bnedmin.
The effectiveness of AVAMYS was studied in six main studies involving almost 2,500 patients, which compared AVAMYS with placebo (a dummy treatment).
L- effikaċja ta ’ AVAMYS kienet studjata f’ sitt studji ewlenin li involvew kważi 2, 500 pazjent, li qabblu AVAMYS ma ’ plaċebo (kura finta).
The first four studies looked at AVAMYS used in adults and adolescents aged 12 years or over.
L- ewwel erba ’ studji studjaw AVAMYS użat fl- adulti u adolexxenti ta ’ età ta ’ 12- il sena jew aktar.
Three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis (hay fever), while the fourth lasted 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Tlieta kienu studji ta ’ qasir żmien li damu ġimagħtejn u involvew total ta ’ 886 pazjent b’ rinite allerġika staġjonali (hay fever), waqt li r- raba ’ wieħed dam 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. four weeks and involved 302 patients with perennial (non-seasonal) allergies, such as allergies to animal dander (skin and hair).
Reproduction is authorised provided the source is acknowledged. erba ’ ġimgħat u involva 302 pazjenti b’ allerġiji perenni (mhux staġjonali), bħal allerġiji għal għadab ta ’ l- annimali (ġilda u xagħar).
The last two studies were carried out in children aged between two and 11 years, in which two doses of AVAMYS were compared with placebo.
L- aħħar żewġ studji saru fuq tfal ta ’ etajiet bejn sentejn u 11- il sena, fejn żewġ dożi ta ’ AVAMYS kienu mqabbla ma ’ plaċebo.
The first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis.
L- ewwel wieħed involva 558 tifel u tifla b’ rinite allerġika perenni u t - tieni involva 554 tifel u tifla b’ rinite allerġika staġjonali.
In all studies, the main measure of effectiveness was the change in four symptoms of allergy affecting the nose.
Fl- istudji kollha, il- miżura ewlenija ta ’ l- effikaċja kienet il- bidla f’ erba ’ sintomi ta ’ allerġija li jaffettwaw l- imnieħer.
Each symptom was measured on a scale from 0 to 3, with a maximum total score of 12.
Kull sintomu tkejjel fuq skala minn 0 sa 3, b’ punteġġ massimu totali ta ’ 12.
What benefit has AVAMYS shown during the studies?
X’ benefiċċju wera AVAMYS waqt l- istudji?
AVAMYS was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
AVAMYS kien aktar effettiv minn plaċebo f’ li jnaqqas sintomi ta ’ rinite allerġika f’ pazjenti ta ’ età ta ’ sitt snin jew aktar.
In the studies of seasonal allergic rhinitis in adults and adolescents, AVAMYS reduced symptom scores from a starting point of around 9 points by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
Fl- istudji ta ’ rinite allerġika staġjonali fl- adulti u adolexxenti, AVAMYS naqqas il - punteġġ ta ’ sintomi minn punt tal- bidu ta ’ madwar 9 punti b’ bejn 3. 6 u 5. 4 punti fuq ġimagħtejn, meta mqabbla ma ’ tnaqqis ta ’ 2. 3 sa 3. 7 punti bi plaċebo.
In the study of perennial allergic rhinitis, AVAMYS reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
Fl- istudju ta ’ rinite allerġika perenni, AVAMYS naqqas il- punteġġ bi 3. 6 punti wara erba ’ ġimgħat, meta mqabbel ma ’ tnaqqis ta ’ 2. 8 punti bi plaċebo.
Similar results were seen in children aged six years and above.
Riżultati simili dehru fi tfal ta ’ età ta ’ sitt snin jew aktar.
However, it was not possible to determine if AVAMYS worked in children below the age of six years, because there were too few children below this age included the studies.
Madankollu, ma kienx possibbli li jiġi stabbilit jekk AVAMYS ħadimx fi tfal taħt l- età ta ’ sitt snin, għaliex kien hemm ftit wisq tfal taħt din l- età inklużi fl- istudji.
What is the risk associated with AVAMYS?
X’ inhu r- riskju assoċjat ma ’ AVAMYS?
The most common side effect with AVAMYS (seen in more than 1 patient in 10) is epistaxis (nosebleeds).
L- aktar effett sekondarju komuni ma ’ AVAMYS (deher f’ aktar minn pazjent 1 minn kull 10) hija epistassi (fsadi mill- imnieħer).
This is generally mild or moderate and tends to affect adults who have used AVAMYS for more than six weeks.
Din hija ġeneralment ħafifa jew moderata u għandha l- ħabta li taffettwa adulti li użaw AVAMYS għal aktar minn sitt ġimgħat.
For the full list of all side effects reported with AVAMYS, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ AVAMYS, ara l- Fuljett ta ’ Tagħrif.
AVAMYS should not be used in people who are allergic to fluticasone furoate or any of the other ingredients.
AVAMYS m’ għandux jintuża f’ nies li huma allerġiċi għal fluticasone furoate jew għal xi sustanzi oħrajn tiegħu.
Why has AVAMYS been approved?
Għaliex ġie approvat AVAMYS?
The Committee for Medicinal Products for Human Use (CHMP) decided that AVAMYS’ s benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ AVAMYS huma akbar mir- riskji tiegħu għall- kura tas- sintomi ta ’ rinite allerġika f’ pazjenti ta ’ età ta ’ sitt snin jew akbar.
The Committee recommended that AVAMYS be given marketing authorisation.
Il- kumitat irrikmanda li AVAMYS jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about AVAMYS:
Tagħrif ieħor dwar AVAMYS:
The European Commission granted a marketing authorisation valid throughout the European Union for AVAMYS to Glaxo Group Ltd on 11 January 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal AVAMYS lil Glaxo Group Ltd fil- 11ta ’ Jannar 2008.
The full EPAR for AVAMYS can be found here.
L- EPAR sħiħ għal AVAMYS jista ’ jinstab hawnhekk.
27.5 micrograms/ spray
27. 5 mikrogrammi/ sprejjatura
Nasal spray suspension
Sprej ta ’ l - imnieħer, suspensjoni
AVAMYS 27.5 micrograms/ spray nasal spray suspension
AVAMYS 27. 5 mikrogrammi f’ kull sprej.
Avamys is indicated for the treatment of: • the symptoms of allergic rhinitis
Avamys hu indikat għat- trattament: • tas- sintomi ta ’ rinite allerġika.
Hypersensitivity to the active substance or to any of the excipients of Avamys.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi ta ’ Avamys.
Avamys contains benzalkonium chloride.
Avamys fih benzalkonium chloride.
It may cause irritation of the nasal mucosa.
Dan jista ’ jikkawża irritazzjoni tal- mukoża ta ’ l- imnieħer.
3 Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Fluticasone fuorate jitneħħa malajr b’ metaboliżmu first pass estensiv medjat biċ- ċitokromju P450 3A4.
Very common > 1/ 10; Common > 1/ 100 to< 1/10; Uncommon > 1/1000 to< 1/100; Rare > 1/10,000 to < 1/ 1000; Very rare < 1/10,000.
Komuni ħafna > 1/ 10; Komuni > 1/ 100 sa < 1/ 10; Mhux komuni > 1/ 1000 sa < 1/ 100; Rari > 1/ 10, 000 sa < 1/ 1000; Rari ħafna < 1/ 10, 000.
4 4.9 Overdose
4 Epistassi kienet ġeneralment ħafifa sa moderata f’ dik li hi intensita`.
In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic effects observed (see section 5.2).
Fi studju dwar bijodisponibilta`, ittieħdu dożi fl- imnieħer sa 2640 mikrogrammi kuljum għal tlett ijiem mingħajr ma ġew osservati ebda effetti sistemiċi avversi (ara sezzjoni 5. 2).
A study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment resulted in increased Cmax (42%) and AUC(0-∞) (172%) and a modest (on average 23%) decrease in cortisol levels in patients compared to healthy subjects.
Studju fuq doża waħda ta ’ 400 mikrogrammi ta ’ fluticasone furoate meħuda mill- ħalq minn pazjenti b’ indeboliment moderat tal- fwied wera żieda ta ’ Cmax (42%) u AUC( 0- ∞) (172%) u tnaqqis moderat (medja ta ’ 23%) fil- livelli ta ’ kortisol fil- pazjenti meta mqabbla ma ’ suġġetti f’ saħħithom.
6 Findings in general toxicology studies were similar to those observed with other glucocorticoids and are associated with exaggerated pharmacological activity.
Sejbiet fi studji tossikoloġiċi ġenerali kienu jixbħu lil dawk osservati bi glucocorticoids oħra u huma assoċjati ma ’ attività farmakoloġika eżaġerata.
Avamys nasal spray is a predominantly off-white plastic device with a dose indicator window, light blue side actuated lever and lid which contains a stopper.
L- isprej ta ’ l- imnieħer Avamys huwa apparat tal- plastik ta 'kulur bajdani, li fih indikatur tad- doża, lieva ta ’ kulur blu ċar ikkontrollata mill- ġenb u għatu b’ tapp miegħu.
The plastic device contains the nasal spray suspension within a Type I amber bottle (glass) fitted with a metering spray pump.
L- apparat tal- plastik fih is - suspensjoni ta ’ l- isprej għal- imnieħer li jinsab fi flixkun safrani ta ’ Tip I (tal- ħġieġ) li għamdu miegħu pompa atomizzatur li tirregola l- isprej.
Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT
Glaxo Operations UK, Ltd, (fil- kummerċ Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT
The MAH must ensure that the system of pharmacovigilance, as described in version YM2007/ 00033/ 00, 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.
L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni YM2007/ 00033/ 00, preżentata fit- Taqsima 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda f’ postha u tiffunzjona qabel ma l- prodott jitqiegħed fis- suq u waqt li l- prodott ikun fis- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version GM2006/ 00247/ 02 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.
L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza dettaljati fil - Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni GM2006/ 00247/ 02 tal- Pjan dwar il- Maniġġjar ta ’ Riskju (RMP), preżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u fl- aġġornamenti sussegwenti tal- RMP mifthema mas- CHMP.
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING THE IMMEDIATE PACKAGING >
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Avamys 27.5 micrograms/ spray nasal spray suspension Fluticasone furoate
Avamys 27. 5 mikrogrammi/ sprejjatura ta ’ suspensjoni li jintuża bħala sprej fl- imnieħer Fluticasone furoate
13 Do not refrigerate or freeze
13 Tagħmlux fil- friġġ jew friża
Avamys 27.5 micrograms/ spray nasal spray suspension Fluticasone fuorate
Avamys 27. 5 mikrogrammi / sprejjatura ta ’ suspensjoni li jintuża bħala sprej fl- imnieħer Fluticasone furoate
Avamys 27.5 micrograms per spray nasal spray suspension Fluticasone furoate
Avamys 27. 5 mikrogrammi/ sprejjatura ta ’ suspensjoni għal użu bħala sprej fl- imnieħer Fluticasone furoate
What Avamys is and what it is used for 2.
X’ inhu Avamys u għalxiex jintuża 2.
Before you use Avamys 3.
Qabel ma tuża Avamys 3.
How to use Avamys 4.
Kif għandek tuża Avamys 4.
How to store Avamys 6.
Kif taħżen Avamys 6.
WHAT AVAMYS IS AND WHAT IT IS USED FOR
X’ INHU X U GĦALXIEX JINTUŻA
Avamys nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over.
Avamys sprej nażali jintuża fit- trattament ta ’ sintomi ta ’ rinite allerġika inklużi mnieħer imblukkat jew inixxi, għatis, u għajnejn idemmgħu u ħakk fl- għajnejn fl- adulti u fit- tfal ta ’ 6 snin u l- fuq.
Avamys belongs to a group of medicines called glucocorticoids.
Avamys jiforma parti mill- grupp ta ’ mediċini msejħa glucocorticoids.
Avamys works to decrease inflammation caused by allergy (rhinitis).
Avamys jaħdem biex inaqqas l- infjammazzjoni fl- imnieħer u l- irritazzjoni fl- għajnejn kawżati minn allerġiji (rinite).
BEFORE YOU USE AVAMYS
QABEL MA TUŻA AVAMYS
If you are allergic (hypersensitive) to fluticasone furoate or any of the other ingredients of Avamys.
Tużax Avamys Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal fluticasone furoate jew sustanzi oħra ta ’ Avamys
If you have any liver problems, tell your doctor or pharmacist.
Oqgħod attent ħafna b’ Avamys Għarraf lit- tabib jew lill- ispiżjar tiegħek jekk għandek xi problemi tal- fwied.
Your doctor may adjust your dose of Avamys.
It- tabib jista jaġġusta d - doża ta ’ Avamys li qiegħed tieħu.
Taking nasal glucocorticoids (such as Avamys) for a long time may cause children to grow more slowly.
It- teħid ta ’ glucocorticoids mill- imnieħer (bħal Avamys) għal żmien twil jista ’ jikkawża d- dewmien fl - iżvilupp tat- tfal.
It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines: • steroid tablets or injected steroids • steroid creams • medicines for asthma • ritonavir, used to treat HIV • ketoconazole, used to treat fungal infections
Hu speċjalment importanti li tgħid lit- tabib tiegħek jekk tkun qed tieħu jew dan l- aħħar ħadt xi waħda minn dawn il- mediċini li ġejjin: • sterojdi injettati jew mill- ħalq • sterojdi forma ta ’ dlik • mediċini għall- ażma.
17 Your doctor will assess whether you should take Avamys with these medicines.
17 • ritonavir, li jintuża għat- trattament ta ’ l- HIV • ketoconazole, li jintuża għat- trattament ta 'infezzjonijiet fungali
Pregnancy and breast-feeding Do not use Avamys if you are pregnant, or planning to become pregnant, unless your doctor or pharmacist tells you to.
Tqala u Treddigħ Tużax Avamys jekk int tqila, jew qed tippjana biex toħroġ tqila, sakemm ma jkunx qallek hekk it- tabib jew l- ispiżjar tiegħek.
Do not use Avamys if you are breast feeding unless your doctor or pharmacist tells you to.
Tużax Avamys jekk qed tredda ’, sakemm ma jkunx qallek hekk it- tabib jew l- ispiżjar tiegħek.
Driving and using machines Avamys is unlikely to affect your ability to drive and use machines.
Sewqan u tħaddim ta ’ magni Mhuwiex probabbli li Avamys jaffettwa l- ħila għas- sewqan jew għat- tħaddim ta ’ magni
Important information about some of the ingredients of Avamys Avamys contains benzalkonium chloride.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Avamys Avamys fih benzalkonium chloride.
HOW TO USE AVAMYS
KIF GĦANDEK TUŻA AVAMYS
Always use Avamys exactly as your doctor has told you.
Dejjem għandek tuża Avamys skond il- parir tat- tabib.
When to use it and how much to use Avamys is sprayed into the nose as a fine mist.
Meta għandek tużah u kemm tuża Avamys jiġi sprejjat fl- imnieħer bħal raxx ħafif.
Avamys is not for use in the eyes.
Avamys m’ għandux jintuża fl- għajnejn.
This will treat your symptoms throughout the day and night.
Meta għandek tuża Avamys • Użah darba kuljum • Dejjem użah fl- istess ħin Dan għandu jikkura s- sintomi bil- lejl u bi nhar.
How long Avamys takes to work Some people will not feel the full effects until several days after first using Avamys.
Kemm idum Avamys qabel jibda jaħdem Xi wħud ma jħossux l- effett sħiħ qabel ma jgħaddu xi ġranet mill- ewwel użu ta ’ Avamys.
If you use more Avamys than you should Talk to your doctor or pharmacist.
Jekk tuża Avamys aktar milli suppost Kellem lit- tabib jew lill- ispiżjar tiegħek
If you forget to use Avamys • If you miss a dose, take it when you remember. • If it is nearly the time for your next dose, wait until then.
Jekk tinsa tuża Avamys • Jekk tinsa tuża xi doża, agħmel dan malli tiftakar. • Jekk ikun wasal il- ħin għad- doża li jmiss, stenna sakemm ikun sar il- ħin għad- doza illi jmiss.
If you have any further questions on the use of this product, ask you doctor or pharmacist.
18 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
18 The nasal spray • Your medicine comes in a glass bottle inside a plastic casing. • The glass bottle contains either 30, 60 or 120 sprays. • A window on the side of the casing allows you to see how much medicine is left.
Kif għandek tittestja l- isprej nażali qabel tużah L- isprej nażali • Din il- mediċina tkun fi flixkun tal- ħġieġ f’ kontenitur tal- plastik. • Il- flixkun tal- ħġieġ ikun fih 30, 60, jew 120 sprejjaturi. • Minn fetħa żgħira fil- ġenb tal- kontenitur tista ’ tara kemm għad fadal mediċina.
19 Using your nasal spray
Użu ta ’ l- isprej nażali tiegħek
Don’ t use water to do this, wipe with a clean, dry tissue.
Biex tagħmel dan tużax ilma; imsaħ b’ karta assorbenti nadifa u xotta.
If you use more Avamys than you should Talk to your doctor or pharmacist.
20 Jekk tuża Avamys aktar milli suppost Kellem lit- tabib jew lill- ispiżjar tiegħek.
If you forget to use Avamys • If you miss a dose take it when you remember. • If it is nearly the time for your next dose, wait until then.
Jekk tinsa tuża Avamys * Jekk taqbeż xi doża ħudha malli tiftakar. * Jekk ikun kważi wasal il- ħin għad- doża li jmissek, stenna sakemm ikun sar il- ħin għad- doza illi jmiss.
Like all medicines, Avamys can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Avamys jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (These can affect more than 1 person in 10) • Nosebleeds (generally minor), particularly if you use Avamys for more than 6 weeks continuously.
Effetti sekondarji komuni ħafna (Dawn jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) • Ħruġ ta ’ demm mill- imnieħer (ġeneralment ftit), partikolarment jekk tuża Avamys għal aktar minn 6 ġimgħat kontinwament.
HOW TO STORE AVAMYS
KIF TAĦŻEN AVAMYS
Do not use Avamys after the expiry date which is stated on the label and carton.
Tużax Avamys wara d- data ta ’ l- iskadenza li tidher fuq it- tikketta u fuq il- kaxxa.
Avamys nasal spray should be used within 2 months after first opening.
L- isprej għall- imnieħer Avamys għandu jintuża fi żmien xagħrejn wara li jinfetaħ..
What Avamys contains The active substance is fluticasone furoate.
X’ fih Avamys:
What Avamys looks like and contents of the pack The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump.
Il- mediċina hi suspensjoni bajda li tkun fi flixkun tal- ħġieġ ta ’ lewn safrani, b’ pompa mwaħħla miegħu.
Avamys is available in pack sizes 30, 60 and 120 sprays.
Avamys ikun f’ pakketti ta ’ 30, 60 u 120 sprejjaturi.
21 For information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- suq:
France Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 diam@gsk. com
22 diam@ gsk. com
Tel: + 4021 3028 208
FI. PT@ gsk. com
EPAR summary for the public
EPAR - sommarju g all- pubbliku
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat g all- Medi ini g all- U u mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, biex wasal g al rakkomandazzjonijiet dwar kif g andha tintu a l- medi ina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Fil- ka li te tie iktar informazzjoni dwar il- kondizzjoni medika jew it- trattament tieg ek, aqra l - Fuljett mal- Pakkett (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispi jar tieg ek. Jekk tixtieq iktar informazzjoni abba i tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Avandamet?
X' inhu Avandament?
Avandamet is a medicine containing two active substances, rosiglitazone and metformin hydrochloride.
Avandament huwa medi ina li fiha ew sustanzi attivi, rosiglitazone u metformina kloridrat (metformin hydrochloride).
It is available as tablets (yellow:
Huwa disponibbli b ala pilloli (sofor:
1 mg rosiglitazone and 500 mg metformin hydrochloride, and 2 mg rosiglitazone and 1,000 mg metformin hydrochloride; pale pink:
1 mg rosiglitazone u 500 mg metformina kloridrat, u 2 mg rosiglitazone u 1, 000 mg metformina kloridrat; ro a ar:
2 mg rosiglitazone and 500 mg metformin hydrochloride; pink:
2 mg rosiglitazone u 500 mg metformina kloridrat; ro a:
4 mg rosiglitazone and 1,000 mg metformin hydrochloride).
4 mg rosiglitazone u 1, 000 mg metformina kloridrat).
What is Avandamet used for?
G al xiex jintu a Avandament?
Avandamet is used in patients (particularly those who are overweight) who have type 2 diabetes (non-insulin-dependent diabetes).
Avandament jintu a f' pazjenti (partikolarment dawk b' pi ejjed) li g andhom id- dijabete tat- tip 2 (dijabete mhux dipendenti fuq l- insulina).
Avandamet is used in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own and at the maximum possible dose (‘ dual therapy’).
Avandament jintu a f' pazjenti li mhumiex ikkontrollati b' mod sodisfa enti bil- metformina (medi ina kontra d- dijabete) meta u ata wa edha u bid- do a massima possibbli ('terapija dupli i').
Avandamet can also be used with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled on metformin and a sulphonylurea at their maximum possible doses (‘ triple therapy’).
Avandament jista 'jintu a wkoll ma' sulfonilurea (tip ie or ta 'medi ina kontra d- dijabete) f' pazjenti li mhumiex ikkontrollati b' mod sodisfa enti bil- metformina u s- sulfonilurea meta u ati bid- do i massimi possibbli tag hom (' terapija tripli i ').
The medicine can only be obtained with a prescription.
Il- medi ina tista 'tinkiseb biss b' ri etta.
How is Avandamet used?
Kif jintu a Avandament?
The recommended starting dose is 4 mg rosiglitazone and 2,000 mg metformin hydrochloride a day.
Id- do a fil- bidu rakkomandata hija 4 mg rosiglitazone u 2, 000 mg metformina kloridrat kuljum.
It is given in two divided doses, either as two 1 mg/ 500 mg tablets or one 2 mg/ 1,000 mg tablet.
Jing ata f 'ew do i mqassma, jew b ala 2 pilloli ta' 1 mg/ 500 mg jew wa da ta '2 mg/ 1000 mg).
The rosiglitazone dose may need to be increased to 8 mg a day after eight weeks if better blood glucose control is needed, but this should be done with caution in patients who are also taking a sulphonylurea, due to the risk of fluid retention.
Jista 'jkun me tie li din id- do a ti died g al 8 mg rosiglitazone kuljum wara 8 img at fil- ka li jkun me tie kontroll a jar tal- gluko ju fid- demm, dan, i da, g andu jsir b' kawtela f' pazjenti li qeg din jie du sulfonilurea, min abba r- riskju ta' amma ta 'fluwidi.
The dose is adjusted to give the best control.
Id- do a hija a ustata biex tag ti l- a jar kontroll.
The maximum recommended daily dose is 8 mg/ 2,000 mg.
Id- do a massima rakkomandata kuljum hija ta '8 mg/ 2000 mg.
The dose of rosiglitazone may be added to metformin and adjusted before a patient is switched to Avandamet.
Id- do a ta 'rosiglitazone tista' ti died mal- metformina u a ustata qabel ma l- pazjent jibda jie u Avandament.
In triple therapy, when starting treatment in patients who are already taking metformin and a sulphonylurea, Avandamet is given so that the patient receives 4 mg of rosiglitazone a day, and the same dose of metformin as before.
F' terapija tripli i, meta jibda trattament f' pazjenti li di à jie du metformina u sulfonilurea, Avandament jing ata biex il- pazjent ikun qed jie u 4 mg rosiglitazone kuljum, u l- istess do a ta 'metformina b al qabel.
If the patient is already using triple therapy, then Avandamet is given to provide the same doses of rosiglitazone and metformin as before.
Fil- ka li l- pazjent ikun qieg ed di à ju a terapija tripli i, g alhekk Avandament jing ata biex jipprovdi l- istess do i ta 'rosiglitazone u metformina b al qabel.
Taking Avandamet with or just after food may reduce any stomach problems caused by metformin.
Meta wie ed jie u Avandament ma 'l- ikel jew e att wara jistg u jitnaqqsu problemi bl- istonku kkaw ati minn metformina.
How does Avandamet work?
Kif ja dem Avandament?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Id- dijabete tat- tip 2 hija marda fejn il- frixa (pankreas) ma tipprodu ix bi ejjed insulina biex jikkontrolla l- livell ta 'gluko ju fid- demm jew il - isem ma kienx kapa i ju a l- insulina b' mod effika i.
Avandamet contains two active substances, which have different modes of action: • rosiglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces; • metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Avandament fih 2 sustanzi attivi li g andhom metodi differenti ta 'azzjoni: • rosiglitazone jag mel i - elloli (tax- xa am, tal- muskoli u tal- fwied) iktar sensittivi g all - insulina, li jfisser li l - isem jag mel u u a jar mill- insulina li jipprodu i; • metformina ta dem l- iktar billi twaqqaf il- produzzjoni tal- gluko ju u jnaqqas l- assorbiment tieg u fl- intestini.
As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
B' ri ultat tal- azzjoni ta - ew sustanzi attivi, jitnaqqas il- gluko ju fid- demm u dan jg in biex ti i kkontrollata d- dijabete tat- tip 2.
Treatment of type 2 diabetes with Avandamet is in addition to diet and exercise.
It- trattament tad- dijabete tat- tip 2 b' Avandament isir flimkien ma 'dieta u e er izzju.
How has Avandamet been studied?
Kif ie studjat Avandament?
Rosiglitazone on its own has been approved by the European Union (EU) under the name Avandia since 2000, to be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Rosiglitazone wa du ie approvat mill- Unjoni Ewroepa (UE) bl- isem Avandia mis- sena 2000, biex jintu a mal- metformina f' pazjenti b' dijabete tat- tip 2 li mhumiex ikkontrollati b' mod sodisfa enti bil - metformina wa edha.
The studies of Avandia taken with metformin as separate tablets were used to support the use of Avandamet in the same indication.
L- istudji ta 'Avandia meta jing ata mal- metformina b ala pilloli separati ntu aw biex jappo aw l- u u ta' Avandament fl- istess indikazzjoni.
Another study was also carried out comparing the effects of adding either rosiglitazone or placebo (a dummy treatment) to metformin.
Twettaq ukoll studju ie or fejn tqabblu l - effetti ta - ieda ta 'rosiglitazone jew pla ebo (trattament finta).
In triple therapy, one study looked at the effect of adding rosiglitazone to a sulphonylurea (glibenclamide) and metformin in 1,202 patients whose blood glucose was not being controlled sufficiently.
F' terapija tripli i, studju wie ed e amina l- effett ta - ieda ta 'rosiglitazone f' sulfonilurea (glibenklamide) u f' metformina f' 1, 202 pazjenti li l- gluko ju tag hom fid- demm ma ma kienx ikkontrollat bi ejjed.
The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
L- istudji kejlu l- livell ta 'sustanza fid- demm mag rufa b ala emoglobina glikosilata (HbA1c), li tag ti indikazzjoni ta' kemm hu kkontrollat tajjeb il- gluko ju fid- demm.
What benefit has Avandamet shown during the studies?
X' benefi ju wera Avandament fl- istudji?
Avandamet was more effective than metformin alone and than placebo in reducing HbA1c.
Avandament kellu aktar effett mill- metformina wa edha u mill- pla ebo fit- tnaqqis tal- HbA1c.
Adding rosiglitazone to treatment with metformin and a sulphonylurea brought about a small but significant extra reduction in HbA1c levels.
I - ieda ta 'rosiglitazone mat- trattament b' metformina u sulfonilurea wassal g al tnaqqis ulterjuri g ir i da sinifikanti fil- livelli ta' HbAlc.
What is the risk associated with Avandamet?
X' riskju hemm asso jat ma 'Avandament?
The most common side effects with Avandamet (seen in more than 1 patient in 10) are hypoglycaemia (low blood sugar levels), oedema (swelling) and gastrointestinal symptoms (upset stomach).
L- iktar effetti sekondarji komuni ta 'Avandament (li dehru f' iktar minn pazjent wie ed minn kull 10) huma l- ipogli emija (livelli baxxi ta' zokkor fid- demm), edema (nef a) u sintomi gastrointestinali (stonku a in).
For the full list of all side effects reported with Avandamet, see the Package Leaflet.
G al- lista s i a tal- effetti sekondarji kollha rrappurtati b' Avandament, ara l- Fuljett ta 'Tag rif.
Avandamet should not be used in people who may be hypersensitive (allergic) to rosiglitazone, metformin or any of the other ingredients.
Avandament m' g andux jintu a f' persuni li jistg u jkunu ipersensittivi (aller i i) g al rosiglitazone, metformina jew kwalunkwe ingredjent ie or imsemmi.
It should not be used in patients who have heart failure, an ‘ acute coronary syndrome’ such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, diseases that could affect the oxygen supply to the tissues (such as lung or heart problems, recent heart attack or shock), problems with their liver or kidneys, acute alcohol intoxication (excessive alcohol consumption), alcoholism, or complications of diabetes (diabetic ketoacidosis or diabetic coma).
Ma g andux jintu a f' pazjenti li jkollhom insuffi jenza kardijaka, 'sindromu koronarju akut' b al an ina instabbli (tip gravi ta 'w ig fis- sider li l- intensità tieg u tinbidel) jew erti tipi ta' attakk tal- qalb, mard li jista 'j alli effett fuq il- provvista ta' ossi enu lit- tissuti (b al problemi tal- pulmuni jew tal- qalb, attakk tal- qalb re enti jew qatg a), problemi fil- fwied jew il- kliewi tag hom, intossikazzjoni akuta mill- alko ol (konsum e essiv ta 'alko ol), alko oli mu, jew kumplikazzjonijiet tad- dijabete (ketoa ido i djabetika jew koma djabetika).
The doses of Avandamet may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Jista 'jkun me tie li d- do i ta' Avandamet ji u a ustati meta jing ata ma 'erti medi ini o ra b al gemfibrozil jew rifampicin.
The full list is available in the Package Leaflet.
Ara l- Fuljett ta 'Tag rif g al- lista s i a.
Why has Avandamet been approved?
G aliex ie approvat Avandament?
The Committee for Medicinal Products for Human Use (CHMP) decided that Avandamet’ s benefits are greater than its risks for the treatment of type 2 diabetes mellitus patients.
Il- Kumitat g all- Prodotti Medi inali g all- U u mill- Bniedem (CHMP) idde ieda li l- benefi ji ta 'Avandament huma akbar mir- riskji tag ha g at- trattament ta' pazjenti li jbatu mid- dijabete mellitu tat - tip 2.
The Committee recommended that Avandamet be given marketing authorisation.
Il- Kumitat irrakomanda li Avandament ting ata awtorizzazzjoni g al tqeg id fis- suq.
Other information about Avandamet:
Informazzjoni o ra dwar Avandament:
The European Commission granted a marketing authorisation valid throughout the EU for Avandamet to SmithKline Beecham plc on 20 October 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni g al tqeg id fis- suq madwar l- UE kollha g al Avandament lil SmithKline Beecham plc fl- 20 ta 'Ottubru 2003.
The marketing authorisation was renewed on 20 October 2008.
L- awtorizzazzjoni g at- tqeg id fis - suq iet im edda fl- 20 ta ’ Ottubru 2008.
The full EPAR for Avandamet is available here.
2/ 3 EPAR s i g al Avandament jista ’ ji i kkonsultat hawn.
AVANDAMET 1 mg/ 500 mg film-coated tablets
AVANDAMET 1 mg/ 500 mg pilloli miksija b’ rita
Each tablet contains 1 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
Kull pillola fiha 1 mg rosiglitazone (bħala rosiglitazone maleate) u 500 mg metformin hydrochloride (jikkorrespondu għal bażi ta ’ 390 mg metformin liberu).
Each tablet contains lactose (approximately 6 mg).
Sustanzi mhux attivi, Kull pillola fiha lattosju (bejn wieħed u ieħor 6 mg)
Yellow film-coated tablets marked "gsk" on one side and "1/ 500" on the other.
Pilloli sofor miksija b’ rita, bil- marka “ gsk ” fuq naħa waħda u “ 1/ 500 ” fuq in- naħa l- oħra.
AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients:
AVANDAMET huwa ndikat għall- kura ta ’ pazjenti bid- dijabete tip 2, l- aktar dawk b’ piż żejjed:
- who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral
- li ma jkunux jistgħu jikkontrollaw tajjeb il- livell tal- glukożju fid- demm bl- ogħla doża li jifilħu
metformin alone.
ta ’ metformin waħdu.
- in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite
- f’ terapija orali trippla ta ’ dijabete b’ sulphonylurea f’ dawk il- pazjenti li ma jistgħux jiksbu
dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).
kontroll gliċemiku biżżejjed minkejja terapija orali doppja b 'metformin u sulphonylurea fl - akbar doża li jittolleraw (ara sezzjoni 4. 4).
The usual starting dose of AVANDAMET is 4 mg/ day rosiglitazone plus 2000 mg/ day metformin hydrochloride.
Id- doża ta ’ AVANDAMET li tinbeda ġeneralment tkun 4 mg kuljum rosiglitazone u 2000 mg kuljum metformin hydrochloride.
Rosiglitazone can be increased to 8 mg/ day after 8 weeks if greater glycaemic control is required.
Wara tmien ġimgħat, id- doża ta ’ rosiglitazone tista ’ tiżdied għal 8 mg kuljum jekk ikun meħtieġ kontroll gliċemiku akbar.
The maximum recommended daily dose of AVANDAMET is 8 mg rosiglitazone plus 2000 mg metformin hydrochloride.
L- ogħla doża ta ’ AVANDAMET rakkomandata hija 8 mg rosiglitazone u 2000mg metformin hydrochloride.
The total daily dose of AVANDAMET should be given in two divided doses.
Id- doża totali ta ’ kuljum ta ’ AVANDAMET għandha tingħata f’ żewġ dożi maqsumin.
Dose titration with rosiglitazone (added to the optimal dose of metformin) may be considered before the patient is switched to AVANDAMET.
Qabel ma ’ l- pazjent jinqaleb fuq AVANDAMET, wieħed jista jnaqqas d- doża b’ rosiglitazone (billi jżidu ma ’ l- aħjar doża ta ’ metformin).
When clinically appropriate, direct change from metformin monotherapy to AVANDAMET may be considered.
Meta jkun jixraq klinikament, wieħed jista jaqleb minn metformin waħdu għal AVANDAMET mill - ewwel.
Taking AVANDAMET with or just after food may reduce gastrointestinal symptoms associated with metformin.
AVANDAMET, meħud waħdu jew eżatt wara l- ikel jista jnaqqas is- sintomi gastro- intestinali assoċjati ma ’ metformin.
Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4)
Terapija orali trippla (rosiglitazone, metformin u sulphonylurea) (ara sezzjoni 4. 4)
- Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at
- Pazjenti li qed jieħdu metformin u sulphonylurea: fejn xieraq AVANDAMET jista ’ jinbeda
4 mg/ day rosiglitazone with the dose of metformin substituting that already being taken.
d’ doża ta 4mg kuljum rosiglitazone bid- doża ta ’ metformin minflok dik li tkun qed tittieħed
An increase in the rosiglitazone component to 8 mg/ day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see sections 4.4 and 4.8).
Żjieda fil- komponent ta ’ rosiglitazone għal 8 mg kuljum trid tiġi magħmula b’ attenzjoni wara evalwazzjoni klinika xierqa li tistabbilixxi r- riskju li pazjent jista ’ jiżviluppa effetti sekondarji relatati ma ’ retenzjoni ta ’ fluwidu (ara sezzjonijiet 4. 4 u 4. 8).
- Patients established on triple oral therapy: when appropriate, AVANDAMET may substitute
- Pazjenti stabbiliti fuq terapija orali trippla: meta xieraq, AVANDAMET tista ’ tintuża minflok
rosiglitazone and metformin doses already being taken.
id- dożi ta ’ metformin u rosiglitazone li qed jittieħdu diġà.
Where appropriate, AVANDAMET may be used to substitute concomitant rosiglitazone and metformin in existing dual or triple oral therapy to simplify treatment.
Meta xieraq, AVANDAMET jista ’ jintuża biex jisostitwixxi użu konkomitanti ta ’ rosiglitazone u metformin f’ terapija orali doppja jew trippla diġà stabbilita biex tissimplifika t- trattament.
Elderly As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking AVANDAMET should have their renal function monitored regularly (see sections 4.3 and 4.4).
L- Anzjani Billi metformin jitneħħa mill- ġisem permezz tal- kliewi, u l- funzjoni tal- kliewi fl- anzjani spiss tkun imnaqqsa, pazjenti anzjani li jieħdu AVANDAMET għandu jkollhom il- funzjoni tal- kliewi segwita regolarment (ara sezzjonijiet 4. 3 u 4. 4).
Patients with renal impairment AVANDAMET should not be used in patients with renal failure or renal dysfunction, e. g. serum creatinine levels > 135 μ mol/ l in males and > 110 μ mol/ l in females and/ or creatinine clearance < 70 ml/ min (see sections 4.3 and 4.4).
Pazjenti b’ funzjoni tal- kliewi baxxa AVANDAMET m’ għandux jintuża f’ pazjenti b’ insuffiċjenza tal- kliewi jew fejn il- kliewi ma jaħdmux sew, eż. livelli seroloġiċi ta ’ krejatinina > 135µmol/ l fl- irġiel u > 110µmol/ l fin- nisa u/ jew clearance tal- krejatinina < 70 ml/ min (ara sezzjonijiet 4. 3 u 4. 4).
Children and adolescents AVANDAMET is not recommended for use in children and adolescents below 18 years of age as there are no data available on its safety and efficacy in this age group (see sections 5.1 and 5.2).
Tfal u adoloxxenti AVANDAMET mhux rakkomandat għal użu fi tfal u adoloxxenti ta ’ taħt it- 18- il sena għax m’ hemmx biżżejjed informazzjoni dwar is- sigurta` u l- effikaċja tiegħu f’ din l- eta (ara sezzjoni 5. 1 u 5. 2).
AVANDAMET is contraindicated in patients with:
AVANDAMET m’ għandux jintuża f’ pazjenti b ’:
- an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4)
− sensittività eċċessiva għal rosiglitazone, għal metformin hydrochloride jew għal xi sustanzi mhux attivi − insuffiċjenza tal- qalb jew passat ta ’ din il- kundizzjoni (stadji tan - New York Heart Association (NYHA) I sa IV) − Sindromu Koronarju Akut (anġina instabbli, NSTEMI u STEMI) (ara sezzjoni 4. 4) − mard akut jew kroniku li jista jikkawża nuqqas ta ’ ossiġnu fil- livell ċellolari bħal: − falliment tas- sistema tal- qalb jew respiratorja − infart tal- qalb reċenti − xokk − indeboliment tal- fwied − intossikazzjoni akuta bl- alkoħol, vizzju ta ’ xorb alkoħoliku eċċessiv (ara sezzjoni 4. 4) − stat dijabetiku ta ’ ketoaċidożi jew stat dijabetiku pre- koma − insuffiċjenza tal- kliewi jew il- kliewi ma jaħdmux sew eż. livelli seroloġiċi tal- krejatinina > 135 µmol/ l fl- irġiel > 110µmol/ l fin- nisa u/ jew tneħħija ta ’ kreatinina ta ’ < 70 ml/ min (ara sezzjoni. 4) − kundizzjonijiet akuti li jistgħu jibdlu l- funzjoni tal- kliewi bħal: − nuqqas ta ’ ilma fil- ġisem − infezzjoni qawwija − xokk − amministrazzjoni intravaskulari ta ’ kimiċi għall- kuntrast li fihom Iodine (ara sezzjoni 4. 4) − nisa li qed ireddgħu.
Lactic acidosis Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation.
Aċidożi Lattika Il- livell għoli ta ’ l- aċidu lattiku hija kumplikazzjoni metabolika, rari ħafna iżda serja, li tista ’ tiġri meta jakkumula metformin.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Każijiet rapportati ta ’ livell għoli ta ’ aċidu lattiku f’ pazjenti fuq metformin ġraw l- iżjed f- pazjenti dijabetiċi b’ insuffiċjenza sinifikanti tal- kliewi.
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis,
L- inċidenza ta ’ aċidozi lattika
3 prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia.
3 tista ’ u għandha tkun imnaqqsa billi wieħed jikkunsidra wkoll fatturi oħra li jżidu r- riskju bħal dijabete mhux ikkontrollata sew, livell għoli ta ’ ketones, sawm fit- tul, xorb alkoħoliku eċċessiv, insuffiċjenza tal- fwied u kull kundizzjoni assoċjata man- nuqqas ta ’ ossiġnu.
Diagnosis:
Dijanjożi:
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
L- aċidożi lattika hija ikkaratterizzata b’ dispnja aċidotika, uġigħ addominali u ipotermja li jwasslu għal koma.
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/ l and an increased anion gap and lactate/ pyruvate ratio.
Karatteristiċi dijanjostiċi tal- laboratorju huma pH tad- demm baxx, livelli tal- lactate fil- plażma ‘ l fuq minn 5 mmol/ l u żjieda fl- anion gap u l- proporzjon ta ’ lactate/ pyruvate.
If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9).
Jekk wieħed jissuspetta li hemm stat ta ’ aċidożi metabolika, il- kura bil- prodott mediċinali għandha titwaqqaf u l- pazjent jiddaħħal l- isptar immedjatament (ara sezzjoni 4. 9).
Renal function As metformin is excreted by the kidney, serum creatinine concentrations should be determined regularly:
Il- funzjoni tal- kliewi Billi huma l- kliewi li jneħħu l- metformin mill- ġisem, il- konċentrazzjoni seroloġika tal- krejatinina għandha tiġi iddeterminata regolarment:
- at least once a year in patients with normal renal function
- mill- anqas darba fis- sena f’ pazjenti fejn il- kliewi jaħdmu sew
- at least two to four times a year in patients with serum creatinine levels at the upper limit of
- mill- anqas darbtejn sa erba ’ darbiet fis- sena f’ pazjenti meta l- livell seroloġiku tal- krejatinina
normal and in elderly patients.
jkun fin- naħa ta ’ fuq tan- normali u fl- anzjani.
Decreased renal function in elderly patients is frequent and asymptomatic.
Fl- anzjani, ta ’ spiss ikun hemm tnaqqis fil- funzjoni tal- kliewi bla sintomi.
Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with an NSAID.
Attenzjoni speċjali għandha tingħata f’ sitwazzjonijiet fejn il- funzjoni tal- kliewi tista tiġi mnaqqsa, bħal meta tkun ser tinbeda xi kura kontra l- pressjoni għolja jew dijuretika jew meta tkun ser tinbeda xi kura bin- NSAID.
Fluid retention and cardiac failure Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
Retenzjoni ta ’ fluwidu u insuffiċjenza tal- qalb Thiazolidinediones jistgħu iwasslu għal retenzjoni ta ’ fluwidu u din tista ’ tħarrax jew tipprovoka sinjali jew sintomi ta ’ insuffiċjenza tal- qalb konġestiva Rosiglitazone jista ’ jikkawża retenzjoni ta ’ fluwidu li tiddependi mid- doża.
Rosiglitazone can cause dose-dependent fluid retention.
Il- kontribuzzjoni possibbli tar- retenzjoni ta ’ fluwidu għal żjieda fil- piż għandha tiġi valutata individwalment billi żjieda ta ’ malajr u eċċessiva ta ’ piż ġiet rappurtata rari ħafna bħala sinjal ta ’ retenzjoni ta ’ fluwidu.
AVANDAMET must be discontinued if any deterioration in cardiac status occurs.
Il- pazjenti kollha, speċjalment dawk li qed jieħdu t- trattament flimkien ma ’ l- insulina u sulphonylurea, dawk li għandhom riskju ta ’ insuffiċjenza tal- qalb u dawk b’ riżerva tal- qalb mnaqqsa, għandhom jiġu monitorjati għal xi sinjali jew sintomi ta ’ effetti sekondarji li għandhom x’ jaqsmu ma retenzjoni ta ’ fluwidu, inklużi żjieda fil- piż u insuffiċjenza tal- qalb. AVANDAMET għandu jitwaqqaf fil- każ ta ’ xi deterjorament fl- istat kardijaku.
The use of AVANDAMET in combination with a sulphonylurea or insulin may be associated with increased risks of fluid retention and heart failure (see section 4.8).
L- użu ta ’ AVANDAMET flimkien ma sulphonylurea jew insulina jista ’ jkun assoċjat ma riskji akbar ta ’ retenzjoni tal- fluwidu jew insuffiċjenza tal- qalb (ara sezzjoni 4. 8).
The decision to initiate AVANDAMET in combination with a sulphonylurea should include consideration of alternative therapies.
Qabel tittieħed id- deċiżjoni li jinbeda AVANDAMET flimkien ma sulphonylurea għandhom jiġu kkunsidrati terapiji alternattivi.