qanastek/EMEA-V3 huggingface dataset:
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 18 April 2006 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġar tar- Riskju L- MAH jintrabat li jagħmel l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mniżżlin fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni tat- 18 ta ’ April 2006 tal- Pjan dwar l- Immaniġġar tar - Riskju (RMP) ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ kull aġġornament ta ’ l- RMP li jista ’ jkun hemm u li jkun qabel miegħu is- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Kif hemm fil- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għal prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien mar- Rapport ta ’ Aġġornament Perjodiku dwar is- Sigurtà (PSUR) li jkun imiss.
26 The Marketing Authorisation Holder will continue to submit yearly PSURs.
Barra minn hekk, RMP aġġornat għandu jiġi ppreżentat:
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Meta jkun hemm informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjonijiet tas - Sigurtà, fuq il- Pjan ta ’ Farmakoviġilanza jew fuq l- attivitajiet li jnaqqsu ir- riskju li jkunu jgħoddu f’ dak il- mument.
MOD or vasopressor dependent septic shock) when treated within a strictly defined time window, to assert the benefit/ risk profile of Xigris .”
Fi żmien 60 ġurnata li jkun milħuq xi avveniment importanti (ta ’ farmakoviġilanza jew tat- tnaqqis tar- riskju)
27 ANNEX III
27 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jkompli jippreżenta l- PSUR’ s kull sena.
LABELLING AND PACKAGE LEAFLET
Aspetti kliniċi
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
TIKKETTA
Xigris 20 mg powder for solution for infusion drotrecogin alfa (activated)
Xigris 20 mg trab għal soluzzjoni għall- infużjoni drotrecogin alfa (attivat)
Each vial contains 20 mg of Drotrecogin alfa (activated).
Kull kunjett fih 20 mg ta ’ Drotrecogin alfa (attivat).
After reconstitution with 10 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Wara r- rikostituzzjoni b’ 10 ml ta ’ Ilma għall- Injezzjonijiet kull ml fih 2 mg ta ’ Drotrecogen alfa (attivat)
Excipients: sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid and sodium hydroxide.
Sustanzi mhux attivi: sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid u sodium hydroxide.
1 vial, powder for solution for infusion.
Kunjett wieħed, trab għal soluzzjoni għall- infużjoni.
For intravenous infusion after reconstitution and dilution.
Għall- infużjoni minn ġol- vina wara li jiġi rikostitwit u dilwit.
Eli Lilly Nederland B. V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA, Houten, L- Olanda
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL TEXT
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KITBA FUQ IL- KUNJETT
Xigris 20 mg powder for infusion For intravenous infusion after reconstitution and dilution
Xigris 20mg trab għal infużjoni
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KITBA FUQ IL- KARTUNA TA ’ BARRA
Xigris 5 mg powder for solution for infusion drotrecogin alfa (activated)
Xigris 5 mg trab għal soluzzjoni għall- infużjoni drotrecogin alfa (attivat)
Each vial contains 5 mg of Drotrecogin alfa (activated).
Kull kunjett fih 5 mg ta ’ Drotrecogin alfa (attivat).
After reconstitution with 2.5 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Wara r- rikostituzzjoni b’ 2. 5 ml ta ’ Ilma għall- Injezzjonijiet kull ml fih 2 mg ta ’ Drotrecogen alfa (attivat)
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL TEXT
35 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KITBA FUQ IL- KUNJETT
Xigris 5 mg powder for infusion For intravenous infusion after reconstitution and dilution
Xigris 5 mg trab għal infużjoni
Xigris 20 mg powder for solution for infusion Drotrecogin alfa (activated)
Xigris 20 mg trab għal soluzzjoni għall- infużjoni Drotrecogin alfa (attivat)
Please read all of this leaflet carefully.
Aqra sew dan il- fuljett kollu.
Please remember that you cannot take Xigris by yourself because both your illness and the use of this medicine need constant medical care.
Ftakar li ma tistax tieħu Xigris waħdek billi kemm il- marda tiegħek kif ukoll l- użu ta ’ din il- mediċina għandhom bżonn ta ’ attenzjoni medika kontinwa.
What Xigris is and what it is used for 2.
X’ inhu Xigris u għalxiex jintuża 2.
Before you are given Xigris 3.
Qabel ma tieħu Xigris 3.
How Xigris is used 4.
Kif għandek tuża Xigris 4.
How to store Xigris 6.
Kif taħżen Xigris 6.
WHAT XIGRIS IS AND WHAT IT IS USED FOR
X’ INHU XIGRIS U GĦALXIEX JINTUŻA
Xigris is very similar to a protein that occurs naturally in your blood.
Xigris huwa simili ħafna għal proteina li tinsab naturali f’ demmek.
This protein helps to control blood clotting and inflammation.
Din il- proteina tgħin biex jiġi kkontrollat it- tagħqid tad- demm u l- infjammazzjoni.
When your body has a severe infection, clots can form in your blood.
Meta ġismek ikollu infezzjoni qawwija, demmek jista ’ jifforma biċċiet magħqudin tad- demm.
These can block the blood supply to important parts of your body such as the kidneys and lungs.
Dawn jistgħu jibblukkaw il- provvista tad- demm għal partijiet importanti ta ’ ġismek bħall- kliewi u l- pulmuni.
This causes an illness called severe sepsis which can make you very ill.
Dan jikkawża marda msejħa sepsis serja li tista ’ tmarrdek ħafna.
Some people will die from this illness.
Xi nies imutu minn din il- marda.
Xigris helps your body to get rid of the clots and also reduces the inflammation caused by the infection.
Xigris jgħin lil ġismek jeħles mill- biċċiet magħqudin tad- demm kif ukoll inaqqas l- infjammazzjoni kkawżata mill- infezzjoni.
Xigris is used to treat adults with severe sepsis.
Xigris jintuża għall- kura ta ’ adulti b’ sepsis serja.
BEFORE YOU ARE GIVEN XIGRIS
QABEL MA TIEĦU XIGRIS
You should not be given Xigris:
M’ għandux jingħatalek Xigris
- if you are allergic (hypersensitive) to drotrecogin alfa (activated) or any of the other ingredients
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal drotrecogin alfa (attivat), jew sustanzi
of Xigris, or bovine (cattle-derived) thrombin (protein)
oħra ta ’ Xigris, jew trombina (proteina) bovina (ġejja mill- baqar)
- if you have internal bleeding
- jekk għandek fsada interna
- if you have a brain tumour, or pressure on the brain
- jekk għandek tumur fil- moħħ, jew pressjoni fuq il- moħħ
- if you are being given heparin at the same time (≥ 15 International Units/ kg/ hr)
- jekk qiegħed fuq terapija b’ eparina fl- istess żmien (≥ 15 Unità Internazzjonali / kg/ siegħa)
- if you have a bleeding tendency which is not related to sepsis
- jekk għandek tendenza ta ’ fsada mhux relatata mas- sepsis
- if you have a long-standing, severe problem with your liver
- jekk għandek problema serja fil- fwied li ilha ħafna
- if your platelet (a type of cell in your blood) count is low, even if this has been increased by a
- jekk l- għadd ta ’ plejtlits (tip ta ’ ċellola fid- demm) ikun baxx, anki jekk dan ikun żdied
transfusion
b’ trasfużjoni
- if you are at high risk of bleeding (for example):
- jekk għandek riskju kbir ta ’ fsada (per eżempju):
you have been born with bleeding tendencies you have bled from your bowels within the last six weeks, unless treated adequately you have had a major accident and are at increased risk of bleeding
a) jekk kellek kirurġija fi żmien tnax- il siegħa qabel ma tingħata Xigris, jew fsada minn kirurġija preċedenti, jew kirurġija fl- istess żmien li tkun qed tingħata Xigris b) jekk dħalt fl- isptar minħabba trawma serja tar- ras, jew kellek kirurġija tal- moħħ jew ta ’ l - ispina, jew kellek fsada fil- moħħ (puplesija emorraġika) fl- aħħar tliet xhur, jew għandek vini jew arterji anormali fil- moħħ, jew massa fir- ras; għandek kateter epidurali (tubu fl- ispina)
Special care should be taken with Xigris if you are at risk of bleeding, for example:
38 c) jekk għandek tendenzi ta ’ fsada mit- twelid d) jekk kellek fsada mill- imsaren fl- aħħar sitt ġimgħat, sakemm ma saritx il- kura neċessarja e) jekk kellek inċident serju u għandek riskju akbar ta ’ fsada
- if you are taking other medicines which affect how your blood clots (for example medicines that
Oqgħod attent ħafna b’ Xigris jekk għandek riskju ta ’ fsada, per eżempju: – jekk qiegħed tieħu mediċini oħra li jaffettwaw kif jagħqad id- demm( per eżempju mediċini li jħollu l- koaguli tad- demm, iraqqu d- demm jew mediċini li jinibixxu l- plejtlits bħall- aspirina) – jekk fl- aħħar tliet xhur kellek puplesija minħabba biċċiet magħqudin tad- demm – jekk għandek problema ta ’ fsada li taf biha
Xigris should not be used if you have a less severe form of sepsis (only one organ failure) and have recently had a surgical operation.
Xigris m’ għandux jintuża jekk għandek xi tip inqas serju ta ’ sepsis (insuffiċjenza ta ’ organu wieħed biss) u reċentement kellek xi operazzjoni
Xigris is not recommended in children below the age of 18 and therefore it should not be used in children.
Xigris m’ huwiex rakkomandat għal tfal taħt it- 18- il sena u għalhekk m’ għandux jiġi użat fit- tfal.
Caution should be employed when Xigris is used with other medicines that affect how your blood clots (for example medicines that dissolve blood clots, thin the blood, or medicines that inhibit platelets such as aspirin, non-steroidal anti-inflammatory medicines, or clopidogrel).
Trid toqgħod attent meta Xigris jingħata ma ’ mediċini oħra li jaffettwaw il- mod kif jgħaqqad id- demm (per eżempju mediċini li jħollu l- koaguli tad- demm, iraqqu d- demm jew mediċini li jinibixxu l- plejtlits bħall- aspirina, mediċini antiinfjammatorji li m’ humiex sterojdi jew clopidegrol).
Pregnancy and breast-feeding It is not known whether drotrecogin alfa (activated) causes damage to an unborn child or affects your ability to have babies.
Tqala u Treddigħ Mhux magħruf jekk drotrecogin alfa (attivat) jagħmilx ħsara lit- tarbija fil- ġuf jew jekk jaffettwax l - abbiltà li jkollok tfal.
If you are pregnant your doctor will only give you Xigris if necessary.
Fit- tqala Xigris jingħata biss jekk ikun neċessarju.
It is not known whether drotrecogin alfa (activated) appears in human milk and therefore you should not breast-feed whilst treated with Xigris.
Mhux magħruf jekk drotrecogin alfa (attivat) johroġx fil- ħalib tal- bniedem u għalhekk m’ għandux isir treddigħ waqt il- teħid ta ’ Xigris.
Important information about some of the ingredients of Xigris This medicinal product contains approximately 68 mg sodium per vial.
Għal kull kunjett dan il- prodott mediċinali fih madwar 68 mg ta ’ sodium.
To be taken into consideration by patients on a controlled sodium diet.
Pazjenti li qegħdin fuq dieta ta ’ restrizzjoni ta ’ sodium għandhom jagħtu kas ta ’ dan il- fatt.
HOW XIGRIS IS USED
KIF GĦANDEK TIEĦU XIGRIS
The recommended dose of Xigris is 24 micrograms (µg) per kilogram (kg) of body weight each hour for 96 hours.
Id- doża rrakkomandata ta ’ Xigris hija 24 mikrogrammi (µg) kull kilogramm (kg) tal- piż tal- ġisem kull siegħa għal 96 siegħa.
A hospital pharmacist, nurse or doctor will have dissolved the Xigris powder in water for injection and sodium chloride solution.
Spiżjar fl- isptar, infermier jew tabib ikun ħall it- trab Xigris fl- ilma għall- injezzjonijiet u soluzzjoni ta ’ sodium chloride.
This liquid is then passed from a bag through a tube into one of your veins for a period of 96 hours.
Dan il- likwidu mbagħad jgħaddi minn ġo borża permezz ta ’ tubu għal ġo waħda mill- vini tiegħek għal perijodu ta ’ 96 siegħa
Like all medicines, Xigris can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Xigris jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Xigris increases the risk of bleeding which can be serious or life-threatening.
Xigris jista ’ jżid ir- riskju ta ’ fsada li jista ’ jkun serju jew ta ’ periklu għall- ħajja.
Bleeding into the brain was uncommon, occurring in 0.2% (1 in 500) of patients treated with Xigris.
Fsada serja waqt il - perijodu ta ’ l- infużjoni seħħet f’ 1% (1 minn kull 100) ta ’ pazjenti b’ sepsis serja u f’ 2. 4% (madwar 1 minn kull 40) ta ’ pazjenti kkurati b’ Xigris, bil- parti l- kbira tal- fsada fiż- żewġ gruppi jkun fl- istonku u fl- imsaren. Fsada fil- moħħ ma kinitx komuni, seħħet f’ 0. 2% (1 minn kull 500) ta ’ pazjenti kkurati b’ Xigris.
STORING XIGRIS
KIF TAĦŻEN XIGRIS
Do not use after the expiry date stated on the label.
Tużahx wara d- data ta ’ skadenza li tidher fuq it- tikketta
Keep the vial in the carton in order to protect it from light.
Żomm il- kunjett fil- kartuna sabiex tilqa ’ mid- dawl.
What Xigris contains
X’ fih Xigris:
- The active substance is 20 mg of drotrecogin alfa (activated) in each vial.
- Is- sustanza attiva hija 20 mg ta ’ drotrecogin alfa (attivat) f’ kull kunjett.
Drotrecogin alfa
Drotrecogin alfa huwa
- The other ingredients are sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid
verżjoni ta ’ Proteina Ċ Attivata li hija proteina naturali li tinsab fid- demm u huwa magħmul b’ teknoloġija rikombinanti. – Is- sustanzi l- oħra huma sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid u sodium hydroxide.
What Xigris looks like and contents of the pack Xigris is presented as a powder for solution for infusion in a vial.
Id- Dehra ta ’ Xigris u l- kontenuti tal- pakkett Xigris jiġi bħala trab għal soluzzjoni għall- infużjoni f’ kunjett
After reconstitution with 10 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Kunjett fih 20 mg ta ’ drotrecogin alfa (attivat). Wara r- rikostituzzjoni b’ 10 ml ta ’ Ilma għall - Injezzjonijiet kull ml fih 2 mg ta ’ Drotrecogin alfa (attivat).
Lilly Pharma Fertigung und Distribution GmbH & Co.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ L- Awtorizzazzjoni Għat- Tqegħid fis- Suq: Eli Lilly Nederland B. V., Grootslag 1- 5, 3991 RA, Houten, L- Olanda Manifattur: Lilly Pharma Fertigung und Distribution GmbH & Co.
KG, Teichweg 3, D- 35396 Giessen, Germany.
KG, Teichweg 3, D - 35396 Giessen, Il- Ġermanja.
Τηλ: +30 210 629 4600
Τηλ: +30 210 629 4600 España
39 España Lilly S. A.
Lilly S. A.
Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600 România Eli Lilly România S. R. L.
Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351- 21- 4126600 România Eli Lilly România S. R. L.
This means that for scientific reasons it has been impossible to get complete information on this medicine.
Din il- mediċina kienet awtorizzata taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’. Dan ifisser li għal raġunijiet xjentifiċi kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
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 Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. < ---------------------------------------------------------------------------------------------------------------------
40 The following information is intended for medical or healthcare professionals only:
41 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Instructions for use and handling
Struzzjonijiet għall- użu u mmaniġġar
Use appropriate aseptic technique during the preparation of Xigris for intravenous administration.
Uża teknika asettika adattata matul il- preparazzjoni biex Xigris jingħata fil- vina.
Each Xigris vial contains 20 mg of drotrecogin alfa (activated).
Kull kunjett ta ’ Xigris fih 20 mg drotrecogin alfa (attivat).
Slowly add the Sterile Water for Injection to the vial and avoid inverting or shaking the vial.
Żid l- Ilma Sterili għall- Injezzjoni fil- kunjett bil- mod u evita li taqleb ta ’ taħt fuq jew li tħawwad il- kunjett.
The solution of reconstituted Xigris must be further diluted with sterile 0.9% Sodium Chloride Injection.
Is- soluzzjoni ta ’ Xigris rikostitwit trid tkompli tiġi dilwita b’ injezzjoni sterili ta ’ 0. 9% sodium chloride.
When adding the reconstituted drotrecogin alfa (activated) into the infusion bag, direct the stream to the side of the bag to minimise the agitation of the solution.
Meta tkun qed iżżid d- drotrecogin alfa (attivat) rikostitwit fil- borża ta ’ infużjoni, iddirezzjona s- soluzzjoni lejn il- ġenb tal- borża biex tnaqqas kemm jista ’ jkun l - aġitazzjoni tas- soluzzjoni.
Do not transport the infusion bag between locations using mechanical delivery systems.
Tmexxix il- borża ta ’ infużjoni minn post għall- ieħor billi tuża sistemi tat- trasport mekkaniċi
However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15 to 30ºC).
Madanakollu, s - soluzzjoni rikostitwita fil- kunjett tista ’ tinżamm sa 3 sigħat fit- temperatura ambjentali (15 sa 30ºC).
After preparation, the intravenous infusion solution can be used at room temperature (15 to 30ºC) for a period up to 14 hours.
Wara l- preparazzjoni, is- soluzzjoni għall- infużjoni fil- vina tista ’ tintuża fit- temperatura ambjentali (15 sa 30ºC) għal perijodu sa 14- il siegħa.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Prodotti mediċinali parenterali għandhom ikunu spezzjonati viżwalment għal xi frak u tibdil fil - kulur qabel jingħataw.
It is recommended that Xigris be infused with an infusion pump to accurately control the infusion rate.
Huwa rrakomandat li Xigris jiġi infuż b’ pompa għall- infużjoni sabiex tiġi kkontrollata bi preċiżjoni r- rata ta ’ infużjoni.
The solution of reconstituted Xigris should be diluted into an infusion bag containing sterile 0.9% Sodium Chloride Injection to a final concentration of between 100 µg/ ml and 200 µg/ ml.
Is- soluzzjoni ta ’ Xigris rikostitwit għandha tiġi dilwita f’ borża ta ’ infużjoni li fiha injezzjoni sterili ta ’ 0. 9% Sodium Chloride sakemm tintlaħaq konċentrazzjoni finali ta ’ bejn 100 µg/ ml u 200 µg/ ml.
41 The use of other types of infusion sets could have a negative impact on the amount and potency of drotrecogin alfa (activated) administered.
L- użu ta ’ tipi oħra ta ’ settijiet ta ’ l- infużjoni jista ’ jkollhom impatt negattiv fuq l- ammont u l- qawwa ta ’ drotrecogin alfa (attivat) li jiġi mogħti.
Care should be taken to administer Xigris at the appropriate rate, calculated based on kg of bodyweight and infused for the correct duration.
Trid tittieħed attenzjoni biex Xigris jingħata b’ rata adattata, ikkalkulata fuq bażi tal- piż tal - ġisem f’ kg u infuża għal tul ta ’ żmien korrett.
It is recommended that the bag be labelled accordingly.
Huwa rrakkomandat li l- borża jkollha t- tiketta kif xieraq.
42 PACKAGE LEAFLET:
43 FULJETT TA ’ TAGĦRIF:
Xigris 5 mg powder for solution for infusion Drotrecogin alfa (activated)
Xigris 5 mg trab għal soluzzjoni għall- infużjoni Drotrecogin alfa (attivat)
You should not be given:
M’ għandux jingħatalek Xigris
you have had surgery within the last twelve hours before you receive Xigris, or you are bleeding from a previous surgery, or you might have surgery while you receive Xigris
kirurġija preċedenti, jew kirurġija fl- istess żmien li tkun qed tingħata Xigris
you have been in hospital with a severe injury to your head, or you have had surgery on your brain or spine, or you have had a bleed in your brain (haemorrhagic stroke) within the past three months, or you have abnormal blood vessels in your brain, or a mass in your head; you have an epidural catheter (a tube in your spine)
jekk dħalt fl- isptar minħabba trawma serja tar- ras, jew kellek kirurġija tal- moħħ jew ta ’ l - ispina, jew kellek fsada fil- moħħ (puplesija emorraġika) fl- aħħar tliet xhur, jew għandek vini jew arterji anormali fil- moħħ, jew massa fir- ras; għandek kateter epidurali (tubu fl - ispina)
c) d) e)
c)
Special care should be taken with Xigris if you are at risk of bleeding, for example:
jekk għandek tendenzi ta ’ fsada mit- twelid
- if you are taking other medicines which affect how your blood clots (for example medicines that
44
dissolve blood clots, thin the blood, or medicines that inhibit platelets such as aspirin)
d) e)
- if within the last three months, you have had a stroke caused by a blood clot
jekk kellek fsada mill- imsaren fl- aħħar sitt ġimgħat, sakemm ma saritx il- kura neċessarja jekk kellek inċident serju u għandek riskju akbar ta ’ fsada
- if you have a known problem with bleeding
Oqgħod attent ħafna b’ Xigris jekk għandek riskju ta ’ fsada, per eżempju: – jekk qiegħed tieħu mediċini oħra li jaffettwaw kif jagħqad id- demm( per eżempju mediċini li jħollu l- koaguli tad- demm, iraqqu d- demm jew mediċini li jinibixxu l- plejtlits bħall- aspirina) – jekk fl- aħħar tliet xhur kellek puplesija minħabba biċċiet magħqudin tad- demm – jekk għandek problema ta ’ fsada li taf biha
Important information about some of the ingredients of Xigris This medicinal product contains approximately 17 mg sodium per vial.
Għal kull kunjett dan il- prodott mediċinali fih madwar 17 mg ta ’ sodium.
Do not use after the expiry date stated on the label.
45 Tużahx wara d- data ta ’ skadenza li tidher fuq it- tikketta
- The active substance is 5 mg of drotrecogin alfa (activated) in each vial.
- Is- sustanza attiva hija 5 mg ta ’ drotrecogin alfa (attivat) f’ kull kunjett.
After reconstitution with 2.5 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Kunjett fih 5 mg ta ’ drotrecogin alfa (attivat). Wara r- rikostituzzjoni b’ 2. 5 ml ta ’ Ilma għall - Injezzjonijiet kull ml fih 2 mg ta ’ Drotrecogin alfa (attivat).
Tel.: +48 (0) 22 440 33 00
Tel.: +48 (0) 22 440 33 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351- 21- 4126600 România Eli Lilly România S. R. L.
Tel: +34- 91 749 76 98 France Lilly France SAS Tél: +33-(0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 Ísland Eli Lilly Danmark A/ S, Útibú á Íslandi Sími: + 354 520 34 00 Italia Eli Lilly Italia S. p. A.
Tél: +33 - (0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353 - (0) 1 661 4377 Ísland Eli Lilly Danmark A/ S, Útibú á Íslandi Sími: + 354 520 34 00 Italia Eli Lilly Italia S. p. A.
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 Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
46 The following information is intended for medical or healthcare professionals only:
47 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Each Xigris vial contains 5 mg of drotrecogin alfa (activated).
Kull kunjett ta ’ Xigris fih 5 mg drotrecogin alfa (attivat).
Prior to administration, 5 mg vials of Xigris must be reconstituted with 2.5 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ ml drotrecogin alfa (activated).
Qabel jingħata, il- kunjetti ta ’ 5 mg ta ’ Xigris għandhom jiġu rikostitwiti b’ 2. 5 ml Ilma Sterili għall- Injezzjoni, li jirriżulta f’ soluzzjoni b’ konċentrazzjoni ta ’ madwar 2 mg/ ml drotrecogin alfa (attivat).
No incompatibilities have been observed between drotrecogin alfa (activated) and glass infusion bottles or infusion bags made of polyvinylchloride, polyethylene, polypropylene, or polyolefin.
Ma ġewx innutati inkompatibilitajiet bejn drotrecogin alfa (attivat) u fliexken ta ’ l -
47 The use of other types of infusion sets could have a negative impact on the amount and potency of drotrecogin alfa (activated) administered.
L- użu ta ’ tipi oħra ta ’ settijiet ta ’ l- infużjoni jista ’ jkollhom impatt negattiv fuq l- ammont u l- qawwa ta ’ drotrecogin alfa (attivat) li jiġi mogħti.
What is Xiliarx?
X’ inhu Xiliarx?
Xiliarx is a medicine containing the active substance vildagliptin.
Xiliarx huwa mediċina li fiha s- sustanza attiva vildagliptin.
The company that makes Galvus has agreed that its scientific data can be used for Xiliarx.
Il - kumpanija li tipproduċi Galvus qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Xiliarx.
What is Xiliarx used for?
Għal xiex jintuża Xiliarx?
Xiliarx is used to treat type 2 diabetes mellitus (non-insulin-dependent diabetes).
Xiliarx jintuża għat- trattament tad- dijabete mellitu tat- 2 tip (dijabete mhux dipendenti mill- insulina).
Xiliarx can be used with metformin, a thiazolidinedione or a sulphonylurea, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.
Xiliarx jista ’ jintuża mal- metformina, thiazolidinedione jew sulfonilurea, iżda jintuża biss f’ kombinazzjoni ma ’ sulfonilurea f’ pazjenti li ma jistgħux jieħdu l- metformina.
How is Xiliarx used?
Kif jintuża Xiliarx?
In adults, the recommended dose of Xiliarx is:  one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione;  one tablet in the morning when taken with a sulphonylurea.
Fl- adulti, id- doża rakkomandata ta ’ Xiliarx hija:  pillola waħda filgħodu u oħra filgħaxija meta użata mal- metformina u ma ’ thiazolidinedione;  pillola waħda filgħodu meta tittieħed ma ’ sulfonilurea.
Xiliarx can be taken with or without food.
Xiliarx jista 'jittieħed fuq stonku vojt jew le.
Xiliarx is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease.
Xiliarx mhuwiex rakkomandat għal pazjenti bi problemi moderati jew gravi fil- kliewi, inkluż dawk f’ emodijaliżi (teknika ta ’ tisfija tad- demm) b’ mard renali fi stat terminali.
Xiliarx is not recommended for patients with liver problems.
Xiliarx mhuwiex rakkomandat għal pazjenti bi problemi fil- fwied.
How does Xiliarx work?
Kif jaħdem Xiliarx?
The active substance in Xiliarx, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Is- sustanza attiva f’ Xiliarx, vildagliptin, hija inibitur tad- dipeptidil peptidażi tat- tip 4 (DPP- 4).
Vildagliptin does 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Billi jżid il- livelli ta ’ ormoni ‘ inkretini ’ fid- demm, vildagliptin jistimula l- frixa biex tipproduċi aktar insulina meta l- livell 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. not work when the blood glucose is low.
Reproduction is authorised provided the source is acknowledged. ta ’ glukożju d- demm ikun għoli.
How has Xiliarx been studied?
Kif ġie studjat Xiliarx?
The effects of Xiliarx were first tested in experimental models before being studied in humans.
L- effetti ta ’ Xiliarx għall- ewwel ġew ittestjati f' mudelli sperimentali qabel ma ġew studjati fil - bniedem.
Xiliarx has also been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Xiliarx ġie studjat ukoll f’ seba ’ studji prinċipali li kienu jinvolvu total ta ’ aktar minn 4, 000 pazjent li jbatu mid- dijabete tat- tip 2 u b’ kontroll insuffiċjenti tal- livelli ta ’ glukożju fid- demm.
Three of these studies looked at the effects of Xiliarx taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it to placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
Tlieta minn dawn l- istudji analizzaw l- effetti ta ’ Xiliarx meta meħud waħdu f’ total ta ’ 2, 198 pazjent mhux ittrattati għad- dijabete qabel, u dan tqabbel ma ’ plaċebo (trattament finta), metformina jew rosiglitazone (thiazolidinedione).
The other four studies compared the effects of Xiliarx, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
L- erba ’ studji l- oħrajn qabblu l- effetti ta ’ Xiliarx, meħud f’ dożi ta ’ 50 jew 100 mg kuljum għal 24 ġimgħa, ma ’ dawk ta ’ plaċebo, meta użat bħala terapija addizzjonali (add- on) għat- trattament eżistenti bil- metformina (544 pazjent), pioglitazone (thiazolidinedione, 463 pazjent), glimepiride (sulfonilurea, 515- il pazjent) jew insulina (296 pazjent).
What benefit has Xiliarx shown during the studies?
X’ benefiċċji wera Xiliarx fl- istudji mwettqa?
Xiliarx reduced levels of HbA1c in all studies.
Xiliarx naqqas il- livelli ta ’ HbA1c fl- istudji kollha.
When used as an add-on to existing treatment for type 2 diabetes, Xiliarx was more effective than placebo in reducing HbA1c levels.
Meta użat bħala terapija addizzjonali għat- trattament eżistenti għad- dijabete tat- tip 2, Xiliarx rriżulta aktar effikaċi minn plaċebo fit- tnaqqis tal- livelli ta ’ HbA1c.
Although adding Xiliarx to existing insulin therapy caused a greater reduction in HbA1c levels than placebo, the size of this effect was too small to be considered meaningful for patients.
Minkejja ż- żieda ta ’ Xiliarx mal- terapija bl- insulina eżistenti kkawżat tnaqqis akbar tal- livelli ta ’ HbA1c meta mqabbla mal- plaċebo, l- entità ta ’ dan l- effett kienet żgħira wisq biex titqies sinifikanti għall- pazjenti.
The company withdrew its application for the use of Xiliarx on its own and as an add-on to insulin during the assessment of the medicine.
Matul il- valutazzjoni tal- mediċina, il- kumpanija irtirat l- applikazzjoni tagħha għall- użu ta ’ Xiliarx waħdu u bħala żieda mal- insulina.
What is the risk associated with Xiliarx?
X’ inhu r- riskju assoċjat ma ’ Xiliarx?
The most common side effect with Xiliarx (seen in between 1 and 10 patients in 100) is dizziness.
L- effett sekondarju l- aktar komuni b’ Xiliarx (li deher f’ bejn pazjent 1 u 10 minn 100) kien sturdament.
For the full list of all side effects reported with Xiliarx, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b’ Xiliarx, ara l- Fuljett ta ’ Tagħrif.
Xiliarx should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Xiliarx ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal vildagliptin jew għal xi ingredjent ieħor tiegħu.
Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Xiliarx and at regular intervals during treatment.
Billi vildagliptin kien assoċjat ma ’ problemi fil- fwied, il- pazjenti għandhom jagħmlu testijiet tal- fwied qabel it- trattament b’ Xiliarx u f’ intervalli regolari matul it- trattament.
Why has Xiliarx been approved?
Għaliex ġie approvat Xiliarx?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Xiliarx’ s benefits in the treatment of type 2 diabetes mellitus are greater than its risks when used as dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji ta ’ Xiliarx fit- trattament tad- dijabete mellitu tat- 2 tip huma ogħla mir- riskji tiegħu meta użat bħala terapija dupliċi orali flimkien mal- metformina, sulfonilurea jew thiazolidinedione.
The Committee recommended that Xiliarx be given marketing authorisation.
Il- Kumitat irrakkomanda li Xiliarx jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Xiliarx:
Aktar tagħrif dwar Xiliarx:
The European Commission granted a marketing authorisation valid throughout the EU for Xiliarx to Novartis Europharm Limited on 19 November 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Xiliarx lil Novartis Europharm Limited fil- 19 ta ’ Novembru 2008.
The full EPAR for Xiliarx can be found here.
L- EPAR sħiħ għal Xiliarx jista ’ jiġi kkonsultat hawn.
Xiliarx 50 mg tablets
Xiliarx 50 mg pilloli
Xiliarx can be administered with or without a meal (see also section 5.2).
Glavus jista ’ jingħata ma ’ ikla jew waħdu (ara wkoll sezzjoni 5. 2).
The use of Xiliarx is not recommended in patients with moderate or severe renal impairment or in haemodialysis patients with end-stage renal disease (ESRD) (see also sections 4.4 and 5.2).
L- użu ta ’ Xiliarx mhux rakkomandat f’ pazjenti b’ indeboliment renali moderat jew sever jew pazjenti fuq emodijalisi b’ mard renali fl- aħħar stadju (ESRD) (ara wkoll sezzjonijiet 4. 4 u 5. 2).
Hepatic impairment Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Indeboliment tal- fwied Xiliarx mgħandux jintuża f’ pazjenti b’ indeboliment tal- fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il- kura > 3 darbiet il- limitu ta ’ fuq tan- normal (ULN) (ara wkoll sezzjonijiet 4. 4 u 5. 2).
Paediatric population (< 18 years) Xiliarx is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Popolazzjoni pedjatrika (< 18- il sena) Xiliarx mhux irrakkomandat għall- użu fit- tfal u adolexxenti peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
General Xiliarx is not a substitute for insulin in insulin-requiring patients.
Ġenerali Xiliarx mhux sostitut ta ’ l- insulina f’ pazjenti li jeħtieġu l- insulina.
Xiliarx should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Xiliarx m’ għandux jintuża f’ pazjenti b’ dijabete tat- tip 1 jew għall- kura ta ’ ketoaċidożi dijabetika.
Therefore, the use of Xiliarx is not recommended in these patients.
Għalhekk, l- użu ta ’ Xiliarx mhux rakkomandat f’ dawn il- pazjenti.
Hepatic impairment Xiliarx should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN.
Indeboliment tal- fwied Xiliarx mgħandux jintuża f’ pazjenti b’ indeboliment tal- fwied, inklużi pazjenti li jkollhom ALT jew AST qabel il- kura ta > 3 darbiet l- ULN.
Liver function tests should be performed prior to the initiation of treatment with Xiliarx in order to know the patient ’ s baseline value.
It- testijiet tal- funzjoni tal- fwied għandhom isiru qabel ma tinbeda l- kura b’ Xiliarx sabiex ikun magħruf il- valur tal- linja bażi tal - pazjent.
Liver function should be monitored during treatment with Xiliarx at three-month intervals during the first year and periodically thereafter.
Il- funzjoni tal- fwied għandha tiġi monitorata waqt il- kura b’ Xiliarx f’ intervalli ta ’ tlett xhur fl- ewwel sena u darba kulltant minn hemm ’ l quddiem.
Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Xiliarx therapy is recommended.
Jekk żieda fl- AST jew ALT ta ’ 3 darbiet il- ULN jew aktar jippersisti, huwa rakkomandat li t- terapija b’ Xiliarx titwaqqaf.
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Xiliarx.
Pazjenti li jiżviluppaw is- suffejra jew sinjali li jindikaw funzjoni anormali tal- fwied għandhom iwaqqfu Xiliarx.
Following withdrawal of treatment with Xiliarx and LFT normalisation, treatment with Xiliarx should not be reinitiated.
Wara t- twaqqif tal- kura b’ Xiliarx u LFT ikun ġie lura għan- normal, il- kura b’ Xiliarx mgħandhiex terġa tinbeda.
Due to lack of human data, Xiliarx should not be used during pregnancy.
Minħabba nuqqas ta ’ dejta fil- bniedem, Xiliarx m’ għandux jintuża waqt it- tqala.
It is not known whether vildagliptin is excreted in human breast milk.
Mhux magħruf jekk Xiliarx joħroġx mal- ħalib tal- mara.
Xiliarx should not be used during lactation.
Xiliarx m’ għandux jintuża waqt it- treddigħ.
Adverse reactions reported in patients who received Xiliarx in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Xiliarx fi studji double blind bħala monoterapija u terapiji miżjuda huma elenkati hawn taħt għall- kull indikazzjoni bil- klassi ta ’ l- organi tas- sistema u frekwenza assoluta.
Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with metformin in double-blind studies (N=208)
5 Tabella 1 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Xiliarx 100 mg kuljum ma ’ metformin fi studji double- blind (N=208)
Adverse reactions reported in patients who received Xiliarx 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Tabella 2 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Xiliarx 100 mg kuljum ma ’ sulphonylurea fi studji double- blind (N=170)
In the pioglitazone add-on study, the absolute weight increases with placebo, Xiliarx 100 mg daily were 1.4 and 2.7 kg, respectively.
Fl- istudju biż- żieda ta ’ pioglitazone, il- piż assolut jiżdied bil- plaċebo u b’ Xiliarx 100 mg kuljum kienu 1. 4 u 2. 7 kg rispettivament.
Adverse reactions reported in patients who received Xiliarx 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
6 Tabella 3 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Xiliarx 100 mg flimkien ma ’ thiazolidinedione fi studji double- blind (N=158)
Adverse reactions reported in patients who received Xiliarx 100 mg daily as monotherapy in double-blind studies (N=1,855)
Tabella 4 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċievew Xiliarx 100 mg kuljum bħala monoterapija fi studji double- blind (N=1, 855)
Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Xiliarx for 10 days.
L- informazzjoni dwar x’ aktarx li jkunu s- sintomi ta ’ doża eċċessiva inkisbu minn studju dwar it - tolleranza għal doża ta ’ Xiliarx miżjuda mogħtija lill- individwi b’ saħħithom għal 10 ijiem.
7 In the event of an overdose, supportive management is recommended.
7 F’ każ ta ’ doża eċċessiva, huwa rakkomandat maniġġar ta ’ support.
Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA-  (Homeostasis Model Assessment–), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Kura b’ vildagliptin 50- 100 mg kuljum f’ pazjenti bid- dijabete tat- tip 2 tejbet b’ mod sinifikanti l- markaturi tal- funzjoni taċ- ċelluli beta inkuż HOMA-  (Evalwar-  tal- Mudell ta ’ Omejostażi), proporzjon tal- pro- insulina ma ’ l- insulina u l- kejl ta ’ kemm juru rispons iċ- ċelluli beta mit- test tat - tolleranza li jieħu ħafna kampjuni.
8 In a 24-week double-blind controlled trial, vildagliptin (50 mg twice daily) was compared to rosiglitazone (8 mg once daily).
8 Fi prova double- blind kontrollata li damet 24- ġimgħa, vildagliptin (50 mg darbtejn kuljum) kien imqabbel ma ’ rosiglitazone (8 mg darba kuljum).
However, the magnitude of change is not clinically significant, so that Xiliarx can be given with or without food.
Madankollu, id- daqs tal- bidla mhiex klinikament sinfikanti, b’ hekk Xiliarx jista ’ jingħata ma ’ l- ikel jew mingħajr ikel.
In vitro studies demonstrated that vildagliptin does not inhibit/ induce CYP 450 enzymes.
Studji in vitro wrew li vildagliptin ma jikkawżax l- impediment/ induzzjoni ta ’ l- enzimi
9 Elimination Following oral administration of [14C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
Eliminazzjoni Wara li [14C] vildagliptin jittieħed mill- ħalq, madwar 85% tad- doża kienet eskretata fl- awrina u 15% tad- doża kienet irkuprata fl- ippurgar.
10 A fertility and early embryonic development study in rats revealed no evidence of impaired fertility, reproductive performance or early embryonic development due to vildagliptin.
Studju dwar il- fertilità u l- ewwel żvilupp ta ’ l- embriju fil- firien wera li mhemmx tixkil fil- fertilità, ħila ta ’ riproduzzjoni jew l- ewwel żvilupp ta ’ l- embriju minn vildagliptin.
PSURs The PSUR cycle of Xiliarx will correspond to the one attributed to the cross-referred product, Galvus, until otherwise specified.
PSURs Iċ- ċiklu tal- PSUR ta ’ Xiliarx se jkun jikkorispondi ma ’ dak attribwit għall- prodott cross- referred, Galvus sakemm ma jiġix speċifikat mod ieħor.
Xiliarx 50 mg tablets vildagliptin
Xiliarx 50 mg pilloli vildagliptin
19 10.
19 BŻONN
Xiliarx 50 mg tablets Vildagliptin
Xiliarx 50 mg pilloli Vildagliptin
What Xiliarx is and what it is used for 2.
X’ inhu Xiliarx u għalxiex jintuża 2.
Before you take Xiliarx 3.
Qabel ma tieħu Xiliarx 3.
How to take Xiliarx 4.
Kif għandek tieħu Xiliarx 4.
How to store Xiliarx 6.
Kif taħżen Xiliarx 6.
WHAT XILIARX IS AND WHAT IT IS USED FOR
X’ INHU XILIARX U GĦALXIEX JINTUŻA
Xiliarx belongs to a group of medicines called “ oral antidiabetics”.
Xiliarx jagħmel parti minn grupp ta ’ mediċini li jissejħu “ antidijabetiċi orali ”.
Xiliarx is used to treat patients with type 2 diabetes.
Xiliarx jintuża biex jikkura pazjenti b’ dijabete tat- tip 2.
Xiliarx works by making the pancreas produce more insulin and less glucagon.
Xiliarx jaħdem billi jġiegħel il- marrara tgħamel aktar insulina u anqas glukagon.
Your doctor will prescribe Xiliarx together with certain other antidiabetic medicines which you will already be taking to control diabetes, if one medicine alone is not enough to control your blood sugar level.
I- tabib tiegħek ser jordnalek Xiliarx flimkien ma ’ ċerti mediċini oħra kontra d- dijabete li diġa kont qed tieħu biex tikkontrolla d- dijabete, jekk mediċina waħda ma tkunx biżżejjed biex tikkontrolla il- livell taz- zokkor fid- demm tiegħek.
BEFORE YOU TAKE XILIARX
QABEL MA TIEĦU XILIARX
Further information).
Tieħux Xiliarx  jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal vildagliptin jew sustanzi oħra ta ’ Xiliarx (ara sezzjoni 6 għal aktar tagħrif).
If you think you may be allergic to vildagliptin or any of the other ingredients of Xiliarx, do not take this medicine and talk to your doctor.
Jekk taħseb li tista ’ tkun allerġiku/ a għal vildagliptin jew kwalunkwe sustanza oħra ta ’ Xiliarx, tieħux din il- mediċina u tkellem mat- tabib tiegħek.
Take special care with Xiliarx:
25 Oqgħod attent ħafna b’ Xiliarx:
25  if you have type 1 diabetes (i. e. your body does not produce insulin).  if you have moderate or severe kidney disease.  if you are on dialysis.  if you have liver disease.  if you suffer from heart failure.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Xiliarx.  jekk għandek dijabete tat- tip 1 (i. e. jekk ġismek ma jipproduċix insulina).  jekk għandek mard moderat jew serju tal- kliewi.  jekk qiegħed/ qiegħda fuq dijalisi.  jekk għandek mard tal- fwied.  jekk għandek insuffiċjenza tal- qalb.
If you have previously taken Xiliarx but had to stop taking it because of side effects (liver disease), you should not take Xiliarx again.
Jekk xi darba hadt Xiliarx iżda kellek twaqqfu minħabba l- effetti sekondarji (mard tal- fwied), m’ għandekx terġa tieħu Xiliarx mill- ġdid.
You are also advised to pay particular attention to new onset of blisters or ulcers while taking Xiliarx.
Għandek ukoll toqgħod attent b’ mod partikolari għal bżieżaq jew ulċeri li jitfaċċaw meta tkun qed tieħu Xiliarx.
The use of Xiliarx in children and adolescents is not recommended.
L- użu ta ’ Xiliarx fi tfal u adolexxenti mhux rakkomandat.
Your doctor may wish to alter your dose of Xiliarx if you are taking other medicines (such as medicines so called thiazides, corticosteroids, thyroid products and certain products affecting the nervous system).
Jista ’ jkun li t- tabib tiegħek ikun jixtieq jibdillek id- doża tiegħek ta ’ Xiliarx jekk qed tieħu mediċini oħrajn (bħal mediċini hekk imsejjħa tajażajds, kortikosterojdi, prodotti tat- tirojde u ċerti prodotti li jeffettwaw is- sistema nervuża).
Taking Xiliarx with food and drink You can take Xiliarx with or without food.
Meta tieħu Xiliarx ma ’ l- ikel u max- xorb Tista ’ tieħu Xiliarx ma ’ l- ikel jew mingħajr ikel.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking Xiliarx.
Tqala u Treddigħ Nisa li ħarġu tqal jew qed jaħsbu għat- tqala għandhom jikkonsultaw mat- tabib tagħhom qabel ma jieħdu Xiliarx.
You should not use Xiliarx during pregnancy.
M’ għandekx tuża Xiliarx waqt it- tqala.
It is not known if Xiliarx passes into breast milk.
Mhux magħruf jekk Xiliarx jgħaddix mal- ħalib tas- sider.
You should not use Xiliarx if you are breast-feeding or plan to breast-feed.
M’ għandekx tuża Galvux jekk qed tredda ’ jew qed taħseb biex tredda ’.
Driving and using machines If you feel dizzy while taking Xiliarx, do not drive or use machines.
Sewqan u tħaddim ta ’ magni Jekk tħossok sturdut meta tkun qed tieħu Xiliarx, m’ għandekx issuq jew tħaddem magni.
Important information about some of the ingredients of Xiliarx Xiliarx contains lactose (milk sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Xiliarx Xiliarx fih lactose (zokkor tal- ħalib).
HOW TO TAKE XILIARX
KIF GĦANDEK TIEĦU XILIARX
Always take Xiliarx exactly as your doctor has told you.
Dejjem għandek tieħu Xiliarx skond il- parir tat- tabib.
How much to take The amount of Xiliarx people have to take varies depending on their condition.
Kemm għandek tieħu L- ammont ta ’ Xiliarx li għandhom jieħdu n- nies tvarja skond il- kundizzjoni tagħhom.
Your doctor will tell you exactly how many tablets of Xiliarx to take.
It- tabib tiegħek sejjer jgħidlek eżattament kemm għandek tieħu pilloli Xiliarx.
The usual dose of Xiliarx is either:  50 mg daily taken as one dose in the morning if you are taking Xiliarx with another medicine called a sulphonylurea, or  100 mg daily taken as 50 mg in the morning and 50 mg in the evening if you are taking Xiliarx with another medicine called metformin or a glitazone.
Id- doża tas- soltu hija:  50 mg kuljum li tittieħed bħala doża waħda filgħodu jekk qed tieħu Xiliarx ma ’ mediċina oħra li tissejjaħ sulphonylurea, jew  100 mg kuljum li tittieħed bħala 50 mg filgħodu u 50 mg filgħaxija jekk qed tieħu Xiliarx ma ’ mediċina oħra li tissejjaħ metformin jew xi glitazone.
26 Your doctor will prescribe Xiliarx together with another medicine to control your blood sugar level.
26 It- tabib tiegħek sejjer jordnalek Xiliarx ma ’ mediċina oħra biex tikkontrolla l- livell taz- zokkor fid - demm tiegħek.
When and how to take Xiliarx  Take this medicine in the morning or in the morning and evening.  Swallow the tablets whole with some water.
Meta u kif għandek tieħu Xiliarx  Ħu din il- mediċina filgħodu jew filgħodu u filgħaxija.  Ibla ’ l- pilloli sħaħ bi ftit ilma.
How long to take Xiliarx  Take Xiliarx every day for as long as your doctor tells you.
Kemm għandek iddum tieħu Xiliarx  Ħu Xiliarx kuljum sakemm jgħidlek it- tabib tiegħek.
You may have to take this treatment over a long period of time.  Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.  Do not stop taking Xiliarx unless your doctor tells you to.
Jista ’ jkollok bżonn tieħu din il- kura fuq perijodu twil ta ’ żmien.  It- tabib tiegħek sejjer jimmontora l- kundizzjoni tiegħek sabiex jara li l- kura qed ikollha l- effett mixtieq.  Tieqafx tieħu Xiliarx sakemm it- tabib tiegħek ma jgħidlekx biex tagħmel hekk.
If you take more Xiliarx than you should If you take too many Xiliarx tablets, or if someone else has taken your medicine, talk to your doctor straight away.
Jekk tieħu Xiliarx aktar milli suppost Jekk tieħu wisq pilloli Xiliarx jew jekk xi ħadd ieħor ħa l- mediċina tiegħek, tkellem mat- tabib tiegħek mill- ewwel.