qanastek/EMEA-V3 huggingface dataset:
If you receive Erbitux with radiation therapy, some of the side effects you may experience can also be related to this combination, such as: • inflammation of the lining of the intestine and mouth • skin reactions typical for radiation therapy • difficulty in swallowing • reduction in the number of white blood cells
Jekk tirċievi Erbitux flimkien ma ’ terapija bir- raġġi, xi wħud mill- effetti sekondarji li jista ’ jkollok jistgħu jkunu marbuta wkoll ma ’ din il- kumbinazzjoni tal- mediċina, bħal: • infjammazzjoni tal- kisja ta ’ l- imsaren u l- ħalq • reazzjonijiet tal- ġilda li huma tipiċi għat- terapija bir- raġġi • diffikultà biex tibla ’ • tnaqqis fin- numru taċ- ċelluli bojod tad- demm
HOW TO STORE ERBITUX
KIF TAĦŻEN ERBITUX
Do not use Erbitux after the expiry date which is stated on the label and the carton after EXP.
Tużax Erbitux wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kaxxa tal- kartun wara JIS.
Once opened, Erbitux is intended for immediate use.
Ġaladarba jinfetaħ, Erbitux għandu jintuża minnufih.
What Erbitux contains • The active substance is cetuximab.
X’ fih Erbitux: • Is- sustanza attiva hi cetuximab.
Each ml of the solution for infusion contains 2 mg cetuximab. • The other ingredients are sodium dihydrogen phosphate, disodium phosphate, sodium chloride and water for injections.
Kull 1 ml ta ’ soluzzjoni għall- infużjoni fiha 2 mg ta ’ cetuximab. • Is- sustanzi l- oħra huma sodium dihydrogen phosphate, disodium phosphate, sodium chloride u ilma għall- injezzjoni.
What Erbitux looks like and contents of the pack Erbitux 2 mg/ ml solution for infusion is supplied in vials containing 50 ml.
Erbitux 2 mg/ ml soluzzjoni għall- infużjoni hu fornut f’ kunjetti li fihom 50 ml.
Each pack contains 1 vial.
Kull pakkett fih 1 kunjett.
Marketing Authorisation Holder and Manufacturer Merck KGaA, 64271 Darmstadt, Germany
Merck KGaA, 64271 Darmstadt, Ġermanja
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
57 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
56 The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Handling instructions
Struzzjonijiet dwar l- immaniġġjar
It must not be mixed with other intravenously applied medicinal products.
M’ għandux jitħallat ma ’ prodotti mediċinali oħrajn li jingħataw minn ġol- vina.
A separate infusion line must be used for the infusion, and the line must be flushed with sterile sodium chloride 9 mg/ ml (0.9%) solution for injection at the end of infusion.
Linja separata ta ’ l- infużjoni trid tintuża għall- infużjoni, u l- linja trid titlaħlaħ fit- tmiem tal- infużjoni b’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni sterili għall- injezzjoni.
Erbitux 2 mg/ ml is compatible • with polyethylene, ethyl vinyl acetate or polyvinyl chloride bags, • with polyethylene, ethyl vinyl acetate, polyvinyl chloride, polybutadiene or polyurethane infusion sets, • with polyethersulfone, polyamide or polysulfone in-line filters.
Erbitux 2 mg/ ml hu kompatibbli • ma ’ boroż tal- polyethylene, ethyl vinyl acetate jew polyvinyl chloride, • ma ’ settijiet ta ’ l- infużjoni tal- polyethylene, ethyl vinyl acetate, polyvinyl chloride, polybutadiene jew polyurethane, • ma ’ filtri in- line tal- polyethersulfone, polyamide jew polysulfone.
Erbitux 2 mg/ ml is chemically and physically stable for up to 20 hours at 25°C.
Erbitux 2 mg/ ml hu kimikament u fiżikament stabbli sa 20 siegħa f’ temperatura ta ’ 25°C.
However, since it does not contain any antimicrobial preservative or bacteriostatic agent, it is intended for immediate use.
Madankollu, billi ma fih l- ebda sustanza preservattiva jew batterjostatika kontra l- mikrobi, hu intenzjonat għall- użu immedjat.
The first dose is 400 mg/ m² body surface area infused over a period of approximately 2 hours.
L- ewwel doża hi ta ’ 400 mg/ m² ta ’ erja tas- superfiċje tal- ġisem infuża fuq perijodu ta ’ madwar sagħtejn.
Each subsequent dose is 250 mg/ m² infused in approximately 1 hour.
Kull doża sussegwenti hi ta ’ 250 mg/ m² infuża f’ madwar siegħa.
Erbitux must not be infused more rapidly than 10 mg/ min.
Erbitux m’ għandux ikun infuż b’ rata ta ’ aktar minn 10 mg/ min.
• In-line filtration with a syringe pump:
• Filtrazzjoni in- line b’ pompa tas- siringa:
Connect the infusion line to the syringe and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/ ml (0.9%) solution.
Waħħal il- linja ta ’ l- infużjoni mas- siringa u ibda l- infużjoni wara li tagħmel priming tal- linja b’ Erbitux jew b’ soluzzjoni sterili ta ’ sodium chloride 9 mg/ ml (0. 9%).
57 PACKAGE LEAFLET:
58 FULJETT TA ’ TAGĦRIF:
Erbitux 5 mg/ ml solution for infusion Cetuximab
Erbitux 5 mg/ ml soluzzjoni għall- infużjoni Cetuximab
58 Take special care with Erbitux Erbitux may cause infusion-related side effects.
59 Oqgħod attent ħafna b ’ Erbitux Erbitux jista ’ jikkawża effetti sekondarji marbuta ma ’ l- infużjoni.
Detailed instructions for your doctor or your nurse on how to prepare the Erbitux infusion are included at the end of this package leaflet (see'Handling instructions').
60 Struzzjonijiet dettaljati għat- tabib jew in- ners tiegħek dwar kif għandhom jippreparaw l- infużjoni b’ Erbitux huma inklużi fit- tmiem ta ’ dan fuljett ta ’ tagħrif (ara ‘ Struzzjonijiet dwar l- immaniġġjar ’).
59 Duration of treatment
Tul tal- kura
Side effects concerning the skin
61 Effetti sekondarji li jikkonċernaw il- ġilda
60 Main side effects concerning the skin include: • acne-like skin alterations • itching • dry skin • scaling • excessive growth of hair • nail disorders, for example inflammation of the nail bed
Effetti sekondarji ewlenin li jikkonċernaw il- ġilda jinkludu: • bidliet fil- ġilda qishom akne • ħakk • ġilda xotta • ġilda li titqaxxar • tkabbir eċċessiv ta ’ xagħar • disturbi fid- dwiefer, per eżempju infjammazzjoni fil- bażi tad- difer
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
62 Jekk tirċievi Erbitux flimkien ma ’ mediċini kontra l- kanċer li jinkludu l- platinum, x’ aktarx li jkun iktar possibbli li l- għadd taċ- ċelluli tad- demm bojod tiegħek jista ’ jonqos.
61 If you receive Erbitux in combination with an anticancer medicine containing 5-fluorouracil, it is more likely that you experience the following side effects of this other medicine: • chest pain • heart attack • heart failure • redness and swelling of the palms of the hands or the soles of the feet which may cause the skin to peel (hand-foot syndrome)
Jekk tirċievi Erbitux flimkien ma ’ mediċina kontra l- kanċer li jkun fiha 5- fluorouracil, x’ aktarx li ser ikollok dawn l- effetti sekondarji li ġejjin ta ’ din il- mediċina l- oħra: • uġigħ fis- sider • attakk tal- qalb • insuffiċjenza tal- qalb • ħmura u nefħa tal- kefef ta ’ l- idejn jew fil- qiegħ tas- saqajn li jistgħu jikkawżaw il- ġilda li titqaxxar (sindrome ta ’ l- idejn- saqajn)
Each ml of the solution for infusion contains 5 mg cetuximab. • The other ingredients are sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide and water for injections.
Kull 1 ml ta ’ soluzzjoni għall- infużjoni fiha 5 mg ta ’ cetuximab. • Is- sustanzi l- oħra huma sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide u ilma għall- injezzjonijiet.
What Erbitux looks like and contents of the pack Erbitux 5 mg/ ml solution for infusion is supplied in vials containing 10 ml, 20 ml, 50 ml or 100 ml.
Erbitux 5 mg/ ml soluzzjoni għall- infużjoni hu fornut f’ kunjetti li fihom 10 ml, 20 ml, 50 ml jew 100 ml.
This leaflet was last approved in {MM/ YYYY}.
63 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
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 /.
62 The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Since Erbitux is only compatible with sterile sodium chloride 9 mg/ ml (0.9%) solution for injection, it must not be mixed with other intravenously applied medicinal products.
Minħabba li Erbitux hu kompatibbli biss ma ’ soluzzjoni għall- injezzjoni sterili ta ’ sodium chloride 9 mg/ ml (0. 9%), m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn li jingħataw minn ġol- vina.
A separate infusion line must be used for the infusion, and the line must be flushed with sterile sodium chloride 9 mg/ ml (0.9%) solution for injection at the end of infusion.
Linja separata ta ’ l- infużjoni trid tintuża għall- infużjoni, u l- linja trid titlaħlaħ fit- tmiem ta ’ l- infużjoni b’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni sterili għall- injezzjoni.
Erbitux 5 mg/ ml is compatible • with polyethylene (PE), ethyl vinyl acetate (EVA) or polyvinyl chloride (PVC) bags, • with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets, • with polypropylene (PP) syringes for syringe pump.
Erbitux 5 mg/ ml hu kompatibbli • ma ’ boroż tal- polyethylene (PE), ethyl vinyl acetate (EVA) jew polyvinyl chloride (PVC), • ma ’ settijiet ta ’ l- infużjoni tal- polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) jew polyvinyl chloride (PVC), • ma ’ siringi tal- polypropylene (PP) għall- pompa tas- siringa.
Erbitux 5 mg/ ml is chemically and physically stable for up to 48 hours at 25°C, if the solution is prepared as described hereafter.
Erbitux 5 mg/ ml hu kimikament u fiżikament stabbli sa 48 siegħa f’ temperatura ta ’ 25°C, jekk is- soluzzjoni tkun ppreparata kif deskritt hawn taħt.
However, since it does not contain any antimicrobial preservative or bacteriostatic agent, it is intended for immediate use.
Madankollu, billi ma fih l- ebda sustanza preservattiva jew batterjostatika kontra l- mikrobi, hu intenzjonat għal użu immedjat.
Connect the infusion line and prime it with the diluted Erbitux before starting the infusion.
Waħħal il- linja ta ’ l- infużjoni u imliha (prime it) b’ Erbitux dilwit ma ’ tibda l- infużjoni.
• For administration with infusion pump or gravity drip (undiluted):
• Biex tagħti l- infużjoni bil- pompa jew bi gravity drip (mhux dilwit):
• For administration with a syringe pump:
64 • Meta tuża b’ pompa tas- siringa:
Repeat this procedure until the calculated volume has been infused.
Irrepeti din il- proċedura sakemm jingħata l- volum ikkalkulat.
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.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Eucreas?
X’ inhi Eucreas?
Eucreas is a medicine containing the active substances vildagliptin and metformin hydrochloride.
Eucreas hija mediċina li fiha s- sustanzi attivi vildagliptin u metformin hydrochloride.
50 mg/ 850 mg; light yellow:
Din tiġi bħala pilloli ovali (isfar skur: ta ’ 50mg/ 850mg u isfar ċar:
What is Eucreas used for?
Għalxiex tintuża Eucreas?
Eucreas is used to treat type 2 diabetes (non insulin-dependent diabetes).
Eucreas jintuża għall- kura tad- dijabete ta ’ tip 2 (magħrufa wkoll bħala dijabete mhux dipendenti fuq l - insulina).
It is used in patients whose disease is insufficiently controlled with the maximum tolerated dose of metformin taken alone or who are already taking the combination of vildagliptin and metformin as separate tablets.
Tintuża f’ pazjenti li l- marda tagħhom ma tkunx biżżejjed ikkontrollata bid- doża massima ttollerata ta ’ metformin meħud waħdu jew li jkunu diġà qed jieħdu l- kumbinazzjoni ta ’ vidagliptin u metformin bħala pilloli separati.
How is Eucreas used?
Kif tintuża Eucreas?
The recommended dose of Eucreas is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Id- doża rakkomandata ta ’ Eucreas hija pillola waħda darbtejn kuljum, waħda tittieħed filgħodu u l - oħra filgħaxija.
The choice of tablet strength to start with depends on the dose of metformin the patient is currently taking, but the recommended dose is 50 mg vildagliptin and 1,000-mg metformin twice a day.
L- għażla tal- qawwa tal- pillola biex tibda biha tiiddependi mid- doża ta ’ metformin li l - pazjent ikun qed jieħu, iżda d- doża rakkomandata hija ta ’ 50mg vildagliptin u 1, 000mg metformin darbtejn kuljum.
Patients already taking vildagliptin and metformin should switch to Eucreas containing the same amounts of each active substance.
Il- pazjenti li jkunu qed jieħdu vildagliptin u metformin għandhom jaqilbu għal Eucreas li fiha l- istess ammonti ta ’ kull sustanza attiva.
Doses of vildagliptin above 100 mg are not recommended.
Dożi ta ’ vildagliptin ‘ il fuq minn 100mg mhumiex rakomandati.
Taking Eucreas with or just after food may reduce any stomach problems caused by metformin.
Meta wieħed jieħu Eucreas ma ’ l- ikel jew eżatt wara jistgħu jitnaqqsu problemi bl- istonku kkawżati minn metformin.
Eucreas should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Eucreas m’ għandux jintuża f’ pazjenti li għandhom problemi moderati jew severi bil- kliewi jew bil - fwied tagħhom.
Elderly patients taking Eucreas should have their kidney function monitored regularly.
Pazjenti anzjani li jkunu qed jieħdu Eucreas għandu jkollhom il- funzjoni tal- kliewi ssorveljata b’ mod regolari.
Eucreas is not recommended for use in patients aged over 75 years.
Eucreas mhuwiex irrakomandat għall- użu f’ pazjenti li għandhom iktar minn 75 sena.
How does Eucreas work?
Kif taħdem Eucreas?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Id- dijabete tat- tieni tip hi marda li fiha, il- frixa ma tagħmilx biżżejjed insulina biex tikkontrolla l- livell ta ’ glukożju (zokkor) fid- demm jew meta l- ġisem ma jkunx jista ’ juża l- insulina b’ mod effettiv..
Eucreas contains two active substances, which each have a different mode of action.
Eucreas fih żewġ sustanzi attivi fejn kull waħda għandha mezz differenti ta ’ azzjoni.
Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘ incretin’ hormones in the body.
Vildagliptin, li hija inibitur dipeptidyl peptidase 4 (DPP- 4), jaħdem billi jimblokka t- tkissir ta ’ l- ormon ‘ incretin ’ fil - ġisem.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Dawn l- ormoni jiġu rilaxxati wara ikla u jistimulaw il- frixa sabiex tipproduċi l- insulina.
By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Billi żżid il- livelli ta ’ ormoni ‘ incretin ’ fid- demm, vildagliptin tistimula l- frixa sabiex tipproduċi iktar insulina meta l- livell ta ’ glukożju d- demm ikun għoli.
Vildagliptin does not work when the blood glucose is low.
Vildagliptin ma jaħdimx meta l- livell ta ’ glukożju fid- demm ikun baxx.
Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Vildagliptin tnaqqas ukoll l- ammont ta 'zokkor magħmul mill- fwied, billi żżid il- livelli ta' l- insulina u tnaqqas il- livelli ta 'l- ormon glukagon.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Metformin jaħdem l- iktar billi 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Eucreas been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged jwaqqaf il- produzzjoni tal- glukożju u jnaqqas l- assorbiment tiegħu fl- intestini.
Vildagliptin on its own was approved by the European Union (EU) in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Vildagliptin kien ġie approvat waħdu mill- Unjoni EWROPEA( U E) f’ Settembru ta ’ l- 20007 taħt l - isem ta ’ Glavus, u metformin ilu disponibbli fl- UE sa mill- 1959.
Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Vildagliptin jista ’ jintuża ma ’ metformin f’ pazjenti bid- dijbete tat- tip 2 li m’ humiex ikkontrollati b’ mod sodisfaċjenti fuq metformin waħdu.
The studies of Galvus as an add-on to metformin were used to support the use of Eucreas in the same indication.
L- istudji ta ’ Galvus bħala aġġunt għal metformin intużaw sabiex isostnu l- użu ta ’ Eucreas fl - istess indikazzjoni.
The studies measured the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Dan il- livell jagħti indikazzjoni ta ’ kemm hu kkontrollat tajjeb iz- zokkor fid - demm.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Eucreas were absorbed in the body in the same way as when they were taken as separate tablets.
L- applikant ippreżenta wkoll ir- riżultati ta ’ żewġ studji li juru li s- sustanzi attivi f’ żewġ qawwiet ta ’ Eucreas ġew assorbiti fil- ġsiem bl- istess mod bħal ma kieku kienu meħuda bħala pilloli separati.
What benefit has Eucreas shown during the studies?
Liema benefiċċju wriet Eucreas waqt l- istudji li ġew mwettqa?
Vildagliptin was more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin.
Vildagliptin kien iktar effettiv minn plaċebo (trattament finta) fit- tnaqqis tal- livelli ta ’ HbA1 meta dan ġie miżjud ma ’ metformin.
Patients adding vildagliptin had falls in HbA1c levels of 0.88% after 24 weeks from a starting level of 8.38%.
Il- pazjenti li żiedu vildagplitin kellhom tnaqqis fil- livelli ta ’ HbA1c ta ’ 0. 88% wara 24 ġimgħa minn livell tal- bidu li kien 8. 38%.
In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23% from a starting level of 8.30%.
B’ kuntrast, il- pazjenti li żiedu l- plaċebo kellhom tibdiliet iżgħar fil- livelli ta ’ HbA1 c, b’ żieda ta ’ 0. 23% minn livell tal- bidu ta ’ 8. 30%.
What is the risk associated with Eucreas?
X’ inhu r- riskju assoċjat ma ’ Eucreas?
The most common side effects with Eucreas (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
L- iktar effetti sekondarji komuni b’ Eucreas (li dehru f’ iktar minn pazjent 1 kull 10) huma n- nawżija (tħossok ma tiflaħx), rimettar, dijarea, uġigħ addominali (fiż- żaqq) u telf ta ’ l- aptit.
For the full list of all side effects reported with Eucreas, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati b' Eucreas, ara l- Fuljett ta 'Tagħrif.
Eucreas should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Eucreas m’ għandux jintuża minn persuni allerġiċi għal vildagliptin, metformin jew għal kull ingredjent ieħor.
Why has Eucreas been approved?
Għaliex ġiet approvata Eucreas?
The Committee for Medicinal Products for Human Use (CHMP) concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment.
Il- Kumitat għall- Prodotii Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li vildagliptin meħud ma ’ metformin inaqqas l- livelli ta ’ glukożju fid- demm u l- kumbinazzjoni taż- żewġ sustanzi f’ pillola waħda tgħin lil pazjenti sabiex iżommu mat- trattament tagħhom.
Therefore, the Committee decided that the benefits of Eucreas are greater than its risks for the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Għalhekk, il- Kumitat iddeċieda li l- benefiċċji ta ’ Eucreas huma akbar mir- riskji għat- trattament ta ’ pazjenti bid- dijabete tat- tip 2 li ma jkunux jistgħu jiksbu biżżejjed kontroll glikemiku fid- doża massima ttollerata tagħhom ta ’ metformin orali meħud waħdu jew li jkunu diġà qed jieħdu l- kura b’ kumbinazzjoni ta ’ vildagliptin u metformin bħala pilloli separati.
The Committee recommended that Eucreas be given marketing authorisation.
Il- Kumitat irrakkomanda li Eucreas tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Eucreas:
Informazzjoni oħra dwar Eucreas:
The European Commission granted a marketing authorisation valid throughout the EU for Eucreas to Novartis Europharm Limited on 14 November 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Eucreas valida fl- Unjoni Ewropea kollha lil Novartis Europharm Limited fl- 14 ta ’ Novembru 2007.
The full EPAR for Eucreas can be found here.
L- EPAR sħiħ għal Eucreas jista ’ jinstab hawnhekk.
This summary was last updated in 10-2007.
Dan is- sommarju ġie aġġornat l- aħħar fl- 10- 2007.
Eucreas 50 mg/ 850 mg film-coated tablets
Eucreas 50 mg/ 850 mg pilloli miksijin b’ rita
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Kull pillola miksija b’ rita fiha 50 mg vildagliptin u 850 mg metformin hydrochloride (li jissarraf f’ 660 mg ta ’ metformin).
Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “ NVR” on one side and “ SEH” on the other side.
Pillola miksija b’ rita safra, b’ għamla li tagħti fl- ovali b’ xifer imżerżaq, ittimbrata b ’ “ NVR ” fuq naħa waħda u “ SEH ” fuq in- naħa l- oħra.
Eucreas is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Eucreas huwa indikat għall- kura ta ’ pazjenti bid- dijabete mellitus tat- tip 2 li ma jistgħux jiksbu kontroll gliċemiku xieraq bl- ogħla doża li jifilħu ta ’ metformin li jittieħed mill- ħalq waħdu jew li diġà qed jiġu kkurati b’ taħlita ta ’ vildagliptin u metformin bħala pilloli separati.
Adults Based on the patient’ s current dose of metformin, Eucreas may be initiated at either the 50 mg/ 850 mg or 50 mg/ 1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Adulti Ibbażat fuq id- doża ta ’ metformin li jkun qed jieħu l- pazjent, Eucreas jista ’ jinbeda b’ pillola ta ’ 50 mg/ 850 mg jew ta ’ 50 mg/ 1000 mg darbtejn kuljum, pillola waħda filgħodu u l- oħra filgħaxija.
The recommended daily dose is 100 mg vildagliptin plus 2000 mg metformin hydrochloride.
Id - doża rakkomandata ta’ kuljum hija 100 mg vildagliptin ma ’ 2000 mg metformin hydrochloride.
Patients receiving vildagliptin and metformin from separate tablets may be switched to Eucreas containing the same doses of each component.
Pazjenti li qed jirċievu vildagliptin u metformin minn pilloli separati jistgħu jinqalbu għal Eucreas li jkun fih l- istess dożi ta ’ kull komponent.
Doses higher than 100 mg of vildagliptin are not recommended.
Dożi ogħla minn 100 mg ta ’ vildagliptin mhumiex rakkomandati.
There is no clinical experience of vildagliptin and metformin in triple combination with other antidiabetic agents.
M’ hemmx esperjenza klinika ta ’ vildagliptin u metformin f’ terapija kombinata bi tlieta ma ’ aġenti kontra d- dijabete oħrajn.
Taking Eucreas with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Jekk Eucreas jittieħed ma ’ l- ikel jew eżatt wara l- ikel jista ’ jnaqqas is- sintomi gastro- intestinali assoċjati ma ’ metformin (ara wkoll sezzjoni 5. 2).
Additional information on special populations Renal impairment Eucreas should not be used in patients with creatinine clearance < 60 ml/ min (see sections 4.3, 4.4 and 5.2).
Informazzjoni oħra fuq popolazzjonijiet speċjali Indeboliment renali Eucreas m’ għandux jintuża f’ pazjenti bi tneħħija tal- krejatinina < 60 ml/ min (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Hepatic impairment Eucreas should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
Indeboliment tal- fwied Eucreas m’ għandux 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 sezzjonijiet 4. 3, 4. 4 u 4. 8).
2 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Eucreas should have their renal function monitored regularly (see section 4.4).
2 Anzjani (≥ 65 sena) Peress illi metformin jitneħħa mill- kilwa, u pazjenti anzjani għandhom it- tendenza li jkollhom funzjoni renali mnaqsa, pazjenti anzjani li jkunu qed jieħdu Eucreas għandu jkollhom il- funzjoni renali immonitorata b’ mod regolari (ara sezzjoni 4. 4).
Eucreas has not been studied in patients older than 75 years.
Eucreas ma kienx studjat f’ pazjenti li għandhom ’ l fuq minn 75 sena.
Therefore the use of Eucreas is not recommended in this population.
Għalhekk l- użu ta ’ Eucreas mhux rakkomandat f’ din il- popolazzjoni.
Paediatric population (< 18 years) Eucreas is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Popolazzjoni pedjatrika (< 18- il sena) Eucreas mhux irrakkomandat għall- użu fit- tfal u adolexxenti peress li hemm nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
− Hypersensitivity to the active substances or to any of the excipients − Diabetic ketoacidosis or diabetic pre-coma − Renal failure or renal dysfunction defined as creatinine clearance < 60 ml/ min (see section 4.4) − Acute conditions with the potential to alter renal function, such as:
− Sensittività eċċessiva għas- sustanzi attivi jew għal xi sustanzi mhux attivi. − Ketoaċidożi tad- dijabete jew pri- koma tad- dijabete. − Insuffiċjenza renali jew disfunzjoni renali definita bħala tneħħija tal- krejatinina < 60 ml/ min (ara sezzjoni 4. 4). − Kundizzjonijiet akuti li jistgħu jibdlu l- funzjoni renali, bħal:
dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
deidrazzjoni, infezzjoni severa, xokk, l- għotja minn ġol- vini ta ’ aġenti tal- kuntrast li fihom l- jodju (ara sezzjoni 4. 4).
−
− Mard akut jew kroniku li jista ’ jikkawża ipoksja tat- tessuti, bħal:
or chronic disease which may cause tissue hypoxia, such as: cardiac or respiratory failure, recent myocardial infarction, shock.
insuffiċjenza kardijaka jew respiratorja, infart mijokardijaku reċenti, xokk.
− Hepatic impairment (see sections 4.2, 4.4 and 4.8) − Acute alcohol intoxication, alcoholism − Lactation (see section 4.6)
− Indeboliment tal- fwied (ara sezzjonijiet 4. 2, 4. 4 u 4. 8). − Intossikazzjoni akuta bl- alkoħol, alkoħoliżmu. − Treddigħ (ara sezzjoni 4. 6).
General Eucreas is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Ġenerali Eucreas mhux sostitut għall- insulina f’ pazjenti li jeħtieġu l- insulina u mgħandux jintuża f’ pazjenti b’ dijabete tat- tip 1.
Lactic acidosis Lactic acidosis is a very rare but serious metabolic complication that can occur due to metformin accumulation.
Aċidożi lattika Aċidożi lattika hija komplikazzjoni metabolika rari ħafna iżda serja li tista ’ tiġri meta metformin jakkumula.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Seħħew każijiet li kienu rrappurtati ta ’ pazjenti fuq metformin l- aktar f’ pazjenti dijabetiċi b’ insuffiċjenza renali sinifikanti.
In patients with impaired liver function, lactate clearance may be restricted.
F’ pazjenti b’ funzjoni epatika indebolita, it- tneħħija tal- lactate tista ’ tkun ristretta.
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors, such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia (see also sections 4.3 and 4.5).
L- inċidenza ta ’ aċidożi lattika tista ’ u għandha titnaqqas ukoll billi jitqiesu fatturi ta ’ riskju oħrajn li huma assoċjati, bħall dijabete mhux kontrollata kif jixraq, kitożi, sawm fuq tul ta ’ żmien, użu eċċessiv ta ’ alkoħol, insuffiċjenza tal- fwied u kwalunkwe kundizzjoni assoċjata ma ’ ipoksja (ara wkoll sezzjonijiet 4. 3 u 4. 5).
Diagnosis of lactic acidosis Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Dijanjosi ta ’ aċidożi lattika L- aċidożi lattika hija karatterizzata minn qtugħ ta ’ nifs b’ aċidożi, uġigħ addominali u ipotermija u wara hekk isseħħ koma.
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l and increased anion gap and lactate/pyruvate ratio.
Sejbiet tal- laboratorju dijanjostiku huma naqsiet fil- pH tad- demm, livelli tal - lactate fil- plażma ’ l fuq minn 5 mmol/ l u żieda fl- anion gap u l- proporzjon laktejt/ pajruvejt.
If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9).
Jekk tkun suspettata l- aċidożi metabolika, il- kura bil- prodott mediċinali għandha tieqaf u l- pazjent għandu jittieħed l- isptar mill- ewwel (ara sezzjoni 4. 9).
Renal impairment As metformin is excreted by the kidney, serum creatinine concentrations should be monitored regularly:
Indeboliment renali Peress li metformin jitneħħa mill- kilwa, il- konċentrazzjonijiet tal- krejatinina fis- serum għandhom jiġu monitorati b’ mod regolari:
- at least once a year in patients with normal renal function
- mill- anqas darba f’ sena f’ pazjenti b’ funzjoni renali normali
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.
Għandha tittieħed kawtela speċjali f’ sitwazzjonijiet fejn il- funzjoni renali tista ’ tkun indebolita, per eżempju meta tibda kura għall- pressjoni għolja jew terapija b’ dijuretiċi jew meta tinbeda kura b’ NSAID.
Hepatic impairment Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Eucreas (see sections 4.2, 4.3 and 4.8).
Indeboliment tal- fwied Pazjenti b’ indeboliment epatik, inklużi pazjenti li jkollhom ALT jew AST qabel il- kura > 3 darbiet ULN, m’ għandhomx jiġu kkurati b’ Eucreas (ara sezzjonijiet 4. 2, 4. 3 u 4. 8).
Liver enzyme monitoring Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin.
Monitoragg ta ’ l- enzimi tal- fwied Każijiet rari ta ’ funzjoni mhux normali tal- fwied (inkluża l- epatite) kienu rrappurtati b’ vildagliptin.
In these cases, the patients were generally asymptomatic without clinical sequelae and liver function tests (LFTs) returned to normal after discontinuation of treatment.
F’ dawn il- każijiet, il- pazjenti b’ mod ġenerali ma kellhomx konsegwenzi kliniċi u r- riżultati tat- testijiet tal- funzjoni tal- fwied (LFTs) reġgħu lura għan- normal wara li twaqfet il- kura.
LFTs should be performed prior to the initiation of treatment with Eucreas in order to know the patient’s baseline value.
It- testijiet tal- funzjoni tal- fwied għandhom isiru qabel ma tinbeda l- kura b’ Eucreas sabiex ikun magħruf il- valur tal- linja bażi tal- pazjent.
Liver function should be monitored during treatment with Eucreas at three-month intervals during the first year and periodically thereafter.
Il- funzjoni tal- fwied għandha tiġi monitorata waqt il- kura b’ Eucreas f’ intervalli ta ’ tlett xhur fl- ewwel sena u darba kulltant minn hemm ’ l quddiem.
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent LFTs until the abnormality(ies) return(s) to normal.
Pazjenti li jiżviluppaw żiediet fil - livelli ta ’ transaminase għandhom jiġu monitorati bit- tieni evalwazzjoni tal- funzjoni tal- fwied sabiex tkun konfermata s- sejba u jiġu segwiti minn hemm ’ l quddiem b’ LFTs spissi sakemm l - anormalità( jiet) tiġi( jiġu) lura għan- normal.
Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Eucreas therapy is recommended.
Jekk iż- żieda fl- AST jew fl- ALT ta ’ 3 darbiet il- ULN jew akbar tippersisti, it- twaqqif tat- terapija b ’ Eucreas huwa rakkomandat.
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Eucreas.
Pazjenti li jiżviluppaw is - suffejra jew sinjali li jindikaw funzjoni anormali tal- fwied għandhom iwaqqfu Eucreas.
Following withdrawal of treatment with Eucreas and LFT normalisation, treatment with Eucreas should not be re-initiated.
Wara t- twaqqif tal- kura b’ Eucreas u LFT ikun ġie lura għan- normal, il- kura b’ Eucreas mgħandhiex terġa tinbeda.
Cardiac failure Experience with vildagliptin therapy in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II is limited and therefore vildagliptin should be used cautiously in these patients.
Insuffiċjenza kardijaka L- esperjenza bit- terapija b’ vildagliptin f’ pazjenti b’ insuffiċjenza tal- qalb konġestiva ta ’ New York Heart Association (NYHA) tal- klassi funzjonali I- II hija limitata u għalhekk vildagliptin għandu jintuża b’ attenzjoni f’ dawn il- pazjenti.
There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class III-IV and therefore use is not recommended in these patients.
M’ hemmx esperjenza b’ vildagliptin f’ pazjenti b’ NYHA tal - klassi funzjonali III- IV u għalhekk l- użu mhux rakkomandat f’ dawn il- pazjenti.
Metformin is contraindicated in patients with heart failure, therefore Eucreas is contraindicated in this patient population (see section 4.3).
Metformin huwa kontra- indikat f’ pazjenti b’ insuffiċjenza tal- qalb, għalhekk Eucreas huwa kontra - indikat f’ din il- popolazzjoni ta ’ pazjenti (ara sezzjoni 4. 3).
Skin disorders Skin lesions, including blistering and ulceration have been reported with vildagliptin in extremities of monkeys in non-clinical toxicology studies (see section 5.3).
Disturbi fil- ġilda Feriti fil- ġilda, inklużi nfafet u ulċeri kienu rrappurtati b’ vildagliptin fl- idejn u saqajn ta ’ xadini f’ provi mhux kliniċi tossikoloġiċi (ara sezzjoni 5. 3).
Although skin lesions were not observed at an increased incidence in clinical trials, there was limited experience in patients with diabetic skin complications.
Għalkemm il- feriti fil- ġilda ma dehrux b’ mod aktar frekwenti fil- provi kliniċi, kien hemm esperjenza limitata f’ pazjenti dijabetiċi b’ kumplikazzjonijiet tal- ġilda.
Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Għalhekk, biex tinżamm il- kura tas- soltu tal- pazjent dijabetiku, monitoraġġ tad- disturbi fil- ġilda, bħall- nfafet jew ulċeri, huwa rakkomandat.
Surgery As Eucreas contains metformin, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Kirurġija Peress li Eucreas fih metformin, il- kura għandha titwaqqaf 48 siegħa qabel kirurġija li tkun ippjanata b’ loppju ġenerali u s- soltu m’ għandhiex terġa tinbeda qabel 48 siegħa wara.
Administration of iodinated contrast agent The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
L- għotja ta ’ aġent ta ’ kuntrast bl- jodju L- għotja minn ġol- vini ta ’ aġenti ta ’ kuntrast bl- jodju fi studji radjuloġiċi tista ’ twassal għall - insuffiċjenza renali.
Therefore, due to the metformin active substance, Eucreas should be discontinued prior to, or at the time of, the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Għalhekk, minħabba s- sustanza attiva metformin, Eucreas għandu jitwaqqaf qabel, jew waqt, it- test u ma jerġax jinbeda sa ’ 48 siegħa wara, u biss f’ każ li l- funzjoni renali tkun reġgħet ġiet evalwata u misjuba normali (ara sezzjoni 4. 5).
4.5 Interaction with other medicinal products and other forms of interaction
4 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
There have been no formal interaction studies for Eucreas.
Ma sarux studji dwar l- effett ta ’ medicini jew ta’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ Eucreas.
The following statements reflect the information available on the individual active substances.
Id- dikjarazzjonijiet li ġejjin jirriflettu l- informazzjoni disponibbli fuq is- sustanzi attivi individwali.
4 Vildagliptin Vildagliptin has a low potential for interactions with co-administered medicinal products.
Vildagliptin Vildagliptin għandu potenzjal baxx għal l- effetti mhux mixtieqa meta jingħata flimkien ma ’ prodotti mediċinali.
Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.
Peress li vildagliptin mhuwiex sottostrat ta ’ cytochrome P (CYP) 450 u la jimpedixxi u l - anqas jinduċi l- enzimi CYP 450, x’ aktarx li ma jinteraġixxix mas- sustanzi attivi li huma sottostrati, impedituri jew indutturi ta ’ dawn l- enzimi.
Results from clinical trials conducted with the oral antidiabetics pioglitazone, metformin and glyburide in combination with vildagliptin have shown no clinically relevant pharmacokinetic interactions in the target population.
Riżultati minn provi kliniċi li saru bil- mediċini kontra d- dijabete li jittieħdu mill- ħalq pioglitazone, metformin u glyburide ma ’ vildagliptin ma wrew l- ebda interazzjonijiet farmakokinetiċi klinikament rilevanti fil- popolazzjoni immirata.
Drug-drug interaction studies with digox in (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after co- administration with vildagliptin.
Studji kliniċi ta ’ interazzjoni bejn il- mediċini li saru b’ digoxin (sottostrat ta ’ glikoproteina- P) u warfarin (sottostrat ta ’ CYP2C9) f’ individwi b’ saħħithom ma wrew l- ebda interazzjonijiet farmakokinetiċi klinikament rilevanti wara li ngħataw flimkien ma ’ vildagliptin.
Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin.
Studji dwar interazzjonijiet bejn il- mediċini f’ individwi b’ saħħithom saru b’ amlodipine, ramipril, valsartan u simvastatin.
In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin.
F’ dawn l- istudji, ma dehru l- ebda interazzjonijiet farmakokinetiċi klinikament rilevanti wara li ngħataw ma ’ vildagliptin.
However, this has not been established in the target population.
Madankollu, dan ma ġiex stabilit fil- popolazzjoni immirata.
As with other oral antidiabetic medicinal products the hypoglycaemic effect of vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.
Bħal prodotti mediċinali kontra d- dijabete oħrajn li jittieħdu mill- ħalq l- effet ipogliċemiku ta ’ vildagliptin jista ’ jitnaqqas minn ċerti sustanzi attivi, li jinkludu thiazides, corticosteroids, prodotti tat - tirodje u simpatomimetiċi.
Metformin Combinations not recommended There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Eucreas (see section 4.4).
Metformin Kumbinazzjonijiet mhux rakkomandat Hemm riskju akbar ta ’ aċidożi lattika f’ intossikazzjoni akuta bl- alkoħol (l- aktar fil- każ ta ’ sawm, malnutrizzjoni jew insuffiċjenza tal- fwied) minħabba s- sustanza attiva metformin li hemm f ’ Eucreas (ara sezzjoni 4. 4).
Consumption of alcohol and medicinal products containing alcohol should be avoided.
Xorb alkoħoliku u prodotti mediċinali li fihom l- alkoħol għandhom jiġu evitati.
Cationic active substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems and hence delay the elimination of metformin, which may increase the risk of lactic acidosis.
Sustanzi attivi cationic li jitneħħew permezz ta ’ sekrezzjoni mit- tubi ż- żgħar tal- kliewi (eż cimetidine) jistgħu jinteraġixxu ma ’ metformin billi jikkompetu mas- sistemi komuni tat- trasport fit- tubi renali komuni u għalhekk jittardjaw l- eliminazzjoni ta ’ metformin, li jista ’ jżid ir- riskju ta ’ aċidożi lattika..
A study in healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50%.
Studju f’ voluntiera b’ saħħithom wera li cimetidine, mogħti bħala 400 mg darbtejn kuljum, żied l - esponiment għal metformin (AUC) b’ 50%.
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4).
Għalhekk, kontroll gliċemiku mill- qrib, tibdil fid- doża fl - ambitu tal- pożoloġija rakkomandata u bidliet fil- kura tad- dijabete għandhom jitqiesu meta prodotti mediċinali cationic li jitneħħew permezz ta ’ sekrezzjoni mit- tubi ż- żgħar tal- kliewi jingħataw flimkien (ara sezzjoni 4. 4).
Intravascular administration of iodinated contrast media may lead to renal failure, resulting in metformin accumulation with the risk of lactic acidosis.
L- għotja minn ġol- vini ta ’ sustanza ta ’ kuntrast li jkun fiha l- jodju jista ’ jwassal għal insuffiċjenza renali, li twassal għall- akkumulu ta ’ metformin bir- riskju li sseħħ ketoaċidożi lattika.
Metformin should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal.
Metformin għandu jitwaqqaf qabel jew meta jsir il- ħin tat- test u ma jerġax jinbeda sa 48 siegħa wara, u biss jekk il- funzjoni renali tkun ġiet evalwata mill- ġdid u misjuba normali.
Combinations requiring precautions for use Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Kumbinazzjonijiet li jeħtieġ prekawzjonijiet għall- użu Glukokortikojdi, agonisti tat- tip beta- 2, u dijuretiċi għandhom attività ipergliċemika minnhom infushom.
The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment.
Il- pazjenti għandu jiġi informat u monitoraġġ aktar spiss taz- zokkor fid- demm għandu jsir, l- aktar fil- bidu tal- kura.
If necessary, the dosage of Eucreas may need to be adjusted during concomitant therapy and on its discontinuation.
Jekk ikun hemm bżonn, id- dożaġġ ta ’ Eucreas jista ’ jeħtieġ aġġustar meta tingħata terapija miegħu u meta titwaqqaf.
Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
5 Impedituri ta ’ angiotensin converting enzyme (ACE) jistgħu jnaqqsu l- livelli tal- glucose fid- demm.
If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Jek ikun hemm bżonn, id- dożaġġ tal- prodott mediċinali kontra l- ipergliċemija għandu jiġi aġġustat waqt it- terapija bil- prodott mediċinali l- ieħor u meta jitwaqqaf.
There are no adequate data from the use of Eucreas in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Eucreas waqt it- tqala.
For vildagliptin studies in animals have shown reproductive toxicity at high doses.
Għal vildagliptin, studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva b’ dożi għoljin.
For metformin, studies in animals have not
Għal metformin, studji fuq bhejjem ma wrewx ħsara fuq is- sistema riproduttiva.
Studies in animals performed with vildagliptin and metformin have not shown evidence of teratogenicity, but foetotoxic effects at maternotoxic doses (see section 5.3).
Studji fuq bhejjem li saru b’ vildagliptin u metformin ma wrewx evidenza ta ’ teratoġeniċità, iżda effetti tossiċi fuq il- fetu b’ dożi tossiċi għall- omm (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju li jista 'jkun hemm fuq il- bniedem, mhux magħruf.
Eucreas should not be used during pregnancy.
Eucreas m’ għandux jintuża waqt it- tqala.
Studies in animals have shown excretion of both metformin and vildagliptin in milk.
Studji fuq annimali wrew eskrezzjoni ta ’ kemm metformin kif ukoll vildagliptin fil- ħalib.
It is not known whether vildagliptin is excreted in human milk, but metformin is excreted in human milk in low amounts.
Mhux magħruf jekk vildagliptin joħroġx mal- ħalib tal- mara, iżda metformin joħroġ fil- ħalib tal- mara f’ ammonti żgħar.
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Eucreas should not be used during lactation (see section 4.3).
Kemm minħabba r- riskju potenzjali li t- tarbija tat- twelid jista ’ jkollha ipogliċemija minħabba metformin kif ukoll minħabba n- nuqqas ta ’ dejta fil- bniedem b’ vildagliptin, Eucreas m’ għandux jintuża waqt it- treddigħ (ara sezzjoni 4. 3).
Patients who may experience dizziness as an undesirable effect should avoid driving vehicles or using machines.
Pazjenti li jista ’ jkollhom sturdament bħala effett mhux mixtieq għandhom jevitaw li jsuqu karozzi jew iħaddmu magni.
There have been no therapeutic clinical trials conducted with Eucreas.
Ma sarux provi kliniċi terapewtiċi b’ Eucreas.
However, bioequivalence of Eucreas with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Madankollu, il- bioekwivalenza ta’ Eucreas meta ngħata flimkien ma ’ vildagliptin u metformin ġiet murija (ara sezzjoni 5. 2).
The data presented here relate to the co-administration of vildagliptin and metformin, where vildagliptin has been added to metformin.
Id- dejta murija hawn tirrelata għall- għotja flimkien ma ’ vildagliptin u metformin, fejn vildagliptin ġie miżjud ma ’ metformin.
There have been no studies of metformin added to vildagliptin.
Ma kienx hemm studji fejn metformin ġie miżjud ma ’ vildagliptin.
The majority of adverse reactions were mild and transient, not requiring treatment discontinuations.
Il- maġġoranza tar- reazzjonijiet avversi kienu ħfief u mumentanji, li ma kellhomx bżonn twaqqif tal - kura.
No association was found between adverse reactions and age, ethnicity, duration of exposure or daily dose.
Ma nstabux assoċjazzjonijiet bejn ir- reazzjonijiet avversi u l- età, razza, tul ta ’ l- esponiment jew doża ta ’ kuljum.