qanastek/EMEA-V3 huggingface dataset:
PACKAGE LEAFLET ra uth or ise d PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
ZIMULTI 20 MG FILM-COATED TABLETS (RIMONABANT)
ZIMULTI 20 mg pilloli miksija b' rita (rimonabant)
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina
What ZIMULTI is and what it is used for 2.
X’ inhu ZIIMULTI u għalxiex jintuża 2.
Before you take ZIMULTI
Qabel ma tieħu ZIMULTI
or 3.
ux 3.
uth 4.
Kif għandek tieħu ZIMULTI 4.
Possible side effects 5 How to store ZIMULTI 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen ZIMULTI ad 6.
ra ge 1.
Aktar tagħrif għ 1.
WHAT ZIMULTI IS AND WHAT IT IS USED FOR on
X’ INHU ZIMULTI U GĦALXIEX JINTUŻA m ’
The active ingredient of ZIMULTI is rimonabant.
Is- sustanza attiva ta ’ ZIMULTI huwa rimonabant.
It works by blocking specific receptors in the brain and fat tissues called CB1 receptors.
Jaħdem billi jibblokka reċetturi speċifiċi fil- moħħ u t- tessut xaħmi, msejjħa reċetturi CB1.
ZIMULTI is indicated in the treatment of obese or overweight ol
ZIMULTI huwa indikat fit- trattament ta ’ pazjenti li qed ibatu mill- obeżità jew jiżnu aktar minn normal u li għandhom fatturi ta ’ riskju oħra bħal dijabete, jew livelli li li
patients with additional risk factors such as diabetes or high levels of fatty substances in the blood called lipids (dyslipidaemia; mainly cholesterol and triglycerides) as adjunct to diet and exercise. tn uc
għolja ta’ sustanzi xaħmin fid- demm magħrufa bħala lipidi (livelli abnormali ta ’ xaħam fid- demm; prinċalment kolesterol u triglycerides) flimkien mad- dieta u l- eżerċizzju. a iċin
BEFORE YOU TAKE ZIMULTI d ro
Tieħux ZIMULTI
Do not take ZIMULTI − if you currently suffer from depression lp
ZIMULTI tt m
− if you are currently being treated for depression − ina
Oqgħod attent/ a ħafna b’ ZIMULTI Qabel ma tibda l- kura b’ ZIMULTI, għid lit- tabib tiegħek: do
if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ZIMULTI − if you are breast-feeding. dic
- jekk qabel kont tbati minn depressjoni jew kellek ħsibijiet suwiċidali
Take special care with ZIMULTI Tell your doctor before you start to take this medicine Me
- jekk int għandek indeboliment tal- fwied
− if you have previously suffered from depression or have had suicidal thoughts − if you have impaired liver function − if you have severely impaired renal function − if you have diabetes (see section 4) − if you are currently being treated for epilepsy − if you are less than 18 years of age.
- jekk inti għandek id- dijabete (ara sezzjoni 4)
There is no information available on the use of ZIMULTI in people under 18 years of age.
M’ hemmx informazzjoni disponibbli dwar l- użu ta ’ ZIMULTI
Serious psychiatric events including depression or mood changes have been reported in patients taking ZIMULTI (see section POSSIBLE SIDE EFFECTS).
Ġrajjiet psikjatriċi serji nklużi depressjoni jew bidla fil- burdata ġew irrapportati f’ pazjenti li kienu qed jieħdu ZIMULTI (ara sezzjoni EFFETTI SEKONDARJI LI JISTA ’ JKOLLU).
If you experience symptoms of depression (see below) during treatment with ZIMULTI you should contact your doctor and stop the treatment.
25 Jekk iġġarrab sintomi ta ’ depressjoni (ara hawn taħt) waqt il- kura b’ ZIMULTI inti għandek tikkuntattja lit- tabib tiegħek u twaqqaf il- kura.
Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability; slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or words about death or suicide.
Swied il- qalb, burdata depressiva; nuqqas ta’ interess f’ attivitajiet li qabel kienu jagħtu gost; aġitazzjoni; irritabilità; inibizzjoni u dewmien biex tagħmel xi ħaġa; konċentrazzjoni baxxa; ansjetà;
You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Għandek tgħarraf lit- tabib tiegħek jekk wara li tinbeda l- kura jiżviluppaw jew jiħżienu xi wieħed mis -
Taking other medicines The activity of ZIMULTI is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as: − itraconazole (antifungal medicine) − ketoconazole (antifungal medicine) − ritonavir (medicine for the treatment of HIV infections) − telithromycin (antibiotic)
tor L- attività ta ’ ZIMULTI tiżdied jekk tieħu miegħu xi sustanzi mediċinali oħra (hekk imsejjħa inibituri ta ’ CYP3A4) bħal:
d − clarithromycin (antibiotic)
- itraconazole (mediċina kontra l- infezzjoni bil- moffa)
ise − nefazodone (anti-depressor) Please inform your doctor or pharmacist if you are taking or have recently taken the above mentioned
- ketoconazole (mediċina kontra l- infezzjoni bil- moffa)
or medicines or any other medicines, including those obtained without a prescription such as St John’ s wort, rifampicin (antibiotic), medicines for weight loss, medicines to improve blood lipids (fats),
- ritonavir (mediċina għall- kura ta ’ l- infezzjonijiet bl- HIV)
uth antidiabetes medicines and medicines to treat epilepsy (e. g. phenytoin, phenobarbital, carbamazepine) or depression.
Jekk jogħgbok, għid lit- tabib jew lill- ispiżjar tiegħek jekk int qiegħed tieħu jew ħadt dan l- aħħar il - ad mediċini msemmija hawn fuq jew xi mediċini oħra, anki dawk mingħajr riċetta, bħal St John’ s wort, rifampicin (antibijotiku), mediċini biex tonqos fil- piż, mediċini biex tikkontrolla x- xaħmijiet fid - għ demm, mediċini għad- dijabete u mediċini biex tikkura l- epilessija (bħal phenytoin, phenobarbital, carbamazepine) jew id- depressjoni. m ’
Pregnancy and breast-feeding ra ge ZIMULTI should not be taken during pregnancy.
Tqala u Treddigħ ZIMULTI m’ għandux jittieħed waqt it- tqala.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning on
Ikkuntattja lit- tabib tiegħek immedjatament jekk toħroġ tqila, jew taħseb li tista ’ tkun tqila jew qed li li
to become pregnant while taking ZIMULTI. ol
tippjana biex toħroġ tqila, waqt li qed tieħu ZIMULTI.
Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby. tn
Għid lit- tabib tiegħek jekk int qed tredda ’ jew għandek a
Driving and using machines uc
f’ moħħok li ser tredda ’ lit- tarbija tiegħek. iċin
At the recommended dose, ZIMULTI is not expected to reduce your ability to drive and use machines. d
Sewqan u tħaddim ta ’ magni Fid- doża irrakkomandata, ZIMULTI mhux mistenni li jnaqqas il- ħila biex issuq jew tħaddem magni. ed
Important information about some of the ingredients of ZIMULTI ro
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ZIMULTI Il- pilloli ta ’ ZIMULTI fihom il- lattosju.
If you are intolerant to some sugars, contact your doctor before lp
Jekk int intolleranti għal xi tipi ta ’ zokkor, kellem lit- tabib tiegħek qabel ma tibda tieħu din il- mediċina. tt m
HOW TO TAKE ZIMULTI dic
KIF GĦANDEK TIEĦU ZIMULTI do
Always take ZIMULTI exactly as your doctor has told you.
Dejjem għandek tieħu ZIMULTI skond il- parir eżatt tat- tabib.
The usual dose is one 20 mg tablet to be taken once daily in the Me
Id- doża li ssoltu tingħata hija pillola waħda ta ’ 20 mg, li tittieħed darba kuljum filgħodu qabel il- kolazzjon.
Swallow the tablet whole.
Pro
Your doctor should recommend the type of diet and the level of physical activity required, that suits your specific condition and overall health.
It- tabib tiegħek għandu jirrakkomanda it- tip ta ’ dieta u l- livell ta ’ attività fiżika meħtieġa, li jaqblu mal- kondizzjoni speċifika tiegħek u saħħtek in ġenerali.
Taking ZIMULTI with food and drink ZIMULTI should be taken once daily in the morning before breakfast.
Tieħu ZIMULTI ma ’ l- ikel u x- xorb ZIMULTI għandu jittieħed darba kuljum filgħodu qabel il- kolazzjon.
If you take more ZIMULTI than you should If you take more ZIMULTI than you should tell a doctor or pharmacist.
26 Jekk tieħu ZIMULTI aktar milli suppost Jekk ħadt aktar ZIMULTI milli suppost għid lit- tabib jew lill- ispiżjar.
25 If you forget to take ZIMULTI Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.
Jekk tinsa tieħu ZIMULTI Ħudha hekk kif tiftakar iżda m’ għandekx tieħu doża doppja biex tpatti għad- doża li tkun insejt tieħu.
If you have any further questions on the use of this product ask your doctor or your pharmacist.
at Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, ZIMULTI can cause side effects, although not everybody gets them Very common side effects, that affect more than 1 per 10, that have occurred in patients on ZIMULTI include: nausea and upper respiratory tract infection.
L- effetti sekondarji komuni ħafna, li jidhru f’ aktar minn 1 f’ kull 10, li kellhom il- pazjenti fuq ZIMULTI kienu jinkludu:
Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in patients on ZIMULTI include:
aw Id- dardir u l- infezzjonijiet tal- passaġġi tan- nifs, tal- parti ta ’ fuq.
d upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness,
Effetti sekondarji komuni, li jidhru f’ aktar minn 1 f’ kull 100 iżda anqas minn 1 f’ kull 10, li kellhom il - pazjenti b’ ZIMULTI kienu jinkludu:
ise diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or
ux Stonku mqalleb, rimettar, problemi fl- irqad, nervożiżmu, depressjoni, irritabilità, sturdament, dijarrea, anzjetà, ħakk, tagħriq eċċessiv, bugħawwieġijiet u spażmu tal- muskoli, għejja, tbenġil, uġigħ fl- għeruq u infjammazzjoni tagħhom (tendonitis), tnaqqis fil- memorja, uġigħ fid- dahar (xjatika), tibdil fil- ħass ad (inqass ħass jew sensazzjoni abnormali ta ’ ħruq jew tingiż) ta ’ l- idejn u s- saqajn, sħanat, waqgħat, l - influwenza u tfekkik ta’ ġog. għ Effetti sekondarji mhux komuni, li jidhru f’ anqas minn 1 f’ kull 100 iżda aktar minn 1 f’ kull 1000, li kellhom il- pazjenti fuq ZIMULTI kienu jinkludu: m ’
or abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint
Telqa (letarġija), tregħid, tagħriq bil- lejl, sintomi ta ’ paniku, sulluzzu, rabja, nuqqas ta ’ kwiet (disforija), mard ħafif emozzjonali, ħsibijiet dwar suwiċidju, aggressività jew mġiba aggressiva, ipogliċemija (zokkor baxx fid- demm). li li
Uncommon side effects, that affect less than 1 per 100 but more than1 per 1000, that have occurred in patients on ZIMULTI include: ra Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), ge emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low blood sugar). on
Effetti sekondarji rari, li jinsabu f’ anqas minn 1 f’ kull 1000, li kellhom il- pazjenti b’ ZIMULTI kienu jinkludu: l- alluċinazzjonijiet. a
Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ZIMULTI include: ol
Mill- esperjenza wara li l- prodott tqiegħed fis- suq ġew irrapportati wkoll dawn l- effetti sekondarji li iċin
hallucinations. tn
ġejjin( il- frekwenza m’ hijiex magħrufa):
During post-marketing experience the following side effects have also been reported (frequency not uc
Konvulżjonijiet, disturbi fl- attenzjoni, taqriq (konvinzjoni qarrieqa) paranojja, raxx, uġigħ ta ’ ras u uġigħ fl- istonku. ed
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please lp
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek. tt m
HOW TO STORE ZIMULTI dic
KIF TAĦŻEN ZIMULTI do
Me
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use ZIMULTI after the expiry date which is stated on the outer packaging after EXP.
Tużax ZIMULTI wara d- data ta ’ skadenza li tidher fuq il- kartuna wara EXP.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza Pro
This medicinal product does not require any special storage conditions
tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
Medicines should not be disposed of via wastewater or household waste.
Din il- mediċina m’ għandiex bżonn ħażna speċjali.
Ask your pharmacist how to dispose of medicines no longer required.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew l- iskart domestiku.
What ZIMULTI contains The active substance is rimonabant.
Is- sustanza attiva hi rimonabant.
Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Tablet coating: lactose monohydrate, hypromellose 15 mPa. s (E464), titanium dioxide (E171), macrogol 3000 Tablet polishing: carnauba wax (E903)
at sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Ir- rita tal- pillola: lactose monohydrate, hypromellose 15 mPa. s (E464), titanium dioxide (E171),
What ZIMULTI looks like and contents of the pack ZIMULTI 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “ 20” on one side.
izz macrogol 3000 Il- lostru tal- pillola: carnauba wax (E903)
d ZIMULTI is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit dose
tor Id- Dehra ta ’ ZIMULTI u l- kontenuti tal- pakkett ZIMULTI 20 mg huwa fornit bħala pilloli bojod taħt forma ta ’ qatra dmugħ, u miksija b’ rita, imnaqqxin bin- numru “ 20 ” fuq faċċata waħda.
Not all pack sizes may be marketed.
aw ZIMULTI huwa disponibbli f’ folja ta ’ 14, 28, 30, 56, 84, 90 u 98 pilloli, f’ folji imtaqqbin doża waħda, doża waħda li fihom 70 x 1 pillola, u fi fliexken bojod tal- plastik li fihom 28, 98 u 500 pillola.
or uth Marketing Authorisation Holder and Manufacturer
ux Mhux id- daqsijiet kollha jistgħu jistgħu ikunu jinstabu fis- suq.
Marketing Authorisation Holder sanofi-aventis 174, avenue de France F-75013 Paris France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur ad Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għ sanofi- aventis 174, avenue de France F- 75013 Paris m ’
on ol
Franza
Manufacturers Sanofi Winthrop Industrie tn
Manifatturi li li
30-36, avenue Gustave Eiffel – BP 27166 uc
Sanofi Winthrop Industrie 30- 36, avenue Gustave Eiffel – BP 27166 F- 37071 Tours Cedex 2 a
F-37071 Tours Cedex 2 France d ro
Franza iċin
Strada Statale 17, Km 22 lp
Strada Statale 17, Km 22 67019 Scoppito (AQ) ed
67019 Scoppito (AQ) Italy ina
L- Italja
For any information about this medicinal product, please contact the local representative of the dic
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok, ikkuntattja lir- rappreżentant lokali tt m
Me
tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq: do Pro
България sanofi-aventis Bulgaria EOOD Тел.: +359 (0)2 970 53 00
България sanofi- aventis Bulgaria EOOD
Č eská republika sanofi-aventis, s. r. o.
izz Česká republika sanofi- aventis, s. r. o.
Danmark sanofi-aventis Denmark A/ S
tor Danmark sanofi- aventis Denmark A/ S
d Tlf: +45 45 16 70 00
aw Tlf: +45 45 16 70 00
or Sanofi-Aventis Deutschland GmbH
Deutschland Sanofi- Aventis Deutschland GmbH
uth Tel: +49 (0)180 2 222010
ux Tel: +49 (0) 180 2 222010
Eesti sanofi-aventis Estonia OÜ
Eesti
Österreich
Österreich ad
Tel: +372 627 34 88
sanofi- aventis Estonia OÜ Tel: +372 627 34 88
ra sanofi-aventis GmbH Tel: +43 1 80 185 – 0 ge
sanofi- aventis GmbH Tel: +43 1 80 185 – 0 għ
Polska on
Polska sanofi- aventis Sp. z o. o. m ’
tn
li li
sanofi-aventis - Produtos Farmacêuticos, S.A.
Tel: +34 93
Tel: +34 93 485 94 00
485 94 00 a
d
sanofi- aventis - Produtos Farmacêuticos, S. A.
ro
iċin
lp
+33 1 57 63 23 23 ed
Tel: +353 (0) 1 403 56 00 Me
Tel: +353 (0) 1 403 56 00 tt m
Italia sanofi-aventis S.p.A.
Pro
This leaflet was last approved in
izz Dan il- fuljett kien approvat l- aħħar f ’
Detaile d information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
tor Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
d ise or uth ra ge on ol tn duc ro lp ina dic Me
aw ux ad għ m ’ li li a iċin ed tt m do Pro
What is Zomarist?
X’ inhu Zomarist?
Zomarist is a medicine containing the active substances vildagliptin and metformin hydrochloride.
Zomarist huwa mediċina li fiha s- sustanzi attivi vildagliptin u metformina kloroidrat (metformin hydrochloride).
The company that makes Eucreas has agreed that its scientific data can be used for Zomarist.
Il - kumpanija li tipproduċi Eucreas qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Zomarist.
What is Zomarist used for?
Għal xiex jintuża Zomarist?
Zomarist is used to treat type 2 diabetes (non-insulin-dependent diabetes).
Zomarist jintuża għat- trattament tad- dijabete tat- tip 2 (dijabete mhux dipendenti mill- insulina).
How is Zomarist used?
Kif jintuża Zomarist?
The recommended dose of Zomarist is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Id- doża rakkomandata ta ’ Zomarist hija pillola waħda darbtejn kuljum, waħda filgħodu u l- oħra filgħaxija.
Patients already taking vildagliptin and metformin should switch to Zomarist containing the same amounts of each active substance.
L- għażla tad- doża inizjali tiddependi mid- doża ta ’ metformina li l- pazjent attwalment ikun qed jieħu, iżda d- doża rakkomandata hija 50 mg vildagliptin u 1, 000 mg metformina darbtejn kuljum. l- pazjenti li diġà jkunu qed jieħdu vildagliptin u metformina għandhom jaqilbu għal Zomarist li fih l - istess dożi ta ’ kull sustanza attiva.
Taking Zomarist with or just after food may reduce any stomach problems caused by metformin.
Meta wieħed jieħu Zomarist mal- ikel jew eżatt wara, jistgħu jitnaqqsu problemi tal- istonku kkawżati mill - metformina.
Zomarist should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Zomarist ma għandux jintuża f’ pazjenti li għandhom problemi moderati jew gravi bil- kliewi jew bil - fwied tagħhom.
Elderly patients taking Zomarist should have their kidney function monitored regularly.
Fil- pazjenti anzjani li jkunu qed jieħdu Zomarist ikun xieraq li jkollhom il- funzjoni tal- kliewi ssorveljata regolarment.
Zomarist is not recommended for use in patients aged over 75 years.
Zomarist mhuwiex rakkomandat għall- użu fil- pazjenti ta ’ età ogħla minn 75 sena.
How does Zomarist work?
Kif jaħdem Zomarist?
Zomarist contains two active substances, which each have a different mode of action.
Zomarist fih żewġ sustanzi attivi li kull waħda minnhom għandha azzjoni differenti.
Vildagliptin, which is a dipeptidyl peptidase 4 (DPP-4) inhibitor, works by blocking the breakdown of ‘ incretin’ hormones in the body.
Vildagliptin, inibitur tal- dipeptidil peptidażi 4 (DPP- 4), jaħdem billi jimblokka d -
Reproduction is authorised provided the source is acknowledged. when blood glucose levels are high.
Reproduction is authorised provided the source is acknowledged. dekompożizzjoni tal- ormoni ‘ inkretini ’ fil- ġisem.
How has Zomarist been studied?
Kif ġie studjat Zomarist?
Vildagliptin can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Vildagliptin jista ’ jintuża mal- metformina fil- pazjenti li jbatu mid- dijabete tat- tip 2 li l- marda tagħhom mhijiex ikkontrollata b’ mod sodisfaċenti bil - metformina waħedha.
The studies of Galvus as an add-on to metformin were used to support the use of Zomarist in the same indication.
L- istudji mwettqa fuq Galvus ġew integrati ma ’ dawk fuq il- metformina biex isostnu l- użu ta ’ Zomarist għall- istess indikazzjoni.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Zomarist 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 dożaġġi ta ’ Zomarist ġew assorbiti fil- ġisem bl- istess mod bħalma kieku ttieħdu bħala pilloli separati.
What benefit has Zomarist shown during the studies?
X' benefiċċji wera Zomarist fl- istudji mwettqa?
What is the risk associated with Zomarist?
X’ inhu r- riskju assoċjat ma ’ Zomarist?
The most common side effects with Zomarist (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
L- effetti sekondarji l- aktar komuni b’ Zomarist (li dehru f’ aktar minn pazjent 1 minn kull 10) huma nawżea (dardir), remettar, dijarrea, uġigħ addominali (ta ’ żaqq) u telf tal- aptit.
For the full list of all side effects reported with Zomarist, see the Package Leaflet.
Għal- lista sħiħa tal - effetti sekondarji irrappurtati b’ Zomarist, ara l- Fuljett ta ’ Tagħrif.
Zomarist should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Zomarist ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal vildagliptin, il- metformina jew għal kwalunkwe ingredjent ieħor.
Why has Zomarist been approved?
Għaliex ġie approvat Zomarist?
Therefore, the Committee decided that the benefits of Zomarist 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 ’ Zomarist huma ogħla mir- riskji tiegħu għat- trattament tal- pazjenti li jbatu mid - dijabete mellitu tat- tip 2 li ma jkunux jistgħu jiksbu biżżejjed kontroll gliċemiku fid- doża massima tollerata tagħhom ta ’ metformina orali meħuda waħedha jew li jkunu diġà ttrattati b’ kombinazzjoni ta ’ vildagliptin u metformina f’ pilloli separati.
The Committee recommended that Zomarist be given marketing authorisation.
Il- Kumitat irrakkomanda li Zomarist jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Zomarist:
Aktar tagħrif dwar Zomarist:
The European Commission granted a marketing authorisation valid throughout the EU for Zomarist to Novartis Europharm Limited on 1 December 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Zomarist lil Novartis Europharm Limited fil- 1 ta ’ Diċembru 2008.
The full EPAR for Zomarist can be found here.
L- EPAR sħiħ għal Zomarist jista ’ jiġi kkonsultat hawn.
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
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folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al) folja (PA/ Al/ PVC/ Al)
10 tablets 30 tablets 60 tablets 120 tablets 180 tablets 360 tablets 10 tablets 30 tablets 60 tablets 120 tablets 180 tablets 360 tablets 120 (2x60) tablets 180 (3x60) tablets 360 (6x60) tablets 120 (2x60) tablets 180 (3x60) tablets 360 (6x60) tablets
10 pilloli 30 pillola 60 pillola 120 pillola 180 pillola 360 pillola 10 pilloli 30 pillola 60 pillola 120 pillola 180 pillola 360 pillola 120 (2x60) pillola 180 (3x60) pillola 360 (6x60) pillola 120 (2x60) pillola 180 (3x60) pillola 360 (6x60) pillola
Zomarist 50 mg/ 850 mg film-coated tablets
Zomarist 50 mg/ 850 mg pilloli miksijin b’ rita
Zomarist 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.
Zomarist 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, Zomarist 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, Zomarist jista ’ jinbeda b’ pillola ta ’ 50 mg/ 850 mg jew ta ’ 50 mg/ 1000 mg darbtejn kuljum, pillola waħda filgħodu u l- oħra filgħaxija.
Patients receiving vildagliptin and metformin from separate tablets may be switched to Zomarist containing the same doses of each component.
Pazjenti li qed jirċievu vildagliptin u metformin minn pilloli separati jistgħu jinqalbu għal Zomarist li jkun fih l- istess dożi ta ’ kull komponent.
Taking Zomarist with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Jekk Zomarist 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 Zomarist 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 Zomarist m’ għandux jintuża f’ pazjenti bi tneħħija tal- krejatinina < 60 ml/ min (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
2 Hepatic impairment Zomarist 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 Zomarist 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).
Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Zomarist 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 Zomarist għandu jkollhom il- funzjoni renali immonitorata b’ mod regolari (ara sezzjoni 4. 4).
Zomarist has not been studied in patients older than 75 years.
Zomarist ma kienx studjat f’ pazjenti li għandhom ’ l fuq minn 75 sena.
Therefore the use of Zomarist is not recommended in this population.
Għalhekk l- użu ta ’ Zomarist mhux rakkomandat f’ din il- popolazzjoni.
Paediatric population (< 18 years) Zomarist is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Popolazzjoni pedjatrika (< 18- il sena) Zomarist mhux irrakkomandat għall- użu fit- tfal u adolexxenti peress li hemm nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
General Zomarist is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Ġenerali Zomarist mhux sostitut għall- insulina f’ pazjenti li jeħtieġu l- insulina u mgħandux jintuża f’ pazjenti b’ dijabete tat- tip 1.
Renal impairment
- mill- anqas darba f’ sena f’ pazjenti b’ funzjoni renali normali
Renal impairment in elderly patients is frequent and asymptomatic.
Indeboliment renali f’ pazjenti anzjani jseħħ ta ’ spiss u mingħajr sintomi.
Hepatic impairment Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Zomarist (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’ Zomarist (ara sezzjonijiet 4. 2, 4. 3 u 4. 8).
LFTs should be performed prior to the initiation of treatment with Zomarist in order to know the patient’s baseline value.
It- testijiet tal- funzjoni tal- fwied għandhom isiru qabel ma tinbeda l- kura b’ Zomarist sabiex ikun magħruf il- valur tal- linja bażi tal- pazjent.
Liver function should be monitored during treatment with Zomarist at three-month intervals during the first year and periodically thereafter.
Il- funzjoni tal- fwied għandha tiġi monitorata waqt il- kura b’ Zomarist f’ intervalli ta ’ tlett xhur fl- ewwel sena u darba kulltant minn hemm ’ l quddiem.
Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Zomarist therapy is recommended.
Jekk iż- żieda fl- AST jew fl- ALT ta ’ 3 darbiet il- ULN jew akbar tippersisti, it- twaqqif tat- terapija b ’ Zomarist huwa rakkomandat.
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Zomarist.
Pazjenti li jiżviluppaw is - suffejra jew sinjali li jindikaw funzjoni anormali tal- fwied għandhom iwaqqfu Zomarist.
Following withdrawal of treatment with Zomarist and LFT normalisation, treatment with Zomarist should not be re-initiated.
Wara t- twaqqif tal- kura b’ Zomarist u LFT ikun ġie lura għan- normal, il- kura b’ Zomarist mgħandhiex terġa tinbeda.
Metformin is contraindicated in patients with heart failure, therefore Zomarist is contraindicated in this patient population (see section 4.3).
Metformin huwa kontra- indikat f’ pazjenti b’ insuffiċjenza tal- qalb, għalhekk Zomarist huwa kontra - indikat f’ din il- popolazzjoni ta ’ pazjenti (ara sezzjoni 4. 3).
Surgery As Zomarist 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 Zomarist 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.
Therefore, due to the metformin active substance, Zomarist 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, Zomarist 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 There have been no formal interaction studies for Zomarist.
4 Ma sarux studji dwar l- effett ta ’ medicini jew ta’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ Zomarist.
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.
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 Zomarist (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 ’ Zomarist (ara sezzjoni 4. 4).
If necessary, the dosage of Zomarist may need to be adjusted during concomitant therapy and on its discontinuation.
Jekk ikun hemm bżonn, id- dożaġġ ta ’ Zomarist jista ’ jeħtieġ aġġustar meta tingħata terapija miegħu u meta titwaqqaf.
5 There are no adequate data from the use of Zomarist in pregnant women.
5 M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Zomarist waqt it- tqala.
Zomarist should not be used during pregnancy.
Zomarist m’ għandux jintuża waqt it- tqala.
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Zomarist 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, Zomarist m’ għandux jintuża waqt it- treddigħ (ara sezzjoni 4. 3).
There have been no therapeutic clinical trials conducted with Zomarist.
Ma sarux provi kliniċi terapewtiċi b’ Zomarist.
However, bioequivalence of Zomarist with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Madankollu, il- bioekwivalenza ta’ Zomarist meta ngħata flimkien ma ’ vildagliptin u metformin ġiet murija (ara sezzjoni 5. 2).
In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations ≥ 3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively.
Minn dejta minn monoterapija kontrollata u provi add- on li damu sa 24 ġimgħa, l- inċidenza ta ’ żiediet fl- ALT jew AST kienet  3 darbiet ULN (klassifikata bħala preżenti f’ mill- anqas 2 kejliet wara xulxin jew fl- aħħar żjara fuq il- kura) kienu 0. 2%, 0. 3% u 0. 2% għal vildagliptin 50 mg kuljum, vildagliptin 50 mg darbtejn kuljum u l- kumparaturi kollha, rispettivament.
Adverse reactions reported in patients who received vildagliptin 100 mg daily as add-on therapy to metformin compared to placebo plus metformin in double-blind studies (N=208)
Tabella 1 Reazzjonijiet avversi rrappurtati f’ pazjenti li rċevew vildagliptin 100 mg kuljum bħala terapija li ġiet miżjuda ma ’ metformin meta mqabbla ma ’ plaċebo ma ’ metformin fi studji double- blind (N=208)
6
6 Disturbi fis- sistema nervuża
Common Uncommon
Komuni Komuni Komuni Mhux komuni
Dizziness Fatigue
Tregħid Uġigħ ta ’ ras Sturdament Għeja
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Fil- provi kliniċi, il- piż ma nbidilx mill- linja bażi meta vildagliptin 100 mg kuljum ingħata bħala monoterapija (- 0. 3 kg u - 1. 3 kg għal vildagliptin u plaċebo, rispettivament).
Known adverse reactions for metformin component
7 Tabella 3 Reazzjonijiet magħrufa għall- komponent metformin
Decrease of vitamin B 12 absorption and lactic acidosis*
Tnaqqis ta ’ l- assorbiment tal- vitamina B 12 u aċidożi lattika *
No data are available with regard to overdose of Zomarist.
M’ hemmx dejta dwar doża eċċessiva b’ Zomarist.
Zomarist combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
8 Zomarist jikkombina żewġ aġenti kontra l- ipergliċemija b’ mekkaniżmu ta ’ azzjoni kumplimentari sabiex jitjieb il- kontroll ta ’ pazjenti bid- dijabete tat- tip 2: vildagliptin, membru tal- klassi li jtejjeb l - islet, u metformin hydrochloride, membru tal- klassi biguanide.
8 Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Vildagliptin, membru tal- klassi li jtejjeb l- islet, huwa impeditur qawwi u silettiv ta ’ dipeptidyl - peptidase- 4 (DPP- 4).
Vildagliptin added to patients whose glycaemic control was not satisfactory despite treatment with metformin monotherapy resulted after 6-month treatment in additional statistically significant mean reductions in HbA 1c compared to placebo (between group differences of -0.7% to -1.1% for vildagliptin 50 mg and 100 mg, respectively).
Meta vildagliptin kien miżjud f’ pazjenti li l- kontroll gliċemiku tagħhom ma kienx sodisfaċenti minkejja kura b’ monoterpija ta ’ metformin irriżulta li wara 6 xhur ta ’ kura kien hemm żieda statistikament sinifikanti fil- medja ta ’ tnaqqis ta ’ HbA 1c meta mqabbel mal- plaċebo (differenzi bejn il - gruppi ta ’ - 0. 7% sa ’ - 1. 1% għal vildagliptin 50 mg u 100 mg rispettivament).
The proportion of patients who achieved a decrease in HbA 1c of ≥ 0.7% from baseline was statistically significantly higher in both vildagliptin plus metformin groups (46% and 60%, respectively) versus the metformin plus placebo group (20%).
Il- proporzjon ta ’ pazjenti li kisbu tnaqqis fl - HbA 1c ta ’ ≥ 0. 7% mill- linja bażi kien ogħla statistikament sinifikanti kemm fil - gruppi ta ’ vildagliptin ma ’ metformin (46% u 60%, rispettivament) kontra l- grupp ta ’ metformin mal - plaċebo (20%).
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 b’ dijabete tat- tip 2 tejjeb b’ mod sinifikanti l- markaturi tal - funzjoni taċ- ċelluli beta inklużi HOMA- β (Stima tal- Mudell B’ Omeostażi- β), proporzjoni tal - proinsulina ma ’ l- insulina u kejl tar- risponsittività taċ- ċelluli beta mit- testijiet tat- tolleranza għall- ikel li jiġu kampjunati spissi.
Metformin may exert its glucose -lowering effect via three mechanisms:
Metformin jista ’ jeżerċita l- effett tiegħu li jnaqqas il- glucose permezz ta ’ tlett mekkaniżmi:
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
9 Fil- bniedem, b’ mod indipendenti mill- effett tiegħu fuq il- gliċemija, metformin għandu effetti tajbin fuq il- metaboliżmu tal- lipidi.
9 The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the long- term benefit of intensive blood glucose control in type 2 diabetes.
L- istudju prospettiv randomised UKPDS (Studju Prospettiv tad- Dijabete UK) stabilixxa l- benefiċċju fuq żmien twil tal- kontroll tal- glucose fid- demm fid- dijabete tat- tip 2.
Zomarist Absorption Bioequivalence has been demonstrated between Zomarist at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Zomarist Assorbiment Intweriet bioekwivalenza mejn Zomarist fi tlett qawwiet ta ’ dożi (50 mg/ 500 mg, 50 mg/ 850 mg u 50 mg/ 1000 mg), kontra kombinazzjoni ħielsa ta ’ pilloli ta ’ vildagliptin u metformin hydrochloride bid- dożi li jikkorrispondu għalihom.
Food does not affect the extent and rate of absorption of vildagliptin from Zomarist.
L- ikel ma jeffettwax il- grad u r- rata ta ’ assorbiment ta ’ vildagliptin minn Zomarist.
The rate and extent of absorption of metformin from Zomarist 50 mg/1000 mg were decreased when given with food as reflected by the decrease in C max by 26%, AUC by 7% and delayed T max (2.0 to 4.0 h).
Ir- rata u l- grad ta ’ assorbiment ta ’ metformin milZomarist 50 mg/ 1000 mg kienu mnaqqsa meta mogħtija ma ’ l- ikel bi tnaqqis fis- C max b’ 26%, AUC b’ 7% u T max ittardjat (2. 0 sa 4. 0 h).
The following statements reflect the pharmacokinetic properties of the individual active substances of Zomarist.
Id- dikjarazzjonijiet li ġejjin jirriflettu il- kwalitajiet farmakokinetiċi tas- sustanzi attivi f’ Zomarist.
Administration of vildagliptin with food resulted in a decreased C max (19%) compared to dosing in the fasting state.
L- għotja ta ’ vildagliptin ma ’ l- ikel irriżultat fi tnaqqis fis- C max (19%) meta mqabbel ma ’ dożi mogħtija fi stat sawmi.
The mean volume of distribution of vildagliptin at steady-state after intravenous administration (V ss) is 71 litres, suggesting extravascular distribution.
Il- medja tal- volum tad- distribuzzjoni ta ’ vildagliptin fi stat- fiss wara li jingħata minn ġol- vina (V ss) hija 71 litru, li jindika distribuzzjoni ekstravaskulari.
Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Biotrasformazzjoni Fil- bniedem il- metaboliżmu huwa l- mezz ewlieni li bih jitnehha vildagliptin, li jgħodd 69% tad- doża.
Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by co- medications that are CYP 450 inhibitors and/or inducers.
Studji in vitro
In vitro studies demonstrated that vildagliptin does not inhibit/induce CYP 450 enzymes.
10 wrew li vildagliptin ma jimpedixxix/ jinduċix l- enzimi CYP 450.
10 Elimination Following oral administration of [14C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose was recovered in the faeces.
Eliminazzjoni Wara li ngħata vildagliptin [14C] mill- ħalq, madwar 85% tad- doża tneħħiet fl- awrina u 15% tad- doża instabet fl- ippurgar.
Linearity / non-linearity The C max for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.
Linjarità / nuqqas ta ’ linjarità Is- Cmax għal vildagliptin u l- erja taħt il- kurva tal- konċentrazzjoni fil- plażma kontra l- ħin (AUC) żdiedu b’ mod li kien kważi proporzjonali mad- doża fuq il- medda terapewtika.
In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (C max 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
F’ individwi b’ indeboliment renali ħafif, moderat, jew sever, l- esponiment sistemiku għal vildagliptin żdiedet (C max 8- 66%, AUC 32- 134%) u t- tneħħija totali mill- ġisem tnaqqset meta mqabbla ma ’ individwi b’ funzjoni renali normali.
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (C max) is achieved after about 2.5 h..
Metformin Assorbiment Wara doża metformin li tittieħed mill- ħalq, il- konċentrazzjoni massima fil- plażma (C max) tintlaħaq wara madwar 2. 5 h.
In controlled clinical trials, maximum metformin plasma levels (C max) did not exceed 4 µg/ml, even at maximum doses.
Fi provi kliniċi bil- kontroll, l- ogħla livelli ta ’ metformin fil - plażma (C max) ma qabżux 4 µg/ ml, anki bl- ogħla dożi.
Food slightly delays and decreases the extent of the absorption of metformin.
L- ikel jittardja bi ftit u jnaqqas il- grad ta ’ assorbiment ta ’ metformin.
The mean volume of distribution (V d) ranged between 63-276 litres.
Il- medja tal- volum tad- distribuzzjoni (V d) kella medda ta ’ bejn 63- 276 litru.
Metabolism Metformin is excreted unchanged in the urine.
11 Metaboliżmu Metformin jitneħħa mingħajr ma jiġi mibdul fl- awrina.
11 Metformin is eliminated by renal excretion.
Eliminazzjoni Metformin jiġi eliminat permezz ta ’ tneħħija renali.
Animal studies of up to 13-week duration have been conducted with the combined substances in Zomarist.
Studji f’ annimali li damu sa ’ 13- il ġimgħa saru bis- sustanzi kombinati f’ Zomarist.
Vildagliptin Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg (7- fold human exposure based on C max).
Vildagliptin Ittardjar fil- konduzzjoni ta ’ impulsi fil- qalb dehru fi klieb b’ doża mingħajr effett ta ’ 15 mg/ kg (7- darbiet l- esponiment fil- bniedem ibbażat fuq C max).
Flaking skin, peeling skin, scabs and tail sores with correlating histopathological changes were noted at doses ≥ 20 mg/kg/day (approximately 3 times human AUC exposure at the 100 mg dose).
12 korrelatanti kienu nnutati b’ dożi ≥ 20 mg/ kg/ jum (madwar 3 darbiet l- esponiment ta ’ l- AUC fil - bniedem b’ doża ta ’ 100 mg).
12 Non-clinical data on metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Metformin Informazzjoni mhux klinika għal metformin ma turi l- ebda periklu speċjali għall- bnedmin ibbażata fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, ġenetossiċita, riskju kanċeroġeniku potenzjali u effett tossiku fuq is- sistema riproduttiva.
Zomarist 50 mg/1000 mg film-coated tablets
Zomarist 50 mg/ 1000 mg pilloli miksijin b’ rita
Adults Based on the patient’s current dose of metformin, Zomarist 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, Zomarist jista ’ jinbeda b’ pillola ta ’ 50 mg/ 850 mg jew ta ’ 50 mg/ 1000 mg darbtejn kuljum, pillola waħda filgħodu u l- oħra filgħaxija.
Additional information on special populations Renal impairment Zomarist 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 Zomarist m’ għandux jintuża f’ pazjenti bi tneħħija tal- krejatinina < 60 ml/ min (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
15 Hepatic impairment Zomarist 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 Zomarist 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).
Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Zomarist should have their renal function monitored regularly (see section 4.4).
15 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 Zomarist għandu jkollhom il- funzjoni renali immonitorata b’ mod regolari (ara sezzjoni 4. 4).
Hepatic impairment Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Zomarist (see sections 4.2, 4.3 and 4.8).
Indeboliment tal- fwied Pazjenti b’ indeboliment epatiku, inklużi pazjenti li jkollhom ALT jew AST qabel il- kura > 3 darbiet ULN, m’ għandhomx jiġu kkurati b’ Zomarist (ara sezzjonijiet 4. 2, 4. 3 u 4. 8).
17 There have been no formal interaction studies for Zomarist.
17 Ma sarux studji dwar l- effett ta ’ medicini jew ta’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ Zomarist.
18 There are no adequate data from the use of Zomarist in pregnant women.
18 M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Zomarist waqt it- tqala.
Nervous system disorders
19 Disturbi fis- sistema nervuża