qanastek/EMEA-V3 huggingface dataset:
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Fil- firien, kien hemm in idenza ikbar ta ’ adenoma u kar inoma fil- fwied b’ espo izzjoni sistemika li kienet 58 darba iktar minn dik Fl- umani.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Billi l- livell tossiku epatikui ntwera li jikkorelata ma ’ l- induzzjoni ta ’ neopla ja epatika fil- firien, din l- in idenza ikbar ta ’ tumuri epati i fil- firien aktarx li kienet sekondarja g at- tossi ità epatika kronika f’ din id - do a g olja.
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
Fi studju dwar l- i vilupp qabel u wara t- twelid li sar fuq il- firien sitagliptin ma wera l- ebda effett avvers.
23 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Qalba tal- pillola: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
6.4 Special precautions for storage
26 6. 4 Prekawzjonijiet spe jali g all - a na
This medicinal product does not require any special storage conditions.
Dan il- prodott medi inali m’ g andux b onn ta’ kundizzjonijiet spe jali ta ’ a na.
6.6 Special precautions for disposal
6. 6 P rekawzjonijiet spe jali li g andhom jittie du meta jintrema.
TESAVEL 100 mg film-coated tablets
TESAVEL pilloli miksija b’ rita tal- 100 mg
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate, ekwivalenti g al 100 mg ta ’ sitagliptin.
Round, beige film-coated tablet with “ 277” on one side.
Pillola miksija b’ rita tonda u beige bi “ 227 ” fuq na a wa da.
26 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
28 Pazjenti b’ insuffi jenza renali ija tal- krejatinina [CrCl] ≥50 ml/ min,, m’ hemmx G al pazjenti b’ insuffi jenza renali afifa (tne b onn bidla fid- do a ta ’ TESAVEL.
TESAVEL has not been studied in patients with severe hepatic insufficiency.
M’ hemmx g alfejn bidla fid- do a g al pazjenti li g andhom TESAVEL ma iex studjat f’ pazjenti b’ insuffi jenza epatika
Limited safety data is available in patients ≥ 75 years of age and care should be exercised.
Hemm tag rif limitat dwar sigurtà f’ pazjenti ta ’ 75 sena u g andha tigi ezercitata attenzjoni.
4.5 Interaction with other medicinal products and other forms of interaction
29 4. 5 Prodotti medi inali o ra li ma jaqblux ma ’ dan il- prodott u affarjiet o ra li jistg u jibdlu l- effett farma ewtiku tal- prodott
Sitagliptin had a small effect on plasma digoxin concentrations.
Sitagliptin kellu effett g ir fuq kon entrazzjonijiet ta ’ digoxin fil- pla ma..
Lactation It is unknown whether sitagliptin is excreted in human breast milk.
30 Treddig Mhux nag ruf jekk sitagliptin jitne iex mal - alib tas- sider fil- bniedem.
28 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Table 1.
31 Tabella 1.
29 In an additional 1-year study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to sulphonylurea/ metformin was 14.5% and 30.3%, respectively.
Fi studju addizzjonali ta ’ sena fejn sitagliptin 100 mg darba kuljum ttie ed flimkien ma ’ metformin, l- in idenza ta ’ reazzjonijiet avversi kkunsidrati relatati mal- medi ina f’ pazjenti li adu sitagliptin/ metformin meta mqabbla ma ’ sulphonylurea/ metformin kienet ta ’ 14. 5% u 30. 3%, rispettivament.
2 In this 24-week study of sitagliptin 100 mg once daily in combination with glimepiride, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ glimepiride compared to treatment with placebo/ glimepiride was 11.3% and 6.6%, respectively.
32 b’ sitagliptin/ glimepiride meta mqabbla ma ’ kura bi pla ebo/ glimepiride kienet ta ’ 11. 3% u 6. 6% rispettivament.
Across clinical studies, a small increase in white blood cell count (approximately 200 cells/ microl difference in WBC vs. placebo; mean baseline WBC approximately 6600 cells/ microl) was observed due to an increase in neutrophils.
F’ numru ta ’ studji klini i, kienet osservata ieda g ira fil- g add ta - elloli bojod tad- demm( bejn wie ed u ie or differenza ta ’ 200 ellula/ microl f’ WBC meta mqabbel mal- pla ebo: linja ba ik medja WBC bejn wie ed u ie or ta ’ 6600 ellula/ microl) min abba ieda fin- newtrofili.
No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with TESAVEL treatment.
F’ kura b ’ TESAVEL ma ewx osservati bidliet b’ relevanza klinika fis- sinjali vitali jew fl- ECG (inklu l- intervall QTc).
30 Post-marketing Experience:
Esperjenza ta ’ Wara t- Tqeg id fis- Suq:
During post-marketing experience the following additional side effects have been reported (frequency not known): hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
Waqt l- esperjenza ta ’ wara t- tqeg id fis- suq ew irrappurtati l- effetti sekondarji o ra li ejjin (il - frekwenza mhix mag rufa): reazzjonijiet ipersensittivi, inklu anafilassi, an joedema, raxx, urtikarja u kundizzjonijiet ta ’ ilda li titqaxxar inklu is- sindromu ta ’ Stevens- Johnson (ara sezzjoni 4. 4).
In the event of an overdose, it is reasonable to employ the usual supportive measures, e. g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
33 Fil- ka ta ’ do a e essiva, ikun ra onevoli li jintu aw il- mi uri ta ’ appo tas- soltu, ng idu a na jitne a materjal mhux assorbit mill- apparat gastro- intestinali, isir monitora kliniku (inklu elettrokardjogramma), u tinbeda terapija ta ’ appo g jekk hemm b onn.
By enhancing active incretin levels, sitagliptin increases insulin release and decreases glucagon levels in a glucose- dependent manner.
Billi jkattar il- livelli ta ’ incretin attiv, sitgliptin twassal biex tintre a iktar insulina u jonqsu l - livelli ta ’ glucagon b’ mod li jiddependi mill- glucose.
31 Overall, sitagliptin improved glycaemic control when given as monotherapy, when used in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea (with or without metformin), and in combination with a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 2).
B’ mod enerali, sitagliptin tejjeb il- kontroll gli emiku meta mog ti b ala monoterapija, meta w at f’ kombinazzjoni ma ’ metformin (terapija inizjali jew mi juda), u f’ kombinazzjoni ma ’ sulphonylurea (bi jew ming ajr metformin), u f’ kombinazzjoni ma ’ thiazolidinedione, kif imkejla bi tnaqqis klinikament relevanti f’ HbA1c mil- linja ba i fi tmiem l- istudju (ara t- Tabella 2).
Improvement of surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
34 Assessjar -), il- proporzjon bejn proinsulina u insulina, u l- kejl tar- respons ta - elluli beta minn kampjuni me uda frekwentament fit- test tat- tolleranza g all- ikel ew osservati.
Table 2.
35 Tabella 2:
HbA1c results in placebo-controlled monotherapy and combination therapy studies*
Ri ultati ta ’ HbA1c fi studji ta ’ monoterapija kkontrollatI bi pla ebo u studji ta ’ terapija kkombinata *
33 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Metaboli mu Sitagliptin primarjament jitne a ma ’ l- urina bla ma jinbidel, u l- metaboli mu huwa mog dija minuri.
In vitro data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Tag rif in vitro wera li sitagliptin mhux inibitur ta ’ l- iso imi CYP CYP3A4, 2C8, 2C9, 2D6, 1°2, 2C19 jew 2B6, and ma huwiex stimulatur ta’ CYP3A4 u CYP1A2.
In vitro, sitagliptin did not inhibit OAT3 (IC50=160 μ M) or p-glycoprotein (up to 250 μ M) mediated transport at therapeutically relevant plasma concentrations.
37 permezz ta ’ OAT3 (IC50=160 µM) jew p- glycoprotein (sa 250 µM) f’ kon entrazzjonijiet fil- pla ma terapewtikament relevanti.
Sitagliptin was modestly removed by hemodialysis (13.5% over a 3- to 4-hour hemodialysis session starting 4 hours postdose).
Sitagliptin tne a xi ftit bl- emodijalisi (13. 5% wara sessjoni ta ’ emodijalisi ta ’ bejn 3 u 4 sig at li idet 4 sig at wara d- do a).
34 Elderly No dosage adjustment is required based on age.
Anzjani M’ hemmx b onn a ustament tad- do a min abba l- età.
Other patient characteristics No dosage adjustment is necessary based on gender, race, or body mass index (BMI).
Karatterisiti i o ra tal- pazjenti M’ hemmx b onn bidla fid- do a min abbasess, razza jew l- indi i tal- massa tal - isem (BMI).
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/ or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Fi klieb li ew esposti g al bejn wie ed u ie or 23 darba l- livell kliniku ta ’ espo izzjoni ew osservati sinjali fi i i li jg addu relatati mal- kura, li xi w ud minnhom jissu gerixxu tossi ità newrali, b al li jittie ed in- nifs bil - alq miftu, ru tal- b ieq, 38 rimettar abjad bir- rag wa, nuqqas ta ’ ko- ordinament tal- muskoli, trehid, attività mnaqqsa, u/ jew po izzjoni m atba.
Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Fil- fniek kien hemm tossi ita materna fl- livelli ta’ espo izzjoni ta ’ aktar minn 29 darba dawk umani. Min abba l- mar ini g olja ta ’ sigurtà, dan it- tag rif ma jissu erix li hemm riskju relevanti g ar- riproduzzjoni umana.
35 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Qalba tal- pillola: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
6.4 Special precautions for storage
39 6. 4 Prekawzjonijiet spe jali g all - a na
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet spe jali li g andhom jittie du meta jintrema. imi
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA’ L AWTORIZZAZZJONI GHAT- TQEG ID FIS- SUQ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI G ALL - RU TAL - LOTT B.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI G ALL - RU TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli g all - ru tal- lott.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Sistema ta ’ farmakovi ilanza Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq g andu ji gura li s- sistema ta ’ farmakovi ilanza, kif deskritta fil- ver joni 2 ippre entata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni g at- Tqeg id fis- Suq u kwalunkwe a ustament sussegwenti, ikun fis- se u li din tkun qed ta dem qabel u waqt li l- prodott ikun fis- suq Pjan ta ’ l- immani ar tar- Riskji Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq jikkommetti ru u li jwettaq l- istudji u l - attivitajiet ta ’ farmakovi ilanza addizzjonali mog tija fid- dettall fil- Pjan ta ’ Farmakovi ilanza, kif sar qbil fuqhom fil- ver joni 1. 1 tal- Pjan ta ’ l- immani ar tar- Riskji (RMP) ippre entat fil- Modulu 1. 8. 2. ta ’ l- Applikazzjoni g all- Awtorizzazzjoni g at- Tqeg id fis- Suq u kull a ornament sussegwenti tal - RMP li jkun sar qbil fuqu mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
B’ mod konformi mal- Linja gwida tal- CHMP dwar Sistemi ta ’ l- immani ar tar- Riskji g al prodotti medi inali g all- u u mill- bniedem, l- RMP a ornat g andu ji i ippre entat fl- istess mien tar - Rapport Perjodiku ta ’ A ornament tas- Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, g andu ji i ppre entat RMP a ornat • Meta ti i r evuta informazzjoni dida li jista ’ jkollha impatt fuq l- Ispe ifikazzjoni tas- Sigurtà attwali, fuq il- Pjan tal- Farmakovi ilanza jew fuq l- attivitajiet li jnaqqsu r- riskji • Fi mien 60 jum minn meta tintla aq mira importanti (farmakovi ilanza jew tnaqqis tar- riskji) • Fuq talba ta ’ l- EMEA
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
44 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for TESAVEL 25 mg film-coated tablets
Kartuna ta ’ barra g all- pilloli mikisja b’ rita ta ’ TESAVEL ta ’ 25 mg
TESAVEL 25 mg film-coated tablets Sitagliptin
TESAVEL 25 mg pilloli miksija b’ rita Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate ekwivalenti g al 25 mg ta ’ sitagliptin.
Oral use.
G al u u orali.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tag rif qabel l- u u.
Keep out of the reach and sight of children.
omm fejn ma jintla aqx u ma jidhirx mit- tfal
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPE JALI G AR- RIMI TA ’ PRODOTTI MEDI INALI MHUX U ATI JEW SKART MINN DAWN IL- PRODOTTI MEDI INALI, JEKK HEMM B ONN.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA ’ SID L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
46 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Blister for TESAVEL 25 mg film-coated tablets
Folja g all- pilloli miksija b’ rita ta ’ TESAVEL ta ’ 25 mg
TESAVEL 25 mg tablets Sitagliptin
Pilloli ta ’ TESAVEL 25 mg Sitagliptin
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for TESAVEL 50 mg film-coated tablets
Kartuna ta ’ barra g al TESAVEL pilloli mikisja b’ rita ta ’ 50 mg
TESAVEL 50 mg film-coated tablets Sitagliptin
TESAVEL 50 mg pilloli miksija b’ rita Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate ekwivalenti g al 50 mg ta ’ sitagliptin.
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 TAG RIF MINIMU LI G ANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister for TESAVEL 50 mg film-coated tablets
Folja g all- pilloli miksija b’ rita ta ’ TESAVEL 50 mg
TESAVEL 50 mg tablets Sitagliptin
Pilloli ta ’ TESAVEL 50 mg Sitagliptin
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TA TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer carton for TESAVEL 100 mg film-coated tablets
Kartuna ta ’ barra g all- pilloli mikisja b’ rita ta ’ TESAVEL ta ’ 100 mg
TESAVEL 100 mg film-coated tablets Sitagliptin
TESAVEL 100 mg pilloli miksija b’ rita Sitagliptin
Each tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
Kull pillola fiha sitagliptin phosphate monohydrate ekwivalenti g al 100 mg ta ’ sitagliptin.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPE JALI G AR- RIMI TA ’ PRODOTTI MEDI INALI MHUX U ATI JEW SKART MINN DAWN IL- PRODOTTI MEDI INALI JEKK HEMM B ONN.
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
52 TAG RIF MINIMU LI G ANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister for TESAVEL 100 mg film-coated tablets
Folja g all- pilloli miksija b’ rita ta ’ TESAVEL ta ’ 100 mg
TESAVEL 100 mg tablets Sitagliptin
Pilloli ta ’ TESAVEL 100 mg Sitagliptin
51 PACKAGE LEAFLET:
54 FULJETT TA ’ TAG RIF:
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tie u din il- medi ina.
- Keep this leaflet.
- omm dan il- fuljett.
You may need to read it again.
Jista ’ jkollok b onn ter a taqrah.
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispi jar tieg ek.
- This medicine has been prescribed for you.
- Din il- medi ina iet mog tija lilek.
It may harm them, even
Tista ’ tag mlilhom
if their symptoms are the same as yours.
il - sara, anki jekk ikollom l- istess sintomi b al tieg ek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wie ed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhux
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib jew lill- ispi jar tieg ek.
What TESAVEL is and what it is used for 2.
X’ inhu TESAVEL u g alxiex jintu a 2.
Before you take TESAVEL 3.
Qabel ma tie u TESAVEL 3.
How to take TESAVEL 4.
Kif g andek tie u TESAVEL 4.
How to store TESAVEL 6.
Kif ta en TESAVEL 6.
WHAT TESAVEL IS AND WHAT IT IS USED FOR
X’ INHU TESAVEL U G ALXIEX JINTU A
TESAVEL is a member of a class of medicines you take by mouth called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with type 2 diabetes mellitus.
TESAVEL huwa membru tal- klassi ta ’ medi ini li tie u minn alqek u li jissej u inibituri ta ’ DPP- 4 (inibituri ta ’ dipeptidyl peptidase- 4) li jbaxxi l- livell taz- zokkor fid- demm f’ pazjenti li g andhom id - dijabete mellitus tat- tip 2.
Type 2 diabetes is also called non-insulin-dependent diabetes mellitus, or NIDDM.
Id- dijabete tat- tip 2 tissejja ukoll dijabete mellitus li ma tiddependix fuq l - insulina, jew NIDDM.
TESAVEL helps to improve the levels of insulin after a meal and decreases the amount of sugar made by the body.
TESAVEL jg in biex itejjeb il- livell ta ’ insulina wara ikla u jnaqqas l- ammont ta ’ zokkor li jipprodu i l - isem.
It is unlikely to cause low blood sugar because it does not work when your blood sugar is low.
Ftit hemm ans li jikkaw a livell baxx ta ’ zokkor fid- demm billi ma ja dimx meta l- livell taz- zokkor fid- demm tieg ek huwa baxx.
However, when TESAVEL is used in combination with a sulphonylurea medicine, low blood sugar (hypoglycaemia) can occur.
Madanakollu, meta TESAVEL jing ata flimkien ma ’ medi ini ta ’ sulphonylurea, jista ’ jkun hemm livell baxx ta ’ zokkor fid- demm (ipogli emija).
Your doctor has prescribed TESAVEL to help lower your blood sugar, which is too high because of your type 2 diabetes.
It- tabib tieg ek ordnalek TESAVEL biex jg inek tnaqqas il- livell tal - okkor fid- demm, li hu g oli wisq min abba id- dijabete ta ’ tip 2 li g andek.
TESAVEL is used in combination with certain other medicines that lower blood sugar, which you will already be taking for your diabetes together with a food and exercise plan.
TESAVEL jintu a ma ’ erti medi ini o ra li jnaqqsu l - livell taz- zokor fid- demm, li tkun di à qed tie u min abba d- dijabete flimkien ma ’ pjan ta ’ ikel u ta ’ e er izzju fi iku.
Your doctor is now prescribing TESAVEL as an additional medicine to help control your blood sugar.
It- tabib tieg ek issa qed jordnalek TESAVEL b ala medi ina o ra biex tg inek tikkontrolla l- livelli taz- zokkor fid- demm.
Your body can also make too much sugar.
Meta g andek id- dijabete tat- tip 2 ismek ma jipprodu ix bi ejjed insulina, u l- insulina li jipprodu i ismek ma ta dimx kif suppost. ismek jista ’ wkoll jipprodu i wisq zokkor.
When this happens, sugar (glucose) builds up in the blood.
Meta ji ri dan, iz - zokkor (glucose) jibda jin ema ’ fid- demm.
This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Dan jista ’ jwassal g al problemi medi i serji b al mard tal- qalb, mard tal- kliewi, g ama u amputazzjoni.
BEFORE YOU TAKE TESAVEL
QABEL MA TIE U TESAVEL
Do not take TESAVEL
Ti ux TESAVEL:
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of TESAVEL.
- jekk inti aller iku/ a (tbati minn sensittivita e essiva) g al sitagliptin jew sustanzi o ra ta ’
Take special care with TESAVEL Tell your doctor if you have or have had:
Lit- tabib tieg ek g idlu jekk g andek jew kellek:
- diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
- ketoa idosi dijabetika (komplikazzjoni tad- dijabete b 'livell g oli ta ’ zokkor fid- demm, tnaqqis
nausea or vomiting)
f’ daqqa fil- pi, dardir jew rimettar)
- any kidney problems, or any past or present medical problems.
- xi problemi bil- kliewi, jew problemi medi i fil- passat jew fil- pre ent.
If you have kidney problems,
Jekk g andek problemi
52
tal- kliewi, TESAVEL jista ’ ma jkunx il- medi ina adattata g alik.
- an allergic reaction to TESAVEL
- reazzjoni aller ika g al TESAVEL.
If you are taking a sulphonylurea with TESAVEL you may experience low blood sugar.
Jekk qed tie u sulphonylurea ma ’ TESAVEL tista ’ tesperjenza livell baxx ta ’ zokkor fid- demm.
Your doctor may reduce the dose of your sulphonylurea medication.
It - tabib tieg ek jista ’ jnaqqas id- do a tal- medi ina ta ’ sulphonylurea tieg ek.
Taking other medicines TESAVEL may be taken with most medicines.
Meta tie u medi ina o ra TESAVEL jista ’ jittie ed mal- bi a l- kbira tal- medi ini.
Tell your doctor or pharmacist about all the medicines you take or have recently taken.
G idlu lit- tabib jew lill- ispi jar tieg ek dwar kull medi ina li qed tie u jew li adt dan l- a ar.
This includes prescription and non-prescription medicines, and herbal supplements.
Dan jinkludi medi ina b’ ri etta jew ming ajrha, u supplementi tal - xejjex.
Taking TESAVEL with food and drink You can take TESAVEL with or without food and drink.
Tista ’ tie u TESAVEL ma ’ l- ikel u x- xorb jew wa edha.
Pregnancy and breast-feeding Women who are pregnant or plan to become pregnant should consult their doctor before taking TESAVEL.
Tqala u treddig Nisa tqal jew li qed jippjanaw tqala g andhom jikkonsultaw mat- tabib tag hom qabel ma jie du TESAVEL.
You should not use TESAVEL during pregnancy.
M’ g andekx tie u TESAVEL waqt it- tqala.
It is not known if TESAVEL passes into breast milk.
Mhux mag ruf jekk TESAVEL jg addix mal - alib tas- sider.
You should not use TESAVEL if you are breast- feeding or plan to breast-feed.
M’ g andekx tu a TESAVEL jekk qed tredda ’ jew be siebek tredda ’.
Driving and using machines TESAVEL is not expected to interfere with your ability to drive or to use machines.
TESAVEL mhux mistenni li jaffettwa l - ila tieg ek li ssuq jew biex t addem il- magni.
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Madankollu, meta ssuq jew tkun t addem il- magni, g andek tikkunsidra l- fatt li sturdament u ng as ew irrappurtati.
HOW TO TAKE TESAVEL
KIF G ANDEK TIE U TESAVEL
Always take TESAVEL exactly as your doctor has told you.
Dejjem g andek tie u TESAVEL skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem g andek ta erta ru ek mat- tabib jew ma ’ l- ispi jar tieg ek jekk ikollok xi dubju.
The usual dose is: − one 100 mg film-coated tablet − once a day − by mouth
- pillola wa da miksija b’ rita tal- 100 mg
Your doctor will prescribe TESAVEL along with certain other medicines that lower blood sugar.
It- tabib tieg ek se jag tik TESAVEL flimkien ma ’ erti medi ini o ra li jbaxxu l- livelli taz- zokkor fid- demm.
Continue to take TESAVEL as long as your doctor prescribes it so you can continue to help control your blood sugar.
Kompi u TESAVEL sakemm jg idlek it- tabib biex tkompli tikkontrolla l- livelli taz- zokkor fid- demm.
Diet and exercise can help your body use its blood sugar better.
Id- dieta u l- e er izzju fi iku jistg u jg inu biex ismek ju a z- zokkor fid- demm a jar.
It is important to stay on the diet, exercise and weight loss program recommended by your doctor while taking TESAVEL.
Waqt li qed tie u TESAVEL importanti li tibqa ’ fuq il- programm ta ’ dieta, e er izzju fi iku u tnaqqis tal- pi li jirrikmandalek it- tabib.
If you take more TESAVEL than you should If you take more than the prescribed dosage of TESAVEL, contact your doctor immediately.
Jekk tie u TESAVEL aktar milli suppost Jekk tie u iktar TESAVEL milli suppost, ikkuntattja mal- ewwel lit- tabib tieg ek.
If you forget to take TESAVEL If you miss a dose, take it as soon as you remember.
56 Jekk tinsa tie u TESAVEL Jekk taqbe do a, udha malli tiftakar.
If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Jekk ma tiftakarx sakemm isir il - in g ad- do a li jmiss, aqbe id- do a li nsejt tie u u er a ’ ibda b’ mod normali.
Do not take a double dose of TESAVEL.
M’ g andekx tie u do a doppja ta ’ TESAVEL.
Like all medicines, TESAVEL may cause side effects, although not everybody gets them.
B al kull medi ina o ra, TESAVEL jista ’ jkollha effetti sekondarji, g alkemm dawn ma jidhrux fuq kul add.
53 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Effetti sekondarji komuni afna (iktar minn 1 minn kull 10 pazjenti) Effetti sekondarji komuni (inqas minn 1 minn kull 10 imma iktar minn 1 minn kull 100 pazjent) Effetti sekondarji mhux komuni (inqas minn 1 minn kull 100 imma iktar minn 1 minn kull 1000 pazjent)
Some patients have experienced the following side effects after adding sitagliptin to metformin:
Xi pazjenti kellhom dawn l- effetti sekondarji wara li iedu sitagliptin ma ’ metformin:
Common: nausea Uncommon: weight loss, loss of appetite, abdominal pain, diarrhoea, low blood sugar, drowsiness.
Komuni: dardir, Mhux komuni: telf tal- pi, telf ta ’ l- aptit, u ig addominali, dijarrea, zokkor baxx fid- demm, edla.
Some patients have experienced stomach discomfort when starting the combination of sitagliptin and metformin together.
Xi pazjenti esperjenzaw skumdità fl- istonku meta bdew jie du l- kombinazzjoni ta ’ sitagliptin u metformin flimkien.
Some patients have experienced the following side effects while taking TESAVEL in combination with a sulphonylurea:
Xi pazjenti kellhom dawn l- effetti sekondarji meta kienu qed jie du TESAVEL flimkien ma ’ sulphonylurea:
Very common: low blood sugar
Komuni afna: livell baxx ta ’ zokkor fid- demm
Some patients have experienced the following side effects while taking TESAVEL in combination with a sulphonylurea and metformin:
Xi pazjenti kellhom dawn l- effetti sekondarji meta kienu qed jie du TESAVEL flimkien ma ’ sulphonylurea u metformin:
Very common: low blood sugar Common: constipation
Komuni afna: livell baxx ta ’ zokkor fid- demm Komuni: stitikezza
Some patients have experienced the following side effects while taking TESAVEL and pioglitazone:
Xi pazjenti kellhom dawn l- effetti sekondarji meta kienu qed jie du TESAVEL u pioglitazone:
Common: low blood sugar and flatulence.
Komuni: zokkor baxx fid- demm u gass fl- istonku.
In addition, some patients have reported foot swelling while taking TESAVEL and pioglitazone.
Barra minn hekk, xi pazjenti kienu rrappurtaw nef a fis- sieq waqt it- te id ta ’ TESAVEL u pioglitazone.
These side effects may be seen with sitagliptin and any glitazone (e. g., rosiglitazone).
Dawn l- effetti sekondarji jistg u ji u osservati b’ sitagliptin u kull glitazone (ng idu a na rosiglitazone).
Some patients have experienced the following side effects while taking TESAVEL alone:
Xi pazjenti kellhom dawn l- effetti sekondarji meta kienu qed jie du TESAVEL wa du:
Common: low blood sugar, headache Uncommon: dizziness, constipation
Komuni: zokkor baxx fid- demm, u ig ta ’ ras, Mhux komuni: sturdament, stitikezza
Common: upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain.
Barra minn hekk, xi pazjenti rrappurtaw dawn l- effetti sekondarji waqt li kienu qed jie du TESAVEL Komuni: infezzjoni fil- parti ta ’ fuq ta ’ l- apparat respiratorju, mnie er misdud jew iqattar u u ig fil - gri mejn ostjoartrite u u ig fid- dirg ajn jew ir- ri jejn.
During post-marketing experience the following side effects have also been reported (frequency not known): allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Waqt l- esperjenza ta ’ wara t- tqeg id fis- suq ew irrappurtati wkoll l- effetti sekondarji li ejjin (il - frekwenza mhix mag rufa): reazzjonijiet aller i i, li jistg u jkunu serji, inklu raxx, mura tal - ilda, u nef a tal- wi, xufftejn, ilsien, u l- ger uma li jistg u jikkaw aw diffikultà fit- te id tan- nifs jew biex wie ed jibla ’.
If you have an allergic reaction, stop taking TESAVEL and call your doctor right away.
Jekk g andek reazzjoni aller ika, tibqax tie u TESAVEL u sejja lit- tabib tieg ek minnufih.
Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.
It- tabib tieg ek jista ’ jippreskrivi medikazzjoni sabiex jittratta r- reazzjoni aller ika tieg ek u medikazzjoni differenti g ad- dijabete tieg ek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effett minn dawn isir serju, jew jekk tinduna b ’ xi effetti sekondarji li mhux imni lin f’ dan il - fuljett, jekk jog bok g arraf lit- tabib jew lill- ispi jar tieg ek.
HOW TO STORE TESAVEL
EN TESAVEL
Keep out of the reach and sight of children.
ommu fejn ma jintla aqx u ma jidhirx mit- tfal.
Do not use TESAVEL after the expiry date which is stated on the blister and the carton.
M’ g andekx tu a TESAVEL wara d- data ta’ skadenza li tidher fuq il- folja u l- kartuna.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tkun l- a ar urnata ta ’ dak ix- xahar.
This medicinal product does not require any special storage conditions.
Dan il- prodott medi inali m’ g andux b onn kundizzjonijiet spe jali g al a na.
Medicines should not be disposed of via wastewater or household waste.
Il- medi ini m’ g andhomx jintremew ma ’ l - ilma tad- drana jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispi jar tieg ek dwar kif g andek tarmi medi ini li m’ g andekx b onn.
These measures will help to protect the environment.
Dawn il- mi uri jg inu jipprote u l- ambjent.
What TESAVEL contains
X’ fih TESAVEL
monohydrate, equivalent to 25 mg sitagliptin.
monohydrate, ekwivalenti g al 25 mg ta ’ sitagliptin.
- The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate,
- L- ingredjenti l- o ra huma: microcrystalline cellulose (E460), calcium hydrogen phosphate,
anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), and sodium stearyl fumarate.
anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), u sodium stearyl fumarate.
The tablet film coating contains: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
Ir- rita li tiksi l- pillola fiha: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), u yellow iron oxide (E172).
What TESAVEL looks like and contents of the pack
Id- Dehra ta ’ TESAVEL u l- kontenuti tal- pakkett:
Round, pink film-coated tablet with “ 221” on one side.
Pillola tonda u ro a miksija b’ rita bi “ 221 ” fuq na a wa da.
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakketti ta ’ 14, 28, 56, 84 or 98 pillola miksija b’ rita u 50 x 1 pillola miksija b’ rita f’ folji perforati ta ’ do i uni i
The Marketing Authorisation Holder is:
Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq huwa:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
58 G al kull tag rif dwar dan il- prodott medi inali, jekk jog bok ag mel kuntatt mar- rappre entant lokali tad- Detentur ta ’ l- Awtorizzazzjoni g at- tqeg id fis- Suq.
Eλλάδα BIANEΞ Α .Ε Τηλ: +3 0210 80091 11 Mailbox@vianex. gr
! ": +3 0210 80091 11 #
France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@msd-france. com
59 France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@ msd- france. com
Τηλ: +357 22866700 info_cyprus@merck. com
Sverige Merck Sharp & Dohme (Middle East) Limited.! ": +357 22866700 #
56 This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- a
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott medi inali tinsab fuq il- website ta ’ l- A enzija Ewropea dwar il- Medi ini (EMEA) sit: http: // www. emea. europa. eu /.
57 PACKAGE LEAFLET:
60 FULJETT TA ’ TAG RIF:
Do not pass it on to others.
M ’ g andekx tg add lil persuni o ra.
It may harm them, even
Tista ’ tag mlilhom il -
if their symptoms are the same as yours.
sara, anki jekk ikollom l- istess sintomi b al tieg ek.
TESAVEL is used in combination with certain other medicines that lower blood sugar, which you will already be taking for your diabetes together with a food and exercise plan.
TESAVEL jintu a ma ’ erti medi ini o ra li jnaqqsu l - livell taz- zokor fid- demm, li tkun di à qed tie u min abba d- dijabete flimkien ma ’ pjan ta ’ ikel u t a ’ e er izzju fi iku.
58
tal- kliewi, TESAVEL jista ’ ma jkunx il- medi ina adattata g alik
Tell your doctor or pharmacist about all the medicines you take or have recently taken.
G id lit- tabib jew lill- ispi jar tieg ek dwar kull medi ina li qed tie u jew li adt dan l- a ar.
Driving and using machines TESAVEL is not expected to interfere with your ability to drive or to use machines.
M’ hemm l- ebda informazzjoni li tindika li TESAVEL mhux mistenni li jaffettwa l - ila tieg ek li ssuq fis- sewqan jew biex t addem il- magni.
If you forget to take TESAVEL If you miss a dose, take it as soon as you remember.
62 Jekk tinsa tie u TESAVEL Jekk taqbe do a, udha malli tiftakar.
59 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Effetti sekondarji komuni afna (iktar minn 1 minn kull 10 pazjenti) Effetti sekondarji komuni (inqas minn 1 minn kull 10 imma iktar minn 1 minn kull 100 pazjent) Effetti sekondarji mhux komuni (inqas minn 1 minn kull 100 imma iktar minn 1 minn kull 1000 pazjent)
The expiry date refers to the last day of that month.
Id- data ta’ skadenza tkun l- a ar urnata ta ’ dak ix- xahar.
- The active substance is sitagliptin.
Is- sustanza attiva hija sitagliptin.
monohydrate, equivalent to 50 mg sitagliptin.
Kull pillola miksija b’ rita fiha sitagliptin phosphate monohydrate, ekwivalenti g al 50 mg ta ’ sitagliptin.
Round, light beige film-coated tablet with “ 112” on one side.
Pillola tonda u beige ara miksija b’ rita bi “ 112 ” fuq na a wa da.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
64 G al kull tag rif dwar dan il- prodott medi inali, jekk jog bok ag mel kuntatt mar- rappre entant lokali tad- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq.
France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@msd-france. com
65 France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@ msd- france. com
62 This leaflet was last approved in {MM/ YYYY}.
Iinformazzjoni dettaljata dwar dan
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
il- prodott medi inali tinsab fuq il- website ta ’ l- A enzija Ewropea
63 PACKAGE LEAFLET:
66 FULJETT TA ’ TAG RIF:
Do not pass it on to others.
M ’ g andekx tg addiha lil persuni o ra.
TESAVEL is used in combination with certain other medicines that lower blood sugar, which you will already be taking for your diabetes together with a food and exercise plan.
TESAVEL jintu a ma ’ erti medi ini o ra li jnaqqsu l - livell taz- zokor fid- demm, li tkun di à qed tie u min abba d- dijabete flimkien ma ’ pjan ta’ ikel u ta ’ e er izzju fi iku.
Do not take TESAVEL
Tihux TESAVEL:
- if you are allergic (hypersensitive) to sitagliptin or any of the other ingredients of TESAVEL.
- jekk inti aller iku/ a (tbati minn sensittivita e essiva).
64
tal- kliewi, TESAVEL jista ’ ma jkunx il- medi ina adattata g alik
However, when driving or operating machinery, it should be taken into account that dizziness and drowsiness have been reported.
Madankollu, meta ssuq jew tkun t addem il- magni, g andek tikkunsidra l- fatt li sturdament u - ng as ew irrappurtati.
If you take more TESAVEL than you should If you take more than the prescribed dosage of TESAVEL, contact your doctor immediately.
68 Jekk tie u TESAVEL aktar milli suppost Jekk tie u iktar TESAVEL milli suppost, ikkuntattja mal- ewwel lit- tabib tieg ek.
If you forget to take TESAVEL If you miss a dose, take it as soon as you remember.
Jekk tinsa tie u TESAVEL Jekk taqbe do a, udha malli tiftakar.
65 Very common side effects (more than 1 per 10 patients) Common side effects (less than 1 per 10 but more than 1 per 100 patients) Uncommon side effects (less than 1 per 100 but more than 1 per 1000 patients)
Effetti sekondarji komuni afna (iktar minn 1 minn kull 10 pazjenti) Effetti sekondarjikomuni (inqas minn 1 minn kull 10 imma iktar minn 1 minn kull 100 pazjent) Effetti sekondarji mhux komuni (inqas minn 1 minn kull 100 imma iktar minn 1 minn kull 1000 pazjent)
- The active substance is sitagliptin.
L- ingredjenti attiva hija sitagliptin.
monohydrate, equivalent to 100 mg sitagliptin.
Kull pillola miksija b’ rita fiha sitagliptin phosphate monohydrate, ekwivalenti g al 100 mg ta ’ sitagliptin.
- The other ingredients are: microcrystalline cellulose (E460), calcium hydrogen phosphate,
- Is- sustanzi l- o ra huma: microcrystalline cellulose (E460), calcium hydrogen phosphate,
What TESAVEL looks like and contents of the pack
Kif tidher TESAVEL u l- kontenut tal- pakk.
Round, beige film-coated tablet with “ 277” on one side.
Pillola tonda u beige miksija b’ rita bi “ 277 ” fuq na a wa da.
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakketti ta ’ 14, 28, 56, 84 or 98 pillola miksija b’ rita u 50 x 1 pillola miksija b’ rita f’ folji perforati ta ’ do i uni i (g all- u u fl- isptar).
The Marketing Authorisation Holder is:
Id- Detentur ta ’ l- Awtorizzazzjoni g at- tqeg id fis- Suq huwa:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
70 G al kull tag rif dwar dan il- prodott medi inali, jekk jog bok ag mel kuntatt mar- rappre entant lokali tad- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq.
Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck. com
71 Ireland Merck Sharp and Dohme Ireland (Human Health) Limited Tel: +353 (0) 1 2998700 medinfo_ ireland@ merck. com
Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 8 626 1400 medicinskinfo@merck. com
Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 8 626 1400
68 This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- a
What is TESLASCAN?
X’ inhu TESLASCAN?
TESLASCAN is a solution for infusion (drip into a vein) containing the active substance mangafodipir trisodium.
TESLASCAN hu sustanza għall- infużjoni (drip fil- vina) li jkun fiha s- sustanza attiva mangafodipir trisodium.
What is TESLASCAN used for?
Għalxiex jintuża TESLASCAN?
TESLASCAN is for diagnostic use.
TESLASCAN jintuża għal skopijiet dijanjostiċi.
TESLASCAN is used in patients who are undergoing magnetic resonance imaging (MRI) to detect lesions (damaged tissue) in the liver that might be caused by liver cancer or cancer that has spread to the liver from other parts of the body.
TESLASCAN jintuża f’ pazjenti li tkun qed issirilhom imaġini b’ reżonanza manjetika (MRI – magnetic resonanace imaging) biex isir magħruf jekk għandhomx leżjonijiet (ħsara fit- tessut) fil- fwied li jistgħu jkunu kkawżati minn kankru tal- fwied jew kankru li jkun infirex għall- fwied minn partijiet oħra tal- ġisem.
TESLASCAN is a ‘ contrast medium ’ that is used to obtain a clearer scan.
TESLASCAN hu ‘ mezz ta ’ kuntrast ’ li jintuża biex jinkiseb skan iktar ċar.
TESLASCAN can also be used with MRI to investigate lesions of the pancreas.
TESLASCAN jista ’ jintuża wkoll ma ’ l- MRI fl - investigazzjoni ta ’ leżjonijiet fil- frixa.
How is TESLASCAN used?
Kif jintuża TESLASCAN?
TESLASCAN is used as a single intravenous infusion at a dose of 0.5 ml per kilogram body weight.
TESLASCAN jintuża bħala infużjoni fil- vina ta ’ darba b’ doża ta ’ 0. 5ml għal kull kilogramma li jiżen il- pazjent.
The rate of infusion is 2 to 3 ml/ min for liver imaging and 4 to 6 ml/ min for imaging the pancreas.
Ir- rata ta ’ infużjoni hi bejn 2 u 3 ml kull minuta għall- ħruġ ta ’ immaġni tal- fwied u bejn 4 u 6 ml kull minuta għall- ħruġ ta ’ immaġni tal- frixa.
The enhancement of imaging starts 15 to 20 minutes after the start of the infusion, and lasts for about 4 hours.
L- immaġni jibdew jissaħħu bejn 15 u 20 minuta wara li tinbeda l- infużjoni, u l- effett idum xi 4 sigħat.
For more information, see the Package Leaflet.
Ara l- Fuljett ta ’ Tagħrif għal iktar informazzjoni.
How does TESLASCAN work?
Kif jaħdem TESLASCAN?
The active substance in TESLASCAN, mangafodipir, contains manganese, a metal element.
Is- sustanza attiva f’ TESLASCAN, mangafodipir, fiha l- manganiż, element metalliku.
Manganese is used as a contrast medium to help obtain better pictures with MRI scanners.
Il- manganiż hu sustanza li jintuża bħala mezz ta ’ kuntrast li jgħin biex jinkisbu stampi aħjar bl- iskaners ta ’ l- MRI.
MRI is an imaging method that uses magnetic fields and radio waves.
L - MRI hu mezz kif jinkisbu immaġni permezz ta ’ kampijiet manjetiċi u radio waves.
Water molecules in the body are affected by the magnetic fields, and produce a signal when the radio waves are applied.
Il- kampijiet manjetiċi jaffettwaw il- molekuli ta ’ l- ilma fil- ġisem, u dawn jipproduċu sinjal meta jkunu applikati r - radio waves.
Manganese interacts with the water molecules.
Il- manganiż jirreaġixxi mal- molekoli ta ’ l- ilma.
As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Minħabba din l- interazzjoni, il- molekuli ta ’ l- ilma jagħtu sinjal iktar b’ saħħtu u dan jgħin biex tinkiseb stampa aqwa.
In TESLASCAN, the manganese is bound to another chemical in a ‘ chelate’.
F’ TESLASCAN, il- manganiż ikun magħqud f ’ ‘ chelate ’ ma ’ kimika oħra.
Once the medicine is injected, the manganese is released and taken up by normal liver and pancreatic tissues more effectively than by the cancer cells.
Hekk kif tiġi injettata l - mediċina, il- manganiż jinħeles u jiġi assorbit mit- tessut normali tal- fwied u tal- frixa b’ rata ikbar milli miċ- ċelloli tal- kankru.
This allows the difference between normal and abnormal tissue to be seen.
B’ hekk tidher id- differenza bejn it- tessut normali u t- tessut anormali.
(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 tomography (CT).
(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 Kif ġie studjat TESLASCAN?
They underwent a TESLASCAN-enhanced MRI scan.
Sarilhom skan ta ’ l- MRI imsaħħaħ bit- TESLASCAN.
The main measure of effectiveness was the difference in the number of liver lesions detected in the previous scan and when using TESLASCAN during MRI.
Il- kejl ewlieni ta ’ l- effikaċja kien id- differenza bejn in- numru ta ’ leżjonijiet tal- fwied misjuba fl- iskan ta ’ qabel u meta ntuża TESLASCAN waqt l- MRI.
The studies of pancreatic disease involved 292 patients, and compared the effectiveness of TESLASCAN-enhanced MRI with that of ‘ spiral CT’, another diagnostic method used to detect pancreatic lesions.
Fl- istudji ta ’ mard fil- frixa ħadu sehem 292 pazjent.
The main measure of effectiveness was based on the agreement between the diagnosis made based on the scans, and the actual lesions as seen during surgery or biopsy.
Tqabblet l- effikaċja ta ’ MRI msaħħaħ bit - TESLASCAN ma ’ dik ta ’ CT ‘ spirali ’, mezz dijanjostiku ieħor użat biex isir tiftix għal leżjonijiet fil - frixa.
What benefit has TESLASCAN shown during the studies?
X’ benefiċċju wera TESLASCAN matul l- istudji?
In the detection of liver lesions, the use of TESLASCAN-enhanced MRI resulted in more lesions being detected.
Irriżulta li l- użu ta ’ MRI imsaħħaħ bit- TESLASCAN wassal għas- sejbien ta ’ iktar leżjonijiet.
Overall, during the studies, 33% of patients had more lesions detected after TESLASCAN but 20% of patients had fewer lesions.
B’ kollox, matul l- istudji, fi 33% tal- pazjenti nstabu iktar leżjonijiet wara TESLASCAN iżda f’ 20% tal- pazjenti nstabu inqas leżjonijiet.
In the detection of pancreatic lesions, TESLASCAN-enhanced MRI was as effective as spiral CT.
Fis- sejbien ta ’ leżjonijiet fil- frixa, MRI msaħħaħ bit - TESLASCAN kien effettiv daqs CT spirali.
What is the risk associated with TESLASCAN?
X’ inhu r- riskju assoċjat ma ’ TESLASCAN?
The most common side effects with TESLASCAN (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), flushing and feeling hot.
L- iktar effetti sekondarji komuni b’ TESLASCAN (li dehru f’ bejn 1 u 10 pazjenti minn 100) huma l - uġigħ ta ’ ras, id- dardir (tħossok ma tiflaħx), fwawar u sensazzjoni ta ’ sħana.
For the full list of all side effects reported with TESLASCAN, see the Package Leaflet.
Għal- lista sħiħa ta ’ l - effetti kollha rrapurtati mat- teħid ta ’ TESLASCAN, ara l- Fuljett ta ’ Tagħrif.
TESLASCAN should not be used in people who may be hypersensitive (allergic) to mangafodipir trisodium or any of the other ingredients.
TESLASCAN m’ għandux jintuża f’ pazjenti li jkollhom sensittività eċċessiva (allerġija) għall - mangafodipir trisodium jew għal xi sostanza oħra tiegħu.
TESLASCAN should not be used in pregnant or breast- feeding women, patients with phaeochromocytoma (a tumour of the adrenal gland), or patients with severe problems with their liver or kidneys.
TESLASCAN m’ għandux jintuża għal nisa li jkunu tqal jew li jkunu qed ireddgħu, pazjenti bi phaeochromocytoma (tumur tal- glandola adrenali), jew pazjenti bi problemi kbar fil- fwied jew fil- kliewi.
Why has TESLASCAN been approved?
Għaliex ġie approvat TESLASCAN?