qanastek/EMEA-V3 huggingface dataset:
Like all medicines, Effentora can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Effentora jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you notice any of these, contact your doctor.
Jekk tara xi wieħed minn dawn, kellem lit- tabib tiegħek.
The most serious side effects are shallow breathing, low blood pressure and shock.
L- aktar effetti mhux mixtieqa serji huma nifs baxx, presjoni baxxa u xokk.
If you become very sleepy or have slow and/ or shallow breathing, you or your carer should contact your doctor immediately and call for emergency help.
Jekk jaqbdek ħafna ngħas jew jekk għandek nifs bil- mod u/ jew baxx, int jew min qed jieħu ħsiebek għandkom tikkuntattjaw lit- tabib tiegħek immedjatament u ċċemplu għal għajnuna ta ’ emerġenza.
Very common side effects (affects more than 1 user in 10): • dizziness • feeling nauseated • at the site of tablet application: pain, ulcer, irritation, numbness, loss of sensation, redness, swelling or spots
Effetti mhux mixtieqa komuni ħafna (jaffetwaw aktar minn persuna minn kull 10 li qed jużawh): • sturdament 95 • tħossok mqalla ’ • fil- post ta ’ l- applikazzjoni tal- pillola: uġigħ, ulċera, irritazzjoni, tnemnim, telf ta ’ sensazzjoni, ħmura, nefħa jew ponot
Common side effects (affects 1 to 10 users in 100): • disorientation, feeling elated • abnormal taste • sleepiness, sedation, excessive tiredness, headache, shaking • vomiting, constipation, inflammation of the mouth, dry mouth, diarrhoea • itching, excessive sweating
Effetti mhux mixtieqa komuni (jaffetwaw minn persuna sa 10 persuni minn kull 100 li qed jużawħ): • disorjentament, tħossok ferħan • togħma mhux normali • jaqbdek in- ngħas, sedazzjoni, għeja eċċessiva, uġigħ ta ’ ras, rogħda • rimettar, stitikezza, infjammazzjoni tal- ħalq, ħalq xott, dijarea • ħakk, għaraq eċċessiv
90 • feeling: anxious, nervous, confused, abnormal, jittery or slow; seeing or hearing things that aren’ t really there, inability to sleep, reduced consciousness, lack of concentration, disturbance in thinking, numbness, loss of balance, migraine, movements disturbance, vertigo, problem with speaking, ringing in the ear, ear discomfort • disturbed or blurred vision, red eye, abnormal sensation in eye, observing flashes of light • unusually fast or low heart rate, hot flushes, raised blood pressure • shortness of breath • one or more of the following problems in the mouth: ulcer, loss of sensation, discomfort, blisters, unusual colour, soft tissue disorder, tongue disorder, painful or blistered or ulcerated tongue, gum pain, chapped or dry lips, oral thrush, tooth disorder, toothache • heartburn, loss of appetite, uncomfortable stomach, indigestion, stomach pain, inflammation of the oesophagus • cold sweat, swollen face, rash, generalised itching, hair loss, brittle nails, muscle pain, muscle twitching, muscular weakness, back pain, weakness, feeling unwell, chest discomfort, thirst, chills, feeling cold, feeling hot, falls, difficulty passing water • drug withdrawal syndrome
Effetti mhux mixtieqa mhux komuni (jaffetwaw minn persuna sa 10 minn kull 1000 li qed jużawħ): • griżmejn jaħarqu u juġgħu, akkumulazzjoni ta ’ materja taħt il- ġilda fil- ħalq • ċelluli bojod fid- demm mhux normali, tnaqqis fiċ- ċelluli bojod fid- demm, tnaqqis fiċ- ċelluli li jgħinu d- demm jgħaqad, tnaqqis fiċ- ċelluli l- ħomor tad- demm • tħossok: anzjuż, nervuż, konfuż, mhux normali, mferfex jew għajjien; tara jew tisma affarijiet li mhux vera hemm, inabilità biex torqod, koxxjenza mnaqqsa, nuqqas ta ’ konċentrazzjoni, disturbi fil- ħsieb, tnemnim, telf tal- bilanċ, emigranja, disturbi fil- movimenti, vertigo, problemi biex titkellem, żanżin fil- widna, skomdu fil- widna • vista disturbata jew imċajpra, għajn ħamra, sensazzjoni mhux normali fl- għajn, tara ’ leħħiet ta ’ dawl • rata tal- qalb mgħaġġla jew baxxa aktar minn normal, fwawar ta ’ sħana, pressjoni għolja • qtugħ ta ’ nifs • waħda jew aktar minn dawn il- problemi li ġejjin fil- ħalq: ulċera, telf ta ’ sensazzjoni, skomdu, nfafet, kulur mhux tas- soltu, disturbi fit- tessut l- artab, disturbi fl- ilsien, ilsien jgħuġa jew bl- infafet jew bl- ulċeri, uġigħ fil- ħanek, xufftejn maqsuma jew xotti, moffa fil- ħalq, disturbi fis- snien, uġigħ fis- snien • ħruq ta ’ stonku, telf ta ’ l- aptit, stonku mhux komdu, indiġestjoni, uġigħ fl- istonku, infjammazzjoni fl- esofagu • għaraq kiesaħ, nefħa fil- wiċċ, raxx, ħakk ġeneralizzat, telf ta ’ xagħar, dwiefer fraġili, uġigħ fil - muskoli, kontrazzjonijiet mhux volontarji tal- muskoli, indebboliment muskolari, uġigħ fid- dahar, debbulizza, tħossok ma tiflaħx, skomdu fis- sider, għatx, kesħa, tħossok kiesaħ, tħossok taħraq, waqat, diffikultà biex tgħaddi l- ilma • sindrome ta ’ rtirar tal- mediċina
HOW TO STORE EFFENTORA
KIF TAĦŻEN EFFENTORA
The pain-relieving medicine in Effentora is very strong and could be life-threatening if taken accidentally by a child.
Il- mediċina li ttaffi l- uġigħ f’ Effentora hija qawwija ħafna u tista ’ tkun ta ’ periklu għall- ħajja jekk bi żball tittieħed mit- tfal.
Effentora must be kept out of the reach and sight of children. • Do not use Effentora after the expiry/ use before date shown on the blister package label and the carton. • Store in the original package in order to protect from moisture. • Medicines should not be disposed of via wastewater or household waste.
• Tużax Effentora wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- pakket tal- folja u fuq il - kartuna. • Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità. • Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
FURTHER INFORMATION
X’ fih Effentora:
What Effentora contains The active substance is fentanyl.
96 Is- sustanza attiva hi fentanyl.
Each tablet contains either: • 100 micrograms fentanyl (as citrate) • 200 micrograms fentanyl (as citrate) • 400 micrograms fentanyl (as citrate) • 600 micrograms fentanyl (as citrate) • 800 micrograms fentanyl (as citrate) The other ingredients are mannitol, sodium starch glycolate type A, sodium hydrogen carbonate, sodium carbonate anhydrous, citric acid anhydrous, magnesium stearate.
Kull pillola fiha jew: • 100 mikrogramma fentanyl (bħala citrate) • 200 mikrogramma fentanyl (bħala citrate) • 400 mikrogramma fentanyl (bħala citrate) • 600 mikrogramma fentanyl (bħala citrate) • 800 mikrogramma fentanyl (bħala citrate)
What Effentora looks like and contents of the pack The buccal tablets are flat-faced, round bevelled-edge tablet, embossed one side with a “ C” and on the other side with “ 1” for Effentora 100 micrograms, with “ 2” for Effentora 200 micrograms, with “ 4” for Effentora 400 micrograms, with “ 6” for Effentora 600 micrograms, with “ 8” for Effentora 800 micrograms.
Il- pilloli għall- ħalq huma pillola b’ wiċċ ċatt, tondi u b’ xifer imtajjar, immarati fuq naħa waħda b ’ “ C ” u fuq in- naħa l- oħra b ’ “ 1 ” għal Effentora 100 mikrogramma, b ’ “ 2 ” għal Effentora 200 mikrogramma, b ’ “ 4 ” għal Effentora 400 mikrogramma, b ’ “ 6 ” għal Effentora 600 mikrogramma, b ’ “ 8 ” għal Effentora 800 mikrogramma.
Each blister contains 4 buccal tablets, supplied in cartons of 4 or 28 buccal tablets.
Kull folja fiha 4 pilloli għall- ħalq, fornuti f’ kartun ta ’ 4 jew 28 pillola għall- ħalq.
Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
91 Cephalon Europe 5 rue Charles Martigny 94700 Maisons-Alfort France
Cephalon Europe 5 rue Charles Martigny 94700 Maisons- Alfort Franza
Armagh BT63 5QD United Kingdom
Armagh BT63 5QD Ir- Renju Unit
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder or call the following number:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
What is Efficib?
X’ inhu Efficib?
Efficib is a medicine containing two active substances, sitagliptin and metformin hydrochloride.
Efficib hija mediċina li fiha ż- żewġ sustanzi attivi sitagliptin u metformin hydrochloride.
It is available as capsule-shaped tablets (pink:
Huwa disponibbli bħala pilloli f' forma ta 'kapsula (roża:
50 mg sitagliptin and 850 mg metformin hydrochloride; red:
50 mg sitagliptin u 850 mg metformin hydrochloride; aħmar:
50 mg sitagliptin and 1000 mg metformin hydrochloride).
50 mg sitagliptin u 1000 mg metformin hydrochloride).
What is Efficib used for?
Għal x' hiex jintuża Efficib?
Efficib is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
Efficib jintuża għat- trattament ta 'pazjenti b' dijabete tat- tip 2, sabiex ittejjeb il- kontroll tal- livelli taz - zokkor fid- demm.
It is used with diet and exercise: • in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) alone; • in patients who are already taking a combination of sitagliptin and metformin as separate tablets; • in combination with a sulphonylurea (another type of antidiabetes medicine) when the combination of a sulphonylurea and metformin is not sufficient to give satisfactory control of the patient’ s diabetes.
Huwa użat flimkien ma ’ dieta u eżerċizzju: • f’ pazjenti li mhumiex kontrollati b’ mod sodisfaċenti fuq metformina (mediċina antidijabetika) biss; • f’ pazjenti li diġa ’ qed jieħdu taħlita ta ’ sitagliptin u metformina bħala pilloli separati; • flimkien ma ’ sulfonilurea (sulphonylurea – tip ta ’ mediċina oħra kontra d- dijabete) meta l - kombinazzjoni ta ’ sulfonilurea u metaformina ma humiex biżżejjed sabiex jikkontrollaw b’ mod sodisfaċenti d- dijabete tal- pazjent.
How is Efficib used?
Kif jintuża Efficib?
Efficib is taken twice a day.
Efficib jiġi meħud darbtejn kuljum.
The strength of tablet to use depends on the dose of the other antidiabetes medicines that the patient was taking before.
Is- saħħa tal- pillola li għandha tintuża tiddependi fuq id- doża tal - mediċini ta ’ kontra d- dijabete l- oħra li l- pazjent kien qed jieħu qabel.
Patients already taking metformin, with or without a sulphonylurea, should take Efficib containing the same dose of metformin.
Pazjenti li diġa ’ jieħdu l - metformina flimkien jew mingħajr sulfonilurea għandhom jieħdu l- Efficib li fiha l- istess doża ta ’ metformina.
Patients already taking sitagliptin and metformin as separate tablets should switch to Efficib containing the same doses of both active substances.
Pazjenti li diġa ’ qed jieħdu sitagliptin u metformina bħala pilloli separate għandhom jaqilbu għal Efficib li fiha l- istess dożi taż- żewġ sustanzi attivi.
If Efficib is taken with a sulphonylurea, the dose of the sulphonylurea may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Jekk Efficib jiġi meħud flimkien ma ’ sulfonilurea, id- doża ta ’ sulfonilurea jista ’ jkun meħtieġ li tiġi mnaqqsa sabiex tiġi evitata ipogliċemija (livelli baxxi ta ’ zokkor fid- demm).
The maximum dose of sitagliptin is 100 mg a day.
Id- doża massima ta ’ sitagliptin hi ta ’ 100 mg kuljum.
Efficib should be taken with food to avoid any stomach problems caused by metformin.
Efficib għandu jiġi meħud ma ’ l- ikel sabiex jiġu evitati problemi ta ’ l- istonku ikkawwżati mill- metformina.
Efficib is not recommended for use in children under 18 years of age because of a lack of information on safety and effectiveness in this group.
Efficib ma huwiex rakkomandat sabiex jintuża fi tfal ta ’ inqas minn 18 – il sena, minħabba nuqqas ta ’ tagħrif fuq is- sigurtà u l- effikaċja f’ dan il- grupp.
How does Efficib work?
Kif jaħdem Efficib?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Id- dijabete ta ’ Tip 2 hija marda li minħabba fiha, il- frixa ma tagħmilx biżżejjed insulina biex tikkontrolla l- livell ta ’ glukosju (zokkor) fid- demm jew meta l- ġisem ma jkunx jista ’ juża l- insulina b’ mod effettiv.
The active substances in Efficib, sitagliptin and metformin hydrochloride, each have a different mode of action.
Is- sustanzi attivi f’ Efficib, sitagliptin u metformina idroklorida kull waħda għandha mod differenti ta ’ azzjoni.
Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Sitagliptin hija inibitur dipeptidyl peptidase 4 (DPP- 4).
It works by blocking the breakdown of 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Taħdem billi 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. ‘ incretin’ hormones in the body.
Reproduction is authorised provided the source is acknowledged. timblokka t- tkissir ta ’ l- ormoni ta ’ ‘ inkretin ’ fil- ġisem.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Dawn l- ormoni jiġu rilaxxati wara ikla u jistimulaw il- frixa sabiex tipproduċi insulina.
By increasing the levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Billi żżid il- livelli ta ’ ormoni ‘ incretin ’ fid- demm, sitagliptin tistimula l- frixa sabiex tipproduċi iktar insulina meta l- livell ta ’ glukożju d- demm ikun għoli.
Sitagliptin does not work when the blood glucose is low.
Sitagliptin ma jaħdimx meta l- livell ta ’ glukosju fid- demm ikun wieħed baxx.
Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Sitagliptin inaqqas ukoll l- ammont ta ’ glukosju magħmul mill- fwied, billi jżid il- livelli ta ’ l- insulina u billi jnaqqas il- livelli ta ’ l- ormon glucagon.
Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Metformin jaħdem l- iktar billi jwaqqaf il- produzzjoni tal - glukożju u jnaqqas l- assorbiment tiegħu fl- intestini.
As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type 2 diabetes.
Ir- riżultat ta 'l- azzjoni kombinata taż- żewġ sustanzi attivi huwa tnaqqis tal- glukożju fid- demm li jgħin fil- kontroll tad- dijabete tat- tip 2.
How has Efficib been studied?
Kif ġiet studjata Efficib?
Sitagliptin on its own has been approved by the European Union (EU) under the name Januvia since 2007.
Sitagliptin waħdu ġie approvat mill- Unjoni Ewropea (UE) taħt l- isem ta ’ Januvia mill- 2007.
Januvia can be used with metformin, and with both metformin and a sulphonylurea, in type 2 diabetes patients.
Januvia jista ’ jintuża flimkien mal- metaformina u kemm mal- metaformina u mas- sulfonilurea, f’ pazjenti b’ dijabete tat- tip 2.
Three studies of Januvia, in patients with type 2 diabetes whose blood glucose levels were not adequately controlled on metformin alone, were used to support the use of Efficib in the same indications.
Tliet studji ta ’ Januvia, f’ pazjenti b’ dijabete tat- tip 2 li l- livelli tal- glukożju f’ demmhom ma ġewx ikkontrollati b’ mod xieraq mill- metformina biss, ġew użati sabiex isostnu l- użu ta ’ Efficib fl- istess indikazzjonijiet.
Two of the studies compared sitagliptin as an add-on to metformin with placebo (in 701 patients) and with glipizide (a sulphonylurea) (in 1,172 patients).
Tnejn mill- istudji qabblu sitagliptin bħala addizzjoni għal metformina flimkien ma ’ plaċebo (f’ 701 pazjent) u ma ’ glipizide (sulfonylurea) (f’ 1, 172 pazjent).
The third study compared sitagliptin with placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
It- tielet studju qabbel sitagliptin ma ’ placebo, meta użat bħala żjieda ma ’ glimepiride (sulfonilurea oħra), bi jew mingħajr metformina, f’ 441 pazjent.
The results of one new study in patients who did not take antidiabetes medicines before were also presented, comparing the effect of sitagliptin plus metformin with that of metformin alone or sitagliptin alone.
Ir- riżultati ta ’ studju ġdid f’ pazjenti li ma ħadux mediċini antidijabetiċi ġew ippreżentati ukoll, fejn qabblu l- effett tas- sitagliptin flimkien mal- metaformina ma ’ dak tal- metaformina waħedha jew sitagliptin waħdu.
All of the studies measured the change in the levels after 24 weeks of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Dan il- livell jagħti indikazzjoni ta ’ kemm hu kkontrollat tajjeb iz- zokkor fid- demm.
Two ‘ bioequivalence’ studies were also carried out, showing that the active substances in the two strengths of Efficib were absorbed in the body in the same way as when they were taken as separate tablets.
Saru żewġ studji ‘ bijoekwivalenti ’ li juru li s- sustanzi attivi f’ żewġ qawwiet ta ’ Efficib ġew assorbiti fil- ġisem bl- istess mod bħal ma kieku kienu meħuda bħala pilloli separati.
What benefit has Efficib shown during the studies?
Liema benefiċċju wriet Efficib waqt l- istudji li ġew mwettqa?
Sitagliptin taken in combination with metformin was more effective than metformin alone.
Sitagliptin meħud flimkien mal- metformina kien aktar effikaċi mill- metformina waħedha.
The addition of 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Iż- żjieda ta ’ 100 mg sitagliptin flimkien mal- metformina naqqset il- livelli tal- HbA1c b’ 0. 67% (minn madwar 8. 0%) wara 24 ġimgħa meta mqabbel ma ’ tnaqqis ta ’ 0. 02% fil- pazjenti li żiedu l- plaċebo.
The effectiveness of adding sitagliptin to metformin was similar to that of glipizide in reducing the levels of HbA1c.
L- effikaċja taż - żjieda ta ’ sitagliptin mal- metformina kienet simili għal dik tal- glipizide fit- tnaqqis tal- livelli tal - HbA1c.
In the study where sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0.59% after 24 weeks, compared with an increase of 0.30% in the patients adding placebo.
Fl- istudju fejn sitagliptin ġie miżjud ma ’ glimepiride u l- metformina, il- livelli tal- HbA1c ġew imnaqqsa b’ 0. 59% wara 24 ġimgħa meta mqabbla ma ’ żjieda ta ’ 0. 30% fil- pazjenti li żiedu l- plaċebo.
In the new study, the combination of sitagliptin plus metformin was more effective than metformin or sitagliptin alone.
Fl- istudju l- ġdid il- kombinazzjoni ta ’ sitagliptin flimkien ma ’ metformina kienet aktar effikaċi mill - metformina waħedha jew is- sitagliptin waħdu.
What is the risk associated with Efficib?
X’ inhu r- riskju assoċjat ma ’ Efficib?
The most common side effect with Efficib (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
L- aktar effett sekondarju komuni ta ’ Efficib (muri f’ bejn pazjent u 10 minn 100) huwa n- nawżja (dardir).
For the full list of all side effects reported with Efficib, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Efficib, ara l- Fuljett ta 'Tagħrif.
Efficib should not be used in people who may be hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Efficib m’ għandux jintuża minn persuni ipersensittivi (allerġiċi) għal sitagliptin, metformina jew għal kull ingredjent ieħor.
It should also not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
M’ għandux jintuża f’ pazjenti li għandhom ketoaċidożi dijabetika (livelli għolja ta ’ ketones u aċidi fid- demm), pre- coma dijabetika, problemi bil- fwied jew bil- kliewi, kundizzjonijiet li jistgħu jaffetwaw il- kliewi, jew marda kkawżata minn provvista mnaqqsa ta ’ ossiġnu lit- tessuti bħal insuffiċjenza tal- qalb jew tal- pulmun jew xi attakk tal- qalb reċenti.
It should also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast- feeding.
M’ għandux jintuża f’ pazjenti b’ intossikazzjoni ta ’ l- akoħol (konsum eċċessiv ta ’ l- alkoħol) jew alkoolożmu, jew matul it- treddigħ.
Why has Efficib been approved?
Għaliex ġie approvat Efficib?
The Committee for Medicinal Products for Human Use (CHMP) decided that Efficib’ s benefits are greater than its risks for the treatment of patients with type 2 diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Efficib għandu iktar benefiċċji milli riskji fit- trattament tad- dijabete tat- tip 2 mellitus.
The Committee recommended that Efficib be given marketing authorisation.
Il- Kumitat irrakkomanda li Efficib jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Efficib:
Informazzjoni oħra dwar Efficib:
The European Commission granted a marketing authorisation valid throughout the EU for Efficib to Merck Sharp & Dohme Ltd on 16 July 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Efficib lil Merck Sharp & Dohme Limited fl- 16 ta ’ Lulju 2008.
2/ 3 The full EPAR for Efficib can be found here.
2/ 3 L- EPAR sħiħ għal Efficib jista ’ jiġi kkonsultat hawnhekk
Efficib 50 mg/ 850 mg film-coated tablets
Efficib 50 mg/ 850 mg pilloli miksijin b’ rita
Each tablet contains 50 mg of sitagliptin (as phosphate monohydrate) and 850 mg of metformin hydrochloride.
Kull pillola fiha 50 mg ta ’ sitagliptin (bħala phosphate monohydrate) u 850 mg ta ’ metformin hydrochloride.
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ sustanzi attivi, ara sezzjoni 6. 1.
Capsule-shaped, pink film-coated tablet with “ 515” debossed on one side.
Pillola roża miksija b’ rita, forma ta ’ kapsula b ’ “ 515 ” imnaqqxa fuq naħa waħda.
For patients with type 2 diabetes mellitus:
Għal pazjenti b’ dijabete mellitus tip 2:
Efficib is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Efficib huwa indikat bħala żieda mad- dieta u ma ’ l- eżerċizzju biex itejjeb il- kontroll gliċemiku għal pazjenti mhux ikkontrollati adegwatament, fuq id- doża massima ttollerata ta ’ metformin waħdu jew għal dawk li diġà qegħdin jiġu kkurati b’ kumbinazzjoni ta ’ sitagliptin u metformin.
Efficib is also indicated in combination with a sulphonylurea (i. e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Efficib huwa indikat ukoll f’ kumbinazzjoni ma ’ sulphonylurea (jiġifieri, terapija ta ’ kumbinazzjoni tripla) bħala żieda mad- dieta u l- eżerċizzju f’ pazjenti mhux ikkontrollati adegwatament fuq id- doża massima ttollerata ta ’ metformin u sulphonylurea.
The dose of antihyperglycaemic therapy with Efficib should be individualised on the basis of the patient’ s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Id- doża ta ’ terapija kontra l- ipergliċemija b’ Efficib għandha tkun individwalizzata fuq il- bażi tal- kors kurrenti, l- effettività, u t- tolerabbilità tal- pazjent waqt li ma tinqabiżx id- doża massima ta ’ kuljum irrakkomandata ta ’ 100 mg sitagliptin.
For patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose of Efficib should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Għal pazjenti mhux ikkontrollati adegwatament fuq id- doża massima ttollerata ta ’ monoterapija b’ metformin Għal pazjenti mhux ikkontrollati adegwatament fuq metformin waħdu, id- doża tal- bidu tas- soltu ta ’ Efficib għandha tkun ta ’ 50 mg sitagliptin darbtejn kuljum (doża totali ta ’ kuljum 100 mg) kif ukoll id - doża ta ’ metformin li tkun diġà bdiet tittieħed.
For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Efficib should be initiated at the dose of sitagliptin and metformin already being taken.
Għal pazjenti li sejrin jaqilbu minn għoti konkomitanti ta ’ sitagliptin u metformin Għal pazjenti li sejrin jaqilbu minn għoti konkomitanti ta ’ sitagliptin u metformin, Efficib għandu jinbeda fid- doża ta ’ sitagliptin u metformin li tkun diġà bdiet tittieħed.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea The dose of Efficib should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Għal pazjenti mhux ikkontrollati adegwatament fuq terapija ta ’ kombinazzjoni doppja bid- doża massima ttollerata ta ’ metformin u sulphonylurea Id- doża ta ’ Efficib għandha tipprovdi sitagliptin 50 mg darbtejn kuljum (doża totali ta ’ kuljum 100 mg) u doża ta ’ metformin simili għad- doża li diġà qegħda tittieħed.
When Efficib is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Meta Efficib jintuża f’ kombinazzjoni ma ’ sulphonylurea, tista ’ tkun meħtieġa doża aktar baxxa ta ’ sulphonylurea biex tnaqqas ir- riskju ta ’ ipogliċemija (ara sezzjoni 4. 4).
2 For the different doses on metformin, Efficib is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1000 mg metformin hydrochloride.
2 Għal dożi differenti ta ’ metformin, Efficib jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1000 mg metformin hydrochloride.
All patients should continue their diet with an adequate distribution of carbohydrate intake during the day.
Il- pazjenti għandhom ikomplu bid- dieta tagħhom li tinkludi t- teħid adegwat ta ’ karboidrat matul il - jum.
Overweight patients should continue their energy-restricted diet.
Pazjenti b’ piż eċċessiv għandhom ikomplu d- dieta tagħhom ta ’ enerġija ristretta.
Efficib should be given twice daily with meals to reduce the gastrointestinal undesirable effects associated with metformin.
Efficib għandu jingħata darbtejn kuljum ma ’ l- ikel biex itaffi l- effetti gastrointestinali mhux mixtieqa assoċjati ma ’ metformin.
Patients with renal insufficiency Efficib should not be used in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/ min) (see sections 4.3 and 4.4).
Pazjenti b’ indeboliment tal- kliewi Efficib m’ għandux jintuża f’ pazjenti b’ indeboliment tal- kliewi moderat jew serju (eliminazzjoni ta ’ kreatinin < 60 ml/ min) (ara sezzjonijiet 4. 3 u 4. 4).
Patients with hepatic insufficiency Efficib should not be used in patients with hepatic impairment (see sections 4.3 and 5.2).
Pazjenti b’ indeboliment tal- fwied Efficib m’ għandux jintuża f’ pazjenti b’ indeboliment tal- fwied (ara sezzjonijiet 4. 3 u 5. 2).
Elderly As metformin and sitagliptin are excreted by the kidney, Efficib should be used with caution as age increases.
L- anzjani Minħabba li metformin u sitagliptin huma eliminati mill- kliewi, Efficib għandu jintuża b’ kawtela fuq pazjenti li huma akbar fl- età.
Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly (see sections 4.3 and 4.4).
Sorveljanza tal- funzjoni tal- kliewi hija neċessarja biex tgħin fil - prevenzjoni ta ’ aċidożi lattika assoċjata ma ’ metformin, partikolarment fl- anzjani (ara sezzjonijiet 4. 3 and 4. 4).
Limited safety data on sitagliptin is available in patients > 75 years of age and care should be exercised.
Hemm dejta limitata fuq is- sigurtà ta ’ sitagliptin f’ pazjenti ta ’ età > 75 sena u jeħtieġ li wieħed joqgħod attent f’ dawn il- każi.
Paediatric population Efficib is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy in this population.
Populazzjoni pedjatrika Efficib mhuwiex irrakkomandat fi tfal taħt l- età ta ’ 18- il sena minħabba nuqqas ta ’ dejta fuq is- sigurtà u l- effikaċja tiegħu f’ din il- popolazzjoni.
Efficib is contraindicated in patients with:
Efficib huwa kontraindikat f’ pazjenti b ’:
- hypersensitivity to the active substances or to any of the excipients (see sections 4.4 and 4.8);
- sensittività eċċessiva għas- sustanzi attivi jew għal kwalunkwe sustanza mhux attiva (ara
- diabetic ketoacidosis, diabetic pre-coma;
- ketoaċidożi dijabetika, stat dijabetiku ta ’ qabel il- koma;
- moderate and severe renal impairment (creatinine clearance < 60 ml/ min) (see section 4.4);
- indeboliment tal- kliewi moderat u serju (eliminazzjoni tal- kreatinina < 60 ml/ min) (ara
- acute conditions with the potential to alter renal function such as:
- kundizzjonijiet akuti bil- potenzjal li jbiddlu l- funzjoni tal- kliewi bħalma huma:
dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4);
deidratazzjoni, infezzjoni severa, xokk, għoti intravaskulari ta ’ mediċini ta ’ kuntrast jodinat (ara sezzjoni 4. 4);
- acute or chronic disease which may cause tissue hypoxia such as:
- mard akut jew kroniku li jista ’ jikkaġuna ipoksja tat- tessut bħalma huwa:
cardiac or respiratory failure, recent myocardial infarction, shock;
falliment kardijaku jew respiratorju, infart majokardjali reċenti, xokk;
- hepatic impairment;
- indeboliment epatiku;
- acute alcohol intoxication, alcoholism;
- intossikazzjoni akuta bl- alkoħol, alkoħoliżmu;
- lactation.
- treddigħ.
General Efficib should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Ġenerali Efficib m’ għandux jintuża f’ pazjenti b’ dijabete tip 1 jew għall- kura ta ’ ketoaċidożi dijabetika.
Lactic acidosis Lactic acidosis is a very rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation.
Aċidożi lattika L- aċidożi lattika hija kumplikazzjoni metabolika rari ħafna, (b’ mortalità għolja fin- nuqqas ta ’ kura fil - pront), li tista ’ sseħħ minħabba akkumulazzjoni ta ’ metformin.
Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Każijiet irrapportati ta ’ aċidożi lattika
3 risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia.
3 f’ pazjenti fuq metformin seħħew primarjament f’ pazjenti dijabetiċi b’ falliment tal- kliewi sinifikattiv.
Diagnosis Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Dijanjożi L- aċidożi lattika hija kkaratterizzata minn dispneja aċidotika, uġigħ ta ’ żaqq u ipotermja segwiti minn koma.
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/ l, and an increased anion gap and lactate/ pyruvate ratio.
Sejbiet dijanjostiċi tal- laboratorju huma tnaqqis fil- pH tad- demm, livelli ta ’ lactate fil- plażma ’ l fuq minn 5 mmol/ l, u żieda fl- ispazju anijonu u fil- proporzjon lactate/ pyruvate.
If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9).
Jekk tkun issuspettata aċidożi lattika (ara sezzjoni 4. 9), għandha titwaqqaf il- kura bil- prodott mediċinali u l- pazjent għandu jiddaħħal l- isptar minnufih.
Renal function Metformin and sitagliptin are known to be substantially excreted by the kidney.
Funzjoni tal- kliewi Metformin u sitagliptin huma magħrufin li huma sostanzjalment eliminati permezz tal- kliewi.
Metformin-related lactic acidosis increases with the degree of impairment of renal function, therefore, serum creatinine concentrations should be determined regularly:
L - aċidożi lattika relatata ma ’ metformin tiżdied mal- grad ta ’ indeboliment tal- funzjoni tal- kliewi, għaldaqstant, konċentrazzjonijiet ta ’ kreatinin fis- serum għandhom jitkejlu regolarment:
- at least once a year in patients with normal renal function
- ta ’ l- anqas darba fis- sena f’ pazjenti b’ funzjoni tal- kliewi normali
- at least two to four times a year in patients with serum creatinine levels at or above the upper
- ta ’ l- anqas darbtejn sa erba ’ darbiet fis- sena f’ pazjenti b’ liveli ta ’ kreatinin fis- serum fi jew ’ l
limit of normal and in elderly patients.
fuq mil- limitu ta ’ fuq tan- normal u f’ pazjenti anzjani.
Decreased renal function in elderly patients is frequent and asymptomatic.
Tnaqqis fil- funzjoni tal- kliewi f’ pazjenti anzjani huwa frekwenti u bla sintomi.
Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID).
Għandha tiġi eżerċitata kawtela speċjali f’ sitwazzjonijiet fejn il- funzjoni tal- kliewi tista ’ tiġi imxekkla, per eżempju meta tinbeda terapija kontra l- pressjoni jew dijuretika jew meta tinbeda kura b’ mediċina mhux sterojdali kontra l- infjammazzjoni (NSAID).
Hypoglycaemia Patients receiving Efficib in combination with a sulphonylurea may be at risk for hypoglycaemia.
Ipogliċemija Pazjenti li qegħdin jirċievu Efficib flimkien ma ’ sulphonylurea jistgħu jkunu f’ riskju għal ipogliċemija.
Therefore, a reduction in the dose of the sulphonylurea may be necessary.
Għaldaqstant, jista ’ jkun meħtieġ tnaqqis fid- doża tas- sulphonylurea.
The use of Efficib in combination with insulin has not been adequately studied.
L- użu ta ’ Efficib f’ kumbinazzjoni ma ’ insulina ma ġiex studjat adegwatament.
Hypersensitivity reactions Postmarketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported.
Reazzjonijiet ta ’ sensittività eċċessiva Wara t- tqegħid fis- suq kien hemm rapporti ta ’ reazzjonijiet ta ’ sensittività eċċessiva serji f’ pazjenti kkurati b’ sitagliptin.
These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Dawn ir- reazzjonijiet inkludew anafilassi, anġjoedima, u kundizzjonijiet esfoljattivi tal- ġilda nklużi s- sindromu ta ’ Stevens- Johnson.
Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose.
Dawn ir- reazzjonijiet seħħu fi żmien l - ewwel 3 xhur wara l- bidu ta ’ kura b’ sitagliptin, b’ xi rapporti li ġraw ukoll wara l- ewwel doża.
If a hypersensitivity reaction is suspected, discontinue Efficib, assess for other potential causes of the event, and institute alternative treatment for diabetes (see section 4.8).
Jekk tkun issuspettata reazzjoni ta ’ sensittività eċċessiva, waqqaf Efficib, ivvaluta kawżi potenzjali oħrajn għar- reazzjoni, u ibda kura alternattiva għad- dijabete (ara sezzjoni 4. 8).
Surgery As Efficib contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Kirurġija Minħabba li Efficib fih metformin hydrochloride, il- kura għandha titwaqqaf 48 siegħa qabel kirurġija elettiva b’ loppju ġenerali, anestesija spinali jew epidurali.
Efficib should not usually be resumed earlier than 48 hours afterwards and only after renal function has been re-evaluated and found to be normal.
Efficib ġeneralment m’ għandux jerġa ’ jinbeda aktar kmieni minn 48 siegħa wara u biss wara li l- funzjoni tal- kliewi tkun ġiet evalwata mill - ġdid u nstabet li hija normali.
Administration of iodinated contrast agent The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure which has been associated with lactic acidosis in patients receiving metformin.
Għoti ta ’ mediċini ta ’ kuntrast bil- jodju L- għoti fil- vina ta ’ mediċini ta ’ kuntrast bil- jodju fi studji radjoloġiċi jistgħu jwasslu għal falliment tal- kliewi li ġie assoċjat ma ’ aċidożi lattika f’ pazjenti li kienu qegħdin jirċievu metformin.
Therefore, Efficib 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).
Għaldaqstant, Efficib għandu jitwaqqaf qabel, jew fiż- żmien tat- test u ma jerġax jinbeda sa 48 siegħa wara, u biss wara li l- funzjoni tal- kliewi tkun ġiet evalwata mill- ġdid u nstabet li hija normali (ara sezzjoni 4. 5).
4 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Efficib who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
4 Bidla fl- istat kliniku ta ’ pazjenti b’ dijabete tip 2 li diġà kienu kkontrollati Pazjent b’ dijabete tip 2 li diġà kien ikkontrollat sewwa fuq Efficib li jiżviluppa anormalitajiet tal - laboratorju jew mard kliniku (speċjalment mard vag u mard mhux ċar biżżejjed) għandu jiġi evalwat minnufih għal evidenza ta ’ ketoaċidożi jew aċidożi lattika.
Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
L- evalwazzjoni għandha tinkludi elettroliti u ketoni fis- serum, zokkor fid- demm, u, jekk indikati, livelli ta ’ pH, lactate, pyruvate, u metformin fid - demm.
If acidosis of either form occurs, Efficib must be stopped immediately and other appropriate corrective measures initiated.
Jekk isseħħ aċidożi ta ’ forma waħda jew l- oħra, Efficib għandu jitwaqqaf minnufih u jinbdew miżuri korrettivi adattati
Co-administration of multiple doses of sitagliptin (50 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either sitagliptin or metformin in patients with type 2 diabetes.
L- għoti konkomitanti ta ’ dożi multipli ta ’ sitagliptin (50 mg darbtejn kuljum) u metformin (1000 mg darbtejn kuljum) ma biddilx b’ mod sinifikanti l- farmakokinetika ta ’ sitagliptin jew ta ’ metformin f’ pazjenti b’ dijabete tip 2.
Pharmacokinetic drug interaction studies with Efficib have not been performed; however, such studies have been conducted with the individual active substances of Efficib, sitagliptin and metformin.
Ma sarux studji farmakokinetiċi ta ’ interazzjoni ta ’ mediċini b’ Efficib; madankollu, studji bħal dawn saru individwalment bis- sustanzi attivi ta ’ Efficib, sitagliptin u metformin.
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 Efficib (see section 4.4).
B’ intossikazzjoni akuta ta ’ alkoħol (partikolarment fil- każ ta ’ sawm, malnutriment jew indeboliment epatiku) hemm żieda ta ’ riskju ta ’ aċidożi lattika minħabba s- sustanza attiva metformin bħala parti minn Efficib (ara sezzjoni 4. 4).
Consumption of alcohol and medicinal products containing alcohol should be avoided.
Konsum ta ’ alkoħol jew prodotti mediċinali li fihom l- alkoħol għandhom jiġu evitati.
Cationic agents that are eliminated by renal tubular secretion (e. g., cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Mediċini katijoniċi li huma eliminati permezz ta ’ tnixxija mit- tubuli tal- kliewi (eż., cimetidine) jistgħu jaħdmu flimkien ma ’ metformin billi jikkompetu ma ’ sistemi komuni ta ’ trasport tubulari tal- kliewi.
A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Sar studju f’ seba ’ voluntiera normali li wrew li cimetidine, mogħti bħala 400 mg darbtejn kuljum, żied l- espożizzjoni sistemika ta ’ metformin (AUC) b’ 50% u s- Cmax b’ 81%.
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic agents that are eliminated by renal tubular secretion are co-administered.
Għaldaqstant, sorveljanza mill- qrib tal- kontroll gliċemiku, aġġustament tad- doża fi ħdan il- pożoloġija rrakkomandata u bidliet fil- kura dijabetika għandhom jiġu kkunsidrati meta mediċini katijoniċi li huma eliminati permezz ta ’ tnixxija mit- tubuli tal- kliewi jingħataw fl- istess ħin.
The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
L- għoti intravaskulari ta ’ mediċini ta ’ kuntrast li fih jodju fi studji radjoloġiċi jistgħu jwasslu għal falliment tal- kliewi, jirriżultaw f’ akkumulazzjoni ta ’ metformin u riskju ta ’ aċidożi lattika.
Therefore, Efficib 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 4.4).
Għaldaqstant, Efficib għandu jitwaqqaf qabel, jew fil- ħin tat- test u ma jerġax jinbeda sa 48 siegħa wara, u biss wara li l- funzjoni tal- kliewi tkun ġiet evalwata mill- ġdid u nstabet li hija normali (ara sezzjoni 4. 4).
Combination requiring precautions for use Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Kumbinazzjoni li teħtieġ prekawzjonijiet għall- użu Il- glukokortikosterojdi (mogħtija permezz ta ’ rotot sistemiċi u lokali), agonisti- beta- 2, u dijuretiċi għandhom attività ipergliċemika minnhom infushom.
The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Il- pazjenti għandhom ikunu infurmati u għandha ssir sorveljanza aktar frekwenti taz- zokkor fid- demm, speċjalment fil- bidu ta ’ kura bi prodotti mediċinali bħal dawn.
If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Jekk meħtieġ, id- doża ta ’ prodott mediċinali kontra l- ipergliċemija bil- prodott mediċinali l- ieħor għandha tkun aġġustata waqt it- terapija u wara li jitwaqqaf.
ACE-inhibitors may decrease the blood glucose levels.
Impedituri- ACE jistgħu jnaqqsu l- livelli ta ’ zokkor fid- demm.
If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Jekk meħtieġ, id- doża ta ’ prodott mediċinali kontra l- ipergliċemija bil- prodott mediċinali l- ieħor għandha tkun aġġustata waqt it- terapija u wara li jitwaqqaf.
Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions following co- administration of other medicinal products is low.
Effetti ta ’ prodotti mediċinali oħrajn fuq sitagliptin Dejta klinika hawn taħt tissuġġerixxi li hemm ftit riskju għal interazzjonijiet klinikament sinifikanti wara l- għoti ta ’ prodotti mediċinali oħra.
Cyclosporine:
Cyclosporine:
A study was conducted to assess the effect of cyclosporine, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
Sar studju biex jistma l- effett ta ’ cyclosporine, impeditur qawwi ta ’ p- glycoprotein, fuq il- farmakokinetika ta ’ sitagliptin.
Co-administration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of cyclosporine increased the AUC and Cmax of sitagliptin by approximately 29% and 68%, respectively.
Għoti konkomitanti ta ’ doża orali waħda ta ’ 100 mg ta ’ sitagliptin u doża orali waħda ta ’ 600 mg ta ’ cyclosporine żiedet l- AUC u s- Cmax ta ’ sitagliptin b’ madwar 29% u 68%, rispettivament.
These changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful.
Dawn il- bidliet fil- farmakokinetika ta ’ sitagliptin ma kinux ikkunsidrati klinikament sinifikanti.
The renal clearance of sitagliptin was not meaningfully altered.
Ir- rata ta ’ eliminazzjoni ta ’ sitagliptin ma kinitx mibdula b’ mod sinifikanti.
Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
5 Għaldaqstant, mhumiex mistennija interazzjonijiet b’ mod sinifikanti b’ impedituri p- glycoprotein oħrajn.
5 In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Studji in vitro indikaw li l- enzima primarja responsabbli għall- metaboliżmu limitat ta ’ sitagliptin hija CYP3A4, b’ kontribuzzjoni minn CYP2C8.
In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
F’ pazjenti b’ funzjoni tal- kliewi normali, il- metaboliżmu, inkluż dak permezz ta ’ CYP3A4, għandu biss rwol żgħir fir- rata ta ’ eliminazzjoni ta ’ sitagliptin.
Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal insufficiency or ESRD.
Il - metaboliżmu jista ’ jkollu rwol aktar sinifikanti fl- eliminazzjoni ta ’ sitagliptin fl- isfond ta ’ indeboliment tal- kliewi sever jew ESRD.
For this reason, it is possible that potent CYP3A4 inhibitors (i. e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the phamacokinetics of sitagliptin in patients with severe renal insufficiency or ESRD.
Għal din ir- raġuni, huwa possibbli li impedituri qawwija ta ’ CYP3A4 (jiġifieri, ketoconazole, itraconazole, ritonavir, clarithromycin) jistgħu jbiddlu l - farmakokinetika ta ’ sitagliptin f’ pazjenti b’ indeboliment tal- kliewi sever jew ESRD.
The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study.
L- effetti ta ’ impedituri qawwija ta ’ CYP3A4 fl- isfond ta ’ indeboliment tal- kliewi ma ġiex stmat fi studju kliniku.
In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and OAT3.
Studji ta ’ trasport in vitro urew li sitagliptin huwa sottostrat għal p- glycoprotein u OAT3.
OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
Trasport ta ’ sitagliptin medjat minn OAT3 kien imfixkel minn probenecid in vitro, għalkemm hemm ftit riskju ta ’ interazzjoni klinikament sinifikanti.
Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Għoti konkomitanti ta ’ impedituri OAT3 ma kienx evalwat in vivo.
Effects of sitagliptin on other medicinal products In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes.
Effetti ta ’ sitagliptin fuq prodotti mediċinali oħrajn Dejta in vitro tissuġġerixxi li sitagliptin ma jfixkilx u lanqas jinduċi iżoenżmi CYP450.
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
Fi studji kliniċi, sitagliptin ma bidilx b’ mod sinifikanti l- farmkokinetika ta ’ metformin, glyburide, simvastatin, rosiglitazone, warfarin, jew kontraċettivi orali, li tipprovdi evidenza in vivo ta ’ tendenza baxxa f’ li jikkaġuna interazzjonijiet ma ’ sottostrati ta ’ CYP3A4, CYP2C8, CYP2C9, u t- trasportatur katijoniku organiku (OCT).
Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p-glycoprotein in vivo.
Sitagliptin għandu effett żgħir fuq livelli ta ’ digoxin fil- plażma, u jista ’ jkun impeditur dgħajjef ta ’ p- glycoprotein in vivo.
Sitagliptin had a small effect on plasma digoxin concentrations.
Sitagliptin kellu effett żgħir fuq livelli ta ’ digoxin fil- plażma.
Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11%, and the plasma Cmax on average by 18%.
Wara l- għoti ta ’ 0. 25 mg digoxin fl- istess ħin ma ’ 100 mg ta ’ sitagliptin kuljum għal 10 ijiem, l- AUC ta ’ digoxin żdied b’ medja ta ’ 11%, u s- Cmax tal- plażma b’ medja ta ’ 18%.
No dose adjustment of digoxin is recommended.
L- ebda aġġustament fid- doża ta ’ digoxin ma huwa rrakkomandat.