qanastek/EMEA-V3 huggingface dataset:
AVAGLIM is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 ml/ min, see section 4.3).
AVAGLIM mhux indikat f’ pazjenti b’ indeboliment serju tal- kliewi (tneħħija ta ’ kreatinina inqas minn 30 ml/ min, ara sezzjoni 4. 3).
Patients with hepatic impairment AVAGLIM is contraindicated in patients with hepatic impairment (see section 4.3).
Pazjenti b’ indeboliment tal- fwied AVAGLIM mhux indikat għal pazjenti b’ indeboliment tal- fwied (ara sezzjoni 4. 3).
Children and adolescents AVAGLIM is not recommended for use in children below 18 years of age as there are no data available on its safety and efficacy.
Tfal u adolexxenti AVAGLIM mhux rakkomandat għal użu fi tfal ta ’ taħt it- 18- il sena għax m’ hawnx tagħrif biżżejjed dwar is- sigurta` u l- effikaċja tiegħu.
Use of AVAGLIM is contraindicated in patients with:
L- użu ta ’ AVAGLIM hu kontra- indikat għal pazjenti bi:
− hypersensitivity to rosiglitazone, glimepiride, other sulphonylureas or sulphonamides or to any of the excipients − cardiac failure or history of cardiac failure (NYHA class I to IV) − an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4) − hepatic impairment − severe renal impairment i. e. creatinine clearance less than 30 ml/ min (including renal dialysis). − insulin dependant diabetes − diabetic ketoacidosis or diabetic coma.
- indeboliment serju tal- kliewi i. e. tneħħija ta ’ kreatinina ta ’ inqas minn 30 ml/ min (inkluża dijalisi
AVAGLIM is not indicated for combination use with metformin and therefore should not be used in triple oral therapy of diabetes.
AVAGLIM mhux indikat għal użu f’ kombinazzjoni ma ’ metformin u għalhekk m’ għandux jintuża f’ terapija orali trippla ta ’ dijabete.
The following statements refer to AVAGLIM or the two individual active substances (rosiglitazone and glimepiride).
Id- dikjarazzjonijiet li ġejjin jirreferixxu għal AVAGLIM jew għaż- żewġ sustanzi individwali u attivi (rosiglitazone u glimepiride)
Hypoglycaemia Patients receiving AVAGLIM may be at risk of dose-related hypoglycaemia (see section 4.8).
Ipogliċemija Pazjenti li jkunu jieħdu AVAGLIM jistgħu ikunu f’ riskju ta ’ ipogliċemija relatata mad- dożi (ara sezzjoni 4. 8).
It is advised that patients established on rosiglitazone and chlorpropamide concomitant therapy should not switch to AVAGLIM as chlorpropamide has a long half-life which may increase the risk of hypoglycaemia.
Hu rakkomandat li pazjenti stabbiliti fuq terapija ta ’ rosiglitazone u chlorpropamide flimkien m’ għandhomx jaqilbu għal AVAGLIM għax chlorpropamide għandu half- life fit- tul li tista ’ żżid ir- riskju ta ’ ipogliċemija.
If risk factors for hypoglycaemia are present (including renal insufficiency, low body weight, malnourishment, co-administration with certain other medicinal products (see section 4.5) or if the patient’ s life-style changes) it may be necessary to revert to concomitant therapy and down titrate the glimepiride dose.
3 sezzjoni 4. 5) jew jekk jinbidel l- istil tal- ħajja tal- pazjent) jista ’ jkun hemm bżonn li wieħed jerga ’ jdur għal terapija konkomitanti b’ doża ta ’ glimepiride li tiżdied jew titnaqqas ftit ftit.
A switch to insulin should be considered in stress situations (e. g. trauma, surgery, infections).
Wieħed jista ’ jdur għall- insulina f’ sitwazzjonijiet ta ’ tensjoni (e. g trawma, operazzjoni, infezzjonijiet).
3 Fluid retention and cardiac failure Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
Retenzjoni ta ’ fluwidu u insuffiċjenza tal- qalb Thiazolidinediones jistgħu jikkawżaw retenzjoni ta ’ fluwidu li tista ’ tħarrax jew tipprovoka sinjali jew sintomi ta ’ insuffiċjenza tal- qalb konġestiva.
Rosiglitazone can cause dose-dependent fluid retention.
Rosiglitazone jista ’ jikkawża retenzjoni ta ’ fluwidu marbuta mad- doża.
The possible contribution of fluid retention to weight gain should be individually assessed as rapid and excessive weight gain has been reported very rarely as a sign of fluid retention.
Il- kontribuzzjoni possibbli tar- retenzjoni ta ’ fluwidu għal żjieda fil- piż għandha tiġi valutata individwalment billi żjieda ta ’ malajr u eċċessiva ta ’ piż ġiet rappurtata rari ħafna bħala sinjal ta ’ retenzjoni ta ’ fluwidu.
All patients, particularly those receiving concurrent insulin therapy, those at risk for heart failure and those with reduced cardiac reserve, should be monitored for signs and symptoms of adverse reactions relating to fluid retention, including weight gain and heart failure.
Il- pazjenti kollha, speċjalment dawk li jieħdu wkoll kura b’ insulina, dawk f’ riskju ta ’ waqfien tal- qalb u dawk b’ riżerva kardijaka mnaqqsa, għandhom jiġu monitorjati għal xi sinjali jew sintomi ta ’ effetti mhux mixtieqa li għandhom x’ jaqsmu ma retenzjoni ta ’ fluwidu, inklużi żjieda fil- piż u waqfien tal- qalb.
Rosiglitazone should be discontinued if any deterioration in cardiac status occurs.
Rosiglitazone għandu jitwaqqaf fil- każ ta ’ xi deterjorament fl- istatus kardijaku.
Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure.
Insuffiċjenza tal- qalb ġiet ukoll rappurtata aktar spiss f’ pazjenti bi storja ta ’ insuffiċjenza tal- qalb; edema u insuffiċjenza tal- qalb kienet irrapurtata aktar spiss f’ pazjenti anzjani u f’ pazjenti b’ insuffiċjenza ħafifa jew moderata tal- kliewi.
Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Għandu ikun hemm kawtela f’ pazjenti ta ’ aktar minn 75 sena minħabba nuqqas ta ’ esperjenza f’ dan il- grupp ta ’ pazjenti.
Since NSAIDs and rosiglitazone are associated with fluid retention, concomitant administration may increase the risk of oedema.
Billi NSAIDs u rosiglitazone huma assoċjati ma ’ retenzjoni ta ’ fluwidu, it- teħid flimkien ta ’ dawn jista ’ jżid ir- riskju ta ’ edema.
Combination with insulin An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
Kombinazzjoni ma ’ insulina Kienet osservata inċidenza akbar ta ’ insuffiċjenza tal- qalb fi studji kliniċi meta rosiglitazone jintuża flimkien ma ’ insulina.
Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease.
Kemm l- insulina kif ukoll rosiglitazone huma assoċjati ma ’ ritenzjoni ta ’ fluwidu, l- għoti flimkien jista ’ jżid ir- riskju ta ’ edema u jista ’ jżid ir- riskju ta ’ mard iskemiku tal- qalb.
Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision.
L- insulina għandha tiżdied biss f’ kura stabbilita b’ rosiglitazone f’ każijiet speċjali u taħt osservazzjoni mill- viċin.
Myocardial Ischaemia The available data indicate that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events (see section 4.8).
Iskemja Mijokardijaka L- informazzjoni disponibbli turi li kura b’ rosiglitazone tista ’ tkun assoċjata ma 'riskju akbar ta ’ eventi iskemiċi mijokardijaċi (ara sezzjoni 4. 8).
There are limited clinical trial data in patients with ischaemic heart disease and/ or peripheral arterial disease.
Hemm informazzjoni limitata minn studji kliniċi f’ pazjenti b’ mard iskemiku tal- qalb u/ jew mard ta ’ l- arterji ta ’ l- idejn u s- saqajn.
Therefore, as a precaution, the use of rosiglitazone is not recommended in these patients, particularly those with myocardial ischaemic symptoms.
Għalhekk, bħala prekawzjoni, l- użu ta 'rosiglitazone m’ huwiex rakkomandat f’ dawn il- pazjenti, l- aktar dawk b’ sintomi ta ’ iskemja mijokardijaka.
Acute Coronary Syndrome (ACS) Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
Sindromu Koronarju Akut (ACS) Pazjenti li esperjenzaw ACS ma ġewx studjati fi studji kliniċi kkontrollati b’ rosiglitazone.
In view of the potential for development of heart failure in these patients, rosiglitazone should therefore not be initiated in patients having an acute coronary event and it should be discontinued during the acute phase (see section 4.3).
Minħabba l- potenzjal ta ’ żvilupp ta ’ falliment tal- qalb f’ dawn il- pazjenti, rosiglitazone m’ għandux jinbeda f’ pazjenti li kellhom event koronarju akut u għandu jitwaqqaf fil- fażi akuta (ara sezzjoni 4. 3).
Monitoring of liver function There have been rare reports of hepatocellular dysfunction during post-marketing experience with rosiglitazone (see section 4.8).
Monitoraġġ tal- funzjoni tal- fwied Kien hemm rapporti rari ta ’ funzjonament epatoċellulari ħażin wara l- esperjenza tat- tqegħid fis- suq ta ’ rosiglitazone (ara sezzjoni 4. 8).
There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT > 2.5X upper limit of normal).
Teżisti esperjenza limitata ta ’ rosiglitazone f’ pazjenti b’ livell għoli ta ’ enzimi fil- fwied (ALT > 2. 5X limitu ta ’ fuq tan- normal).
Therefore, liver enzymes should be checked prior to the initiation of therapy with AVAGLIM in all patients and periodically thereafter based on clinical judgement.
Għalhekk, enzimi fil- fwied għandhom jiġu ċċekkjati qabel tinbeda terapija b’ AVAGLIM fil- pazjenti kollha u perjodikament wara, dejjem skond ġudizzju kliniku.
Therapy with AVAGLIM should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5X upper limit of normal) or with any other evidence of liver disease.
Terapija b’ AVAGLIM m’ għandhiex tinbeda f’ pazjenti b’ livelli baseline ta ’ enzimi tal- fwied miżjuda.
If ALT levels are increased to > 3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Jekk il- livelli ta ’ ALT jiżdiedu għal > 3X il- limitu għoli tan- normal waqt terapija b’ rosiglitazone, il- livelli ta ’ enzimi tal- fwied għandhom jerġgħu jiġu eżaminati mill- ġdid kemm jista ’ jkun malajr.
If ALT levels remain > 3X the upper limit of normal, therapy should be discontinued.
Jekk il- livelli ALT jibqgħu > 3X il- limitu ta ’ fuq tan- normal, it- terapija għandha titwaqqaf.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/ or dark urine, liver enzymes should be checked.
Jekk xi pazjent jiżviluppa sintomi li jindikaw funzjonament ħażin tal- fwied, li jinkludu dardir bla raġuni għalih, remettar, uġigħ addominali, għeja, anoreksja u/ jew awrina skura, għandhom jiġu ċċekkjati l- enzimi tal- fwied.
The decision whether to continue the patient on therapy with AVAGLIM should be guided by clinical judgement pending laboratory evaluations.
Id- deċiżjoni dwar jekk il- pazjent għandux jitħalla fuq terapija b’ AVAGLIM għandha ssir fuq ġudizzju kliniku sakemm isiru l- valutazzjonijiet tal- laboratorju.
If jaundice is observed, drug therapy should be discontinued.
Jekk jidhru sinjali ta ’ suffejra, it- terapija bil- mediċini għandha titwaqqaf.
Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
4 Mard ta ’ l- għajnejn Kien hemm rapporti ta ’ wara t- tqegħid fis- suq ta ’ bidu ta ’ edema makulari tad- dijabete b’ tnaqqis fl - akutezza fil- vista jew li din tmur għall- agħar wara li jittieħdu t - thiazolidinediones, incluż ir - rosiglitazone.
Many of these patients reported concurrent peripheral oedema.
Ħafna minn dawn il- pażjenti rrappurtaw edema periferali fl- istess ħin.
It is unclear whether or not there is a direct association between rosiglitazone and macular oedema but prescribers should be alert to the possibility of macular
Mhux ċar jekk hemmx assoċjazzjoni diretta bejn ir- rosiglitazone u l- edema makulari imma min jippreskrivi dan il - prodott għandu jkun avżat bil- possibilta ’ ta ’ edema makulari jekk pażjent jirrappurta disturbi fl - akutezza tal- vista u għandu jikkunsidra jibgħat lil- pazjent għall- parir xieraq ta ’ speċjalista ta ’ l - għajnejn.
Patients with renal impairment Patients with mild or moderate renal impairment (creatinine clearance 30 to 80 ml/ min) may be at an increased risk of hypoglycaemia (see sections 4.2, 4.3 and 4.4).
Pazjenti b’ indeboliment tal- kliewi Pazjenti b’ indeboliment ħafif jew moderat tal- kliewi (tneħħija ta ’ kreatinina 30 sa 80 ml/ min) jistgħu ikunu f’ riskju ogħla ta ’ ipogliċemija (ara sezzjonijiet 4. 2, 4. 3, u 4. 4).
Appropriate monitoring is advised.
Hu rakkomandat monitoraġġ xieraq.
Premenopausal anovulatory women Premenopausal women have received rosiglitazone during clinical studies.
Nisa anovulatorji qabel il- menopawsa Nisa ta ’ qabel il- menopawsa ħadu rosiglitazone waqt studji kliniċi.
Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Għalkemm deher żbilanċ ormonali fi studji pre- kliniċi (ara sezzjoni 5. 3), ebda effetti sinifikanti mhux mixtieqa assoċjati ma ’ mard menstruwali ma ġew osservati.
As a consequence of improving insulin sensitivity, resumption of ovulation may occur in patients who are anovulatory due to insulin resistance.
B’ riżultat ta ’ titjib ta ’ sensittivita` mill- insulina, tista ’ terġa tibda l - ovulazzjoni f’ pazjenti li huma anovulatorji minħabba reżistenza għall- insulina.
Patients should be aware of the risk of pregnancy (see section 4.6).
Il- pazjenti għandhom ikunu jafu bir- riskju li joħorġu tqal (ara sezzjoni 4. 6).
Weight gain In clinical trials with rosiglitazone there was evidence of dose-related weight gain, which was greater when used in combination with insulin.
Żjieda fil- piż Fi provi kliniċi b’ rosiglitazone kien hemm sinjali ta ’ żjieda fil- piż li għandha x’ taqsam mad- dożi, li kien akbar meta intuża flimkien ma ’ insulina.
Therefore weight should be closely monitored, given that it may be attributable to fluid retention, which may be associated with cardiac failure.
Għalhekk il- piż għandu jkun osservat mill- qrib, billi dan jista ’ jkun minħabba ritenzjoni ta ’ fluwidu, li jista ’ jkun assoċjat ma ’ insuffiċjenza tal- qalb.
Haematological monitoring Rosiglitazone treatment is associated with a dose-related reduction of haemoglobin levels.
Monitoraġġ ematoloġiku Trattament b’ rosiglitazone hu assoċjat ma ’ tnaqqis ta ’ livelli ta ’ emoglobina relatat mad- dożi.
In patients with low haemoglobin levels before initiating therapy, there is an increased risk of anaemia during treatment with AVAGLIM.
F’ pazjenti b’ livelli baxxi ta ’ emoglobina qabel tinbeda t- terapija, ikun hemm riskju ogħla ta ’ anemija waqt it- trattament b’ AVAGLIM.
Periodic haematological monitoring (especially leucocytes and thrombocytes) are required during treatment with AVAGLIM.
Monitoraġġ ematoloġiku perjodikament (speċjalment leucocytes u thrombocytes) hu meħtieġ waqt it - trattament b’ AVAGLIM.
Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia.
Trattament b’ sustanzi sulphonylurea, f’ pazjenti li għandhom nuqqas ta ’ G6PD jista ’ jwassal għal anemija emolitika.
Since glimepiride belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.
Peress li glimepiride tagħmel parti mil- klassi kimika ta ’ mediċini sulphonylurea, għandha tintuża kawtela f’ pazjenti b’ nuqqas ta ’ G6PD u alternattiva li mhijiex sulphonylurea għandha tiġi kkunsidrata.
Bone disorders In a long-term study an increased incidence of bone fractures (foot, hand and arm) was observed in female patients taking rosiglitazone as monotherapy (see section 4.8).
Mard ta ’ l- għadam Fi studju fit- tul ġiet osservata inċidenza akbar ta ’ ksur fl- għadam (fis- saqajn, fl- idejn u fid- dirgħajn) f’ pazjenti nisa li jkunu qed jieħdu rosiglitazone bħala monoterapija (ara sezzjoni 4. 8).
This increased incidence was noted after the first year of treatment and remained during the course of the study.
Din l- inċidenza akbar ġiet innotata wara l- ewwel sena tat- trattament u matul il- kumplament ta ’ l- istudju.
The risk of fracture should be considered in the care of patients, especially female patients, treated with rosiglitazone.
Ir- riskju ta ’ ksur għandu jiġi kkunsidrat fil- kura ta ’ pazjenti, speċjalment pazjenti nisa, li jkunu jieħdu rosiglitazone.
Administration with other medicinal products Rosiglitazone should be used with caution during concomitant administration of CYP2C8 inhibitors (e. g. gemfibrozil) or inducers (e. g. rifampicin).
Teħid flimkien ma prodotti mediċinali oħra Rosiglitazone għandu jintuża b’ attenzjoni waqt li jkun jittieħed flimkien ma ’ impedituri CYP2C8 (e. g. gemfibrozil) jew inducers (e. g. rifampicin).
Glimepiride should be used with caution during concomitant administration of CYP2C9 inhibitors (e. g. fluconazole) or inducers (see section 4.5).
Glimepiride għandu jintuża b’ attenzjoni waqt li jkun jittieħed flimkien ma ’ impedituri CYP2C9( e. g. fluconazole) jew inducers (ara sezzjoni 4. 5).
Glycaemic control should be monitored closely.
Kontroll gliċemiku għandu jiġi monitorjat b’ attenzjoni.
AVAGLIM dose adjustment within the recommended posology or changes in diabetic treatment should be considered.
L- aġġustament tad- doża ta ’ AVAGLIM skond il - posoloġija rakkomandata jew tibdil fit- trattament dijabetiku għandu jiġi kkunsidrat.
Lactose intolerance AVAGLIM tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
5 Intolleranza ta ’ lattosju Il- pilloli AVAGLIM fihom il- lattosju u għalhekk m’ għandhomx jingħataw lil pazjenti bi problemi rari u ereditarji ta ’ intolleranza galattosja, ta ’ defiċjenza Lapp lactase jew ta ’ assorbiment ħażin ta ’ glukosju- galattosju.
There have been no formal interaction studies for AVAGLIM.
Ma saru l- ebda studji formali dwar interazzjoni fuq AVAGLIM.
However, the concomitant use of the active substances in patients in clinical studies and in widespread clinical use has not resulted in any unexpected interactions.
Madankollu, l- użu konkomitanti tas - sustanzi attivi fuq pazjenti fi studji kliniċi u fl- użu kliniku wiesgħa ma rriżulta f’ ebda interazzjonijiet mhux mistennija.
The following statements reflect the information available on the individual active substances (rosiglitazone and glimepiride).
Dawn il- konklużjonijiet li ġejjin jirriflettu t- tagħrif disponibbli dwar is- sustanzi attivi individwali (rosiglitazone u glimepiride).
5 Rosiglitazone In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Rosiglitazone Studji in vitro juru li rosiglitazone jimmetabolizza prinċipalment b’ CYP2C8, waqt li CYP2C9 iservi biss ta ’ passaġġ żgħir.
Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Interazzjonijiet sinifikanti kliniċi ma ’ substrati jew impedituri ta ’ CYP2C9 mhumiex mistennija.
Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.
L- għoti flimkien ta ’ rosiglitazone ma ’ gemfibrozil (impeditur ta ’ CYP2C8) irriżulta f’ żjieda doppja ta ’ konċentrazzjonijiet fil- plażma b’ rosiglitazone.
Since there is a potential for an increase in the risk of dose-related adverse reactions, a decrease in rosiglitazone dose may be needed.
Billi jeżisti l- potenzjal ta ’ żjieda ta ’ riskju ta ’ reazzjonijiet avversi li għandhom x’ jaqsmu mad- dożi, jista ’ jkun meħtieġ tnaqqis fid- doża ta ’ rosiglitazone.
Close monitoring of glycaemic control should be considered (see section 4.4).
Monitoraġġ b’ attenzjoni ta ’ kontroll gliċemiku għandu jiġi kkunsidrat (ara sezzjoni 4. 4).
Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
L- għoti flimkien ta ’ rosiglitazone ma ’ rifampiċin (inducer ta ’ CYP2C8) irriżulta fi tnaqqis ta ’ 66% fil- konċentrazzjonijiet tal- plażma b’ rosiglitazone.
It cannot be excluded that other inducers (e. g. phenytoin, carbamazepine, phenobarbital, St John’ s wort) may also affect rosiglitazone exposure.
Ma jistax jiġi eskluż li inducers oħra (e. g. phenytoin, carbamazepine, phenobarbital, St John’ s wort) jistgħu wkoll ikollhom effett fuq l - esponiment għal rosiglitazone.
The rosiglitazone dose may need to be increased.
Jista ’ jkun li d- doża ta ’ rosiglitazone għandha tiżdied.
Close monitoring of glycaemic control should be considered (see section 4.4).
Għandu jiġi kkunsidrat il- monitoraġġ b’ attenzjoni tal- kontroll gliċemiku (ara sezzjoni 4. 4).
Concomitant administration of rosiglitazone with the oral anti-diabetic agents metformin, glimepiride, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions.
It- teħid flimkien ta ’ rosiglitazone ma ’ l- aġenti anti- dijabetiċi mill- ħalq metformin, glimepiride, glibenclamide u acarbose ma rriżultaw f’ ebda interazzjoni farmakokinetika rilevanti klinika.
No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone.
Ma ġew osservati ebda interazzjonijiet kliniċi rilevanti ma ’ digoxin, is- substrat CYP2C9 warfarin, is - substrati CYP3A4 nifedipine, ethinylestradiol jew norethindrone wara li ttieħdu flimkien ma ’ rosiglitazone.
Glimepiride If glimepiride is taken simultaneously with certain other medicines, both undesired increases and decreases in the hypoglycaemic action of glimepiride can occur.
Jekk glimepiride jittieħed fl- istess ħin ma ’ ċerti mediċini oħra, jistgħu jirriżultaw żjidiet u tnaqqis mhux mixtieqa fl- azzjoni ipogliċemika ta ’ glimepiride.
For this reason, other medicines should only be taken with the knowledge (or at the prescription) of the doctor.
Għaldaqstant, m’ għandhomx jittieħdu mediċini oħra mingħajr ma jkun jaf bihom it- tabib (jew bir- riċetta).
Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9).
Glimepiride jimmetabolizza bis- cytochrome P450 2C9 (CYP2C9).
Its metabolism is known to be influenced by concomitant administration of CYP2C9 inducers (e. g. rifampicin) or inhibitors (e. g. fluconazole
Hu magħruf li l- metaboliżmu tiegħu hu influwenzat mit- teħid konkomitanti ta ’ inducers (e. g. rifampicin) jew impedituri (e. g. fluconazole) ta ’ CYP2C9.
Results from an vivo interaction study reported in literature show that glimepiride AUC is increased approximately 2-fold by fluconazole, one of the most potent CYP2C9 inhibitors.
Riżultati minn studju dwar interazzjoni in vivo li dehru fl- istampa juru li glimepiride AUC jiżdied kważi għal darbtejn bil- fluconazole, wieħed mill- aktar impedituri potenti ta ’ CYP2C9.
Based on the experience with glimepiride and with other sulphonylureas the following interactions have to be mentioned.
Fuq il- bażi ta ’ esperjenza bi glimepiride u b’ sulphonylureas oħra l- interazzjonijiet li ġejjin għandhom jissemmew.
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example:
Il- potenzjament ta ’ effett ta ’ tnaqqis fil- glukosju fid- demm u għalhekk, kultant ipogliċemija, jistgħu iseħħu meta tittieħed xi waħda mill- mediċini li ġejjin, per eżempju:
phenylbutazone, azapropazon and oxyfenbutazone, insulin and oral antidiabetic products, metformin, salicylates and p-amino-salicylic acid, anabolic steroids and male sex hormones, chloramphenicol, coumarin anticoagulants, fenfluramine, fibrates, ACE inhibitors, fluoxetine, allopurinol, sympatholytics, cyclo-, tro-and iphosphamides,
phenylbutazone, azapropazon u oxyfenbutazone, insulina u prodotti orali anti- dijabetiċi,
sulphinpyrazone, certain long acting sulphonamides, tetracyclines, MAO-inhibitors, quinolone antibiotics, probenecid, miconazol, pentoxifylline (high dose parenteral), tritoqualine, fluconazole.
tetracyclines, impedituri MAO, antibijotiċi quinolone, probenecid, miconazol, pentoxifylline (parenteral ta ’ doża qawwija),
6 Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example:
Indeboliment ta ’ l- effett ta ’ tnaqqis ta ’ glukosju fid- demm u, għalhekk, livelli għolja ta ’ glukosju fid - demm jistgħu iseħħu meta tittieħed xi waħda mill- mediċini li ġejjin, per eżempju:
oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high dosages) and nicotinic acid derivatives, laxatives (long term use), phenytoin, diazoxide, glucagon, barbiturates and rifampicin, acetozolamide.
oestrogens u progestagens, saluretics, thiazide diuretics, aġenti li jistimulaw it- tirojde, glucocorticoids, derivattivi tal- phenothiazine, chlorpromazine, adrenaline u sympathicomimetics, aċidu nikotiniku( dożi għolja) u derivattivi ta ’ l- aċidu nikotiniku, lassattivi (użu fit- tul), phenytoin, diazoxide, glucagon, barbiturates u rifampicin, acetozolamide.
H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of the blood glucose lowering effect.
Antagonisti H2, betablockers, clonidine u reserpine jistgħu jwasslu għal potenzjament jew indeboliment ta ’ l- effett ta ’ tnaqqis ta ’ glukosju fid- demm.
Under the influence of sympatholytic drugs such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Taħt l- influwenza ta ’ mediċini simpatolitiċi bħal betablockers, clonidine, guanethidine u reserpine, is - sinjali ta ’ kontra- regolament adrenerġiku għal ipogliċemija jistgħu jonqsu jew ma jkunux hemm.
Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable fashion.
It- teħid ta ’ alkoħol jista ’ jsaħħaħ jew idgħajjef l- azjoni ipogliċemika ta ’ glimepiride b’ mod mhux mistenni.
Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
Glimepiride jista ’ jsaħħaħ jew idgħajjef l- effettii tad- derivattivi ta ’ coumarin.
For AVAGLIM no preclinical or clinical data on exposed pregnancies or lactation are available.
Dwar AVAGLIM m’ hawnx disponibbli tagħrif prekliniku jew kliniku dwar it- tqala exposed jew il - ħalib tas- sider.
Rosiglitazone has been reported to cross the human placenta and to be detectable in foetal tissues.
Ġie rappurtat li rosiglitazone għadda mill- plaċenta umana u li kien hemm traċċi tiegħu fit- tessuti tal - fetu.
There are no adequate data from the use of either active substance (rosiglitazone and glimepiride) in pregnant women.
Ma hemm ebda tagħrif adegwat dwar l- użu tas- sustanzi attivi (rosiglitazone u glimepiride) f’ nisa fit- tqala.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji f’ annimali wrew tossiċita` riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
M’ hawnx tagħrif dwar ir - riskju potenzjali għall- bniedem.
Therefore, AVAGLIM should not be used during pregnancy and the use of insulin is recommended.
Għalhekk, AVAGLIM m’ għandux jintuża waqt it- tqala u l- użu ta ’ insulina hu rakkomandat.
If a patient wishes to become pregnant or if pregnancy occurs, treatment with AVAGLIM should be discontinued.
Jekk persuna tixtieq toħroġ tqila jew titqal, it- trattament b’ AVAGLIM għandu jitwaqqaf.
Both rosiglitazone and glimepiride have been detected in the milk of experimental animals.
Kemm rosiglitazone u kemm glimepiride instabu fil- ħalib ta ’ annimali waqt esperimentazzjoni.
It is not known whether breast-feeding will lead to exposure of the infant to medicinal product.
Mhux magħruf jekk it- treddigħ iwassalx lit- tarbija għal esponiment għal prodott mediċinali.
Therefore, AVAGLIM should not be used during lactation.
Għalhekk, AVAGLIM m’ għandux jintuża meta mara tkun tredda ’.
4.7 Effects on ability to drive and use machines
7 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
No studies of the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila tas- sewqan jew tħaddim ta ’ magni.
Nevertheless, the potential for hypoglycaemia should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (e. g. driving).
Madankollu, il- potenzjal għal ipogliċemija għandu jitqies meta tkun qed tiġi kkunsidrata l- ħila ta ’ pazjent biex iwettaq xogħolijiet li jeħtieġu ġudizzju u kapaċitajiet għal tħaddim ta ’ magni jew xogħolijiet oħra bħal dawn (e. g. sewqan)
Adverse reactions are presented below for each of the component parts of AVAGLIM.
Reazzjonijiet mhux mixtieqa għal kull komponent ta’ AVAGLIM huma ppreżentati hawn taħt.
An adverse reaction is only presented for the fixed dose combination if it has not been seen in one of the component parts of AVAGLIM or if it occurred at a higher frequency than that listed for a component part.
Reazzjoni mhux mixtieqa għad- doża fissa kombinata hija ppreżentata biss jekk din ma ’ tfaċċatx f’ wieħed mill- komponenti ta ’ AVAGLIM jew jekk intweriet b’ frekwenza ogħla minn dik indikata f - komponent minnhom.
7 AVAGLIM Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and glimepiride is similar to that of the combined adverse reaction profile for the two active substances.
AVAGLIM Tagħrif minn studji double- blind jikkonferma li l- profil ta ’ sigurta` ta ’ rosiglitazone u glimepiride flimkien hu l- istess bħall- profil tar- reazzjoni avversa kombinata għaż- żewġ sustanzi attivi.
Limited data with AVAGLIM is also consistent with this combined adverse reaction profile.
Tagħrif limitat dwar AVAGLIM hu wkoll konsistenti ma ’ dan il- profil ta ’ reazzjoni avversa kombinata.
Clinical trial data Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Tagħrif minn provi kliniċi Reazzjonijiet mhux mixtieqa għal kull terapija huma elenkati hawn taħt skond is- sistema tal- ġisem, klassi ta ’ organi u frekwenza assoluta.
For dose-related adverse reactions the frequency category reflects the higher dose of rosiglitazone.
Għar- reazzjonijiet mhux mixtieqa relatati mad- doża l - kategorija ta ’ frekwenza tirrifletti l- ogħla doża tar- rosiglitazone.
Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Il- kategoriji ta ’ frekwenza ma jirriflettux fatturi oħra incluż it- tul ta ’ żmien varjabbli ta ’ l- istudju, kundizzjonijiet li kienu hemm qabel u karatteristiċi ta ’ linja bażi tal- pazjent.
Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Il- kategoriji ta ’ frekwenza ta ’ reazzjonijiet mhux mixtieqa assenjati fuq bażi ta ’ esperjenza minn provi kliniċi mhux neċessarjament jirriflettu l - frekwenza ta ’ effetti mhux mixtieqa li jseħħu fil- prattika klinika.
Frequencies are defined as: very common ≥ 1/ 10; common ≥ 1/ 100, < 1/ 10; and uncommon ≥ 1/ 1000, < 1/ 100.
Il- frekwenzi huma definiti bħala: komuni ħafna ≥1/ 10; komuni ≥1/ 100, < 1/ 10; u mhux komuni ≥1/ 1000, < 1/ 100.
Table 1 lists adverse reactions identified from an integrated clinical trial population of over 5,000 rosiglitazone-treated patients.
Tabella 1 t’ elenka reazzjonijiet mhux mixtieqa identifikati fi prova klinika f’ grupp integrat ta ’ aktar minn 5, 000 pazjent li kienu fuq trattament b’ rosiglitazone.
Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
F’ kull sistema ta ’ klassi ta ’ organu, effetti mhux mixtieqa għal monoterapija b’ rosiglitazone huma ppreżentati fit- tabella f’ ordni ta ’ tnaqqis fil - frekwenza.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, effetti mhux mixtieqa jidhru f’ ordni ta ’ tnaqqis fis- serjeta` tal - każ.
The frequency of adverse reactions identified from clinical trial data with rosiglitazone
Frekwenza ta ’ reazzjonijiet mhux mixtieqa identifikati mit- tagħrif minn provi kliniċi b’ rosiglitazone.
Adverse reaction
Reazzjoni avvers
Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy Rosiglitazone with sulphonylurea
Frekwenza ta ’ reazzjonijiet avversi skond it- terapija Monoterapija bir - Rosiglitazone ma ’ Rosiglitazone sulphonylurea
Blood and the lymphatic system disorders anaemia leucopaenia thrombocytopaenia
Mard tad- demm u tas- sistema limfatika anemija lewkopenja tromboċitopenja
Metabolism and nutrition disorders hypercholesterolaemia1 hypertriglyceridaemia hyperlipaemia weight increase increased appetite hypoglycaemia
Mard marbut mal- metaboliżmu u n- nutrizzjoni iperkolesterolemija 1 ipertrigliċeridemija iperlipemija żjieda fil- piż żjieda fl- aptit ipogliċemja
Common Common Common Common Common
Komuni Komuni Komuni Komuni Komuni
Common Common Common Common Uncommon Very common
Komuni Komuni Komuni Komuni Mhux komuni Komuni ħafna
dizziness*
sturdamenti *
Cardiac disorders cardiac failure2
Mard tal- qalb waqfien tal- qalb 2
cardiac ischaemia3*
iskemija kardijaka 3 *
Gastrointestinal disorders
Mard gastro- intestinali
constipation
stitikezza
Musculoskeletal and connective tissue disorders bone fractures4
Mard muskolu- skelettrali u tal- connective tissue ksur ta ’ l- għadam4
General disorders and administration site conditions oedema
Mard ġenerali u kondizzjonijiet
*The frequency category for the background incidence of this event, as taken from placebo group data from clinical trials, is'common '.
* Il- kategorija ta ’ frekwenza għall- isfond ta ’ l- inċidenza ta ’ dan l- effett, kif meħud mit- tagħrif mill - grupp plaċebo fi provi kliniċi, hija ‘ komuni ’.
1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone (monotherapy or dual oral therapy).
1 Iperkolesterolemija ġiet irrappurtata sa f’ 5. 3% ta’ pazjenti fuq terapija ta ’ rosiglitazone (monoterapija jew terapija orali doppja).
The elevated total cholesterol levels were associated with increase in both LDLc and HDLc, but the ratio of total cholesterol: HDLc was unchanged or improved in long term studies.
Il- livell sħiħ elevat tal- kolesterol kien assoċjat ma ’ żjieda kemm fill- LDLc kif ukoll fil - HDLc, imma il- proporzjon tal- kolesterol sħiħ: HDLc ma nbidilx jew tjieb fis- studji fit- tul.
Overall, these increases were generally mild to moderate and usually did not require discontinuation of treatment.
Ġeneralment, dawn iż- żjidiet kienu l- biċċa l- kbira ħfief sa moderati u normalment ma kienux jeħtieġu li t- trattament jitwaqqaf.
2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
2 Inċidenza ikbar ta ’ waqfien tal- qalb ġiet osservata meta rosiglitazone ġie miżjud ma ’ terapija b’ sulphonylurea (b’ terapija doppja jew trippla), u deher li kienet ogħla b’ 8 mg rosiglitazone meta mqabbla ma 4 mg rosiglitazone (doża sħiħa ta ’ kuljum).
The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
L- inċidenza ta ’ waqfien tal- qalb f’ kombinazzjoni ma ’ l- insulina (rosiglitazone miżjud ma ’ terapija b’ insulina stabbilita) kienet ta ’ 2. 4%, meta mqabbla ma ’ insulina waħedha, 1. 1%.
Moreover in patients with congestive heart failure NYHA class I-II, a placebo- controlled one-year trial demonstrated worsening or possible worsening of heart failure in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
Barra dan, f’ pazjenti b’ waqfien tal- qalb konġestiva NYHA klassi I- II, prova ta ’ sena kontrollata bi plaċebo wriet deterjorament jew deterjorament possibbli ta ’ waqfien tal- qalb f’ 6. 4% ta ’ pazjenti trattati b’ rosiglitazone, meta mqabbla ma ’ 3. 5% bi plaċebo.
3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 1.99% versus combined active and placebo comparators, 1.51% [Hazard ratio 1.31 (95% confidence interval 1.01 - 1.70)].
9 3 F’ analiżi retrospettiva ta ’ tagħrif minn 42 studji kliniċi fuq tul ta ’ żmien qasir, miġbura flimkien, l - inċidenza ġenerali ta ’ każi assoċjati tipikament ma ’ iskemija kardijaka kienet ogħla fil- każ ta ’ terapija li jkun fiha rosiglitazone, 1. 99% kontra komparaturi attivi kombinati u plaċebo, 1. 51% (Hazard ratio 1. 31 (95% confidence interval 1. 01 – 1. 70)).
This risk was increased when rosiglitazone was added to established insulin and
Dan ir- riskju żdied meta rosiglitazone ġie miżjud f’ pazjenti stabbiliti fuq insulina u f’ pazjenti li kienu qegħdin jieħdu nitrates minħabba mard iskemiku tal- qalb magħruf.
In a large observational study where patients were well-matched at baseline, the incidence of the composite endpoint myocardial infarction and coronary revascularization was 17.46 events per 1000 person years for rosiglitazone containing regimens and 17.57 events per 1000 person years for other anti-diabetic agents [Hazard ratio 0.93 (95% confidence interval 0.80 - 1.10)].
Fi studju estensiv ta ’ osservazzjoni li fih pazjenti kienu magħżulin tajjeb f’ linja bażika, l- inċidenza ta ’ infart mijokardijaku endpoint b’ mod kompost u rivaskularizzazzjoni koronarja kienet ta ’ 17. 46 każi kull 1000 ħajja ta ’ persuna b’ terapija li fiha rosiglitazone u 17. 57 każi kull 1000 sena ħajja ta ’ persuna fil- każ ta ’ aġenti oħra anti- dijabetiċi (Hazard ratio 0. 93 (95% confidence interval 0. 80 – 1. 10)).
Three large long-term prospective randomised controlled clinical trials (mean duration 41 months; 14,067 patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk.
Tlett studji kliniċi kbar fuq tul ta ’ żmien twil, prospettivi, randomised u kontrollati (tul ta 'żmien medja ta ’ 41 xahar; 14, 067 pazjenti), li qabblu rosiglitazone ma ’ xi aġenti orali anti- dijabetiċi jew plaċebo, ma kkonfermawx jew eskludew dan ir- riskju.
In their entirety, the available data on the risk of myocardial ischaemia are inconclusive.
Ma ’ tulhom kollha, l - informazzjoni disponibbli fuq ir- riskju ta ’ iskemja mijokardijaka m’ hijiex konklussiva.
4 In a long-term randomised (4 to 6 year) monotherapy study in recently diagnosed patients with type 2 diabetes mellitus, an increased incidence of bone fractures was noted after the first year of treatment in female patients taking rosiglitazone (9.3%, 2.7 patients per 100 patient years) vs metformin (5.1%, 1.5 patients per 100 patient years) or glyburide/ glibenclamide (3.5%, 1.3 patients per 100 patient years).
4 Fi studju fit- tul (4 sa 6 snin) b’ monoterapija magħmul b’ għażla mhux ippjanata fuq pazjenti li jkunu għadhom kemm instabu li jbatu bid- dijabete mellitus tip 2, ġiet innotata inċidenza akbar ta ’ ksur fl - għadam wara l- ewwel sena ta ’ trattament f’ pazjenti nisa li jkunu jieħdu rosiglitazone (9. 3%, 2. 7 pazjenti kull 100 sena ta ’ ħajja bħala pazjenti) vs metformin (5. 1%, 1. 5 pazjenti kull 100 sena ta ’ ħajja bħala pazjenti) jew glyburide/ glibenclamide (3. 5%, 1. 3 pazjenti kull 100 sena ta ’ ħajja bħala pazjenti).
This increased risk remained during the course of the study.
Dan ir- riskju akbar baqa ’ hekk matul il- kumplament ta ’ l- istudju.
The majority of the fractures in the females who received rosiglitazone were reported in the foot, hand and arm.
Il- biċċa l- kbira ta ’ ksur f’ nisa fuq rosiglitazone ġew rappurtati fis- saqajn, fl- idejn u fid- dirgħajn.
In double-blind clinical trials with rosiglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo (0.2%) and less than that of the active comparators (0.5% metformin/ sulphonylureas).
Fi studji kliniċi double- blind b’ rosiglitazone l- inċidenza ta ’ għoli ta ’ ALT aktar minn tliet darbiet tal - limitu ta ’ fuq tan- normal kienet ugwali għall- plaċebo (0. 2%) u inqas minn dik tal- komparaturi attivi (0. 5% metformin/ sulphonylureas).
The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
L- inċidenza tal- każi avversi kollha relatati ma sistemi tal- fwied u biljari kienet < 1. 5% f’ kull grupp trattat u l- istess għall- plaċebo.
Post-marketing data In addition to the adverse reactions identified from clinical trial data, the adverse reactions presented in Table 2 have been identified in post approval use of rosiglitazone.
10 Tagħrif ta ’ wara t- tqegħid fis- suq Min barra r- reazzjonijiet mhux mixtieqa identifikati mit- tagħrif minn provi kliniċi, reazzjonijiet mhux mixtieqa ġew identifikati waqt l- użu ta ’ wara l- awtorizzazzjoni tar- rosiglitazone u dawn huma ppreżentati f’ tabella 2.
Frequencies are defined as: rare ≥ 1/ 10,000, < 1/ 1000 and very rare < 1/ 10,000 including isolated reports.
Il- frekwenzi huma definiti bħala: rari ≥1/ 10, 000, < 1/ 1000 u rari ħafna < 1/ 10, 000 inclużi rapporti iżolati.
The frequency of adverse reactions identified from post-marketing data with rosiglitazone
Il- frekwenza ta ’ reazzjonijiet mhux mixtieqa identifikati mit- tagħrif ta ’ wara t - tqegħid fis- suq tar- rosiglitazone
Adverse reaction
Reazzjoni mhux mixtieqa
Metabolism and nutrition disorders
Mard marbut mal- metaboliżmu u n- nutrizzjoni
rapid and excessive weight gain
żjieda mgħaġġla u eċċessiva fil- piż
Immune system disorders (see Skin and subcutaneous tissue disorders)
Mard tas- sistema immuni (ara mard tal- ġilda u tat- tessuti ta ’ taħt il- ġilda)
anaphylactic reaction
Reazzjoni anafilattika
rare
Rari ħafna
Eye disorders
Mard ta ’ l- għajnejn
macular oedema
edema makulari
Cardiac disorders
Mard tal- qalb
congestive heart failure/ pulmonary oedema
b’ waqfien tal- qalb konġestiva / edema pulmonari
Hepatobiliary disorders
Mard tal- fwied u tal- marrara
hepatic dysfunction, primarily evidenced by elevated hepatic enzymes5
Indeboliment tal- funzjoni tal- fwied, indikat primarjament minn għoli fl- enzimi tal- fwied 5
Skin and subcutaneous tissue disorders (see Immune system disorders) 5
Mard tal- ġilda u tat- tessuti ta ’ taħt il- ġilda (ara Mard tas- sistema immuni) 5
angioedema skin reactions (e. g. urticaria, pruritis, rash)
anġjodema reazzjonijiet fil- ġilda (eż. urtikarja, ħakk, raxx)
Rare cases of elevated liver enzymes and hepatocellular dysfunction have been reported.
Każi rari ta ’ enzimi tal- fwied għolja u funzjonament ħażin epatoċellulari kienu rappurtati.
In very rare cases a fatal outcome has been reported.
F’ każi rari ħafna kienu rappurtati riżultati ta ’ mewt
Clinical trial data and post-marketing data Table 3 presents adverse reactions by system organ class and by frequency category based on experience with glimepiride and other sulphonylureas.
Tagħrif minn provi kliniċi u tagħrif ta ’ wara t- tqegħid fis- suq F’ tabella 3 huma ppreżentati reazzjonijiet mhux mixtieqa b’ sistema ta ’ klassi ta ’ organu u skond il - kategorija ta ’ frekwenza bbażata fuq l- esperjenza b’ glimepiride u sulphonylureas oħra.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1000) and very rare (< 1/ 10,000 including isolated reports).
Il- frekwenzi huma definiti bħala: komuni ħafna (≥1/ 10), komuni (≥1/ 100, < 1/ 10), mhux komuni (≥1/ 1000, < 1/ 100), rari (≥1/ 10, 000, < 1/ 1000) u rari ħafna (< 1/ 10, 000 inclużi rapporti iżolati).
The frequency of glimepiride adverse reactions identified from clinical trial and post- marketing data
Il- frekwenza ta ’ reazzjonijiet mhux mixtieqa għal glimepiride identifikati mit- tagħrif minn provi kliniċi u tagħrif ta ’ wara t- tqegħid fis- suq
Blood and lymphatic system disorders
Mard tad- demm u tas- sistema limfatika
agranulocytosis granulocytopenia pancytopenia haemolytic anaemia thrombocytopenia leukopenia erythrocytopenia
agranuloċitożi granuloċitopenja panċitopenja anemija emolitika tromboċitopenja lewkopenja eritroċitopenja
Rare Rare Rare Rare Rare Rare Rare
Rari Rari Rari Rari Rari Rari Rari
Immune system disorders6 allergic vasculitis hypersensitivity reactions7
Mard tas- sistema immuni6 vaskulite allerġika reazzjonijiet ta ’ sensittivita` eċċessiva 7
hypoglycaemia8
ipogliċemija 8
Very common
Very common
Gastrointestinal disorders vomiting diarrhoea nausea abdominal distension abdominal pain abdominal discomfort
Mard gastro- intestinali remettar dijarreja dardir distensjoni addominali wġigħ addominali skonfort addominali
Very rare Very rare Very rare Very rare Very rare Very rare
Rari ħafna Rari ħafna Rari ħafna Rari ħafna Rari ħafna Rari ħafna
Hepatobiliary disorders9
Mard tal- fwied u tal- marrara9
hepatitis10 impairment of liver function (e. g. with cholestasis and jaundice)
Epatite10 indeboliment tal- funzjoni tal- fwied (e. g. b’ kolestasi u suffejra)
Skin and subcutaneous tissue disorders11 hypersensitivity of the skin to light
Mard tal- ġilda u tat- tessuti ta ’ taħt il- ġilda 11 sensittivita` eċċessiva fil- ġilda għad- dawl
serum sodium decrease 6
tnaqqis tas- sodju fis- serum 6
Cross-allergenicity with sulphonylureas, sulphonamides or related substances 7
7 Reazzjonijiet ħfief ta ’ sensittivita` eċċessiva jistgħu jiżviluppaw f’ reazzjonijiet serji b’ dispneja, tnaqqis fil- pressjoni tad- demm u kultant xokk.
8 Based on what is known of other sulphonylureas, hypoglycaemia may be prolonged.
8 Bażat fuq dak magħruf dwar sulphonylureas oħra, l- ipogliċemija tista ’ tieħu fit- tul.
Rarely hypoglycaemic reactions can occur immediately and may be severe and not always easy to correct.
Rarament reazzjonijiet ipogliċemiċi jistgħu jseħħu immedjatament u jistgħu ikunu qawwijin u mhux dejjem possibbli li jitreġġgħu lura.
9 Elevation of liver enzymes may occur.
9 Jista ’ jkun hemm żieda fl- enzimi tal- fwied.
11 11 Hypersensitivity reactions of the skin may occur as itching, rash and urticaria.
10 L- epatite tista ’ twassal għal waqfien tal- funzjoni tal- fwied 11 Jista ’ jkun hemm reazzjonijiet ta ’ sensittivita` eċċessiva fil- ġilda bħal ħakk, raxx u urtikarja.
Transient visual disturbances may occur especially on initiation of treatment, due to changes in blood glucose levels.
12 Disturbi viżwali li jgħaddu jistgħu jseħħu speċjalment fil- bidu tat- trattament, minħabba bidliet fil - livelli ta ’ glukosju fid- demm.
No data are available with regard to overdose of AVAGLIM.
M’ hawnx tagħrif disponibbli dwar it- teħid ta ’ doża eċċessiva ta ’ AVAGLIM.
Limited data are available with regard to overdose of rosiglitazone in humans.
Hawn tagħrif limitat dwar it- teħid ta ’ doża eċċessiva ta ’ rosiglitazone mill- bniedem.
In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
Fi studji kliniċi fuq voluntieri rosiglitazone ingħata f’ dożi singoli mill- ħalq ta ’ sa 20 mg u baqa ’ tollerat tajjeb.
Overdose of sulphonylureas, including glimepiride, can result in severe life-threatening hypoglycaemia lasting 12 to 72 hours, which may recur after apparent recovery.
Doża eċċessiva ta ’ sulphonylureas, inkluż glimepiride, jistgħu jwasslu għal ipogliċemija li tista ’ tkun fatali u li ddum minn 12 sa 72 siegħa, li tista tirrepeti ruħha wara li tkun għaddiet.
The symptoms may be delayed for up to 24 hours after ingestion.
Is- sintomi jistgħu idumu sa 24 siegħa wara li jkunu ttieħdu dawn il- mediċini.
Hospitalisation should be considered as appropriate.
L- isptar hu l- post indikat għal dawn il - każi.
In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated as dictated by the patient’ s clinical status.
Fil- każ ta ’ doża eċċessiva, hu rakkomandat li trattament xieraq ta ’ sapport għandu jinbeda kif jitlob l - istatus kliniku tal- pazjent.