qanastek/EMEA-V3 huggingface dataset:
Trevaclyn (2000 mg/ 40 mg) co-administered with simvastatin when compared with simvastatin alone or Trevaclyn (2000 mg/ 40 mg) alone for 12 weeks, significantly lowered LDL-C (-47.9%, -37.0%, -17.0% respectively), TG (-33.3%, -14.7%, -21.6% respectively), apo B
Trevaclyn 2, 000 mg/ 40 mg mogħti flimkien ma ’ simvastatin, meta mqabbel ma ’ simvastatin waħdu jew ma ’ Trevaclyn 2, 000 mg/ 40 mg waħdu għal 12- il ġimgħa, naqqas b’ mod sinjifikanti LDL- C (- 47. 9%, - 37. 0%, - 17. 0% rispettivament), TG (- 33. 3%, - 14. 7%, - 21. 6% rispettivament), apo B (- 41. 0%, - 28. 8%, - 17. 1% rispettivament), u TC (- 29. 6%, - 24. 9%, 9. 1% rispettivament), kif ukoll LDL- C: HDL- C (- 57. 1%, - 39. 8%, - 31. 2% rispettivament), non- HDL- C (- 45. 8%, - 33. 4%, - 18. 1% rispettivament), u TC: HDL - C (- 43. 0%, - 28, 0%, - 24. 9% rispettivament), u żied b’ mod sinjifikanti HDL- C (27. 5%, 6. 0%, 23. 4% rispettivament).
Further analysis showed Trevaclyn (2000 mg/ 40 mg) co-administered with simvastatin when compared with simvastatin alone significantly increased apo A-I (8.6%, 2.3% respectively) and significantly decreased Lp(a) (-19.8%, 0.0% respectively).
Analiżi addizzjonali wriet li Trevaclyn 2000 mg/ 40 mg mogħti fl- istess ħin ma ’ simvastatin meta mqabbel ma ’ simvastatin waħdu żied b’ mod sinifikanti l- apo A- I (8. 6%, 2. 3% rispettivament) u naqqas b’ mod sinifikanti l- Lp( a) (- 19. 8%, 0. 0% rispettivament).
Efficacy and safety of Trevaclyn in combination with simvastatin > 40 mg were not included in this study.
L- effikaċja u s - sigurtà ta ’ Trevaclyn f’ kombinazzjoni ma ’ simvastatin > 40 mg ma kinux inklużi f’ dan l- istudju.
Flushing In two large clinical trials measuring patient-reported flushing symptoms, patients taking Trevaclyn experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
10 Fwawar F’ żewġ provi kliniċi kbar li kejlu s- sintomi ta ’ fawra rrappurtati mill- pazjenti stess, il- pazjenti li ħadu Trevaclyn esperjenzaw anqas fawra minn dawk li ħadu l- aċidu nikotiniku (formulazzjonijiet li jerħu l - mediċina bil- mod).
In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Trevaclyn declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6).
Fil- pazjenti li komplew fl- ewwel studju (24 ġimgħa), il- frekwenza ta ’ fawra moderata jew akbar f’ pazjenti trattati bi Trevaclyn naqset jew avviċinat dik tal- pazjenti li rċevew plaċebo (ara Figura 1), filwaqt li fil- pazjenti trattati bl- aċidu nikotiniku (formulazzjoni li terħi l - mediċina bil- mod) il- frekwenza tal- fwawar baqgħet kostanti (wara Ġimgħa 6).
● Trevaclyn (1000 mg/ 20 mg to 2000 mg/ 40 mg at week 5) ▲ Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5) ○ Placebo *Includes patients with moderate, severe, or extreme flushing symptoms † Dose advancement at Week 5
●Trevaclyn (1, 000 mg/ 20 mg għal 2000 mg/ 40 mg f’ Ġimgħa 5) ▲Aċidu nikotiniku (rilaxx bil- mod 1000 mg għal 2000 mg f’ Ġimgħa 5) ○Plaċebo * Jinkludi pazjenti b’ sintomi moderati, severa, jew estremi ta ’ fawra † Avvanzament tad- doża f’ Ġimgħa 5
In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Trevaclyn experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2000 mg titration) (p < 0.001).
Fit- tieni studju (16- il ġimgħa) fejn kien permess l- aċidu aċetilsaliċiliku, il- pazjenti li ħadu Trevaclyn esperjenzaw ġranet konsiderevolment inqas fil- ġimgħa b’ fawra moderata jew akbar meta mqabbel ma ’ l- aċidu nikotiniku (formulazzjoni li terħi l- mediċina bil- mod meħuda bħala titrazzjoni multi- step ta ’ 500 mg għal 2000 mg fuq tnax- il ġimgħa) (p < 0. 001).
Characteristics in patients Renal insufficiency Trevaclyn:
Karatteristiċi fil- pazjenti Insuffiċjenza tal- kliewi Trevaclyn:
Hepatic insufficiency Trevaclyn:
Insuffiċjenza tal- fwied Trevaclyn:
There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Trevaclyn.
M’ hemmx differenza fil- bijodisponibilità orali ta ’ l- aċidu nikotiniku fl- irġiel u n- nisa li jirċievu Trevaclyn.
Paediatric Trevaclyn:
Pedjatriċi Trevaclyn:
Trevaclyn Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to human use.
Trevaclyn Fi studji li m’ humiex kliniċi, effetti dehru biss wara esponimenti meqjusa ferm aktar għolja mill - massimu ta ’ l- esponimenti fil- bnedmin, li juru ftit li xejn rilevanza ma ’ l- użu fil- bnedmin.
Pack sizes of 14, 28, 56; 168 modified-release tablets and 32 x 1modified-release tablets in a perforated unit dose blister.
Pakketti ta ’ 14, 28, 56, 168 pillola li terħi l- mediċina b’ mod modifikat u 32 x 1 pillola li terħi l- mediċina b’ mod modifikat f’ folja ta ’ doża waħda perforata.
Trevaclyn 1000 mg/ 20 mg modified-release tablets Nicotinic acid/ laropiprant
Trevaclyn 1, 000 mg/ 20 mg pilloli li jerħu l- mediċina b’ mod modifikat Aċidu nikotiniku/ laropiprant
14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1modified-release tablets
14- il pillola li terħi l- mediċina b’ mod modifikat 28 pillola li terħi l- mediċina b’ mod modifikat 56 pillola li terħi l- mediċina b’ mod modifikat 168 pillola li terħi l- mediċina b’ mod modifikat 32 x 1 pillola li terħi l- mediċina b’ mod modifikat
Do not store above 30°C.
21 Taħżinx f’ temperatura ’ l fuq minn 30°C.
EU/ 1/ 08/ 458/ 009 14 modified-release tablets EU/ 1/ 08/ 458/ 010 28 modified-release tablets EU/ 1/ 08/ 458/ 011 56 modified-release tablets EU/ 1/ 08/ 458/ 013 168 modified-release tablets EU/ 1/ 08/ 458/ 014 32 x 1modified-release tablets
EU/ 1/ 08/ 458/ 009 14- il pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 010 28 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 011 56 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 013 168 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 014 32 x 1 pillola li terħi l- mediċina b’ mod modifikat
EU/ 1/ 08/ 458/ 001 14 modified-release tablets EU/ 1/ 08/ 458/ 002 28 modified-release tablets EU/ 1/ 08/ 458/ 003 56 modified-release tablets EU/ 1/ 08/ 458/ 004 84 modified-release tablets EU/ 1/ 08/ 458/ 005 98 modified-release tablets EU/ 1/ 08/ 458/ 006 168 modified-release tablets EU/ 1/ 08/ 458/ 007 196 modified-release tablets EU/ 1/ 08/ 458/ 008 49 x 1 modified-release tablets EU/ 1/ 08/ 458/ 012 196 (2 packs of 98) modified-release tablets
EU/ 1/ 08/ 458/ 001 14- il pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 002 28 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 003 56 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 004 84 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 005 98 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 006 168 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 007 196 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 008 49 x1 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 458/ 012 196 (2 pakketti ta ’ 98) pillola li terħi l- mediċina b’ mod modifikat
Trevaclyn 1000 mg/ 20 mg modified-release tablets Nicotinic acid/ laropiprant
Trevacyln 1000 mg/ 20 mg pilloli li jerħu l- mediċina b’ mod modifikat Nicotinic acid/ laropiprant
Trevaclyn 1000 mg/ 20 mg modified-release tablets nicotinic acid/ laropiprant
Trevaclyn 1, 000 mg/ 20 mg pilloli li jerħu l- mediċina b’ mod modifikat aċidu nikotiniku/ laropiprant
What Trevaclyn is and what it is used for 2.
X’ inhu Trevaclyn u għaliex jintuża 2.
Before you take Trevaclyn 3.
Qabel ma tieħu Trevaclyn 3.
How to take Trevaclyn 4.
Kif għandek tieħu Trevaclyn 4.
How to store Trevaclyn 6.
Kif taħżen Trevaclyn 6.
WHAT TREVACLYN IS AND WHAT IT IS USED FOR
X’ INHU TREVACLYN U GĦALIEX JINTUŻA
The name of your medicine is Trevaclyn.
L- isem tal- mediċina tiegħek huwa Trevaclyn.
Trevaclyn is used in addition to diet • to lower your ‘ bad’ cholesterol level.
Trevaclyn jintuża mad- dieta: • biex ibaxxi l- livell tal- kolesterol ‘ ħażin ’ tiegħek.
Trevaclyn is used if you need to improve cholesterol and fat levels in your blood (primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia): • when you cannot control your cholesterol levels with a statin (class of cholesterol-lowering medicines working in the liver); • when you cannot tolerate a statin or when a statin is not recommended for you.
Trevaclyn jintuża jekk għandek bżonnittejjeb il- livelli tal- kolesterol u tax- xaħam fid- demm tiegħek (iperkolesterolemija primarja (eterozigota familjali u mhux familjali) jew dislipidemija mħallta): • meta ma tistax tikkontrolla l- livelli tal- kolesterol tiegħek bi statin (kategorija ta ’ mediċini li jbaxxu l- kolesterol li taħdem fil- fwied); • meta ma tistax tittollera statin jew meta statin ma jkunx rakkomandat għalik.
Trevaclyn can be used by itself or with other medicines to treat cholesterol problems.
Trevaclyn jista ’ jintuża waħdu jew ma ’ mediċini oħra li jittrattaw problemi tal- kolesterol.
BEFORE YOU TAKE TREVACLYN
QABEL MA TIEĦU Trevaclyn
Do not take Trevaclyn if • you are allergic (hypersensitive) to nicotinic acid, to laropiprant, or to any of the other ingredients of Trevaclyn (listed in section 6). • you currently have liver problems. • you have an ulcer in your stomach. • you have arterial bleeding.
Tiħux Trevaclyn • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- aċidu nikotiniku, għal laropiprant, jew għal xi sustanzi oħra ta ’ Trevaclyn (elenkati f’ sezzjoni 6). • jekk bħalissa għandek problemi bil- fwied. • jekk għandek ulċera fl- istonku tiegħek. • jekk għandek fsada arterjali.
Do not take Trevaclyn if any of the above apply to you.
Tiħux Trevaclyn jekk xi waħda minn dawn ta ’ hawn fuq tgħodd għalik.
If you are not sure, talk to your doctor or pharmacist before taking Trevaclyn.
Jekk m’ intix ċert, kellem lit - tabib jew lill- ispiżjar tiegħek qabel tieħu Trevaclyn.
Take special care with Trevaclyn Tell your doctor about all of your medical conditions.
Oqgħod attent ħafna bi Trevaclyn Għid lit- tabib tiegħek dwar il- kundizzjonijiet mediċi tiegħek kollha.
33 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Trevaclyn.
Jekk m’ intix ċert dwar jekk xi waħda minn dawn ta ’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu Trevaclyn.
Blood tests and monitoring • See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level. • Your doctor should do a blood test before you start taking Trevaclyn to check how well your liver is working. • Your doctor may also want you to periodically have blood tests after you start taking Trevaclyn, to check how well your liver is working and for other side effects.
Testijiet tad- demm u monitoraġġ • Ara lit- tabib tiegħek regolarment biex tiċċekkja l- livelli tal- kolesterol LDL (ħażin) u HDL (tajjeb) u l- livell tat- trigliċeridi tiegħek. • It- tabib tiegħek għandu jagħmillek test tad- demm qabel ma tibda tieħu Trevaclyn biex jiċċekkja
Children and adolescents Trevaclyn has not been studied in children and adolescents who are under 18 years of age.
Tfal u adoloxxenti Trevaclyn ma ġiex studjat fi tfal u adoloxxenti ta ’ taħt it- 18- il sena.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Trevaclyn.
Jekk m’ intix ċert dwar jekk xi waħda minn dawn ta ’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu Trevaclyn.
Taking Trevaclyn with food and drink • Take Trevaclyn with food. • To lower your chance of flushing, avoid drinking alcohol or hot drinks near the time you take your dose of Trevaclyn. • It is important to follow the advice given in section 3 How to take Trevaclyn.
Meta tieħu Trevaclyn ma ’ l- ikel u max- xorb • Ħu Trevaclyn ma ’ l- ikel. • Biex tbaxxi ċ- ċans tiegħek ta ’ fwawar, evita li tixrob alkoħol jew xorb jaħraq qrib il- ħin li tieħu d- doża tiegħek ta ’ Trevaclyn. • Huwa importanti li ssegwi l- parir mogħti f’ sezzjoni 3 Kif għandek tieħu Trevaclyn.
Pregnancy and breast-feeding Talk with your doctor before taking Trevaclyn if: • You are pregnant or plan to become pregnant.
Tqala u treddigħ Tkellem mat- tabib tiegħek qabel tieħu Trevaclyn jekk: • Inti tqila jew qiegħda tippjana biex tinqabad tqila.
It is not known if Trevaclyn will harm your unborn baby. • You are breast-feeding or plan to breast-feed.
Mhux magħruf jekk Trevaclyn jagħmilx ħsara lit- tarbija mhux imwielda tiegħek. • Qiegħda tredda ’ jew qiegħda tippjana li tredda ’.
It is not known if Trevaclyn will pass into your breast milk.
Mhux magħruf jekk Trevaclyn jgħaddix għal ġol- ħalib tas- sider tiegħek.
However, nicotinic acid a component of Trevaclyn does pass into breast milk.
Madankollu, l- aċidu nikotiniku, li huwa component ta ’ Trevaclyn, jgħaddi għal ġol- ħalib tas- sider.
Your doctor will decide if Trevaclyn is right for you.
It- tabib tiegħek jiddeċiedi jekk Trevaclyn hux tajjeb għalik.
34 Driving and using machines The effects of Trevaclyn on the ability to drive and use machines have not been studied.
Sewqan u tħaddim ta ’ magni L- effetti ta ’ Trevaclyn fuq il- ħila li ssuq u tħaddem magni għadu ma ġiex studjat.
However, some people get dizzy after taking Trevaclyn.
Madankollu, xi nies jistordu wara li jieħdu Trevaclyn.
If you get dizzy, you should avoid driving or operating machines after taking Trevaclyn.
Jekk tistordi, inti għandek tevita li ssuq jew tħaddem magni wara li tieħu Trevaclyn.
Important information about some of the ingredients of Trevaclyn Trevaclyn contains a sugar called lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Trevaclyn Trevaclyn fih tip ta ’ zokkor imsejjaħ lattożju.
HOW TO TAKE TREVACLYN
KIF GĦANDEK TIEĦU TREVACLYN
Always take Trevaclyn exactly as your doctor has told you.
Dejjem għandek tieħu Trevaclyn skond il- parir tat- tabib.
How to take • Take Trevaclyn once a day, in the evening or at bedtime. • Take Trevaclyn with food. • Swallow each tablet whole.
Kif għandek tieħdu • Ħu Trevaclyn darba kuljum, filgħaxija jew qabel torqod. • Ħu Trevaclyn ma ’ l- ikel. • Ibla ’ kull pillola sħiħa.
In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it. • Avoid drinking alcohol or hot drinks near the time you take your dose of Trevaclyn.
Sabiex il- mediċina tiegħek taħdem kif suppost, m’ għandekx taqsam, tkisser, tfarrak, jew tomgħod il- pillola qabel ma tiblagħha. • Evita li tixrob alkoħol jew xarbiet sħan qrib il- ħin meta għandek tieħu Trevaclyn.
This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back). • Taking aspirin before you take Trevaclyn does not reduce your flushing more than taking Trevaclyn alone.
Dan għandu jnaqqas iċ- ċans ta ’ fawra (fawra tal- ġilda, sensazzjoni ta ’ sħana, ħakk, jew tingiż, speċjalment f’ rasek, għonqok, sidrek u l- parti ta ’ fuq ta ’ dahrek). • It- teħid ta ’ aspirina qabel tieħu Trevaclyn ma jnaqqasx il- fwawar tiegħek aktar milli tieħu Trevaclyn waħdu.
If you take more Trevaclyn than you should • In the event of an overdose, the following adverse events were reported: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/ discomfort, and back pain. • If you take more than you should, talk to a doctor or pharmacist straight away.
Jekk tieħu Trevaclyn aktar milli suppost • Fil- każ ta ’ doża eċċessiva, ġew irrapportati l- episodji avversi li ġejjin: fwawar, uġigħ ta ’ ras, prurite (ħakk), dardir, sturdament, rimettar, dijarrea, uġigħ addominali/ skumdità u uġigħ fid- dahar. • Jekk tieħu aktar milli suppost, kellem tabib jew spiżjar immedjatament.
If you forget to take Trevaclyn • If you miss a dose, do not take an extra dose.
Jekk tinsa tieħu Trevaclyn • Jekk tinsa tieħu doża, tiħux doża żejda.
However, if you do not take Trevaclyn for 7 or more days in a row, talk to your doctor before restarting Trevaclyn.
Madankollu, jekk ma tiħux Trevaclyn għal sebat ijiem jew aktar konsekuttivi, kellem lit- tabib tiegħek qabel terġa ’ tibda Trevaclyn.
If you stop taking Trevaclyn Do not stop taking Trevaclyn without talking to your doctor.
Jekk tieqaf tieħu Trevaclyn Tiqafx tieħu Trevaclyn mingħajr ma tkellem lit- tabib tiegħek.
Like all medicines, Trevaclyn can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Trevaclyn jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects of Trevaclyn are:
L- effetti sekondarji ta ’ Trevaclyn huma:
Uncommon (affects less than 1 in 100 patients) In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Trevaclyn. • swelling of the face, lips, tongue, and/ or throat that may cause difficulty in breathing or swallowing (angioedema, which may require treatment right away) • fainting • shortness of breath • loss of control over urine and stool • cold sweats • shivering • chills • increased blood pressure • swelling of the lips • burning sensation • whole body rash • joint pain • swelling of the legs • rapid heart rate.
• nefħa fil- wiċċ, xufftejn, ilsien, u/ jew gerżuma li tista ’ tikkawża diffikultà fit- teħid tan- nifs jew biex tibla ’ (anġjoedema, li jista ’ jkollha bżonn trattament mill- ewwel) • ħass ħażin • qtugħ ta ’ nifs • telf tal- kontroll fuq l- awrina u l- ippurgar • għaraq kiesaħ • rogħda • kesħa • pressjoni tad- demm aktar għolja • nefħa fix- xufftejn • sensazzjoni ta ’ ħruq • raxx mal- ġisem kollu • uġigħ fil- ġogi • nefħa fis- saqajn • taħbita tal- qalb mgħaġġla
HOW TO STORE TREVACLYN
KIF TAĦŻEN TREVACLYN
Do not use Trevaclyn after the expiry date (EXP) which is stated on the carton and the blister.
Tużax Trevaclyn wara d- data ta ’ skadenza (JIS) li tidher fuq il- kartuna u l- folja.
What Trevaclyn contains • The active substances are nicotinic acid and laropiprant.
X’ fih Trevaclyn • Is- sustanzi attivi huma l- aċidu nikotiniku u laropiprant.
What Trevaclyn looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “ 552” debossed on one side.
33 Id- dehra ta ’ Trevaclyn u l- kontenuti tal- pakkett Kull pillola li terħi l- mediċina b’ mod modifikat hija pillola bajda għal offwajt, forma ta ’ kapsula, li għandha “ 552 ” ibbuzzat fuq naħa waħda.
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail@merck. com
Danmark Merck Sharp & Dohme Tlf: +45 43 28 77 66 dkmail @ msd. dk
TRISENOX 1 mg/ ml, concentrate for solution for infusion
TRISENOX 1 mg/ ml, konċentrat għal solużjoni għall- infużjoni
One ml of TRISENOX contains 1 mg of Arsenic trioxide
1 ml ta ’ TRISENOX fih 1 mg ta ’ Arsenic trioxide
For a full list of excipients, see section 6.1
Għall- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1
Concentrate for solution for infusion Sterile, clear, colourless, aqueous solution.
Konċentrat għal soluzzjoni għall- infużjoni Soluzzjoni sterili, ċara, bla kulur, milwima.
TRISENOX is indicated for induction of remission and consolidation in adult patients with relapsed/ refractory acute promyelocytic leukaemia (APL), characterised by the presence of the t(15; 17) translocation and/ or the presence of the Pro-Myelocytic Leukaemia/ Retinoic-Acid-Receptor- alpha (PML/ RAR-alpha) gene.
TRISENOX hu indikat għall- induzzjoni tar- remissjoni u l- konsolidazzjoni f’ pazjent adulti li jbatu minn lewkimja promijeloċitika li tirkadi/ refrattarja (APL), karatterizata mill- preżenza tat - translokazzjoni t( 15; 17) u/ jew il- preżenza tal- ġene ta ’ Lewkimja Pro- Mijeloċitika/ alfa Riċettur- Aċidu - Retinojku( PML/ RAR- alfa).
Previous treatment should have included a retinoid and chemotherapy.
It- trattament li ngħata qabel messu nkluda r- retinojdi u l- kemoterapija.
The response rate of other acute myelogenous leukaemia subtypes to TRISENOX has not been examined.
Ir- rata tar- rispons tas- sottotipi oħra tal- lewkimja mijeloġenuża akuta għal TRISENOX ma ġietx eżaminata.
TRISENOX must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in Section 4.4 must be followed.
TRISENOX irid jingħata taħt is- supervisjoni ta ’ tabib li għandu esperjenza fl- immaniġġjar tal - lewkimji akuti, u proċeduri speċjali tal- monitoraġġ li ġew deskritti f' Sezzjoni 4. 4 iridu jkunu osservati.
The same dose is recommended for children, adults, and elderly.
Hu rrakkomandat li tingħata l- istess doża lit- tfal, adulti, u anzjani.
Induction treatment schedule:
L- iskeda tat- trattament ta 'l- induzzjoni:
TRISENOX must be administered intravenously at a fixed dose of 0.15 mg/ kg/ day given daily until the bone marrow remission is achieved (less than 5% blasts present in cellular bone marrow with no evidence of leukaemic cells).
TRISENOX irid jingħata ġol- vina f’ doża fissa ta ’ 0. 15 mg/ kg/ kuljum mogħtija kuljum sakemm isseħħ ir- remissjoni tal- mudullun tal- għadma (inqas minn 5% ta ’ ċelluli primittivi preżenti fil- mudullun ċellulari ta ’ l- għadma bl- ebda xhieda ta ’ ċelluli lewkimatiċi).
If bone marrow remission has not occurred by day 50, dosing must be discontinued.
Jekk ma jkun hemm l- ebda remissjoni tal- mudullun ta ’ l- għadma sal- jum 50, id- dożaġġ għandu jitwaqqaf.
Consolidation schedule:
Skeda ta ’ konsolidazzjoni:
Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy.
It- trattament ta ’ konsolidazzjoni irid jibda mit- 3 sar- 4 ġimgħa wara t - tmiem tat- terapija ta 'l- induzzjoni.
TRISENOX is to be administered intravenously at a dose of 0.15 mg/ kg/ day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks.
TRISENOX għandu jingħata ġol- vina b’ doża ta ’ 0. 15 mg/ kg/ kuljum għal 25 doża mogħtija matul 5 ġranet kull ġimgħa, segwiti minn waqfien ta ’ 2 ġranet, u ripetuti għal 5 ġimgħat.
The experience in children is limited.
L- esperjenza dwar l- użu fit- tfal hija limitata.
Of 7 patients under 18 years of age (range 5 to 16 years) treated with TRISENOX at the recommended dose of 0.15 mg/ kg/ day, 5 patients achieved a complete response.
Minn 7 pazjenti taħt it- 18- il sena (minn 5 sa 16- il sena) li kienu kkurati b’ TRISENOX b’ doża rrakkomandata ta ’ 0. 15 mg/ kg/ kuljum, 5 pazjenti kellhom rispons komplet.
Safety and effectiveness in paediatric patients under 5 years of age have not been studied.
Is- sigurtà u l- effettività f’ pazjenti pedjatriċi taħt il- 5 snin ma ġewx studjati.
Patients with hepatic and/ or renal impairment:
Pazjenti b’ indeboliment epatiku u/ jew renali:
Since limited data are available across all hepatic impairment groups and across all renal impairment groups, caution is advised in the use of TRISENOX in patients with hepatic and/ or renal impairment.
Peress li tagħrif limitat biss huwa disponibbli tul il- gruppi kollha ta ’ indeboliment epatiku u tul il - gruppi kollha ta ’ indeboliment renali, attenzjoni hija rrakkomandata fl- użu ta ’ TRISENOX f’ pazjenti b’ indeboliment epatiku u/ jew renali.
Method of administration 2 TRISENOX must be administered intravenously over 1-2 hours.
2 Kif għandu jingħata:
The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
Il- perijodu ta ’ infużjoni għandu mnejn jittawwal sa 4 sigħat jekk ir- reazzjonijiet vażomotoriċi ikunu osservati.
A central venous catheter is not required.
M’ hemmx bżonn ta ’ kateter fil- vina ċentrali.
Patients must be hospitalised at the beginning of treatment due to symptoms of disease and to ensure adequate monitoring.
Il- pazjenti jridu jinżammu l- isptar fil- bidu tat- trattament minħabba s- sintomi tal - marda u biex niżguraw li jkun hemm monitoraġġ adekwat.
Clinically unstable APL patients are especially at risk and will require more frequent monitoring of electrolyte and glycaemia levels as well as more frequent haematologic, hepatic, renal and coagulation parameter tests.
Pazjenti APL li mhux klinikalment stabbli huma aktar u aktar fir- riskju u ser ikollhom bżonn ta ’ monitoraġġ ta ’ spiss tal- livelli ta ’ elektroliti u tal- gliċemija u testijiet ta ’ spiss tal- paremetri ematoloġiċi, epatiċi, renali u ta ’ koagulazzjoni.
Leukocyte Activation Syndrome (APL Differentiation Syndrome):
Sindrom ta ’ Attivazzjoni tal- Lewkoċiti (APL Sindrom tad- Differentjazzjoni):
Twenty-five percent of patients with APL treated with TRISENOX have experienced symptoms similar to a syndrome called the retinoic-acid-acute promyelocytic leukaemia (RA-APL) or APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis.
Ħamsa u għoxrin fil - mija tal- pazjenti APL li kienu kkurati b’ TRISENOX kellhom sintomi simili għas- sindrom magħruf bħala lewkimja promijeloċitika akuta- aċida- retinojka (RA- APL) jew sindrom ta ’ differentjazzjoni ta ’ APL, kkaraterizzat minn deni, qtugħ ta 'nifs, żjieda fil- piż, infiltrati pulmonari u effużjonijiet plewrali jew perikardjali, ma ’ jew mingħajr il- lewkoċiti.
This syndrome can be fatal.
Dan is- sindrom jista 'jkun fatali.
The management of the syndrome has not been fully studied, but high-dose steroids have been used at the first suspicion of the APL differentiation syndrome and appear to mitigate signs and symptoms.
L- immaniġġjar tas - sindrom ma ġiex studjat għal kollox, imma sterojdi f' dożi għoljin ġew użati hekk kif kien hemm l - ewwel suspett tas- sindrom ta ’ differentjazzjoni ta ’ APL u jidher li jtaffu s– sinjali u s- sintomi.
At the first signs that could suggest the syndrome (unexplained fever, dyspnoea and/ or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously twice a day) must be immediately initiated, irrespective of the leukocyte count and continued for at least 3 days or longer until signs and symptoms have abated.
Malli jidhru l- ewwel sinjali li jistgħu jissuġġerixxu s- sindrom (deni, qtugħ ta 'nifs u/ jew żjieda fil- piż, każi awskultatori abnormali fis- sider jew abnormalitajiet radjugrafiċi mingħajr spjegazzjoni) għandhom jingħataw minnufih dożi għoljin ta ’ sterojdi (10 mg ta ’ dexamethasone ġol- vina darbtejn kuljum) hu x’ inhu l- kownt tal- lewkoċiti u jitkomplew sa ta ’ l- anqas 3 ijiem jew aktar sakemm is- sinjali u sintomi jonqsu.
The majority of patients do not require termination of TRISENOX therapy during treatment of the APL differentiation syndrome.
Il- biċċa l- kbira tal- pazjenti ma jinħtiġux waqfien tat- terapija b’ TRISENOX matul it- trattament tas- sindrom ta ’ differentjazzjoni ta ’ APL.
It is recommended that chemotherapy not be added to treatment with steroids since there is no experience with administration of both steroids and chemotherapy during treatment of the leukocyte activation syndrome due to TRISENOX.
Hu rrakkomandat li l- kimoterapija ma ’ tingħatax ukoll flimkien mat- trattament bl- isterojdi għax m' hemmx esperjenza dwar l- għoti taż- żewġ sterojdi u l - kimoterapija matul it- trattament tas- sindrom ta ’ attivazzjoni tal- lewkoċiti minħabba TRISENOX.
Post-marketing experience suggests that a similar syndrome may occur in patients with other types of malignancy.
L - esperjenza wara tqegħid fis- suq tissuġġerixxi li sindrom simili għandu mnejn iseħħ f’ pazjenti b’ tipi oħra ta ’ malinnjetà.
Monitoring and management for these patients should be as described above.
Il- monitoraġġ u l- immaniġġjar ta ’ dawn il- pazjenti għandu jsir kif inhu deskritt hawn fuq.
Electrocardiogram (ECG) Abnormalities:
Abnormalitajiet Elektrokardjogrammi (ECG):
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block.
L- Arsenic trioxide jista ’ jikkawża prolongazzjoni ta ’ l - intervall QT u l- imblokkar komplet atrijoventrikulari.
QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Il- prolongazzjoni tal- QT jista ’ jwassal għal arritmija ventrikulari tat- tip- torsade de pointes li tista ’ tkun fatali.
Previous treatment with anthracyclines may increase the risk of QT prolongation.
It- trattament li ngħata qabel permezz ta 'l- antraċiklini għandu mnejn jżied ir- riskju tal- prolongazzjoni QT.
The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products (such as class Ia and III antiarrythmics (e. g. quinidine, amiodarone, sotalol, dofetilide), antipsychotics (e. g. thioridazine), antidepressants (e. g. amitriptyline), some macrolides (e. g. erythromycin), some antihistamines (e. g. terfenadine and astemizole), some quinolone antibiotics (e. g. sparfloxacin), and other individual drugs known to increase QT interval (e. g. cisapride)), a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, amphotericin B or other conditions that result in hypokalemia or hypomagnesaemia.
Ir- riskju tat- torsade de pointes hu marbut ma ’ kemm tkun il- prolongazzjoni QT, l- għoti konkomitanti tal- prodotti mediċinali li jipprolungaw il- QT (bħal ngħidu aħna antjarrimiċi tal- klassi Ia u III (eż. quinidine, amiodarone, sotalol, dofetilide), antipsikotiċi (eż. thioridazine), antidipressanti (eż. amitriptyline), xi macrolides (eż. erythromycin), xi antistamini (eż. terfenadine u astemizole), xi antibijotiċi quinolone (eż. sparfloxacin), u mediċini individwali oħra li huma magħrufa li jżidu l- intervall QT (eż. cisapride), passat ta ’ torsade de pointes, prolongazzjoni pre- eżistenti ta ’ l- intervall QT, insuffiċjenza tal- qalb konġestiva, l- għoti ta ’ djuretiċi li jnaqqsu l- potassju, amphotericin B jew kondizzjonijiet oħra li jikkaġunaw ipokalimja jew ipomagnesemija.
In clinical trials, 40% of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec.
Fi studji kliniċi, 40% tal- pazjenti li kienu kkurati bit - TRISENOX esperjenzaw ta ’ l- anqas prolangazzjoni ta ’ l- intervall QT kkorreġut (QTc) ta ’ aktar minn 500 msec.
Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned to baseline by the end of 8 weeks after TRISENOX infusion.
Il- prolongazzoni tal- QTc kien osservat bejn 1- ewwel u l- 5 ġimgħa wara l- infużjoni ta ’ TRISENOX, u mbagħad mar lura għall- linja bażi sa tmiem it- 8 ġimgħa wara l- infużjoni ta ’ TRISENOX.
One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.
Pazjent (li rċieva prodotti mediċinali multipliċi, konkomitanti, inklużi amphotericin B) kellu torsade de pointes asimptomatiku matul it- terapija ta ’ l- induzzjoni għall- APL rikadut bl- arsenic trioxide.
ECG and Electrolyte Monitoring Recommendations:
3 Rakkomandazzjonijiet dwar il- Monitoraġġ ta ’ l- ECG u ta ’ l- Elektrolit:
Prior to initiating therapy with TRISENOX, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; preexisting electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Qabel ma tibda tingħata t - terapija b’ TRISENOX, irid isir 12- lead ECG u l- elektroliti fis- serum (potassium, calcium, u magnesium) u l- kreatinina jridu jkunu assessjati, abnormalitajiet ta ’ elektroliti li diġà kienu jeżistu jridu jkunu kkorreġuti u, jekk hu possibbli, prodotti mediċinali li huma magħrufa li jtawlu l- intervall QT iridu jitwaqqfu.
Patients with risk factors of QTc prolongation or risk factors of torsade de pointes should be monitored with continuous cardiac monitoring (ECG).
Pazjenti li għandhom fatturi ta 'riskju ta' prolongazzjoni QTc jew fatturi ta 'riskju ta' torsade de pointes iridu jkunu monitorjati b’ monitoraġġ kontinwu kardijaku (ECG).
For QTc greater than 500 msec, corrective measures must be completed
Fil- każ ta ’ QTc akbar minn 500 msec, il- miżuri korrettivi jridu jintemmu u l- QTc jerġa ’ jkun assessjat b’ ECG serjali qabel ma wieħed jara jekk għandux jintuża TRISENOX.
During therapy with TRISENOX, potassium concentrations must be kept above 4 mEq/ l and magnesium concentrations must be kept above 1.8 mg/ dl.
Matul it- terapija b’ TRISENOX il - konċentrazzjonijiet tal- potassju jridu jinżammu ogħla minn 4 mEq/ l u l- konċentrazzjonijiet tal - magnesium iridu jinżammu ogħla minn 1. 8 mg/ dl.
Patients who reach an absolute QT interval value > 500 msec must be reassessed and immediate action must be taken to correct concomitant risk factors, if any, while the risk/ benefit of continuing versus suspending TRISENOX therapy must be considered.
Pazjenti li jilħqu l- valur assolut ta ’ l- intervall QT > 500 msec jridu jerġgħu jiġu assessjati u għandha tittieħed minnufih azzjoni biex il- fatturi konkomitanti tar- riskju ikunu kkoreġuti, jekk hemm, waqt lir- riskju/ benefiċċju tal- kontinwazzjoni kontra s- sospensjoni tat- terapija b’ TRISENOX għandu jkun meqjus.
If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, TRISENOX therapy must be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease.
Jekk sinkopu, il- qalb tibda tħabbat mgħaġġel jew b' mod irregulari, il- pazjent għandu jintbagħat l- isptar u jkun monitorjat il- ħin kollu, l- elektroliti fis- serum għandhom ikunu assessjati, it- terapija b’ TRISENOX għandha titwaqqaf temporanjament sakemm l- intervall QTc jerġa ’ jinżel taħt il- 460 msec, l- abnormalitjiet elektrolitiċi ikun ikkoreġuti, u s- sinkopu u t- taħbit irregolari tal- qalb jieqfu.
There are no data on the effect of TRISENOX on the QTc interval during the infusion.
M’ hemm l- ebda tagħrif dwar l- effett ta ’ TRISENOX fuq l- intervall QTc matul l- infużjoni.
Electrocardiograms must be obtained twice weekly, and more frequently for clinically unstable patients, during induction and consolidation.
Għandhom jittieħdu elektrocardjogrammi darbtejn fil- ġimgħa, u aktar ta 'spiss għall- pazjenti li mhumiex klinikalment stabbli, matul l- induzzjoni u l- konsolidazzjoni.
Dose Modification:
Modifakazzjoni tad- Dożaġġ:
Treatment with TRISENOX must be interrupted, adjusted, or discontinued before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria, Version 2 is observed and judged to be possibly related to TRISENOX treatment.
It- trattament b’ TRISENOX għandu jkun interrott, aġġustat, jew ma jitkomplix qabel it- tmiem skedat tat- terapija f' kwalunkwe ħin meta t- tossiċità grad 3 jew ogħla skond il- Kriterji tat- Tossiċità Komuni ta ’ l- Istitut Nazzjonali tal- Kanċer Verżjoni 2 tkun innotata u ġġudikata li hi probabbli marbuta mat- trattament b’ TRISENOX.
Patients who experience such reactions that are considered TRISENOX related must resume treatment only after resolution of the toxic event or after recovery to baseline status of the abnormality that prompted the interruption.
Pazjenti li ħassew dawn ir- reazzjonijiet li huma meqjusa li huma marbuta ma ’ TRISENOX iridu jerġgħu jibdew it- trattament wara r- riżoluzzjoni ta ’ l- episodju tossiku jew wara li jmur lura għall- istatus tal- linja bażi ta ’ l- abnormalità li wasslet għall - interruzzjoni biss u mhux qabel.
In such cases, treatment must resume at 50% of the preceding daily dose.
F' dawn il- każi, it- trattament irid jerġa 'jibda f' 50% tad- doża preċedenti ta' kuljum.
If the toxic event does not recur within 3 days of restarting treatment at the reduced dose, the daily dose can be escalated back to 100% of the original dose.
Jekk l- episodju tossiku ma jerġax jiġri fi żmien 3 ijiem minn meta jerġa ’ jibda t - trattament bir- rata ridotta, id- doża ta ’ kuljum tista 'terġa ’ tiżdied għall- 100% tad- doża oriġinali.
Patients who experience a recurrence of toxicity must be removed from treatment.
Pazjenti m' għandhomx jingħataw aktar trattament jekk jesperjenzaw rikorrenza tat- tossiċità.
Laboratory tests:
Testijiet fil- laboratorju:
The patient ’ s electrolyte and glycaemia levels, as well as haematologic, hepatic, renal and coagulation parameter tests must be monitored at least twice weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly during the consolidation phase.
Il- livelli ta ’ elektroliti u tal- gliċemija tal- pazjent, flimkien mat- testijiet tal - parametri ematoloġiċi, epatiċi, renali u tal- koagulazzjoni jridu jkunu monitorjati ta ’ l- anqas darbtejn fil- ġimgħa, u aktar ta ’ spiss fil- każ ta ’ pazjenti li klinikalment mhumiex stabbli matul il- fażi ta ’ induzzjoni u ta ’ l- anqas darba fil- ġimgħa matul il- fażi ta ’ konsolidazzjoni.
Since limited data are available across all renal impairment groups, caution is advised in the use of TRISENOX in patients with renal impairment.
Peress li tagħrif limitat biss huwa disponibbli tul il- gruppi kollha ta ’ indeboliment renali, attenzjoni hija rrakkomandata fl- użu ta ’ TRISENOX f’ pazjenti b’ indeboliment renali.
The experience in patients with severe renal impairment is insufficient to determine if dose adjustment is required.
L- esperjenza f’ pazjenti b’ indeboliment renali sever mhux suffiċjenti biex jiġi determinat jekk hux meħtieġ aġġustament fid- doża.
The use of TRISENOX in patients on dialysis has not been studied.
L- użu ta ’ TRISENOX f’ pazjenti fuq id- dijalisi ma ġiex studjat.
Since limited data are available across all hepatic impairment groups, caution is advised in the use of TRISENOX in patients with hepatic impairment.
Peress li tagħrif limitat biss huwa disponibbli tul il- gruppi kollha ta ’ indeboliment epatiku, attenzjoni hija rrakkomandata fl- użu ta ’ TRISENOX f’ pazjenti b’ indeboliment epatiku.
The experience in patients with severe hepatic impairment is insufficient to determine if dose adjustment is required..
L- esperjenza f’ pazjenti b’ indeboliment epatiku sever mhux suffiċjenti biex jiġi determinat jekk hux meħtieġ aġġustament fid - doża.
There is limited clinical data on the use of TRISENOX in the elderly population.
Hemm tagħrif kliniku limitat dwar l- użu ta ’ TRISENOX fil- każ ta ’ pazjenti anzjani.
Caution is needed in these patients.
Attenzjoni hija meħtieġa f’ dawn il- pazjenti.
Hyperleukocytosis:
Iperlewkoċitożi:
Treatment with TRISENOX has been associated with the development of hyperleukocytosis (≥ 10 x 103/μ l) in some patients.
It- trattament b’ TRISENOX kien assoċjat ma ’ l- iżvilupp ta ’ iperlewkoċitożi (≥ 10 x 103/ μl) f’ xi pazjenti.
There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleukocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts.
Ma jidhirx li kien hemm rabta bejn il- kownts tal- linjabażi taċ- ċelluli bojod fid- demm (WBC) u l- iżvilupp ta 'iperlewkoċitożi u l- anqas ma jidher li kien hemm korrelazzjoni bejn il- kownt tal- linjabażi tal- WBC u l- ogħla kownts tal- WBC.
Hyperleukocytosis was never treated with additional chemotherapy and resolved on continuation of TRISENOX.
Il- kownts
WBC counts during consolidation were not as high as during induction treatment and were < 10 x 103/μ l, except in one patient who had a WBC count of 22 x 103/ μ l during consolidation.
4 tal- WBC matul il- konsolidazzjoni ma kinux għoljin daqshekk matul it- trattament ta 'l- induzzjoni u kienu < 10 x 103/ μl, barra fil- każ ta ’ pazjent wieħed li kellu kownt ta' WBC ta '22 x 103/ μl matul il - konsolidazzjoni.
Twenty patients (50%) experienced leukocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leukopheresis was not required.
Għoxrin pazjent (50%) esperjenzaw lewkoċitożi; imma, fil- każ ta ’ dawn il- pazjenti kollha, il- kownts WBC kienu qed jonqsu jew kienu reġgħu saru normali sa meta r- remissjoni tal - mudullun ta 'l- għadma u l- kemoterapija ċitotossika jew il- lewkofereżi ma kinux meħtieġa aktar.
No formal assessments of pharmacokinetic interactions between TRISENOX and other therapeutic medicinal products have been conducted.
Ma saru l- ebda assessjamenti formali ta ’ interazzjonijiet ta ’ farmakokinetiċi bejn TRISENOX u prodotti mediċinali terapewtiċi oħra.
QT/ QTc prolongation is expected during treatment with TRISENOX, and torsade de pointes and complete heart block have been reported.
Il- prolongazzjoni QT/ QTc hi mistennija matul it- trattament b’ TRISENOX u ġew rrapportati torsade de pointes u imblokkar komplet tal- qalb.
Patients who are receiving, or who have received, medicinal products known to cause hypokalemia or hypomagnesaemia, such as diuretics or amphotericin B, may be at higher risk for torsade de pointes.
Pazjenti li qed jingħataw, jew li diġà ngħataw, prodotti mediċinali magħrufa li jikkawżaw ipokalemija jew ipomagnesemija, bħal ngħidu aħna djuretiċi jew amphotericin B, għandhom mnejn ikollhom riskju ogħla ta ’ torsade de pointes.
Caution is advised when TRISENOX is coadministered with other medicinal products known to cause QT/ QTc interval prolongation such as macrolide antibiotics, the antipsychotic thioridazine, or medicinal products known to cause hypokalemia or hypomagnesaemia.
Wieħed irid joqgħod attent meta TRISENOX jingħata flimkien ma 'prodotti mediċinali oħra li huma magħrufa li jikkawżaw prolongazzjoni ta ’ l- intervall Qt/ QTc bħal ngħidu aħna antibijotiċi makrolidi, l- antipsychotic thioridazine, jew prodotti mediċinali magħrufa li jikkawżaw ipokalemija jew ipomagnesemija.
Additional information about QT prolonging medicinal agents, is provided in Section 4.4.
Tagħrif ieħor dwar l- aġenti mediċinali li jipprolungaw il - QT, jinsab f' Sezzjoni 4. 4.
The influence of TRISENOX on the efficacy of other antileukaemic medicinal products is unknown.
L- influwenza ta ’ TRISENOX fuq l- effikaċja ta ’ prodotti mediċinali oħra antilewkemiċi mhix magħrufa.
Arsenic trioxide has been shown to be embryotoxic and teratogenic in animal studies (see 5.3).
Hemm tagħrif li juri li l- arsenic trioxide hu embrijutossiku u teratoġeniku fi studju fuq bhejjem (ara 5. 3).
There are no studies in pregnant women using TRISENOX.
M’ hemmx studji fuq nisa tqal li jużaw TRISENOX.
If this medicinal product is used during pregnancy or if the patient becomes pregnant while taking this product, the patient must be informed of the potential harm to the foetus.
Jekk dan il- prodott mediċinali jintuża matul it- tqala jekk jekk il- pazjenta ssir tqila waqt li tkun qed tieħu dan il- prodott, il- pazjent għandu jiġi nfurmat dwar il- ħsara potenzjali għall- fetu.
Men, and women of childbearing potential must use effective contraception during treatment with TRISENOX.
Irġiel, u nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettivi li huma effettivi waqt it- trattament b’ TRISENOX.
Arsenic is excreted in human milk.
Arsenic joħroġ ġol- ħalib uman.
Because of the potential for serious adverse reactions in nursing infants from TRISENOX, breastfeeding must be discontinued prior to and throughout administration.
Peress li hemm potenzjal ta ’ reazzjonijiet mhux mixtieqa serji fi tfal li qed jieħdu ż- żejża kaġun ta 'TRISENOX, it- treddigħ għandu jitwaqqaf qabel u matul l- għoti.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem il- magni.
Related adverse reactions of CTC grade 3 and 4 occurred in 37% of patients in clinical trials.
Effetti mhux mixtieqa relattati ta ’ Grad 3 u 4 CTC seħħu fi 37% tal- pazjenti fi studji kliniċi.
The most commonly reported reactions were hyperglycaemia, hypokalaemia, neutropenia, and increased alanine amino transferase (ALT).
L- aktar reazzjonijiet komuni li ġew irrapportati kienu ipergliċemija, ipokalemija, newtropenija, u żjieda fl - alanine amino transferase (ALT).
Leukocytosis occurred in 50% of patients with APL, as determined by haematology assessments, rather than adverse event reports.
50% tal- pazjenti bil- APL kellhom il- lewkoċitożi, kif kien determinat minn assessjamenti ematoloġiċi, u mhux minn rapporti ta ’ episodji avversi.
Serious adverse reactions were common (1-10%) and not unexpected in this population.
Reazzjonijiet serji avversi kienu komuni (1- 10%) u kienu mistennija f’ din il- popolazzjoni.
Those serious adverse reactions attributed to TRISENOX included APL differentiation syndrome (3), leukocytosis (3), prolonged QT interval (4, 1 with torsade de pointes), atrial fibrillation/ atrial flutter (1), hyperglycaemia (2) and a variety of serious adverse reactions related to haemorrhage, infections, pain, diarrhoea, nausea.
Dawk ir - reazzjonijiet avversi serji attribwiti għal TRISENOX jinkludu sindrom ta ’ differentjazzjoni ta ’ APL (3), lewkoċitożi (3), intervall QT prolongat (4, 1 b’ torsade de pointes), pulsazzjoni veloċi atrijali fibrillazzjoni/ atrijali (1), ipergliċemija (2) u varjetà ta ’ reazzjonijiet avversi serji marbutin ma ’ emorraġija, infezzjonijiet, uġigħ, dijarea, tqallih.
In general, treatment-emergent adverse events tended to decrease over time, perhaps accounted for by amelioration of the underlying disease process.
Fi kliem ieħor, l- episodji avversi li jirriżultaw mit- trattament normalment jonqsu fuq perijodu ta 'żmien, forsi kawża tat- titjib tal- proċess fondamentali tal- marda.
Patients tended to tolerate consolidation and maintenance treatment with less toxicity than in induction.
Il- pazjenti kellhom it- tendenza li jittoleraw trattament ta ’ konsolidazzjoni u ta ’ manteniment b’ inqas tossiċità mill- induzzjoni.
This is probably due to the confounding of adverse events by the uncontrolled disease process early on in the treatment course and the myriad concomitant medicinal products required to control symptoms and morbidity.
Dan probabbilment hu frott tal- fatt li hu diffiċli tissepara l– episodji avversi wieħed mill- ieħor bil- proċess mhux ikkontrollat tal- marda kmieni matul il- kors tat- trattament u l- ħafna prodotti mediċinali konkomitanti li huma meħtieġa biex jiġu kkontrollati is- sintomi u l- morbidità.
The table below lists the related grade 3 and 4 adverse drug reactions for the 107 patients treated with TRISENOX in clinical trials (frequencies defined as: common ≥ 1/ 100 to < 1/ 10, uncommon ≥ 1/ 1,000 to < 1/ 100).
5 It- tabella t’ hawn taħt telenka r- reazzjonijiet avversi tal- mediċina grad 3 u 4 għal 107 pazjent kkurati b’ TRISENOX fi studji kliniċi (frekwenzi definiti bħala: komuni ≥1/ 100 sa < 1/ 10, mhux komuni ≥ 1/ 1, 000 sa < 1/ 100).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Fi ħdan kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma ppreżentati f’ ordni fejn dawk li huma inqas serji jidhru l- ewwel.
Blood and lymphatic system Neutropenia disorders Thrombocytopenia
Disturbi tad- demm u tas- sistema Newtropenja limfatika Tromboċitopenja
Febrile neutropenia Leucocytosis Leucopenia
Newtropenja febrili Lewkoċitożi Lewkopenja
System Organ Class Common disorders Hypokalaemia Nervous system disorders Paraesthesia
Disturbi fil- metaboliżmu u n - Ipergliċemija nutrizzjoni Ipokalemija Disturbi fis- sistema nervuża Paresteżija
Uncommon Hypernatraemia Ketoacidosis
Ipermagnesemija Ipernatremija Ketoaċidożi
Pericardial effusion Tachycardia
Effużjoni perikardjali Takikardija
Vascular disorders Respiratory, thoracic and Pleuritic pain mediastinal disorders Dyspnoea
Dispneja
Vasculitis Pulmonary alveolar haemorrhage Pleural effusion Hypoxia
Vaskulite Emorraġija alveolari pulmunari Effużjoni Plewrali Ipossija
Gastrointestinal disorders Skin and subcutaneous tissue disorders Musculoskeletal and Bone pain connective tissue disorders Arthralgia
Disturbi gastro- intestinali Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Disturbi muskolu- skeltrali u tal - Uġigħ fl- għadam Artralġja connective tissue
Diarrhoea Pruritus Erythema Myalgia
Dijarea Ħakk Eritema Mijalġja
Investigations ECG QT prolonged ALT increased
Disturbi ġenerali u Deni kondizzjonijiet ta ’ mnejn jingħata Għeja Investigazzjonijiet ECG QT prolongat ALT ogħla Żjieda fl- Aspartate amino transferase