qanastek/EMEA-V3 huggingface dataset:
In healthy volunteers under fasting conditions, dividing the total
F’ voluntiera b’ saħħithom fl- istat sajjem, meta d- doża
13 daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 58% over 48 hours.
13 tal- jum (800 mg) kienet maqsuma f’ 200 mg erba ’ darbiet kuljum imqabbel ma ’ 400 mg darbtejn kuljum, intwera li l- esponiment ta ’ posconazole żdied b’ 58% fuq 48 siegħa.
Pharmacokinetics in special populations Children (< 18 years) Following administration of 800 mg per day of posaconazole as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8 - 17 years of age (776 ng/ ml) were similar to concentrations from 194 patients 18 - 64 years of age (817 ng/ ml).
Farmakokinetiċi f’ popolazzjonijiet speċjali Tfal (< 18- il sena) Wara li jingħataw 800 mg posaconazole kuljum bħala dożi maqsuma għall- kura ta ’ infezzjonijiet invażivi tal- fungu, il- medja tal- konċentrazzjonijiet fil- plażma minn 12- il pazjent ta ’ etajiet bejn 8 – 17- il sena (776 ng/ ml) kienu simili għall- konċentrazzjonijiet minn 194 pazjent ta ’ etajiet bejn 18 – 64- il sena (817 ng/ ml).
In subjects with severe renal impairment (n=6, Cl cr< 20 ml/min/1.73 m2), the AUC of posaconazole was highly variable [> 96% CV (coefficient of variance)] compared to other renal groups [< 40% CV].
F’ individwi li jkollhom insuffiċjenza renali severa (n=6, Cl cr < 20 ml/ min/ 1. 73 m2), l - AUC ta ’ posaconazole varja ħafna [> 96% CV (koeffiċjenti tal- varjanza)] imqabbel mal- gruppi renali l- oħrajn [< 40% CV].
However, as posaconazole is not significantly renally eliminated, an effect of
Madankollu, peress li posaconazole ma jiġix eliminat mill- kliewi b’ mod
14 severe renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended.
14 sinifikanti, mhux mistenni li jkun hemm effett ta ’ insuffiċjenza renali severa fuq il- farmakokinetiċi ta ’ posaconazole u mhux rakkomandat li tinbidel id- doża.
No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the exposures obtained at therapeutic doses in humans.
Ma dehrux bidliet fl- elettrokardjogrammi, inklużi l- intervalli QT u QTc, fi studju farmakoloġiku dwar is- sigurtà b’ dożi ripetuti f’ xadini b’ esponimenti sistemiċi 4. 6- il darba ogħla mill- esponimenti li jinkisbu b’ dożi terapewtiċi fil- bnedmin.
Polysorbate 80 Simeticone Sodium benzoate (E211) Sodium citrate dihydrate
Polysorbate 80 Simeticone Sodium benzoate (E211) Sodium citrate dihydrate
15 Citric acid monohydrate Glycerol Xanthan gum Liquid glucose Titanium dioxide (E171) Artificial cherry flavour containing benzyl alcohol and propylene glycol Purified water
15 Citric acid monohydrate Glycerol Xanthan gum Glucose likwidu Titanium dioxide (E171) Togħma artifiċjali ta ’ ċirasa li fiha benzyl alcohol u propylene glycol Ilma purifikat
Posaconazole SP 40 mg/ ml oral suspension posaconazole
Posaconazole SP 40 mg/ ml suspensjoni orali posaconazole
What Posaconazole SP is and what it is used for 2.
X’ inhu Posaconazole SP u għalxiex jintuża 2.
Before you take Posaconazole SP 3.
Qabel ma tieħu Posaconazole SP 3.
How to take Posaconazole SP 4.
Kif għandek tieħu Posaconazole SP 4.
How to store Posaconazole SP 6.
Kif taħżen Posaconazole SP 6.
WHAT POSACONAZOLE SP IS AND WHAT IT IS USED FOR
X’ INHU POSACONAZOLE SP U GĦALXIEX JINTUŻA
Posaconazole SP belongs to a group of medicines called triazole antifungal agents.
Posaconazole SP jgħamel parti minn grupp ta ’ mediċini li jissejjħu aġenti triazole kontra l- fungu.
These medicines are used to prevent and treat a wide variety of fungal infections.
Dawn il- mediċini jintużaw biex jiġu evitati u kkurati varjetà wiesa ’ ta ’ infezzjonijiet tal- fungu.
Posaconazole SP works by killing or stopping the growth of some types of fungi that can cause infections in humans.
Posaconazole SP jaħdem billi joqtol jew iwaqqaf it- tkabbir ta ’ ċerti tipi ta ’ fungu li jistgħu jikkawżaw infezzjonijiet fil- bnedmin.
Posaconazole SP can be used to treat the following types of fungal infections in adults:
Posaconazole SP jista ’ jintuża biex jikkura dawn it- tipi ta ’ infezzjonijiet tal- fungu fl- adulti:
Posaconazole SP can be used to prevent fungal infections in patients whose immune systems may be weakened due to other medicines or diseases.
Posaconazole SP jista ’ jintuża biex jevita infezzjonijiet tal- fungu f’ pazjenti li jkollhom is- sistema immuni dgħajfa minħabba mediċini oħra jew mard.
BEFORE YOU TAKE POSACONAZOLE SP
QABEL MA TIEĦU POSACONAZOLE SP
Do not take Posaconazole SP
Tieħux Posaconazole SP
- If you are allergic (hypersensitive) to posaconazole or to any of the other ingredients of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal posaconazole jew sustanzi oħra ta ’
these medicines, which can lead to very serious disturbances in heart rhythm: • terfenadine (used to treat allergies) • astemizole (used to treat allergies) • cisapride (used to treat stomach problems) • pimozide (used to treat symptoms of Tourette's disorder) • halofantrine (used to treat malaria) • quinidine (used to treat abnormal heart rhythms).
dawn il- mediċini, li jista ’ jwassal għal disturbi serji ħafna fir- ritmu li bih tħabbat il- qalb: • terfenadine (jintuża għall- kura ta ’ allerġiji) • astemizole (jintuża għall- kura ta ’ allerġiji) • cisapride (jintuża għall- kura ta ’ problemi fl- istonku) • pimozide (jintuża għall- kura ta ’ sintomi ta ’ disturbi ta ’ Tourette) • halofantrine (jintuża għall- kura ta ’ malarja) • quinidine (jintuża għall- kura ta ’ meta l- qalb tkun qed tħabbat b’ ritmu anormali).
Please see the section “ Taking other medicines” for information on other medicines which may interact with Posaconazole SP.
Jekk jogħġbok irreferi għas- sezzjoni “ Meta tieħu mediċini oħra ” għal tagħrif fuq mediċini oħra li jistgħu jinteraġixxu ma ’ Posaconazole SP.
Take special care with Posaconazole SP Ask your doctor or pharmacist for advice before taking any medicine.
Oqgħod attent ħafna b’ Posaconazole SP Saqsi lit- tabib jew lill- ispiżjar tiegħek għal parir qabel ma tibda tieħu xi mediċina.
are taking Posaconazole SP.
speċjali meta tkun qed tieħu Posaconazole SP.
Posaconazole SP.
effettiv Posaconazole SP.
Please note that Posaconazole SP is only for use in adults (older than 18 years of age).
Jekk jogħġbok innota li Posaconazole SP jintuża biss f’ adulti (akbar minn 18- il sena).
Please look at the list of medicines that must not be taken while you are taking Posaconazole SP that is given above.
Jekk jogħġbok ara l- lista ta ’ mediċini li m’ għandhomx jittieħdu meta tkun qed tieħu Posaconazole SP li tidher hawn fuq.
There are other medicines that can sometimes be given while you are taking Posaconazole SP but special care may be needed.
Hemm mediċini oħrajn li jistgħu jingħataw jekk qed tieħu Posaconazole SP iżda jista ’ jkun hemm bżonn ta ’ kawtela speċjali.
If you are already being treated with rifabutin, your blood counts and some possible side effects to rifabutin will need to be monitored. • Some medicines used to treat or prevent fits, such as phenytoin, carbamazepine, phenobarbital, primidone. • Efavirenz, which is used to treat HIV infection.
Jekk qed tiġi kkurat b’ rifabutin, l- għadd tad- demm u xi effetti sekondarji ta ’ rifabutin jkollhom bżonn jiġu monitorati. • Xi mediċini li jintużaw biex jevitaw aċċessjonijiet, bħal phenytoin, carbamazepine, phenobarbital, primidone. • Efavirenz, li jintuża għall- kura ta ’ infezzjoni b’ HIV.
27 • Medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.
27 • Mediċini li jintużaw biex inaqqsu l- aċidu fl- istonku bħal cimetidine u ranitidine jew omeprazole u mediċini simili li jissejħu impedituri tal- pompi tal- protoni.
Posaconazole SP may increase (possibly increasing the risk of side effects) the blood levels of some other medicines.
Posaconazole SP jista ’ jżid (possibilment jżid ir- riskju ta ’ effetti sekondarji) fil- livelli ta ’ mediċini oħrajn fid- demm.
Taking Posaconazole SP with food and drink Each dose of Posaconazole SP should be taken with food or a nutritional supplement if you are unable to tolerate food to enhance the oral absorption.
Meta tieħu Posaconazole SP ma ’ l- ikel u max- xorb Kull doża ta ’ Posaconazole SP għandha tittieħed ma ’ l- ikel jew ma ’ suppliment nutrizzjonali jekk ma tistax iżżomm ikel li jgħin biex ikun hemm assorbiment orali aħjar.
Pregnancy and breast-feeding Tell your doctor if you are or think you are pregnant before you start to take Posaconazole SP.
Tqala u treddigħ Għid lit- tabib tiegħek jekk int jew taħseb li jista ’ jkun li ħriġt tqila qabel ma tibda tieħu Posaconazole SP.
Do not use Posaconazole SP during pregnancy unless you are told by your doctor.
Tużax Posaconazole SP waqt it- tqala sakemm ma jkunx qallek it- tabib tiegħek.
You should use effective contraception while you are taking Posaconazole SP if you are a woman who could become pregnant.
Għandek tuża kontraċezzjoni effettiva meta tkun qed tieħu Posaconazole SP jekk int mara li tista ’ toħroġ tqila.
Contact your doctor immediately if you become pregnant while being treated with Posaconazole SP.
Għamel kuntatt mat- tabib teigħek mill- ewwel jekk toħroġ tqila waqt li tkun fuq kura b’ Posaconazole SP.
Do not breast-feed while being treated with Posaconazole SP.
M’ għandekx tredda ’ meta tkun qed tingħata kura b’ Posaconazole SP.
Driving and using machines There is no information on the effect of Posaconazole SP on the ability to drive and use machines.
Sewqan u tħaddim ta ’ magni M’ hemmx tagħrif dwar l- effett ta ’ Posaconazole SP fuq il- ħila biex issuq u tħaddem magni.
Important information about some of the ingredients of Posaconazole SP Posaconazole SP contains approximately 1.75 g of glucose per 5 ml of suspension.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Posaconazole SP Posaconazole SP fih madwar 1. 75 g ta ’ glucose għal kull 5 ml ta ’ suspensjoni.
You should not take this medicine if you have a condition called glucose-galactose malabsorption and should take note of this amount of glucose if you need to watch your sugar intake for any reason.
M’ għandekx tieħu din il- mediċina jekk għandek kondizzjoni li tissejjaħ malassorbiment tal- glucose- galactose u għandek iżżomm nota ta ’ dan l- ammont ta ’ glucose jekk għal xi raġuni għandek toqgħod attent għall- ammont ta ’ zokkor li tieħu.
HOW TO TAKE POSACONAZOLE SP
KIF GĦANDEK TIEĦU POSACONAZOLE SP
Posaconazole SP must only be used as directed by your doctor.
Posaconazole SP għandu jintuża biss kif jindikalek it- tabib tiegħek.
Your doctor will monitor your response and condition to determine how long Posaconazole SP needs to be given and whether any change is needed to your daily dose.
It- tabib tiegħek ser jeżamina r - rispons u l- kundizzjoni sabiex jiddeċidi kemm għandu jdum jingħata Posaconazole SP u jekk ikunx hemm bżonn ta ’ xi tibdil fid- doża ta ’ kuljum.
If you take more Posaconazole SP than you should If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.
Jekk tieħu Posaconazole SP aktar milli suppost Jekk qed tinkwieta li ħadt iżżejjed, għamel kuntatt mat- tabib tiegħek jew ma professjonist fil- kura tas - saħħa mill- ewwel.
If you forget to take Posaconazole SP If you have missed a dose, take it as soon as you remember and then carry on as before.
Jekk tinsa tieħu Posaconazole SP Jekk qbiżt doża, ħudha malli tiftakar u imbagħad kompli bħal qabel.
Like all medicines, Posaconazole SP can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Posaconazole SP jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Anaemia, low numbers of cells called platelets that help the blood to clot, low numbers of some types of white blood cells, enlargement of lymph glands Allergic reaction High blood levels of glucose Disturbances in feeling or moving, tremor, fits Heart rhythm problems including very fast heartbeat (palpitations), abnormal findings on heart tests (like ECGs that show heart rhythm) High or low blood pressure Inflammation of the pancreas Inflammation of liver, liver damage, jaundice (yellow colour of the skin or the eyes) Problems with kidney function, failure of the kidneys Menstrual disorder Blurred vision Hair loss, itching Mouth ulcers 29 Shivering, generally feeling unwell or weak Scattered body pain, including in muscles and joints, back pain Fluid retention, altered medicine levels.
Anemija, numru baxx ta ’ ċelluli li jissejħu plejlets li jgħinu d- demm biex jagħqad, numri baxxi ta ’ ċerti tipi ta ’ ċelluli bojod tad- demm, tkabbir tal- glandoli tal- limf Reazzjoni allerġika Livelli għoljin ta ’ glucose Disturbi ta ’ kif tħoss jew tiċċaqlaq, tregħid, aċċesjonijiet Problemi tar- ritmu tal- qalb inkluż taħbit mgħaġġel ħafna (palpitazzjonijiet), sejbiet anormali tat - testijiet tal- qalb (bħall- ECGs li juru r- ritmu tal- qalb) Pressjoni għolja jew baxxa Infjammazzjoni tal- pankrejas Infjammazzjoni tal- fwied, fil- fwied, suffejra (kulur isfar tal- ġilda jew ta ’ l- għajnejn) Problemi fil- funzjoni tal- kliewi, insuffiċjenza tal- kliewi Disturbi menstruwali Vista mċajpra Jaqa x- xagħar, ħakk 29 Ulċeri fil- ħalq Tirtod, tħossok ma tiflaħx b’ mod ġenerali jew dgħajjef Uġigħ mifrux mal- ġisem, inkluż fil- muskoli u l- ġogi, uġigħ fid- dahar Ritenzjoni ta ’ fluwidi, tibdil fil- livelli ta ’ mediċini.
HOW TO STORE POSACONAZOLE SP
KIF TAĦŻEN POSACONAZOLE SP
Do not use Posaconazole SP after the expiry date which is stated on the label.
Tużax Posaconazole SP wara d- data ta ’ skadenza li tidher fuq it- tikketta.
What Posaconazole SP contains
X’ fih Posaconazole SP
- The active substance in Posaconazole SP oral suspension is posaconazole.
- Is- sustanza attiva fis- suspensjoni orali ta’ Posaconazole SP hija posaconazole.
30 What Posaconazole SP looks like and contents of the pack
30 31 Id- Dehra ta ’ Posaconazole SP u l- kontenuti tal- pakkett
Posaconazole SP is a white, cherry flavoured, 105 ml oral suspension packaged in amber glass bottles.
Posaconazole SP huwa suspensjoni bajda, b’ togħma taċ- ċirasa, 105 ml ta ’ suspensjoni orali impakkettati fi fliexken tal- ħġieġ kannella jagħtu fl- oranġjo.
What is Pradaxa?
X’ inhu Pradaxa?
Pradaxa is a medicine containing the active substance dabigatran etexilate.
Pradaxa huwa mediċina li fiha s- sustanza attiva dabigatran etexilate.
It is available as capsules (75 mg and 110 mg).
Jiġi bħala kapsuli (75 mg u 110 mg).
What is Pradaxa used for?
Għalxiex jintuża Pradaxa?
Pradaxa is used to prevent the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee.
Pradaxa jintuża biex jipprevjeni l- formazzjoni ta ’ għoqiedi tad- demm fil- vini ta ’ l- adulti li tkun saritilhom operazzjoni ta ’ rimpjazzament tal- ġog tal- ġenb jew ta ’ l- irkobba.
How is Pradaxa used?
Kif jintuża Pradaxa?
Treatment with Pradaxa should start with one 110 mg capsule taken one to four hours after the end of the operation.
It- trattament bi Pradaxa għandu jinbeda b’ kapsula waħda tal- 110 mg meħuda bejn siegħa u erba ’ sigħat wara tmiem l- operazzjoni.
Treatment then continues with two 110 mg capsules (220 mg) once a day for 28 to 35 days after hip replacement and for 10 days after knee replacement.
Imbagħad it- trattament jitkompla b’ żewġ kapsuli tal- 110 mg (220 mg) darba kuljum għal bejn 28 u 35 jum wara r- rimpjazzament tal- ġog ta ’ l- irkobba u għal għaxart ijiem wara r- rimpjazzament ta ’ l- irkobba.
The start of the treatment should be delayed in patients who are still bleeding from the site of surgery.
Il- bidu tat- trattament għandu jitbiegħed f’ pazjenti li jkunu għadhom bid- demm ħiereġ mis- sit ta ’ l- operazzjoni.
If treatment is not started on the day of the operation, it should start with two capsules once a day.
Jekk it- trattament ma jinbediex fil- jum ta ’ l- operazzjoni, għandu jinbeda b’ żewġ kapsuli darba kuljum.
The capsules should be swallowed whole with water.
Il- kapsuli għandhom jinbelgħu sħaħ ma ’ l- ilma.
A lower dose (150 mg once a day) is used in patients with mild or moderate kidney problems, in patients over 75 years of age, and in patients taking amiodarone (a medicine used to regulate the heart rhythm).
Għandha tintuża doża iktar baxxa (150 mg darba kuljum) f’ pazjenti bi problemi ħfief jew moderati tal - kliewi, f’ pazjenti ta ’ iktar minn 75 sena, u f’ pazjenti li jkunu qed jieħdu amiodarone (mediċina użata biex tirregola r- ritmu tal- qalb).
Pradaxa should not be used in patients who have severe problems with their kidneys and it is not recommended for use in patients with signs of existing liver problems.
Pradaxa għandu jintuża f’ pazjenti li jkollhom problemi severi fil- kliewi u mhuwiex rakkomandat għall- użu f’ pazjenti b’ sinjali ta ’ problemi eżistenti fil- fwied.
Pradaxa should be used with caution in patients at risk of bleeding or who could have high blood levels of the medicine, such as those who have moderate problems with their kidneys.
Pradaxa għandu jintuża b’ kawtela f’ pazjenti b’ riskju ta ’ ħruġ ta ’ demm jew li jkollhom livelli għoljin tal- mediċina fid - demm, bħal dawk li jkollhom problemi moderati fil- kliewi.
Patients weighing less than 50 kg or more than 110 kg should be closely monitored for signs of bleeding or anaemia (low red blood cell counts).
Il- pazjenti li jkunu jiżnu inqas minn 50 kg jew iktar minn 110 kg għandhom jiġu sorveljati mill- qrib għal sinjali ta ’ ħruġ ta ’ demm jew ta ’ anemija (għadd baxx ta ’ ċelloli ħomor fid- demm).
How does Pradaxa work?
Kif jaħdem Pradaxa?
Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in the veins.
Il- pazjenti li tkun se ssirilhom operazzjoni ta ’ rimpjazzament tal- ġog tal- ġenb jew ta ’ l- irkobba li jkollhom riskju kbir għall- formazzjoni ta ’ għoqiedi tad- demm fil- vini.
These clots, which include deep vein thrombosis (DVT), can be dangerous if they move to another part of the body such as the lungs or the brain.
Dawn l- għoqiedi, li jinkludu t - trombożi fil- vini fil- fond (DVT), jistgħu jkunu perikolużi jekk jimxu għal parti oħra tal- ġisem bħall - pulmun jew il- moħħ.
The active substance in Pradaxa, dabigatran etexilate, is a ‘ prodrug ’ of dabigatran.
Is- sustanza attiva f’ Pradaxa, dabigatran etexilate, hija ‘ prodroga ’ ta ’ dabigatran.
This means that it is converted into dabigatran in the body.
Dan ifisser li dan jinbidel f’ dabigatran fil- ġisem.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Dabigatran huwa antikoagulant, li jfisser li 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. jipprevjeni d- demm milli jagħqad (jikkoagula).
How has Pradaxa been studied?
Kif ġie studjat Pradaxa?
The effects of Pradaxa were first tested in experimental models before being studied in humans.
Għall- ewwel, l- effetti ta ’ Pradaxa ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The effectiveness of Pradaxa was studied in two main studies, both of which compared Pradaxa (either 220 or 150 mg a day) with enoxaparin (another anticoagulant).
L- effettività ta ’ Pradaxa ġiet studjata f’ żewġ studji ewlenin, li t- tnejn li huma qabblu Pradaxa (220 jew 150 mg kuljum) ma ’ enoxaparin (anticoagulant ieħor).
The first study involved a total of 2,101 patients who had had a knee replacement operation, and the second involved a total of 3,494 patients who had had a hip replacement.
Fl- ewwel studju b’ kollox ħadu sehem 2, 101 pazjent li kienet saritilhom operazzjoni tal- bdil ta ’ l- irkobba, u fit- tieni wieħed b’ kollox ħadu sehem 3, 494 pazjent li kien sarilhom rimpjazzament tal- ġog tal- ġenb.
In both studies, the main measure of effectiveness was the number of patients who formed blood clots in the veins or who died of any cause during the treatment period.
Fiż- żewġ studji, il- mezz ewlieni tal- kejl ta ’ l- effettività kien l- għadd ta ’ pazjenti li ffurmaw għoqiedi tad- demm jew li mietu minħabba kwalunkwe kawża waqt il- perjodu tat- trattament.
In most cases, blood clot formation was detected using scans of the veins or by looking for signs of blood clots in the lungs.
F’ ħafna mill- każijiet, il- formazzjoni tal- għoqiedi tad- demm kienet konfermata permezz ta ’ skens tal- vini jew b’ tiftix għal sinjali ta ’ għoqiedi tad- demm fil- pulmun.
What benefit has Pradaxa shown during the studies?
Liema benefiċċju wera Pradaxa waqt l- istudji mwettqa?
In both studies, Pradaxa was as effective as enoxaparin in preventing the formation of blood clots or death.
Fiż- żewġ studji, Pradaxa kien effettiv daqs enoxaparin fil- prevenzjoni tal- formazzjoni tal- għoqiedi tad- demm jew tal- mewt.
In the study of patients undergoing knee replacement, blood clots were detected in 182 (36%) of the 503 patients taking the 220-mg dose of Pradaxa, compared with 192 (38%) of the 512 receiving enoxaparin.
Fl- istudju dwar pazjenti li saritilhom operazzjoni tal- bdil ta ’ l- irkobba, instabu għoqiedi tad- demm f’ 182 (36%) mill- 503 pazjenti li kienu qed jieħdu doża ta ’ 220 mg Pradaxa, meta mqabbla ma ’ 192 (38%) mill- 512 li kienu qed jingħataw enoxaparin.
There was only one death in each group (less than 1%).
Kien hemm mewta waħda biss f’ kull grupp (inqas minn 1%).
After hip replacement, blood clots were detected in 50 (6%) of the 880 patients taking 220 mg Pradaxa, compared with 60 (7%) of the 897 receiving enoxaparin.
Wara t- tibdil tal- ġog tal- ġenb, instabu għoqiedi tad- demm f’ 50 (6%) mit- 880 pazjent li kienu qed jieħdu 220 mg Pradaxa, meta mqabbla ma ’ 60 (7%) mit- 897 li kienu qed jieħdu enoxaparin.
Three patients in the Pradaxa group died (less than 1%), but two of these deaths were unrelated to blood clots.
Tliet pazjenti fil- grupp li ngħataw Pradaxa mietu (inqas minn 1%), iżda tnejn minn dawn l- imwiet ma kellhomx x’ jaqsmu mal- għoqiedi tad- demm.
In both studies, the 220-mg dose showed a trend towards being more effective than the 150-mg dose.
Fiż- żewġ studji, id- doża ta ’ 220 mg tat lil wieħed x’ jifhem li kienet effettiva iktar mid- doża ta ’ 150 mg.
What is the risk associated with Pradaxa?
X’ inhu r- riskju assoċjat ma ’ Pradaxa?
The most common side effect with Pradaxa (seen in more than 1 patient in 10) is bleeding.
L- iktar effett sekondarju komuni ma ’ Pradaxa (li deher f’ iktar minn pazjenti wieħed minn kull għaxra) hu l- ħruġ tad- demm.
For the full list of all side effects reported with Pradaxa, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati ma ’ Pradaxa, ara l- Fuljett ta ’ Tagħrif.
Pradaxa should not be used in people who may be hypersensitive (allergic) to dabigatran etexilate or any of the other ingredients.
Pradaxa m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal dabigatran etexilate jew għal xi wieħed mill- ingredjenti l- oħra.
It should not be used in patients who have severe problems with their kidneys, active significant bleeding, tissue damage that could lead to bleeding, problems with the blood clotting process (this may be inborn, of unknown cause or due to other medicines), or liver problems that could be life-threatening.
M’ għandux jintuża f’ pazjenti li jkollhom problemi severi fil - kliewi, ħruġ attiv sinjifikanti ta ’ demm, ħsara fit- tessuti jista ’ jwassal għal ħruġ ta ’ demm, problemi fil- proċess ta ’ koagulazzjoni tad- demm (dan jista ’ jkun mit- twelid, ikkawżat minn kwalunkwe kawża jew minħabba mediċini oħra), jew problemi tal- fwied li jistgħu jkunu ta ’ theddida tas- saħħa.
Pradaxa should also not be used in patients taking quinidine (another medicine used to regulate the heart rhythm).
Pradaxa lanqas m’ għandu jintuża minn pazjenti li jkunu qed jieħdu quinidine (mediċina oħra użata biex tirregola r- ritmu tal- qalb).
Why has Pradaxa been approved?
Għaliex ġie approvat Pradaxa?
The Committee for Medicinal Products for Human Use (CHMP) decided that Pradaxa’ s benefits are greater than its risks for primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Pradaxa huma ikbar mir- riskju tiegħu fil- prevenzjoni primarja ta ’ inċidenzi tromboemboliċi venużi f’ pazjenti adulti li jkunu għaddew minn kirurġija elettiva tal- bdil totali tal- ġog tal- ġenb jew tal- bdil totali ta ’ l- irkobba.
The Committee recommended that Pradaxa be given marketing authorisation.
Il- Kumitat irrakkomanda li Pradaxa jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Other information about Pradaxa:
Informazzjoni oħra dwar Pradaxa:
The European Commission granted a marketing authorisation valid throughout the European Union for Pradaxa to Boehringer Ingelheim International GmbH on 18 March 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Pradaxa lil Boehringer Ingelheim International GmbH fil- 18 ta ’ Marzu 2008.
The full EPAR for Pradaxa can be found here.
L- EPAR sħiħ għal Pradaxa jista ’ jinstab hawnhekk.
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (Alu/ alu) blister (Alu/ alu) blister (Alu/ alu) bottle (PP) blister (Alu/ alu) blister (Alu/ alu) blister (Alu/ alu) bottle (PP)
folja (Alu/ alu) folja (Alu/ alu) folja (Alu/ alu) flixkun (PP) folja (Alu/ alu) folja (Alu/ alu) folja (Alu/ alu) flixkun (PP)
10 x 1 capsules 30 x 1 capsules 60 x 1 capsules 60 capsules 10 x 1 capsules 30 x 1 capsules 60 x 1 capsules 60 capsules
10 x 1 kapsula 30 x 1 kapsula 60 x 1 kapsula 60 kapsula 10 x 1 kapsula 30 x 1 kapsula 60 x 1 kapsula 60 kapsula
Pradaxa 75 mg hard capsules
Pradaxa 75 mg, kapsuli iebsin
Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate) Excipients:
Sustanzi mhux attivi:
Each hard capsule contains 2 micrograms sunset yellow (E110)
Kull kapsula iebsa fiha 2 mikrogrammi ta ’ sunset yellow (E110)
Hard capsule
Kapsula iebsa.
Imprinted capsules with light blue, opaque cap and cream-coloured, opaque body of size 2 filled with yellowish pellets.
Kapsuli stampati b’ għatu blu ċar u opak, u korp opak mil- lewn il- krema ta ’ daqs 2 mimli bi pritkuni jagħtu fl- isfar.
The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “ R75”.
L- għatu hu stampat bis- simbolu tal- kumpanija Boehringer Ingelheim, u l- korp stampat b ’ “ R75 ”.
Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Prevenzjoni primarja ta ’ avvenimenti tromboemboliċi venużi f’ pazjenti adulti li kellhom operazzjoni mhux urġenti tas- sostituzzjoni totali tal- ġenbejn jew operazzjoni tas- sostituzzjoni sħiħa ta ’ l- irkoppa.
Prevention of Venous Thromboembolism (VTE) in patients following elective knee replacement surgery:
Prevenzjoni ta ’ Tromboemboliżmu Venuż (Venous Thromboembolism - VTE) fil- pazjenti wara operazzjoni mhux urġentitas- sostituzzjoni ta ’ l- irkoppa:
The recommended dose of Pradaxa is 220 mg once daily taken as 2 capsules of 110 mg.
Id- doża rakkomandata ta ’ Pradaxa hi ta ’ 220 mg darba kuljum, li tittieħed bħala 2 kapsuli ta ’ 110 mg.
Treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
Il- kura għandha tinbeda mill- ħalq fi żmien 1 – 4 sigħat mit- tmiem ta ’ l- operazzjoni, b’ kapsula waħda u mbagħad titkompla b’ 2 kapsuli darba kuljum wara dan il- perjodu, għal total ta ’ 10 tijiem.
Prevention of Venous Thromboembolism (VTE) in patients following elective hip replacement surgery:
Prevenzjoni ta ’ Tromboemboliżmu Venuż (VTE) fil- pazjenti wara operazzjoni mhux urġentitas- sostituzzjoni tal- ġenbejn:
Treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Il- kura għandha tinbeda mill- ħalq fi żmien 1 – 4 sigħat mit- tmiem ta ’ l- operazzjoni, b’ kapsula waħda u mbagħad titkompla b’ 2 kapsuli darba kuljum wara dan il- perjodu, għal total ta ’ 28- 35 jum.
For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed.
Għaż- żewġ operazzjonijiet, jekk ma tinkisibx l- emostasi, il- bidu tal- kura għandu jiġi ttardjat.
If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Jekk il- kura ma tinbediex fil- jum ta ’ l- operazzjoni, allura l- kura għandha tinbeda b’ 2 kapsuli darba kuljum.
Special patient populations:
Popolazzjonijiet speċjali ta ’ pazjenti:
Treatment with Pradaxa in patients with severe renal impairment (creatinine clearance < 30 ml/ min) is contraindicated (see section 4.3).
Il- kura bi Pradaxa f’ pazjenti b’ indeboliment renali sever (rata ta ’ tneħħija tal- krejatinina ta ’ < 30 ml/ min) hi kontra- indikata (ara sezzjoni 4. 3).
2 In patients with moderate renal impairment (creatinine clearance 30-50 ml/ min), there is limited clinical experience.
2 F’ pazjenti b’ indeboliment renali moderat (tneħħija tal- krejatinina ta ’ 30- 50 ml/ min), hemm esperjenza klinika limitata.
These patients should be treated with caution.
Dawn il- pazjenti għandhom jiġu kkurati bl- attenzjoni.
The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg (see section 4.4 and 5.1).
Id- doża rakkomandata hi ta ’ 150 mg li tittieħed darba kuljum bħala 2 kapsuli ta ’ 75 mg (ara sezzjoni 4. 4 u 5. 1).
After knee replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
Wara operazzjoni tas- sostituzzjoni ta ’ l- irkoppa, il- kura għandha tinbeda mill- ħalq fi żmien 1 – 4 sigħat mit - tmiem ta ’ l- operazzjoni, b’ kapsula waħda u mbagħad titkompla b’ 2 kapsuli darba kuljum wara dan il - perjodu, għal total ta ’ 10 tijiem.
After hip replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Wara operazzjoni tas- sostituzzjoni tal- ġenbejn, il- kura għandha tinbeda mill- ħalq fi żmien 1 – 4 sigħat mit - tmiem ta ’ l- operazzjoni, b’ kapsula waħda u mbagħad titkompla b’ 2 kapsuli darba kuljum wara dan il - perjodu, għal total ta ’ 28- 35 jum.
In elderly patients (> 75 years) there is limited clinical experience.
F’ pazjenti anzjani (> 75 sena) hemm esperjenza klinika limitata.
After knee replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
Wara operazzjoni tas- sostituzzjoni ta ’ l- irkoppa, il- kura għandha tinbeda mill- ħalq fi żmien 1 – 4 sigħat mit - tmiem ta ’ l- operazzjoni, b’ kapsula waħda u mbagħad titkompla b’ 2 kapsuli darba kuljum wara dan il - perjodu, għal total ta ’ 10 ijiem.
Patients with elevated liver enzymes > 2 upper limit of normal (ULN) were excluded in clinical trials.
Pazjenti b’ livell għoli ta ’ enzimi tal- fwied ta ’ > 2 limitu ta ’ fuq tan- normal (ULN) kienu esklużi fil- provi kliniċi.
Therefore the use of Pradaxa is not recommended in this population (see sections 4.4 and 5.2).
Għalhekk, l- użu ta ’ Pradaxa mhux rakkomandat f’ din il- popolazzjoni (ara sezzjonijiet 4. 4 u 5. 2).
ALT should be measured as part of the standard pre-operative evaluation (see section 4.4).
L - ALT għandu jitkejjel bħala parti mill- evalwazzjoni standard ta ’ qabel l- operazzjoni (ara sezzjoni 4. 4).
There is very limited clinical experience in patients with a body weight < 50 kg or > 110 kg at the recommended posology.
Hemm esperjenza klinika limitata ħafna f’ pazjenti b’ piż tal- ġisem ta ’ < 50 kg jew > 110 kg fil- pożoloġija rakkomandata.
Given the available clinical and kinetic data no adjustment is necessary (see section 5.2) but close clinical surveillance is recommended (see section 4.4).
Bid- dejta klinika u kinetika disponibbli, l- ebda aġġustament mhu meħtieġ (ara sezzjoni 5. 2) iżda sorveljanza klinika mill- qrib hi rakkomandata (ara sezzjoni 4. 4).
Post-surgical patients with an increased risk for bleeding:
Pazjenti ta ’ qabel l- operazzjoni b’ żieda fir- riskju għal fsad:
Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (creatinine clearance 30 – 50 ml/ min), should be treated with caution (see sections 4.4 and 5.1).
Pazjenti li qegħdin f’ riskju ta ’ fsad jew pazjenti f’ riskju ta ’ espożizzjoni eċċessiva, b’ mod speċjali pazjenti b’ indeboliment renali moderat (tneħħija tal- krejatinina ta ’ 30 – 50 ml/ min), għandhom ikunu kkurati bl - attenzjoni (ara sezzjonijiet 4. 4 u 5. 1).
There is no experience in children and adolescents.
M’ hemmx esperjenza dwar l- użu fit- tfal u l- adolexxenti.
Pradaxa is not recommended for use in patients below 18 years due to lack of data on safety and efficacy.
Pradaxa mhix rakkomandata għall- użu f’ pazjenti taħt it- 18- il sena minħabba nuqqas ta ’ dejta dwar is- sigurtà u l- effikaċja.
Concomitant use of Pradaxa with Amiodarone:
3 L- użu fl- istess ħin ta ’ Pradaxa ma ’ Amiodarone:
Dosing should be reduced to 150 mg Pradaxa daily in patients who received concomitantly dabigatran etexilate and amiodarone (see section 4.5).
Id- dożaġġ għandu jitnaqqas għal 150 mg ta ’ Pradaxa kuljum f’ pazjenti li jkunu rċivew dabigatran etexilate u amiodarone fl- istess ħin (ara sezzjoni 4. 5).
Switching from Pradaxa treatment to parenteral anticoagulant:
Kif taqleb mill- kura bi Pradaxa għal mediċina antikoagulanti parentali:
It is recommended to wait 24 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Hu rakkomandat li tistenna 24 siegħa wara l- aħħar id- doża qabel ma taqleb minn Pradaxa għal mediċina li traqqaq id- demm li tingħata permezz ta ’ tilqima (ara sezzjoni 4. 5).
3 Switching from parenteral anticoagulants treatment to Pradaxa:
Kif taqleb minn mediċina antikoagulanti parentali għal Pradaxa:
No data are available, therefore it is not recommended to start the administration of Pradaxa before the next scheduled dose of the parenteral anticoagulant would have been due (see section 4.5).
L- ebda dejta mhi disponibbli, u għalhekk mhux rakkomandat li tibda l- għoti ta ’ Pradaxa qabel ma jasal il- ħin li fih kieku kienet tingħata d- doża skedata li jmiss tal- mediċina li traqqaq id- demm li tingħata permezz ta ’ tilqima (ara sezzjoni 4. 5).
Pradaxa should be swallowed as a whole with water, with or without food.
Pradaxa għandha tinbela ’ sħiħa ma ’ l- ilma, ma ’ l- ikel jew mingħajru.
• Hypersensitivity to the active substance or to any of the excipients • Patients with severe renal impairment (CrCl < 30 ml/ min) • Active clinically significant bleeding • Organic lesion at risk of bleeding • Spontaneous or pharmacological impairment of haemostasis • Hepatic impairment or liver disease expected to have any impact on survival • Concomitant treatment with quinidine (see section 4.5)
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi • Pazjenti b’ indeboliment sever renali (CrCl < 30 ml/ min) • Fsad attiv u klinikament sinifikanti • Leżjoni organika li tkun f’ riskju ta ’ fsad • Indeboliment spontanju jew farmakoloġiku ta ’ emostasi • Indeboliment epatiku jew mard tal- fwied li hu mistenni li jkollu xi impatt fuq is- sopravivenza • Il- kura fl- istess ħin bi quinidine (ara sezzjoni 4. 5).
Patients with elevated liver enzymes > 2 ULN were excluded in controlled clinical trials.
Pazjenti b’ livell għoli ta ’ enzimi tal- fwied ta ’ > 2 ULN kienu esklużi fil- provi kliniċi kkontrollati.
Therefore the use of Pradaxa is not recommended in this population.
Għalhekk, l- użu ta ’ Pradaxa mhux rakkomandat f’ din il- popolazzjoni.
ALT should be measured as part of the standard pre- operative evaluation.
L- ALT għandu jitkejjel bħala parti mill - evalwazzjoni standard ta ’ qabel l- operazzjoni.
Haemorrhagic risk:
Riskju emorraġiku:
Close clinical surveillance (looking for signs of bleeding or anaemia) is recommended throughout the treatment period, especially in the following situations that may increase the hemorrhagic risk: diseases associated with an increased risk of bleeding, such as congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, active ulcerative gastrointestinal disease, recent biopsy or major trauma, recent intracranial haemorrhage or brain, spinal or ophthalmic surgery, bacterial endocarditis.
Sorveljanza klinika mill- qrib (tfittex għal sinjali ta ’ fsad jew anemija) hi rakkomandata matul il- perjodu tal - kura, speċjalment fis- sitwazzjonijiet li ġejjin li jistgħu jżidu r- riskju emorraġiku: mard marbuta ma ’ żieda fir - riskju ta ’ fsad, bħal disturbi konġenitali jew miksuba tal- koagulazzjoni, tromboċitopenja jew difetti funzjonali tal- plejtlits, mard gastrointestinali ulċerattiv attiv, bijopsija riċenti jew trawma maġġuri, emorraġija intrakranjali riċenti jew operazzjoni fil- moħħ, fil- kolonna vertebrali jew oftalmika, endokardite batterjali.
Patients with moderate renal impairment have an increased exposure to dabigatran.
Pazjenti b’ indeboliment renali moderat għandhom żieda fl- espożizzjoni għal dabigatran.
Limited data is available in patients < 50 kg and the elderly (see sections 4.2 and 5.2).
Dejta limitata hi disponibbli f’ pazjenti b’ piż ta ’ < 50 kg fl- anzjani (ara sezzjonijiet 4. 2 u 5. 2).
In these situations, Pradaxa should be used with caution and a close clinical surveillance (looking for signs of bleeding or anemia) is required throughout the treatment period (see section 4.2).
F’ dawn is- sitwazzjonijiet, Pradaxa għandha tintuża bl- attenzjoni, u sorveljanza klinika mill- qrib (tfittex għal sinjali ta ’ fsad jew anemija) hi meħtieġa matul il- perjodu kollu tal- kura (ara sezzjoni 4. 2).
When severe bleedings occur treatment must be discontinued and the source of bleeding investigated (see section 4.9).
Meta jseħħ fsad sever, il- kura għandha titwaqqaf u s- sors ta ’ fsad għandu jkun investigat (ara sezzjoni 4. 9).
Agents that may enhance the risk of haemorrhage should not be administered concomitantly or should be administered with caution with Pradaxa (see section 4.5).
4 Mediċini li jistgħu jżidu r- riskju ta ’ emorraġija m’ għandhomx jingħataw fl- istess ħin, jew għandhom jingħataw bl- attenzjoni ma ’ Pradaxa (ara sezzjoni 4. 5).
Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events:
Pazjenti f’ riskju għoli ta ’ mortalità kirurġika u b’ fatturi intrinsiċi ta ’ riskju għal avvenimenti tromboemboliċi:
There are limited efficacy and safety data for dabigatran available in these patients and therefore they should be treated with caution.
Hemm dejta limitata dwar l- effikaċja u s- sigurtà għal dabigatran disponibbli f’ dawn il- pazjenti, u għalhekk għandhom ikunu kkurati bl- attenzjoni.
4 Spinal anaesthesia/ epidural anaesthesia/ lumbar puncture:
Loppju fil- kolonna vertebrali/ loppju epidurali/ titqiba fis- sinsla:
In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long- term or permanent paralysis cannot be excluded with the concurrent use of dabigatran and spinal/ epidural anaesthesia or spinal puncture.
F’ pazjenti li jkollhom operazzjoni ortopedika maġġuri, ematomi epidurali jew tal- kolonna vertebrali li jistgħu jirriżultaw f’ paralisi fit- tul jew permanenti, ma jistgħux ikunu esklużi bl- użu fl- istess ħin ta ’ dabigatran u ta ’ loppju fil- kolonna vertebrali/ epidurali jew titqiba fil- kolonna vertebrali.
The risk of these rare events may be higher with postoperative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Ir- riskju ta ’ dawn l - avvenimenti rari jista ’ jkun ogħla bl- użu ta ’ kateters epidurali indwelling wara l- operazzjoni, jew bl- użu fl - istess ħin ta ’ prodotti mediċinali li jaffettwaw l- emostasi.
Therefore the use of Pradaxa is not recommended in patients undergoing anaesthesia with post-operative indwelling epidural catheters.
Għalhekk, l- użu ta ’ Pradaxa mhuwiex rakkomandat f’ pazjenti li jkun qed jingħatalhom il- loppju b’ kateters epidurali indwelling wara l- operazzjoni.
Administration of the first dose of Pradaxa should occur a minimum of two hours after the catheter is removed.
L- għoti ta ’ l- ewwel doża ta ’ Pradaxa għandu jseħħ wara mill- inqas sagħtejn wara li l- kateter jitneħħa.
These patients require frequent observation for neurological signs and symptoms.
Dawn il- pazjenti jeħtieġu osservazzjoni frekwenti għal sinjali u sintomi newroloġiċi.
Hip fracture surgery:
Operazzjoni minħabba ksur fil- ġenbejn:
There is no data on the use of Pradaxa in patients undergoing hip fracture surgery.
M’ hemmx dejta dwar l- użu ta ’ Pradaxa f’ pazjenti li jkollhom operazzjoni minħabba ksur fil- ġenbejn.
Therefore treatment is not recommended.
Ghalhekk, il- kura mhijiex rakkommandata.
Colorants:
Koloranti:
Pradaxa hard capsules contain the colorant sunset yellow (E110), which may cause allergic reactions.
Pradaxa kapsuli iebsin fihom il- kolorant sunset yellow (E110), li jista ’ jikkawża reazzjonijiet allerġiċi.
Interaction studies have only been performed in adults.
L- istudji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott, saru biss fuq l - adulti.
Anticoagulants and platelet aggregation agents:
Mediċini kontra l- koagulazzjoni tad- demm u sustanzi ta ’ l- aggregazzjoni tal- plejtlits:
The following treatments are not recommended concomitantly with Pradaxa: unfractionated heparins and heparin derivatives, low molecular weight heparins (LMWH), fondaparinux, desirudin, thrombolytic agents, GPIIb/ IIIa receptor antagonists, clopidogrel, ticlopidine, dextran, sulfinpyrazone and vitamin K antagonists.
Il- kuri li ġejjin m’ għandhomx mhumiex rakkomandati li jingħataw fl- istess ħin ma ’ Pradaxa: eparini mhux frazzjonati u derivattivi ta ’ l- heparin, eparini b’ piż molekulari baxx (low molecular weight heparins - LMWH), fondaparinux, desirudin, sustanzi trombolitiċi, antagonisti tar- riċettur GPIIb/ IIIa, clopidogrel, ticlopidine, dextran, sulfinpyrazone u antagonisti tal- vitamina K.
It should be noted that unfractionated heparin can be administered at doses necessary to maintain a patent central venous or arterial catheter (see sections 4.2 and 4.4).
Wieħed għandu jinnota li l- heparin mhux frazzjonata tista ’ tingħata fid- dożi meħtieġa biex iżżomm kateter ċentrali miftuħ jew kateter arterjali tal - pazjent (ara sezzjonijiet 4. 2 u 4. 4).
Interactions linked to dabigatran etexilate and dabigatran metabolic profile:
Interazzjonijiet marbuta mal- profil metaboliku ta ’ dabigatran etexilate u dabigatran:
Dabigatran etexilate and dabigatran are not metabolised by the cytochrome P450 system and have no in vitro effects on human cytochrome P450 enzymes.
Dabigatran etexilate u dabigatran mhumiex metabolati mis- sistema taċ- ċitokrom P450 u m’ għandhom l- ebda effetti in vitro fuq l- enzimi taċ- ċitokrom P450 tal- bniedem.
Therefore, related medicinal product interactions are not expected with dabigatran.
Għalhekk, interazzjonijiet relatati tal- prodott mediċinali mhumiex mistennija b’ dabigatran.
NSAIDs:
5 NSAIDs:
When Pradaxa was coadministered with diclofenac, the plasma exposure of both medicinal products remained unchanged indicating a lack of a pharmacokinetic interaction between dabigatran etexilate and diclofenac.
Meta Pradaxa ingħatat flimkien ma ’ diclofenac, l- espożizzjoni tal- plażma taż- żewġ prodotti mediċinali baqgħet mhux mibdula, u dan jindika nuqqas ta ’ interazzjoni farmakokinetika bejn dabigatran etexilate u diclofenac.
However, due to the risk of haemorrhage, notably with NSAIDs with elimination half-lives > 12 hours, close observation for signs of bleeding is recommended (see section 4.4).
Madankollu, minħabba r- riskju ta ’ emorraġija, speċjalment ma ’ NSAIDs b’ half- lives ta ’ l- eliminazzjoni > 12- il siegħa, osservazzjoni mill- qrib għal sinjali ta ’ fsad hi rakkomandata (ara sezzjoni 4. 4).
Transporter interactions:
Interazzjonijiet tat- trasportatur:
Amiodarone is an inhibitor of the efflux transporter P-glycoprotein and dabigatran etexilate a substrate of this transporter.
Amiodarone hu inibitur tat- trasportatur ta ’ l- effluss P- glycoprotein u dabigatran etexilate hu substrat ta ’ dan it- trasportatur.
When Pradaxa was coadministered with amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.
Meta Pradaxa ingħatat flimkien ma ’ amiodarone, il- medda u r- rata ta ’ l - assorbiment ta ’ amiodarone u tal- metabolit attiv tiegħu DEA kienu essenzjalment mhux mibdula.
The dabigatran AUC and Cmax were increased by about 60% and 50%, respectively.
L- AUC u s- Cmax ta ’ dabigatran żdiedu b’ madwar 60% u 50%, rispettivament.
The mechanism of the interaction has not been completely clarified.
Il- mekkaniżmu ta ’ l- interazzjoni ma kienx iċċarat kompletament.
In view of the long half-life of amiodarone the potential for drug interaction may exist for weeks after discontinuation of amiodarone.
Minħabba l- half- life twila ta ’ amiodarone, il- potenzjal għal interazzjoni tal - mediċina jista ’ jeżisti għal xi ġimgħat wara t- twaqqif tal- kura b’ amiodarone.
5 Dosing should be reduced to 150 mg Pradaxa daily in patients who received concomitantly dabigatran etexilate and amiodarone (see section 4.2).
Id- dożaġġ għandu jitnaqqas għal 150 mg ta ’ Pradaxa kuljum f’ pazjenti li jkunu rċivew dabigatran etexilate u amiodarone fl- istess ħin (ara sezzjoni 4. 2).
P- glycoprotein inhibitors:
Inibituri ta ’ P- glycoprotein:
Caution should be exercised with strong P- glycoprotein inhibitors like verapamil, clarithromycin, and others.
Għandha tingħata attenzjoni b’ inibituri qawwija ta ’ P- glycoprotein bħal verapamil, clarithromycin, u oħrajn.
The P- glycoprotein inhibitor quinidine is contraindicated (see section 4.3).
L- inibitur ta ’ quinidine, P - glycoprotein, hu kontra- indikat (ara sezzjoni 4. 3).
P- glycoprotein inducers:
Indutturi ta ’ P- glycoprotein:
Potent P- glycoprotein inducers such as rifampicin or St John’ s wort (Hypericum perforatum), may reduce the systemic exposure of dabigatran.
Indutturi qawwija ta ’ P- glycoprotein bħal rifampicin jew St John’ s wort (Hypericum perforatum), jistgħu jnaqqsu l- espożizzjoni sistemika ta ’ dabigatran.
Caution is advised when co-administering these medicinal products.
L- attenzjoni hi rakkomandata meta dawn il- prodotti mediċinali jingħataw flimkien.
In a study performed with 24 healthy subjects, when Pradaxa was coadministered with digoxin, no changes on digoxin and no clinical relevant changes on dabigatran exposure have been observed.
Fi studju li sar fuq 24 persuni b’ saħħithom, meta Pradaxa ingħatat flimkien ma ’ digoxin, ma kien osservat l- ebda tibdil fuq digoxin u l- ebda tibdil klinikament rilevanti fuq l- espożizzjoni għal dabigatran.
Gastric pH:
pH gastrika:
When Pradaxa was coadministered with pantoprazole, a decrease in the dabigatran area under the plasma concentration - time curve of approximately 30% was observed.
Meta Pradaxa ingħatat flimkien ma ’ pantoprazole, kien osservat tnaqqis fiż- żona taħt il- kurva tal- konċentrazzjoni tal- plażma - ħin ta ’ dabigatran ta ’ madwar 30%.
Pantoprazole and other proton- pump inhibitors were co-administered with Pradaxa in clinical trials and no effects on bleeding or efficacy were observed.
Pantoprazole u inibituri proton- pump oħrajn ingħataw flimkien ma ’ Pradaxa fi provi kliniċi, u l- ebda effetti fuq il- fsad jew fuq l- effikaċja ma kienu osservati.
Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran.
L- għoti ta ’ ranitidine flimkien ma ’ Pradaxa ma kellu l- ebda effett klinikament rilevanti fuq l - ammont ta ’ assorbiment ta ’ dabigatran.
There are no adequate data from the use of Pradaxa in pregnant women.
M’ hemmx dejta biżżejjed mill- użu ta ’ Pradaxa f’ nisa tqal.