qanastek/EMEA-V3 huggingface dataset:
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex
tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Pradaxa is and what it is used for 2.
X’ inhi Pradaxa u għalxiex tintuża 2.
Before you take Pradaxa 3.
Qabel ma tuża Pradaxa 3.
How to take Pradaxa 4.
Kif tuża Pradaxa 4.
How to store Pradaxa 6.
Kif taħżen Pradaxa 6.
WHAT PRADAXA IS AND WHAT IT IS USED FOR
X’ INHI PRADAXA U GĦALXIEX TINTUŻA
What is Pradaxa:
X’ inhi Pradaxa?
Pradaxa is a medicine which is used to prevent the formation of blood clots.
Pradaxa hi mediċina li tintuża biex tkun evitata l- formazzjoni ta ’ emboli tad- demm.
It works by blocking a substance in the body which is involved in blood clot formation.
Taħdem billi timblokka sustanza fil- ġisem li hi involuta fil- formazzjoni ta ’ l- emboli tad- demm.
What Pradaxa is used for:
Għalxiex tintuża Pradaxa
Pradaxa is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery.
Pradaxa tintuża biex tevita l- formazzjoni ta ’ emboli tad- demm fil- vini wara operazzjoni tas- sostituzzjoni ta ’ l- irkoppa jew tal- ġenbejn.
BEFORE YOU TAKE PRADAXA
QABEL MA ’ TUŻA PRADAXA
Do NOT take Pradaxa
Tiħux Pradaxa
- if you are allergic to dabigatran etexilate, dabigatran or any of the other ingredients of Pradaxa.
- jekk inti allerġiku/ a għal dabigatran etexilate, dabigatran jew għal xi sustanza oħra ta ’ Pradaxa.
- if you have severely reduced kidney function.
- jekk għandek funzjoni tal- kliewi mnaqqsa b’ mod sever.
- if you are currently bleeding
- jekk bħalissa għandek xi fsad
- if you have a disease in an organ of the body that increases the risk of serious bleeding.
- jekk għandek marda f’ xi organu tal- ġisem li żżid ir- riskju ta ’ ħruġ serju tad- demm.
- if you have an increased tendency to bleed.
- jekk għandek tendenza għal żieda fir- riskju ta ’ fsad.
This may be inborn, of unknown cause or due to other
Dan jista ’ jkun konġenitali, ġej minn kawża mhux
medicines.
magħrufa, jew minħabba mediċini oħrajn.
- if you have a severely reduced liver function or liver disease which could possibly cause death.
- jekk għandek tnaqqis sever fil- funzjoni tal- fwied jew mard tal- fwied li possibbilment jista ’ jikkawża l -
- if you are taking quinidine, a medicine to treat abnormal heart beats.
- jekk qed tieħu quinidine, mediċina għall- kura ta ’ taħbit anormali tal- qalb.
Take special care with Pradaxa
47 Oqgħod attent ħafna bi Pradaxa
Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:
Għid lit- tabib tiegħek jekk għandek jew kellek kwalunkwe kundizzjonijiet mediċi jew mard, partikularment xi waħda minn dawn li ġejjin:
- if you have a liver disease that is associated with changes in the blood tests, the use of Pradaxa is not
- jekk għandek marda tal- fwied li hi assoċjata ma ’ tibdil fit- testijiet tad- demm, l- użu ta ’ Pradaxa mhuwiex
recommended.
rakkomandat.
- if you have an increased bleeding risk, as could be the case in the following situations:
- jekk għandek żieda fir- riskju ta ’ fsad, kif jista ’ jkun il- każ fis- sitwazzjonijiet li ġejjin:
Pradaxa should not be used in children.
jekk kellek tneħħija kirurġika ta ’ xi tessut (bijopsija) fl- aħħar xahar. jekk kellek korriment serju (eż. ksur ta ’ l- għadam, korriment f’ rasek jew kwalunkwe korriment li kien jeħtieġ kura kirurġika). jekk qed tirċievi kuri li jistgħu jżidu r- riskju ta ’ fsad. jekk qed tieħu mediċini kontra l- infjammazzjoni. jekk qed tbati minn infezzjoni tal- qalb (endokardite batterjali). jekk għandek funzjoni tal- kliewi moderatament indebolita Pradaxa m’ għandux jintuża fit- tfal.
- if you have a tube (catheters) inserted into the back:
- jekk għandek tubu (kateter) imdaħħal ġo dahrek:
A tube can be inserted into your back e. g. for anesthesia or pain relief during or after surgery.
Tubu jista ’ jiddaħħal f’ dahrek, qrib is- sinsla, eż. għal loppju jew solliev mill- uġigħ waqt jew wara l - operazzjoni.
If you are administered Pradaxa after removal of a catheter your doctor will examine you regularly.
Jekk tingħata Pradaxa wara li l- kateter ikun tneħħa, it- tabib tiegħek ser jeżaminak regolarment.
For instance:
Per eżempju:
- Blood thinners (e. g. warfarin, heparin)
- Mediċini li jraqqu d- demm (eż. warfarin, heparin)
- Non-steroidal anti-inflammatory medicines
- Mediċini mhux sterojdi kontra l- infjammazzjoni
John´s wort, rifampicin, verapamil, clarithromycin
John´s wort, rifampicin, verapamil, clarithromycin
- Amiodarone
- Amiodarone
If you are taking amiodarone-containing medicines you should be treated with a reduced dose of 150 mg Pradaxa
Jekk qed tieħu mediċini li jkun fihom amiodarone, għandek tkun ikkurat b’ doża mnaqqsa ta ’ 150 mg ta ’ Pradaxa.
Taking Pradaxa with food and drink
Meta tieħu Pradaxa ma ’ l- ikel u max- xorb
Pradaxa can be taken with or without food.
Pradaxa tista ’ tittieħed ma ’ l- ikel jew mingħajr l- ikel.
The effects of Pradaxa on pregnancy and the unborn child are not known.
L- effetti ta ’ Pradaxa fuq it- tqala u fuq it- tarbija mhix imwielda mhumiex magħrufa.
You should not take Pradaxa if you are pregnant unless your doctor advises you that it is safe to do so.
M’ għandekx tieħu Pradaxa jekk inti tqila ħlief jekk it- tabib tiegħek jagħtik parir li hu sigur li tagħmel hekk.
If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Pradaxa.
Jekk inti mara ta ’ età li fiha jista ’ jkollhok it- tfal, għandek tevita li toħroġ tqila meta tkun qed tieħu Pradaxa.
You should not breast-feed while you are taking Pradaxa.
M’ għandekx tredda ’ meta tkun qed tieħu Pradaxa.
The effect of Pradaxa on the ability to drive and use machines is not known.
L- effett ta ’ Pradaxa fuq il- ħila biex issuq jew tħaddem il- magni mhuwiex magħruf.
Your doctor will tell you when you can start to drive.
It- tabib tiegħek ser jgħidlek meta tkun tista ’ tibda ssuq.
Important information about some of the ingredients of Pradaxa
48 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Pradaxa
Pradaxa hard capsules contain a colorant with the name sunset yellow, which may cause allergic reactions.
Pradaxa kapsuli iebsin fihom kolorant bl- isem ta ’ sunset yellow, li jista ’ jikkawża reazzjonijiet allerġiċi.
HOW TO TAKE PRADAXA
KIF GĦANDEK TUŻA PRADAXA
When taking Pradaxa capsules out of the blister pack, please observe the following instructions
Meta tkun qed toħroġ il- kapsuli Pradaxa mill- pakkett tal- folji, jekk jogħġbok osserva l- istruzzjonijiet li ġejjin
• take the capsules by peeling off the backing foil of the blister card. • do not push the capsules through the blister foil. • do not peel off the blister foil until a capsule is required.
• ħu l- kapsuli billi tqaxxar il- fojl ta ’ wara tal- kard tal- folja. • timbuttax il- kapsuli minn ġol- fojl tal- folja. • tqaxxarx il- fojl tal- folja ħlief jekk ikollok bżonn tieħu kapsula.
When taking Pradaxa capsules out of the bottle, please observe the following instructions
Meta tkun qed toħroġ il- kapsuli Pradaxa mill- flixkun, jekk jogħġbok osserva l- istruzzjonijiet li ġejjin
• push and turn for opening
• imbotta u dawwar biex tiftaħ
The generally recommended dose of Pradaxa is 220 mg once a day (taken as 2 capsules of 110 mg).
Normalment, id- doża rakkomandata ta ’ Pradaxa hi ta ’ 220 mg darba kuljum (li tittieħed bħala 2 kapsuli ta ’ 110 mg).
If your kidney function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).
Jekk il- funzjoni tal- kliewi tiegħek tonqos b’ iktar min- nofs, jew jekk għandek 75 sena jew iktar, id- doża rakkomandata hi ta ’ 150 mg darba kuljum (li tittieħed bħala 2 kapsuli ta ’ 75 mg).
After knee replacement surgery
Wara operazzjoni tas- sostituzzjoni ta ’ l- irkoppa:
You should start treatment with Pradaxa within 1 – 4 hours after surgery finishes, taking a single capsule.
Għandek tibda l- kura bi Pradaxa fi żmien 1 – 4 sigħat wara li tispiċċa l- operazzjoni, billi tieħu kapsula waħda.
Thereafter two capsules once a day should be taken for a total of 10 days.
Wara dak il- perjodu, għandek tieħu żewġ kapsuli darba kuljum għal total ta ’ 10 ijiem.
After hip replacement
Wara s- sostituzzjoni tal- ġenbejn:
Thereafter two capsules once a day should be taken for a total of 28 - 35 days.
Wara dak il- perjodu, għandek tieħu żewġ kapsuli darba kuljum għal total ta ’ 28 - 35 jum.
For both surgery types, treatment should not be started if there is bleeding from the site of operation.
Għaż- żewġ tipi ta ’ operazzjoni, il- kura m’ għandhiex tinbeda jekk ikun hemm fsad mis- sit ta ’ l- operazzjoni.
If the treatment cannot be started until the day after surgery, dosing should be started with 2 capsules once daily.
Jekk il- kura ma tkunx tista ’ tinbeda sal- jum ta ’ wara l- operazzjoni, id- dożaġġ għandu jinbeda b’ 2 kapsuli darba kuljum.
Always take Pradaxa exactly as your doctor has told you.
Dejjem għandek tieħu Pradaxa skond il- parir tat- tabib.
The capsule should be swallowed with some water.
Il- kapsula għandha tinbela ’ ma ’ ftit ilma.
Do not chew the capsule.
Tomgħodx il- kapsula.
Changing from treatment with Pradaxa to anticoagulant treatment given by injection Do not start treatment with injectable anticoagulant medicines (for example, heparin) until 24 hours after the final dose of Pradaxa.
Tibdiex il- kura b’ mediċini antikoagulanti li jistgħu jiġu injettati (pereżempju, heparin) sa 24 siegħa wara d - doża finali ta ’ Pradaxa.
Changing from anticoagulant treatment given by injection to treatment with Pradaxa Stop the treatment by injection and then start taking Pradaxa at the time you would have had the next injection.
Waqqaf il- kura permezz ta ’ injezzjoni u mbagħad ibda ħu Pradaxa fil- ħin li kieku tkun ħadt l- injezzjoni li jmiss.
If you take more Pradaxa than you should If you take more Pradaxa than recommended, you may have an increased risk of bleeding.
Jekk tieħu Pradaxa aktar milli suppost Jekk tieħu aktar Pradaxa minn dak rakkomandat, jista ’ jkollok żieda fir- riskju ta ’ fsad.
Your doctor can perform a blood test to assess the risk of bleeding.
It- tabib tiegħek jista ’ jagħmel test tad- demm biex jevalwa r- riskju ta ’ fsad.
Inform your doctor as soon as possible if you take more than the prescribed dose of Pradaxa.
49 Informa lit- tabib tiegħek kemm jista ’ jkun malajr jekk tieħu iktar mill- ammont tad- doża ta ’ Pradaxa li għaliha ngħatatek riċetta.
If bleeding occurs, surgical treatment or treatment with blood transfusions may be required.
Jekk iseħħ fsad, kura kirurġika jew kura bi trasfużjonijiet tad- demm tista ’ jkun meħtieġa.
If you forget to take Pradaxa Continue with your remaining daily doses of Pradaxa at the same time of the next day.
Jekk tinsa tieħu Pradaxa Kompli bil- bqija tad- dożi ta ’ kuljum ta ’ Pradaxa fl- istess ħin tal- jum li fih kieku kont tieħu d- doża li tkun insejt.
Do not take a double dose to make up for missed individual doses.
Tiħux doża doppja biex tpatti għad- dożi individwali li tkun insejt tieħu.
47 If you stop taking Pradaxa Do not stop taking Pradaxa without first consulting your doctor, since the risk of developing a blood clot in a vein could be higher if you stop treatment early.
Jekk tieqaf tieħu Pradaxa Tiqafx tieħu Pradaxa mingħajr ma l- ewwel titkellem mat- tabib tiegħek, għax ir- riskju li tiżviluppa embolu tad- demm f’ xi vina jista ’ jkun ogħla jekk twaqqaf il- kura kmieni.
Like all medicines, Pradaxa can cause side effects, although not in all patients.
Bħal kull mediċina oħra, Pradaxa jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq il- pazjenti kollha.
As this medicine affects blood clotting, most side effects are related to signs such as bruising or bleeding.
Billi din il- mediċina taffettwa t- tagħqid tad- demm, il- biċċa l- kbira ta ’ l- effetti huma marbuta ma ’ sinjali bħal tbenġil jew fsad.
The side effects are listed below, grouped by how likely they are to happen:
L- effetti sekondarji huma elenkati hawn taħt, ikklassifikati skond kemm x’ aktarx li ser iseħħu:
With Pradaxa the following common and uncommon side effects are known:
Bi Pradaxa, l- effetti sekondarji komuni u mhux komuni li ġejjin huma magħrufa:
Common side effects (affects 1 to 10 users in 100):
Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100):
- A fall in the number of red cells in the blood
- Tnaqqis fin- numru ta ’ ċelluli ħomor fid- demm
- Haematoma formation
- Formazzjoni ta ’ ematoma
- Bleeding from an injury
- Fsad minn ferita
- A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
- Tnaqqis fl- ammont ta ’ emoglobina fid- demm (is- sustanza fiċ- ċelluli ħomor tad- demm)
- Wound secretion (liquid exuding from the surgical wound)
- Tnixxija minn ferita (likwidu li joħroġ minn ferita kirurġika)
- Bruising occurring after an operation
- Tbenġil li jseħħ wara xi operazzjoni
- Bleeding occurring after an operation
- Fsad li jseħħ wara xi operazzjoni
- A fall in the number of red cells in the blood after an operation
- Tnaqqis fin- numru ta ’ ċelluli ħomor fid- demm wara operazzjoni
- Bruising due to an injury
- Tbenġil minħabba xi korriment
- Exudation of a small amount of liquid from the incision made for a surgical procedure
- Il- ħruġ ta ’ ammont żgħir ta ’ likwidu mill- inċiżjoni li ssir għal proċedura kirurġika
- Blood found in the urine on laboratory testing.
- Demm li jinstab fl- awrina wara ttestjar fil- laboratorju.
Uncommon side effects (affects 1 to 10 users in 1,000):
Effetti sekondarji mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1, 000):
- Bleeding
- Fsad
- Bleeding into a joint
- Fsad ġo ġog
- A fall in the number of platelets in the blood
- Tnaqqis fin- numru ta ’ plejtlits fid- demm
- Nose bleed
- Tinfaraġ
- Bleeding into the stomach or bowel
- Fsad għal ġo l- istonku jew l- imsaren
- Bleeding from piles
- Fsad mill- murliti
- Bleeding into the rectum
- Fsad ġor- rektum
- Blood in the urine that stains the urine pink or red
- Demm fl- awrina li jagħti lewn roża jew aħmar lill- awrina
- Bleeding under the skin
- Fsad taħt il- ġilda
- Blood-stained discharge from the site of entry of a catheter into a vein
- Tnixxija ta ’ likwidu bid- demm mis- sit minn fejn il- kateter jidħol ġo vina
- Bleeding from the site of entry of a catheter into a vein
- Fsad mis- sit minn fejn il- kateter jidħol ġo vina
- Blood detected in the stools by a laboratory test
50 Demm osservat fl- ippurgar permezz ta ’ test tal- laboratorju
- A decrease in the proportion of red cells in the blood
Tnaqqis fil- proporzjon ta ’ ċelluli ħomor fid- demm
- Bleeding from a surgical incision
Fsad minn inċiżjoni kirurġika
- Unusual laboratory test results on liver function
Riżultati mhux tas- soltu tat- testijiet tal- laboratorju fuq il- funzjoni tal- fwied
HOW TO STORE PRADAXA
KIF TAĦŻEN PRADAXA
Keep out of the reach and sight of children.
Żommu fejn ma tintlaħaqx u ma tidhirx mit- tfal.
Do not use Pradaxa after the expiry date which is stated on the carton, blister or bottle.
Tużax Pradaxa wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun, folja jew flixkun.
Once opened, the product must be used within 30 days.
Ġaladarba jinfetaħ, il- prodott għandu jintuża fi żmien 30 jum.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni ta ’ l - ambjent.
What Pradaxa contains
X’ fiha Pradaxa
The active substance is dabigatran, which is administered in the form of 75 mg or 110 mg dabigatran etexilate given as mesilate.
Is- sustanza attiva hi dabigatran, li jingħata taħt is- sura ta ’ 75 mg or 110 mg dabigatran etexilate mogħti bħala mesilate.
The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and hydroxypropylcellulose
Is- sustanzi l- oħra huma tartaric acid, acacia, hypromellose, dimeticone 350, talc, u hydroxypropylcellulose
The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, sunset yellow, hypromellose and purified water
Il- qoxra tal- kapsula fiha carrageenan, potassium chloride, titanium dioxide, indigo carmine, sunset yellow, hypromellose, u ilma ppurifikat
The black printing ink contains shellac, N-butyl alcohol, isopropyl alcohol, industrial methylated spirit, iron oxide black, purified water and propylene glycol
Il- linka sewda ta ’ l- istampar fiha shellac, N- butyl alcohol, isopropyl alcohol, industrial methylated spirit, iron oxide black, ilma ppurifikat, u propylene glycol
What Pradaxa looks like and contents of the pack
Id- dehra ta ’ Pradaxa u l- kontenuti tal- pakkett
Pradaxa is a hard capsule.
Pradaxa hi kapsula iebsa.
Pradaxa 75 mg hard capsules have an opaque, light blue-coloured cap and an opaque, cream-coloured body.
Pradaxa 75 mg kapsuli iebsin għandhom għatu blu ċar u opak, u korp opak mil- lewn il- krema.
The Boehringer Ingelheim logo is printed on the cap and “ R75 ” on the body of the capsule.
Il- logo ta ’ Boehringer Ingelheim hu stampat fuq l- għatu u “ R75 ” fuq il- korp tal- kapsula.
Pradaxa 110 mg hard capsules have an opaque, light blue-coloured cap and an opaque, cream-coloured body.
Pradaxa 110 mg kapsuli iebsin għandhom għatu blu ċar u opak, u korp opak mil- lewn il- krema.
The Boehringer Ingelheim logo is printed on the cap and “ R110 ” on the body of the capsule.
Il- logo ta ’ Boehringer Ingelheim hu stampat fuq l- għatu u “ R110 ” fuq il- korp tal- kapsula.
Pradaxa 75 mg and 110 mg hard capsules are available in packs containing 10 x 1, 30 x 1, 60 x 1 capsules in aluminium perforated unit dose blisters.
Pradaxa 75 mg jew 110 mg kapsuli iebsin huma disponibbli f’ pakketti li fihom 10 x 1, 30 x 1, jew 60 x 1 kapsuli f’ folji ta ’ l- aluminju perforat tad- doża ta ’ l- unità.
Pradaxa 75 mg and 110 mg hard capsules are also available in polypropylene (plastic) bottles with 60 hard capsules.
51 Pradaxa 75 mg u 110 mg kapsuli iebsin huma disponibbli wkoll fi fliexken tal- polypropylene (plastik) b’ 60 kapsula iebsa.
49 Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
50 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
52 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA): http: // www. emea. europa. eu /
What is Pramipexole Teva?
X’ inhu Pramipexole Teva?
Pramipexole Teva is a medicine containing the active substance pramipexole base.
Pramipexole Teva huwa mediċina li fiha s- sustanza attiva pramipexole base.
It is available as white, round tablets (0.088, 0.18, 0.35 and 0.7 mg).
Huwa disponibbli f' pilloli tondi u bojod (0. 088, 0. 18, 0. 35 u 0. 7 mg).
Pramipexole Teva is a ‘ generic medicine’.
Pramipexole Teva huwa ‘ mediċina ġenerika ’.
This means that Pramipexole Teva is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Sifrol.
Dan ifisser li Pramipexole Teva huwa simili għall - ‘ mediċina ta ’ referenza ’ diġà awtorizzata fl- Unjoni Ewropea (UE) bl- isem Sifrol.
For more information on generic medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar il- mediċini ġeneriċi, ikkonsulta d- dokument mistoqsija- u- tweġiba hawn.
What is Pramipexole Teva used for?
Għal xiex jintuża Pramipexole Teva?
Pramipexole Teva is used to treat the symptoms of Parkinson’ s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Pramipexole Teva jintuża għat- trattament tas- sintomi tal- marda ta 'Parkinson li hija disturb mentali progressiv li jikkawża rogħda, dewmien fil- movimenti u ebusija muskolari.
Pramipexole Teva can be used either on its own or in combination with levodopa (another medicine for Parkinson’ s disease), at any stage of disease including the later stages when levodopa starts becoming less effective.
Pramipexole Teva jista ’ jintuża jew waħdu jew flimkien ma ’ levodopa (mediċina oħra għall- marda ta ’ Parkinson) f’ kull stadju tal- marda inkluż fl- aħħar stadji meta levodopa jibda jkun anqas effikaċi.
How is Pramipexole Teva used?
Kif jintuża Pramipexole Teva?
Pramipexole Teva tablets should be swallowed with water, with or without food.
Il- pilloli ta ’ Pramipexole Teva għandhom jinbelgħu mal- ilma, mal- ikel jew fuq stonku vojt.
The dose should be increased every five to seven days until symptoms are controlled without causing side effects that cannot be tolerated.
Id- doża għandha tiġi miżjuda kull ħames sa sebat ijiem sakemm is- sintomi jiġu kontrollati mingħajr ma jiġu kkawwżati effetti sekondarji li ma jistgħux jiġu tollerati.
The maximum daily dose is 1.1 mg three times per day.
Id- doża massima kuljum hija ta ’ 1. 1 mg tliet darbiet kuljum.
Pramipexole Teva must be given less frequently in patients who have problems with their kidneys.
Pramipexole Teva għandu jingħata anqas frekwentement lil pazjenti li għandhom problemi fil- kliewi tagħhom.
If treatment is stopped for any reason, the dose should be decreased gradually.
Jekk jitwaqqaf it - trattament għal kwalunkwe raġuni, id- doża għandha titnaqqas gradwalment.
How does Pramipexole Teva work?
Kif jaħdem Pramipexole Teva?
The active substance in Pramipexole Teva, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Is- sustanza attiva f' Pramipexole Teva, pramipexole, hija agonista tad- dopamina li jfisser li timita l - azzjoni tad- dopamina.
In patients with Parkinson’ s disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Fil- pazjenti li jbatu mill- marda ta ’ Parkinson, iċ- ċelluli li jipproduċu d- dopamina jibdew imutu u b' hekk l- ammont ta 'dopamina fil- moħħ jonqos.
Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’ s disease, such as shaking, stiffness and slowness of movement.
Pramipexole jistimola l- moħħ hekk kif tagħmel id- dopamina, biex b' hekk il- pazjenti jkunu jistgħu jikkontrollaw il - movimenti tagħhom u jkollhom inqas sinjali u sintomi tal- marda ta 'Parkinson, bħar- rogħda, l- ebusija u d- dewmien fil- movimenti.
How has Pramipexole Teva been studied?
Kif ġie studjat Pramipexole Teva?
Because Pramipexole Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Minħabba li Pramipexole Teva huwa mediċina ġenerika, l- istudji ġew limitati għal testijiet biex jiġi determinat li huwa bijoekwivalenti għall- mediċina ta ’ referenza (jiġifieri li ż- żewġ mediċini jipproduċu l- istess livelli ta ’ sustanza attiva fil- ġisem).
What are the benefit and risk of Pramipexole Teva?
X’ inhu l- benefiċċju u r- riskju ta ’ Pramipexole Teva?
Because Pramipexole Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Minħabba li Pramipexole Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall- mediċini ta ’ referenza, il- benefiċċju u r- riskju tiegħu huma meqjusa li huma l- istess bħal dawk tal- mediċina ta ’ referenza.
Why has Pramipexole Teva been approved?
Għaliex ġie approvat Pramipexole Teva?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pramipexole Teva has been shown to have comparable quality and to be bioequivalent to Sifrol.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, b’ mod konformi mal- ħtiġijiet tal- UE, Pramipexole Teva wera li għandu kwalità komparabbli ma ’ u huwa bijoekwivlenti għal Sifrol.
The Committee recommended that Pramipexole Teva be given marketing authorisation.
Il- Kumitat irrakkomanda li Pramipexole Teva jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Pramipexole Teva:
Tagħrif ieħor dwar Pramipexole Teva:
The European Commission granted a marketing authorisation valid throughout the EU for Pramipexole Teva to Teva Pharma B. V. on 18 December 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Pramipexole Teva lil Teva Pharma BV fi 18 ta ’ Diċembru 2008.
The full EPAR for Pramipexole Teva can be found here.
L- EPAR sħiħ għal Pramipexole Teva jista ’ jinstab hawn.
The full EPAR for the reference medicine can also be found on the EMEA’ s website.
L- EPAR sħiħ għall- mediċina ta ’ referenza jista ’ jinstab ukoll fuq is- sit tal- internet tal- EMEA.
Pramipexole Teva 0.088 mg tablets
Pramipexole Teva 0. 088 mg pilloli
Each tablet contains 0.088 mg pramipexole base (as 0.125 mg pramipexole dihydrochloride monohydrate).
Kull pillola fiha 0, 088 mg bażi ta ’ pramipexole (bħala 0. 125 mg pramipexole dihydrochloride monohydrate).
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Għalhekk id - dożi għandhom jiġu mfissrin f’ termini kemm ta ’ bażi ta ’ pramipexole u tal- melħ ta ’ pramipexole (fil - parentesi).
White, round, flat face bevel edge tablet, 5.55 mm diameter, embossed with “ 93 ” on one side and “ P1” on the other side.
Pillola tonda, wiċċ ċatt b’ xifer imżerżaq, b’ dijametru ta ’ 5. 55 mm, intaljat b ’ "93" fuq naħa waħda u "P1" fuq in- naħa l- oħra.
Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i. e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “ on off ” fluctuations).
Pramipexole Teva hu indikat għal trattament tas- sinjali u s- sintomi tal- marda idjopatika ta ’ Parkinson, meta jingħata waħdu (mingħajr levodopa) jew f’ kombinazzjoni ma ’ levodopa, i. e. matul il- kors tal - marda, sal- istadji tardivi meta l- effett ta ’ levodopa jonqos ħafna jew isir inkonsistenti u jseħħu varjazzjonijiet tal- effett terapewtiku (fl- aħħar tad- doża jew varjazzjonijiet “ on off ”).
The tablets should be taken orally, swallowed with water, and can be taken either with or without food.
Il- pilloli għandhom jittieħdu orali, jinbelgħu mal- ilma u jistgħu jittieħdu mal- ikel jew mingħajr ikel.
Initial treatment:
Trattament tal- bidu:
Providing patients do not experience intolerable side-effects, the dosage should be titrated to achieve a maximal therapeutic effect.
Kemm- il darba pazjenti ma jkollhomx effetti mhux mixtieqa intollerabbli, id- dożaġġ għandu jkun ittitrat biex jilħaq l- ogħla effett terapewtiku.
Ascending – Dose schedule of Pramipexole Teva Week
Doża Totali ta ’
Dosage (mg of base)
(mg ta ’ bażi)
Total Daily Dose (mg of base)
Kuljum (mg ta ’ bażi)
Dosage (mg of salt)
(mg ta ’ melħ)
Total Daily Dose (mg of salt)
Kuljum (mg ta ’ melħ)
0.264 0.54 1.05
0. 264 0. 54 1. 05
If a further dose increase is necessary the daily dose should be increased by 0.54 mg base (0.75 mg salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5 mg of salt) per day.
Jekk żieda fid- doża hi meħtieġa, id- doża ta ’ kuljum għandha tiżdied b’ 0. 54 mg ta ’ bażi (0. 75 mg ta ’ melħ) f’ intervalli ta ’ ġimgħa sakemm tilħaq doża massima ta ’ 3. 3 mg ta ’ bażi (4. 5 mg ta ’ melħ) kuljum.
However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.8).
2 Madankollu, għandu jkun innutat li l- inċidenza ta ’ ngħas tiżdied f’ dożi ogħla minn 1. 5 mg/ kuljum (ara sezzjoni 4. 8).
2 Maintenance treatment:
Trattament ta ’ manteniment:
The individual dose should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Id- doża individwali għandha tkun fil- medda ta ’ bejn 0. 264 mg ta ’ bażi (0. 375 mg ta ’ melħ) sa doża massima ta ’ 3. 3 mg ta ’ bażi (4. 5 mg ta ’ melħ) kuljum.
During dose escalation in three pivotal studies, efficacy was observed starting at a daily dose of 1.1 mg of base (1.5 mg of salt).
Fi tliet studji tal- pern, l- effikaċja kienet osservata b’ doża ta ’ kuljum li tibda b’ 1. 1 mg ta ’ bażi (1. 5 mg ta ’ melħ).
Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions.
Aġġustamenti oħra fid- doża għandhom isiru skont ir- rispons kliniku tal- okkorrenza ta ’ reazzjonijiet avversi.
It is recommended that the dosage of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Teva, depending on reactions in individual patients.
Hu rakkomandat li d- doża ta ’ levodopa għandha titnaqqas kemm meta d- doża tkun qed tiżdied, kif ukoll matul il- kura tal- manteniment bi Pramipexole Teva, skont ir- reazzjonijiet fil- pazjenti individwali.
Treatment discontinuation:
It- twaqqif tat- trattament:
Abrupt discontinuation of dopaminergic therapy can lead to the development of aneuroleptic malignant syndrome.
It- twaqqif f’ daqqa tat- terapija dopaminerġika jista ’ jwassal għall- iżvilupp ta ’ sindromu newrolettiku malinn.
Dosing in patients with renal impairment:
Id- doża f’ pazjenti b’ indeboliment renali:
In patients with a creatinine clearance between 20 and 50 ml/ min, the initial daily dose of Pramipexole Teva should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/ 0.25 mg of salt daily).
F’ pazjenti bi tneħħija tal- kreatinina ta ’ bejn 20 u 50 ml/ min, id- doża inizjali ta ’ kuljum ta ’ Pramipexole Teva għandha tingħata f’ żewg dożi maqsumin ugwalment, li jibdew minn 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) darbtejn kuljum (0. 176 mg ta ’ bażi/ 0. 25 mg ta ’ melħ kuljum).
In patients with a creatinine clearance less than 20 ml/ min, the daily dose of Pramipexole Teva should be administered in a single dose, starting at 0.088 mg of base (0.125 mg of salt) daily.
F’ pazjenti bi tneħħija tal- kreatinina ta ’ inqas minn 20 ml/ min, id- doża ta ’ kuljum ta ’ Pramipexole Teva għandha tingħata f’ doża waħda, li tibda b’ 0. 088 mg ta ’ bażi (0. 125 mg ta ’ melħ) kuljum.
If renal function declines during maintenance therapy, reduce Pramipexole Teva daily dose by the same percentage as the decline in creatinine clearance, i. e. if creatinine clearance declines by 30%, then reduce the Pramipexole Teva daily dose by 30%.
Jekk il- funzjoni renali tonqos matul it- terapija tal- manteniment, naqqas id- doża ta ’ kuljum ta ’ Pramipexole Teva bl- istess perċentwali bħat- tnaqqis fit- tneħħija ta ’ kreatinina, i. e. jekk it- tneħħija tal - kreatinina tonqos bi 30%, naqqas id- doża ta ’ kuljum ta ’ Pramipexole Teva bi 30%.
The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/ min, and as a single daily dose if creatinine clearance is less than 20 ml/ min.
Id- doża ta ’ kuljum tista ’ tingħata f’ żewġ dożi kondiviżi jekk it- tneħħija tal- kreatinina tkun ta ’ bejn 20 u 50 ml/ min, u bħala doża waħda kuljum jekk it- tneħħija tal- kreatinina tkun inqas minn 20 ml/ min.
90% of absorbed active substance is excreted through the kidneys.
Id- dożaġġ f’ pazjenti b’ indeboliment epatiku L- aġġustament fid- doża f’ pazjenti b’ insuffiċjenza epatika probabbilment ma jkunx meħtieġ peress li madwar 90% tas- sustanza attiva assorbita tiġi eliminata minn ġol- kliewi.
However, the potential influence of hepatic insufficiency on pramipexole pharmacokinetics has not been investigated.
Madankollu, l- influwenza potenzjali ta ’ insuffiċjenza epatika fuq il- farmakokinetiċi ta ’ prampexole ma ġietx mistħarrġa.
Dosing in children and adolescents Pramipexole is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.
Id- dożaġġ fi tfal u l- adoloxxenti Pramipexole mhux rakkomandat għal użu fi tfal u l- adoloxxenti li għandhom inqas minn 18- il sena minħabba nuqqas ta ’ dejta tas- sigurtà u effikaċja.
4.3 Contraindications
4. 3 Kontrindikazzjonijiet
When prescribing Pramipexole Teva in a patient with Parkinson’ s disease with renal impairment a reduced dose is suggested in line with section 4.2.
3 Meta tingħata riċetta għal pilloli Pramipexole Teva f’ pazjent bil- marda ta ’ Parkinson b’ indeboliment renali, doża mnaqqsa hi suġġerita skont kif spjegat f’ sezzjoni 4. 2
Hallucinations are known as an adverse event of treatment with dopamine agonists and levodopa.
L- alluċinazzjonijiet huma magħrufa bħala effett avvers tal- kura b’ agonisti ta ’ dopamine u b’ levodopa.
Patients should be informed that (mostly visual) hallucinations can occur.
Il- pazjenti ghandhom ikunu infurmati li jistgħu jesperjenzaw alluċinazzjonijiet (l- aktar viżwali).
3 In advanced Parkinson’ s disease, in combination treatment with levodopa, dyskinesias can occur during the initial titration of Pramipexole Teva.
Fi stadju avvanzat ta ’ Parkinson, flimkien ma ’ kura b’ levodopa, id- diskinesija tista ’ sseħħ matul it - titrazzjoni inizjali ta ’ Pramipexole Teva.
If they occur, the dose of levodopa should be decreased.
Jekk din iseħħ, id- doża ta ’ levodopa għandha titnaqqas.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with pramipexole.
Il- pazjenti għandhom ikunu infurmati b’ dan u jkunu avżati biex joqgħodu attenti waqt is- sewqan jew tħaddim ta ’ magni meta jkunu qegħdin fuq kura bi pramipexole.
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Pazjenti li kellhom ngħas u/ jew episodju ta ’ irqad f’ daqqa m’ għandhomx isuqu jew iħaddmu inġenji.
Furthermore a reduction of dosage or termination of therapy may be considered.
Barra minn hekk, tnaqqis fid- dożaġġ jew it- twaqqif ta ’ terapija jistgħu jkunu kunsidrati.
Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see section 4.7 and section 4.8).
Minħabba l- possibilità ta ’ effetti addittivi, il- kawtela hija rakkomandata meta l- pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew alkoħol flimkien ma ’ pramipexole (ara sezzjoni 4. 7 u sezzjoni 4. 8).
Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson’ s disease, including pramipexole.
Logħob tal- ażżard patoloġiku, żieda fil- ħajra sesswali u ipersesswalità ġew rapportati f’ pazjenti trattati b’ agonisti tad- dopamine, li jinkludi pramipexole għal mard ta ’ Parkinson.
Furthermore, patients and caregivers should be aware of the fact that behavioural changes can occur.
Barra minn hekk, pazjenti u persuni li jieħdu ħsiebhom għandhom ikunu konxji mill- fatt li bidliet fl- imġieba jistgħu jseħħu.
Dose reduction/ taper or discontinuation should be considered.
Tnaqqis fid- doża/ gradwali jew waqfien għandhom jiġu kkunsidrati.
Patients with psychotic disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Pazjenti b’ disturbi psikotiċi għandhom ikunu trattati b’ agonisti ta ’ dopamine biss jekk is- siwi potenzjali jiżboq ir- riskji.
In case of severe cardiovascular disease, care should be taken.
Għandu jkun hemm attenzjoni f’ każ ta ’ mard kardjovaskulari sever.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Hu rakkomandat li jkun hemm monitoraġġ tal- pressjoni tad- demm, b’ mod speċjali fil- bidu tal- kura, minħabba r- riskju potenzjali ta ’ pressjoni tad- demm baxxa li tiddependi mill qagħda assoċjata mat- terapija dopominerġika.
Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Rapporti fil- letteratura medika jindikaw li trattament għal indikazzjoni oħra bi prodotti mediċinali dopominerġiċi jista ’ jirriżulta fi tiżjid.
Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities.
It- tiżjid jirreferi għall- bidu aktar bikri tas- sintomi filgħaxija (jew anke wara nofsinhar), żieda fis- sintomi, u l- firxa ta ’ sintomi biex jiġu involuti aktar estremitajiet.
The frequency of augmentation after longer use of pramipexole and the appropriate management of these events have not been evaluated in controlled clinical trials.
Il- frekwenza tat- tħarriex wara użu aktar fit- tul ta ’ pramipexole u l- immaniġġjar xieraq ta ’ dawn l - avvenimenti ma kienux evalwati fil- provi kliniċi b’ kontrolli
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Għalhekk, effetti ma ’ prodotti mediċinali oħra li jaffettwaw ir- rabta ta ’ proteini ma ’ plażma jew eliminażjoni bijotrasformazzjoni mhumiex probabbli.
As anticholinergics are mainly eliminated by biotransformation, the potential for an interaction is limited, although an interaction with anticholinergics has not been investigated.
Peress li antikolinerġiċi huma prinċipalment eliminati b’ bijotransformazzjoni, il- potenzjal għal interazzjoni hu limitat, għalkemm l- interazzjoni ma ’ antikolinerġiċi ma ġiex mistħarrġa.
Cimetidine reduced the renal clearance of pramipexole by approximately 34%, presumably by inhibition of the cationic secretory transport system of the renal tubules.
4 Cimetidine naqqas it- tneħħija renali ta ’ pramipexole b’ madwar 34%, preżumibilment permezz tal- inibizzjoni tas- sistema tat- trasport li tnixxi l- ketajins tat- tubuli renali.
Therefore, medicinal products that are inhibitors of this active renal elimination pathway or are eliminated by this pathway, such as cimetidine and amantadine, may interact with pramipexole resulting in reduced clearance of either or both medicinal products.
Għalhekk, prodotti mediċinali li huma inibituri ta ’ dan il- passaġġ attiv tal- eliminazzjoni renali, jew li jkunu mneħħija permezz ta ’ dan il- passagg, bhal cimetidine u amantadine, jistgħu jirreaġixxu ma ’ pramipexole, u dan jirrizulta fi tneħħija mnaqqsa ta ’ wieħed jew iż- żewġ prodotti mediċinali.
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with Pramipexole Teva.
It- tnaqqis fid- doża ta ’ pramipexole ghandu jkun ikkunsidrat meta dawn il- prodotti medicinali jinghataw ma ’ Pramipexole Teva.
4 When Pramipexole Teva is given in combination with levodopa, it is recommended that the dosage of levodopa is reduced and the dosage of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Pramipexole Teva.
Meta Pramipexole Teva jingħata flimkien ma ’ levodopa, hu rakkomandat li d- dożaġġ ta ’ levodopa jitnaqqas u li d- dożaġġ ta ’ prodotti mediċinali oħrajn kontra l- marda ta ’ Parkinson jinżamm kostanti, filwaqt li d- doża ta ’ Pramipexole Teva tiżdied.
Coadministration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e. g. if antagonistic effects can be expected.
L- għoti flimkien ta ’ prodotti mediċinali antipsikotiċi ma ’ pramipexole ghandu jkun evitat (ara sezzjoni 4. 4), eż. jekk hu mistenni li jkun hemm effetti antagonistiċi.
The effect on pregnancy and lactation has not been investigated in humans.
L- effett fuq it- tqala u t- treddigħ ma kienx mistħarreġ fil- bniedem.
Pramipexole Teva should not be used during pregnancy unless clearly necessary, i. e. if the potential benefit justifies the potential risk to the foetus.
Pramipexole Teva m’ għandux jingħata waqt it- tqala għajr meta ikun meħtieġ b’ mod ċar, i. e. is- siwi potenzjali jiġġustifika r- riskju potenzjali għall- fetu.
The excretion of pramipexole into breast milk has not been studied in women.
L- eliminazzjoni ta ’ pramipexole fil- ħalib tal- omm ma kinetx studjata fin - nisa.
In the absence of human data, Pramipexole Teva should not be used during breast-feeding.
Fin- nuqqas ta ’ dejta dwar dan fil- bniedem, Pramipexole Teva m’ għandux jintuża waqt it- treddigħ.
However, if its use is unavoidable, breast-feeding should be discontinued.
Madankollu, jekk l- użu tiegħu ma jkunx jista ’ jigi evitat, it- treddigħ għandu jitwaqqaf.
Pramipexole Teva can have a major influence on the ability to drive an use machines.
Pramipexole Teva jista ’ jkollu influwenza ewlenija fuq il- ħila biex issuq jew tħaddem magni.
Patients being treated with Pramipexole Teva and presenting with somnolence and/ or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5, and 4.8).
Pazjenti li qed jiġu ttrattati bi Pramipexole Teva u li jkollhom episodji ta ’ ngħas u/ jew ta ’ rqad li jiġi għal għarrieda għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet fejn vigilanza indebolita tista ’ tpoġġi lilhom jew lil persuni oħra f’ riskju ta ’ ferriment serju jew mewt (eż. tħaddim ta ’ magni) sakemm dawn l- episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4. 4, 4. 5, u 4. 8).
The following adverse reactions are expected under the use of Pramipexole Teva: abnormal dreams, confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hypotension, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia; pathological gambling, hypersexuality and other abnormal behaviour, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
Ir- reazzjonijiet avversi li ġejjin mistennija li jseħħu meta jintuża Pramipexole Teva: ħolm abnormali, konfużjoni, stitikezza, delużjoni, sturdament, diskinesja, għeja, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesja, pressjoni baxxa, żieda fit- teħid tal- ikel (tiekol bl- addoċċ, iperfaġja), nuqqas ta ’ rqad, problemi ta ’ tqanqil sesswali, tqalligħ, edema periferika, paranojja, logħob patoloġiku tal- ażżard, ipersesswalità u mġieba abnormali oħra, ngħas, żieda fil- piż, l- irqad jiġi f’ daqqa, ħakk u raxx, u sensittività eċċessiva oħra.
Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both groups.
Minn analiżi bbażżata fuq provi miġbura li saru fi provi bi plaċebo bħala kontroll, li kienu jinkludu total ta ’ 1, 923 pazjent fuq pramipexole u 1, 354 pazjent fuq il- plaċebo, reazzjonijiet avversi tal -
63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse reaction.
63% ta ’ pazjenti fuq pramipexole u 52% ta ’ pazjenti fuq il- plaċebo rrappurtaw minn ta ’ lanqas reazzjoni avversa waħda.
Table 1 and 2 displays the frequency of adverse reactions from placebo-controlled clinical trials in Parkinson’ s disease and another indication.
It- tabelli 1 u 2 juru l- frekwenza ta ’ reazzjonijiet avversi għal mediċina fi provi kliniċi kontrollati bi plaċebo b’ Parkinson u indikazzjonijiet oħra.
The adverse reactions reported in these tables are those events that occurred in 0.1% or more of patients treated with pramipexole and were reported significantly more often in patients taking pramipexole than placebo, or where the event was considered clinically relevant.
Ir- reazzjonijiet avversi rapportati f’ dawn it- tabelli huma dawk li seħħew f’ 0. 1% jew aktar tal- pazjenti kurati b’ pramipexole u kienu rapportati b’ mod sinifikanti aktar ta ’ spiss f’ pazjenti li ħadu pramipexole milli l- plaċebo, jew fejn il- każ kien konsidrat klinikament rilevanti.
However, the majority of common adverse reactions were mild to moderate, they usually start early in therapy, and most tended to disappear even as therapy was continued.
Madankollu, il- maġġoranza ta ’ reazzjonijiet avversi komuni kienu ħfief għal moderati, ġeneralment jibdew kmieni bit- terapija, u ħafna kellhom tendenza li jisparixxu kif it- terapija kompliet.
5 patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Fi ħdan il- klassi tas- sistema tal- organi, effetti mhux mixtieqa huma elenkati taħt titli ta ’ frekwenza, taħt il- kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100 to < 1/ 10); mhux komuni (≥1/ 1, 000 to ≤ 1/ 100); rari (≥1/ 10, 000 to ≤1/ 1, 000); rari ħafna (≤1/ 10, 000),
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’ s disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
L- aktar reazzjonijiet avversi komuni (≥ 5%) rapportati f’ pazjenti li għandhom il- marda tal- Parkinson aktar frekwenti bit- trattament ta ’ pramipexole milli bil- plaċebo kienu tqalligħ, diskinesja, pressjoni ortostatika baxxa, sturdament, ngħas, nuqqas ta ’ rqad, stitikezza, alluċinazzjoni viżwalil, uġigħ ta ’ ras u għeja.
The incidence of somnolence is increased at doses higher than 1.5 mg/ day (see section 4.2).
L- inċidenza ta ’ ngħas hija ogħla f’ dożi ogħla minn 1. 5 mg/ jum (ara sezzjoni 4. 2).
More frequent adverse drug reactions in combination with levodopa was dyskinesia.
Reazzjonijiet avversa aktar frekwenti f’ kombinazzjoni ma ’ levodopa kienet diskinesjasi.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Il- pressjoni baxxa tista ’ sseħħ fil- bidu tat- trattament, speċjalment jekk pramipexole jiġi ttittrat malajr wisq.
Parkinson’ s disease System Organ Class Psychiatric disorders
Marda ta ’ Parkinson Sistema tal- Klassifika tal- Organi Disturbi psikjatriċi
Common Uncommon Not known Nervous system disorders
Mhux komuni Mhux magħruf Disturbi fis- sistema nervuża
abnormal dreams, confusion, hallucinations, insomnia delusion, libido disorder, paranoia abnormal behaviour, hypersexuality, increased eating, pathological gambling
delużjoni, problemi dwar xewqat sesswali, paranojja mġieba mhux normali, ipersesswalità, żieda fit- teħid tal- ikel, loħob tal- ażżard patoloġiku
Very common Common Uncommon Vascular disorders
Komuni ħafna Komuni Mhux komuni Disturbi vaskulari
dizziness, dyskinesia, somnolence headache hyperkinesias, sudden onset of sleep
sturdament, diskinesja, ngħas uġigħ ta ’ ras iperkinesija, in- ngħas jiġi f’ daqqa
Very common Gastrointestinal disorders
Komuni ħafna Disturbi gastrointestinali
nausea constipation
tqalligħ stitikezza
weight increase
Żieda fl- piż
The most commonly (≥ 5%) reported adverse drug reactions in patients with other indication treated with pramipexole were nausea, headache, dizziness and fatigue.
L- aktar reazzjonijiet avversi komuni (≥ 5%) irraportati f’ pazjenti li għandhom l- indikazzjoni oħra kurati bi pramipexole kienu tqalligħ, uġigħ ta ’ ras, stordament u għeja.
Nausea and fatigue were more often reported in female patients treated with pramipexole (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
It- tqalligħ u l- għeja kienu aktar komuni f’ pazjenti nisa ttrattati bi pramipexole (20. 8% u 10. 5%, rispettivament) meta mqabbla mal - irġiel (6. 7% u 7. 3%, rispettivament).
Other Indication System Organ Class Psychiatric disorders
Indikazzjoni oħra Sistema tal- Klassifika tal- Organi Disturbi psikjatriċi
Common Uncommon Not known Nervous system disorders
Komuni Mhux komuni
abnormal dreams, insomnia confusion, hallucination, libido disorder abnormal behaviour, delusion, hypersexuality, increased eating, paranoia, pathological gambling
ħolm abnormali, nuqqas ta ’ rqad konfużjoni, alluċinazzjoni, problemi fix- xewqa sesswali
Common Uncommon Not known Vascular disorders
Komuni Mhux komuni Mhux magħruf Disturbi vaskulari
dizziness, headache, somnolence sudden onset of sleep dyskinesia, hyperkinesia
sturdament, uġigħ ta ’ ras, ngħas l- irqad jiġi f’ daqqa diskinesja, iperkinesja