qanastek/EMEA-V3 huggingface dataset:
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ARICLAIM 40 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 40 mg, kapsuli gastro- reżistenti ibsin Duloxetine
67 10.
74 10.
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS (2X98 CAPSULES, 40 MG) WRAPPED IN FOIL (INCLUDING BLUE BOX)
TIKKETTA TA ’ BARRA MGEŻWRA MADWAR IL- PAKKETTI MULTIPLI( 2X98 KAPSULA, 40 MG) IMGEŻWRA FIL- FOJL (INKLUŻA L- KAXXA ĊELESTI)
69 10.
76 10.
70 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (40 mg hard gastro- resistant capsules)
77 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI (kapsuli gastro- reżistenti ibsin ta ’ 40 mg)
ARICLAIM 40 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 40 mg kapsuli gastro- reżistenti ibsin Duloxetine
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Duloxetine
ARICLAIM 20 mg, kapsuli gastro- reżistenti ibsin Duloxetine
72 10.
79 10.
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (20 mg hard gastro- resistant capsules)
80 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI (kapsuli gastro- reżistenti ibsin ta ’ 20 mg)
ARICLAIM 20 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 20 mg kapsuli gastro- reżistenti ibsin Duloxetine
74 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
81 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Duloxetine
ARICLAIM 30mg, kapsuli gastro- reżistenti ibsin Duloxetine
75 10.
82 10.
ARICLAIM 30 mg
ARICLAIM 30mg
76 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 30 mg hard gastro-resistant capsules
83 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
ARICLAIM 30 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 30mg kapsuli gastro- reżistenti ibsin Duloxetine
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
84 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Duloxetine
ARICLAIM 60mg, kapsuli gastro- reżistenti ibsin Duloxetine
ARICLAIM 60 mg
ARICLAIM 60mg
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine
ARICLAIM 60mg kapsuli gastro- reżistenti ibsin Duloxetine
80 B.
87 B.
81 PACKAGE LEAFLET:
88 FULJETT TA ’ TAGĦRIF:
ARICLAIM 40 mg hard gastro-resistant capsules ARICLAIM 20 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
ARICLAIM 40 mg kapsuli gastro- reżistenti ibsin ARICLAIM 20 mg kapsuli gastro- reżistenti ibsin Duloxetine (bħala hydrochloride)
What ARICLAIM is and what it is used for 2.
X’ inhu ARICLAIM u għalxiex jintuża 2.
Before you take ARICLAIM 3.
Qabel ma tieħu ARICLAIM 3.
How to take ARICLAIM 4.
Kif għandek tieħu ARICLAIM 4.
How to store ARICLAIM 6.
Kif taħżen ARICLAIM 6.
WHAT ARICLAIM IS AND WHAT IT IS USED FOR
X’ INHU ARICLAIM U GĦALXIEX JINTUŻA
ARICLAIM increases the levels of serotonin and norepinephrine in the nervous system.
ARICLAIM iżid il- livelli ta ’ serotonin u ta ’ norepinephrine fis- sistema nervuża.
ARICLAIM is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women or to treat a condition called diabetic neuropathic pain in adults.
ARICLAIM huwa prodott mediċinali li jittieħed mill- ħalq għal kura ta ’ Inkontinenza Awrinarja minħabba Sforz (SUI) fin- nisa jew għal kura ta ’ kundizzjoni li tissejjaħ uġigħ newropatiku tad- dijabete fl- adulti.
ARICLAIM is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
Huwa maħsub li ARICLAIM jaħdem billi jżid is- saħħa tal- muskolu li jżomm lura l- awrina waqt li tkun qiegħed tidħaq, tgħatas, jew tagħmel xi attivitajiet fiżiċi.
The efficacy of ARICLAIM is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
L- effikaċja ta ’ ARICLAIM tiġi rinforzata meta tkun ikkombinata ma ’ programm ta ’ taħriġ msejjaħ Taħriġ tal- Muskoli tal- Qiegħ tal- Pelvis (PFMT).
The effect of ARICLAIM may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment.
F’ ħafna pazjenti b’ uġigħ newropatiku tad- dijabete, l- effett ta ’ ARICLAIM jista ’ jidher fi żmien ġimgħa minn mindu tibda l- kura.
BEFORE YOU TAKE ARICLAIM
QABEL MA TIEĦU ARICLAIM
Do not take ARICLAIM
Tieħux ARICLAIM
82
jew enoxacineli jintużaw għall- kura ta ’ xi infezzjonijiet.
Take special care with ARICLAIM The following are reasons why ARICLAIM may not be suitable for you.
Oqgħod attent ħafna b’ ARICLAIM Li ġejjin huma raġunijiet għaliex ARICLAIM jista ’ ma jkunx tajjeb għalik.
If any of them apply to you, talk to your doctor before you take the medicine:
Jekk xi wħud minnhom jgħoddu għalik, kellem lit- tabib tiegħek qabel ma tieħu din il- mediċina:
- You are considering stopping ARICLAIM (see section 3).
- Għandek il- ħsieb li twaqqaf ARICLAIM (ara sezzjoni 3)
ARICLAIM may cause a sensation of restlessness or an inability to sit or stand still.
ARICLAIM jista ’ jikkawża sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod bilqiegħda jew bilwieqfa mingħajr ma jiċċaqlaq.
Use in children and adolescents under 18 years of age ARICLAIM should not be used for children and adolescents under the age of 18 years.
Użu fit- tfal jew f’ adolexxenti taħt it- tmintax- il sena ARICLAIM m’ għandux jintuża fit- tfal u f’ adolexxenti taħt it- tmintax- il sena.
Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Għandek tkun taf ukoll li pazjenti taħt it- 18 għandhom riskju ogħla ta ’ effetti sekondarji bħal tentattiv ta ’ suwiċidju, ħsibijiet ta ’ suwiċidju u ostilità (l- iżjed aggressjoni, Imġiba konfrontali u rabja) meta jieħdu dan it- tip ta ’ mediċini.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated.
Barra minn hekk, f’ dan il- grupp ta ’ etajiet, l- effetti tas- sigurtà fit- tul għadhom ma ġewx ippruvati, f’ dak li għandu x’ jaqsam ma ’ l- iżvilupp tal- ġisem, il- maturazzjoni, u l- iżvilupp kemm konjittiv kif ukoll tal- mod ta ’ imġiba.
The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions (depression and urinary incontinence).
Is- sustanza l- aktar importanti f’ ARICLAIM, duloxetine, hija wżata f’ medicini oħra għall- kundizzjonijiet oħra (depressjoni u inkontinenza awrinarja).
Your doctor should decide whether you can take ARICLAIM with other medicines.
It- tabib tiegħek irid jiddeċiedi jekk għandekx tieħu ARICLAIM ma ’ mediċini oħra.
Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Tibdiex tieħu jew twaqqaf xi mediċini, inklużi dawk mixtrija mingħajr riċetta tat- tabib u mediċini magħmula mill - ħxejjex, qabel ma taċċerta ruħek mat- tabib tiegħek.
83 Monoamine Oxidase Inhibitors (MAOI): you should not take ARICLAIM with an MAOI or within 14 days of stopping an MAOI.
M’ għandekx tieħu ARICLAIM ma ’ MAOI jew fi żmien 14- il ġurnata minn mindu waqaft tieħu MAOI.
Taking an MAOI together with many prescription medicines, including ARICLAIM, can cause serious or even life-threatening side effects.
It- teħid ta 'xi MAOI flimkien ma' ħafna mill- mediċini mgħotija bir- riċetta, inkluż ARICLAIM, jista ’ jikkawża effetti sekondarji serji jew li jkunu ta ’ periklu għall- ħajja.
You must wait at least 14 days after you have stopped taking an MAOI before you can take ARICLAIM.
Għandek tistenna ta 'l- anqas 14- il ġurnata wara li tkun waqaft tieħu xi MAOI biex tkun tista' tieħu ARICLAIM.
Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take an MAOI.
Għandek bżonn ukoll tistenna ta 'l- anqas 5 ijiem wara li tieqaf tieħu ARICLAIM biex tkun tista' tieħu xi MAOI.
CNS medicines: caution is advised when ARICLAIM is taken in combination with other centrally acting medicines or substances, including alcohol and sedative medicines(benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Mediċini li jaffettwaw is- CNS: hija rakkomandata l- attenzjoni meta ARICLAIM jintuża flimkien ma ’ sustanzi jew mediċini oħra li jaġixxu fuq is- sistema nervuża ċentrali, li jinkludi l- alkoħol u l- mediċini sedattivi (benzodiazepines, morfinomimetiċi, anti- psikotiċi, phenobarbital u l- antistaminiċi sedattivi).
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ARICLAIM, you should see your doctor.
Dawn il- mediċini jżidu r- riskju ta ’ effetti sekondarji; jekk ikollok xi sintomu li mhux mistenni meta qiegħed/ qiegħda tieħu xi mediċini minn dawn flimkien ma ’ ARICLAIM, għandek tmur għand it- tabib tiegħek.
Taking ARICLAIM with food and drink ARICLAIM may be taken with or without food.
Meta tieħu ARICLAIM ma ’ l- ikel u max- xorb ARICLAIM jista 'jittieħed ma' l- ikel jew fuq stonku vojt.
You should take extra care if you drink alcohol while taking ARICLAIM.
Għandek toqgħod iżjed attent jekk tixrob l - alkoħol waqt li tkun qiegħed/ qiegħda tieħu ARICLAIM.
Pregnancy and breast-feeding Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking ARICLAIM.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk issir tqila jew qiegħda tipprova ssir tqila, waqt li qiegħda tieħu ARICLAIM..
You should use ARICLAIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Għandek biss tuża ARICLAIM wara li tkun iddiskutejt mat- tabib tiegħek il- benefiċċji possibbli u kull riskju possibbli għat- tarbija li għada ma twelditx.
The use of ARICLAIM while breastfeeding is not recommended.
M, huwiex rakkomandat l- użu ta ’ ARICLAIM waqt it- treddigħ.
Driving and using machines ARICLAIM may make you feel sleepy of dizzy.
Sewqan u tħaddim ta ’ magni Tista ’ tħossok bi ngħas jew sturdut minħabba ARICLAIM.
Do not drive or use any tools or machines until you know how ARICLAIM affects you.
Issuqx u tagħmilx użu minn għodda jew tħaddem magni sakemm tkun taf b’ liema mod jaffettwak ARICLAIM..
Important information about some of the ingredients of ARICLAIM ARICLAIM contains sucrose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ARICLAIM ARICLAIM fih s- sucrose.
HOW TO TAKE ARICLAIM
KIF GĦANDEK TIEĦU ARICLAIM
Always take ARICLAIM exactly as your doctor has told you.
Dejjem għandek tieħu ARICLAIM skond kif qallek it- tabib.
The recommended dose of ARICLAIM for the treatment of Stress Urinary Incontinence is 40 mg twice a day (in the morning and late afternoon/ evening).
Id- doża rakkomandata ta ’ ARICLAIM għall- kura ta ’ l- Inkontinenza Awrinarja minħabba Sforz hija ta ’ kapsula waħda ta ’ 40 mg darbtejn kuljum (filgħodu u tard wara nofsinhar/ filgħaxija).
The usual dose of ARICLAIM for the treatment Neuropathic pain is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Id- doża ta ’ ARICLAIM li ssoltu tingħata għall- kura ta ’ l- uġigħ Newropatiku hija ta ’ 60 mg darba kuljum, iżda t- tabib tiegħek se jiktiblek riċetta skond id- doza li tgħodd għalik.
ARICLAIM is for oral use.
ARICLAIM għandu jittieħed mill- ħalq.
84 To help you remember to take ARICLAIM, you may find it easier to take it at the same times every day.
Biex tiftakar tieħu ARICLAIM, tista ’ ssibha aktar faċli li teħodha kuljum fl- istess ħinijiet.
Do not stop taking ARICLAIM without talking to your doctor.
Tieqafx tieħu ARICLAIM mingħajr ma tkellem lit- tabib tiegħek.
If you take more ARICLAIM than you should Call your doctor or pharmacist immediately if you take more than the amount of ARICLAIM prescribed by your doctor.
Jekk tieħu ARICLAIM aktar milli suppost Ċempel immedjatament lit- tabib jew lill- ispiżjar tiegħek jekk tieħu aktar ammont ta 'ARICLAIM minn kemm ordnalek it- tabib.
If you forget to take ARICLAIM Do not take a double dose to make up for forgotten doses.
Jekk tinsa tieħu ARICLAIM M’ għandekx tieħu doża doppja biex tpatti għad dożi li tkun insejt tieħu.
Do not take more than the daily amount of ARICLAIM that has been prescribed for you in one day.
Tieħux iżjed mill- ammont ta 'ARICLAIM li ordnalek it- tabib għal ġurnata waħda.
If you stop taking ARICLAIM Do not stop taking your capsules without the advice of your doctor even if you feel better.
Jekk tieqaf tieħu ARICLAIM Tieqafx tieħu l- kapsuli tiegħek mingħajr ma tieħu l- parir tat- tabib anki jekk tħossok aħjar.
If your doctor thinks that you no longer need ARICLAIM he will ask you to reduce your dose over 2 weeks.
Jekk it- tabib tiegħek jaħseb li m' għadx għandek bżonn tieħu ARICLAIM huwa se jgħidlek biex tnaqqas id- doża fuq perijodu ta ’ ġimgħatejn.
Some patients, who suddenly stop taking ARICLAIM after more than 1 week of therapy, have had symptoms such as dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo..
Xi pazjenti li waqqfu jieħdu ARICLAIM f' daqqa wara iżjed minn ġimgħa ta ’ kura kellhom sintomi bħal sturdament, sensazzjonijiet ta ’ tniggiż, problemi ta ’ irqad( ħolm stramb, ħmar il- lejl, ma tkunx tista ’ torqod), iħossuhom irrekweti u aġitati, iħossuhom ansjużi, iħossuhom ħażin (tqalligħ) jew jgħamillhom ħażin (rimettar), tregħid (ċaqliq ripetut) uġigħ ta 'ras, iħossuhom irritabbli, dijarea, għaraq esaġerat jew vertigo..
Like all medicines, ARICLAIM can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ARICLAIM jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (these can affect more than 1 in 10 patients treated)with ARICLAIM when taken to treat stress urinary incontinence Feeling sick (nausea), dry mouth, and tiredness.
Efetti sekondarji komuni ħafna (dawn jistgħu jaffettwaw iżjed minn pazjent 1 minn kull 10 pazjenti kkurati) ta ’ ARICLAIM meta jittieħed għall- kura ta ’ l- inkontinenza awrinarja minħabba sforz Tħossok ma tiflaħx (tqalligħ), nixfa fil- ħalq, u għeja.
Very common side effects (these can affect more than 1 in 10 patients treated)with ARICLAIM when taken to treat diabetic neuropathic pain Feeling sick (nausea), somnolence, headache, dizziness and constipation.
Efetti sekondarji komuni ħafna (dawn jistgħu jaffettwaw iżjed minn pazjent 1 minn kull 10 pazjenti kkurati) ta ’ ARICLAIM meta jittieħed għall- kura ta ’ l- uġigħ newropatiku tad- dijabete Tħossok ma tiflaħx (tqalligħ), ngħas, uġigħ ta ’ ras, sturdament u stitikezza.
Common side effects (these can affect from 1 to 10 users in 100 patients treated) • Anxiety, having abnormal dreams. • Dizziness, tremor or numbness, including numbness or tingling of the skin. • Being sick (vomiting), heartburn or breaking wind, lack of appetite. • Blurred eyesight. • Feeling the heart pumping in the chest or hot flushes. • Problems getting an erection, changes in orgasm or less sex drive. • (itchy) Rash. • Muscle pain, muscle tightness or muscle spasm.
92 Effetti sekondarji komuni (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 100 pazjent ikkurat) • Ansjetà, ikollok ħolm mhux normali. • Sturdament, rogħda jew tnemnin, inkluż it- tnemnin jew tingiż tal- ġilda. • Tħossok ma tiflaħx (rimettar), ħruq ta ’ stonku jew ikollok bżonn tgħaddi l- arja, tnaqqis fil- piż jew nuqqas ta ’ aptit. • Vista sfokata. • Tħoss il- qalb tħabbat f’ sidrek jew ikollok il- fwawar. • Problemi biex ikollok erezzjoni, kambjamenti fl- orgażmu jew nuqqas ta ’ ħajra għas- sess. • Raxx (ħakk) • Uġigħ fil- muskoli, riġidità fil- muskoli jew spażmu fil- muskoli
85 • Tasting things differently than usual, disturbance in attention or spasms and involuntary movements of the muscles. • Weight loss or weight gain, burping, indigestion or gastroenteritis. • Inflammation of the liver that may cause abdominal pain, tiredness or yellow coloration of the skin. • Vertigo, tinnitus (perception of sound in the ear when there is no external sound, ear pain. • Larger pupils (the dark centre of the eye) or visual disturbance. • Flushing, increase in blood pressure, feeling cold in your fingers and/ or toes, feeling dizzy (particularly when standing up too quickly), fast or irregular heart beat, night sweats, cold sweats, shivering or fainting. • Changes in ejaculation, abnormal periods, including heavy or prolonged periods • Allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight. • Muscle twitching. • Need to pass urine during the night or difficulty or inability to pass urine. • Grinding of teeth, dehydration, feeling hot/ cold, thirst, throat tightness or nose bleeds • Increased level of cholesterol in the blood.
Effetti sekondarji mhux komuni( dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 1, 000 pazjent ikkurat) • Infjammazzjoni tal- gerżuma. • Tħossok aġitat, tħossok disorjentat, tħossok bi ngħas, ikollok kwalità ħażina ta ’ irqad, nuqqas ta ’ motivazzjoni jew tittewweb iżjed mis- soltu. • Ttiegħem l- affarijiet differenti mis- soltu, disturbi fl- attenzjoni jew spażmi u movimenti involontarji tal- muskoli • Tnaqqis fil- piż jew żieda fil- piż, tfewwiq, indiġestjoni jew gastroenterite. • Infjammazzjoni tal- fwied li jista ’ jikkawża wġigħ addominali, għeja jew sfurija tal- ġilda. • Vertigo, tinnitus (sensazzjoni ta ’ ħsejjes fil- widna meta ma jkunx hemm ħsejjes esterni), uġigħ fil- widnejn. • Il- ħbub ta ’ l- għajnejn ikunu ikbar (iċ- centru skur ta ’ l- għajnejn) jew disturbi fil- vista. • Ħmura fil- wiċċ, il- pressjoni tad- demm togħla, tħoss is- swaba ’ ta ’ idejk jew/ u ta ’ saqajk kesħin, tħossok se tistordi (speċjalment meta tqum bil- wieqfa malajr wisq), tħabbit mgħaġġel jew irregolari tal- qalb, tegħreq matul il- lejl, ġħaraq kiesaħ, tregħid jew ħass ħażin. • Kambjamenti fl- eġakulazzjoni, pirjids mhux tas- soltu, li jinkludu pirjids b’ ħafna demm jew li jdumu iżjed mis- soltu. • Reazzjonijiet allerġiċi, tendenza ogħla li titbenġel, nfafet jew sensittività għad- dawl tax- xemx. • Ġbid involontarju tal- muskoli. • Il- bżonn li tgħaddi l- awrina matul il- lejl jew diffikultà jew inkapaċità li tgħaddi l- awrina. • Tagħżiż tas- snien, deidrazzjoni, tħossok sħun/ kiesaħ, għatxan, rassa fil- gerżuma jew tinfaġar. • Żieda fil- livell tal- kolesterol fid- demm
Rare side effects (these can affect from 1 to 10 users in 10,000 patients treated) • Mania (a disorder which symptoms are over activity, racing thoughts and decrease need for sleep), experiencing hallucinations • Increased level of sugar in the blood, low levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused), syndrome of inadequate secretion of anti-diuretic hormone (SIADH). • Bad breath. • Increased pressure in the eye. • Menopausal symptoms. • Sexual problems. • Abnormal manner of walking, contraction of the jaw muscle. • Decrease of activity of the thyroid gland, chest or stomach pain. • Need to pass more urine then usual or urine flow decreased.
Effetti sekondarji rari (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 10, 000 pazjent ikkurat) • Manija (marda fejn is- sintomi huma li tkun attiv iżżejjed, ikollok ħsibijiet li jiġru bik u jonqos il- bżonn ta ’ l- irqad), ikollok l- alluċinazzjonijiet. • Żieda fil- livell taz- zokkor fid- demm, livelli baxxi ta ’ sodium fid- demm (is- sintomu huma tħossok ma tiflaħx u m’ intix f’ sikktek bil- muskoli dgħajfin jew konfuż), sindromu ta ’ sekrezzjoni insuffiċjenti ta ’ l- ormon kontra d- djuresi (SIADH). • Riħa ħażina fil- ħalq • Tiżdied il- pressjoni ġewwa l- għajn. • Sintomi tal- menopawża. • Problemi sesswali • Timxi b’ mod mhux normali, kontrazzjoni tal- muskolu tax- xedaq. • Tnaqqis fl- attività tal- glandola tat- tirojde, uġigħ fis- sider jew fl- istonku. • Il- bżonn li tgħaddi aktar awrina mis- soltu jew tnaqqis fil- fluss ta ’ l- awrina.
Other possible side effects • Experiencing aggression and anger suicidal thoughts or behaviour. • A sensation of restlessness or an inability to sit or stand still, “ Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits or stiffness. • Passing bright red blood in your stools vomiting blood, or black tarry stools (faeces). • Abnormal urine odour. • Yellow colouration of the skin (jaundice), hepatic failure, Stevens-Johnson syndrome, sudden swelling of skin of mucosa (angioedema).
Effetti sekondarji oħra possibbli • Tkun aggressiv/ a u irrabjat/ a, ħsibijiet jew imġiba suwiċidali. • Sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod bilqiegħda jew bilwieqfa mingħajr ma jiċċaqlaq, “ Is- Sindrome ta ’ Serotonin ” (reazzjoni rari li tista ’ tikkawża sensazzjoni ta ’ ferħ kbir, ħedla, guffaġni, irrekwitezza, sensazzjoni bħallikieku fis- sakra, deni, għaraq jew riġidità tal- muskoli), aċċessjonijiet jew ebusija.
HOW TO STORE ARICLAIM
KIF TAĦŻEN ARICLAIM
Do not use ARICLAIM after the expiry date which is stated on the carton.
Tużax ARICLAIM wara d- data ta ’ skadenza li tidher fuq il- kartuna.
What ARICLAIM contains The active substance is duloxetine.
Is- sustanza attiva hija duloxetine.
What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule.
ARICLAIM issibu bħala kapsula gastro- reżistenti, iebsa.
Each capsule of ARICLAIM contains pellets of the active substance with a covering to protect them from stomach acid.
Kull kapsula ta ’ ARICLAIM fiha pellits tas- sustanza attiva b’ kisja sabiex tipproteġihom mill- aċidu ta ’ l- istonku.
ARICLAIM is available in 2 strengths:
ARICLAIM issibu f’ żewġ dożi:
ARICLAIM 40 mg is available in blister packs of 28, 56, 98, 140 and 196 (2 x 98) capsules.
ARICLAIM 40 mg issibu f’ pakketti b’ folji ta ’ 28, 56, 98, 140 u 196 (2 x 98) kapsula.
ARICLAIM 20 mg is available in blister packs of 28 and 56 capsules.
ARICLAIM 20 mg issibu f’ pakketti b’ folji ta ’ 28 u 56 kapsula.
Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten, L- Olanda.
For any information about this medicine product, please contact the local representative of the Marketing Authorisation Holder.
94 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
88 PACKAGE LEAFLET:
95 FULJETT TA ’ TAGĦRIF:
ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
Duloxetine (bħala hydrochloride)
Possible side effects 5 How to store ARICLAIM 6.
Kif taħżen ARICLAIM 6.
ARICLAIM is used in adults to treat a condition called diabetic neuropathic pain.
Fl- adulti, ARICLAIM jintuża bħala kura għal kundizzjoni li tissejjaħ uġigħ newropatiku tad- dijabete.
The effect of ARICLAIM may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment.
F’ ħafna pazjenti b’ uġigħ newropatiku tad- dijabete, l- effett ta ’ ARICLAIM jista ’ jidher fi żmien ġimgħa minn mindu tibda l- kura..
Do not take ARICLAIM − If you are allergic (hypersensitive) to duloxetine or any of the other ingredients of ARICLAIM. − If you are taking or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) (see also below in section: ‘ Taking other medicines’). − If you have liver disease. − If you have severe kidney disease. − If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacine which are used to treat some infections. − If you suffer from uncontrolled high blood pressure.
oħra kontra d- depressjoni msejħa inibituri ta ’ monoamino oxidase (MAOI) (ara aktar ’ l isfel fis - sezzjoni: ‘ Meta tieħu medicini oħra ’)
Take special care with ARICLAIM The following are reasons why ARICLAIM may not be suitable for you.
depressjoni, ciprofloxacine jew enoxacine li jintużaw għall- kura ta ’ xi infezzjonijiet
ARICLAIM may cause a sensation of restlessness or an inability to sit or stand still.
ARICLAIM jista ’ jikkawża sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq.
Use in children and adolescents under 18 years of age ARICLAIM should normally not be used for children and adolescents under 18 years.
Użu fit- tfal jew adolexxenti taħt it- tmintax- il sena Normalment ARICLAIM m’ għandux jintuza fit- tfal u f’ adolexxenti taħt it- tmintax- il sena.
Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/ she decides that this is in their best interests.
Madankollu, it- tabib tiegħek jista ’ jordna ARICLAIM lil pazjenti taħt it- 18 għax jiddeċiedi/ tiddeċiedi li huwa fl- aħjar interess għalihom.
If your doctor has prescribed ARICLAIM for a patient under 18 and you want to discuss this, please go back to your doctor.
Jekk it- tabib ordna ARICLAIM għal pazjent taħt it- 18 u tixtieq xi spjegazzjonijiet, jekk jogħġbok erġa ’ mur għand it- tabib tiegħek.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking ARICLAIM.
Għandek tavża lit- tabib tiegħek jekk jiżviluppaw jew jiggravaw xi sintomi li ssemmew hawn fuq, meta pazjenti taħt it- 18 ikunu qegħdin jieħdu ARICLAIM.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated.
Barra minn hekk, f’ dan il- grupp ta ’ età, l- effetti tas- sigurtà fit- tul għadhom ma ġewx ippruvati, f’ dak li għandu x’ jaqsam l- iżvilupp tal- ġisem, il - maturazzjoni, u l- iżvilupp kemm konjittiv kif ukoll tal- mod ta ’ komportament.
The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions (depression and urinary incontinence).
Is- sustanza l- aktar importanti f’ ARICLAIM, duloxetine, hija użata f’ medicini oħra għal kundizzjonijiet oħra (depressjoni u inkontinenza urinarja).
Your doctor should decide whether you can take ARICLAIM with other medicines.
97 jiddeċiedi jekk għandekx tieħu ARICLAIM ma ’ mediċini oħra.
Monoamine Oxidase Inhibitors (MAOIs):
Inibituri ta ’ Monoamine Oxidase( MAOI):
You should not take ARICLAIM if you are taking, or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
M’ għandekx tieħu ARICLAIM jekk qiegħed/ qiegħda tieħu jew ħadt recentament f’ dawn l- aħħar 14- il ġurnata, xi mediċina oħra kontra d- depressjoni msejħa inibitur ta ’ monamino oxidase.
You must wait at least 14 days
It- teħid ta 'xi MAOI flimkien ma' ħafna mill- mediċini mgħotija bir - riċetta, inkluż ARICLAIM, jista ’ jikkawża effetti sekondarji serji jew li jkunu ta ’ periklu għall- ħajja.
90 after you have stopped taking an MAOI before you can take ARICLAIM.
Għandek tistenna ta 'l- anqas 14- il ġurnata wara li tkun waqaft tieħu xi MAOI biex tkun tista' tieħu ARICLAIM.
Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take a MAOI.
Għandek bżonn ukoll tistenna ta 'l- anqas 5 ijiem wara li tieqaf tieħu ARICLAIM biex tkun tista' tieħu xi MAOI.
Care should be taken if you drink alcohol while you are being treated with ARICLAIM.
Għandek toqgħod attent jekk tixrob l- alkoħol waqt li tkun qiegħed/ qiegħda tirċievi l- kura b’ ARICLAIM.
You should use ARICLAIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk issir tqila jew qiegħda tipprova ssir tqila, waqt li qiegħda tieħu ARICLAIM. Ghandek biss tuża ARICLAIM wara li tkun iddiskutejt mat- tabib tiegħek il- benefiċċji possibbli u kull riskju possibbli għat- tarbija li għada ma twelditx.
The use of ARICLAIM while breastfeeding is not recommended.
M’ huwiex rakkomandat l- użu ta ’ ARICLAIM waqt it- treddigħ.
Do not drive or use any tools or machines until you know how ARICLAIM affects you.
Sewqan u tħaddim ta ’ magni Tista ’ tħossok bi ngħas jew sturdut minħabba ARICLAIM Issuqx u tagħmilx użu minn għodda jew tħaddem magni sakemm tkun taf b’ liema mod jaffettwak ARICLAIM.
Always take ARICLAIM exactly as your doctor has told you.
Dejjem għandek tieħu ARICLAIM skond il- parir tat- tabib.
The usual dose of ARICLAIM is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Id- doża ta ’ ARICLAIM li ssoltu tingħata hija ta ’ 60 mg darba kuljum, iżda t- tabib jiktiblek ricetta skond id- doza li tgħodd għalik.
ARICLAIM is for oral use.
98 ARICLAIM għandu jittieħed mill- ħalq.
To help you remember to take ARICLAIM, you may find it easier to take it at the same times every day.
Biex tiftakar tieħu ARICLAIM, tista ’ ssibha aktar faċli li teħodha kuljum fl- istess ħinijiet.
Do not stop taking ARICLAIM without talking to your doctor.
Tkellem mat- tabib tiegħek dwar kemm trid iddum tieħu ARICLAIM. Tieqafx tieħu ARICLAIM mingħajr ma tkellem lit- tabib tiegħek.
If you take more ARICLAIM than you should
Jekk tieħu ARICLAIM aktar milli suppost
91 Call your doctor or pharmacist immediately if you take more than the amount of ARICLAIM prescribed by your doctor.
Ċempel immedjatament lit- tabib jew lill- ispiżjar tiegħek jekk tieħu aktar ammont ta 'ARICLAIM minn kemm ordnalek it- tabib.
If you forget to take ARICLAIM Do not take a double dose to make up for a forgotten dose.
Jekk tinsa tieħu ARICLAIM M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
If your doctor thinks that you no longer need ARICLAIM he will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Jekk it- tabib tiegħek jaħseb li m' għadx għandek bżonn tieħu ARICLAIM huwa se jgħidlek biex tnaqqas id- doża fuq perijodu ta ’ għallinqas ġimgħatejn qabel ma twaqqaf għal kollox il- kura.
Some patients who stop taking ARICLAIM suddenly have had symptoms such as dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo.
Xi pazjenti li waqqfu jieħdu ARICLAIM f' daqqa kellhom sintomi bħal sturdament, sensazzjonijiet ta ’ tniggiż, problemi ta ’ irqad( ħolm stramb, ħmar il- lejl, ma tkunx tista ’ torqod), iħossuhom irrekweti u aġitati, iħossuhom ansjużi, iħossuhom ħażin (dardir) jew jgħamillhom ħażin (rimettar), tregħid (ċaqliq ripetut) uġigħ ta 'ras, iħossuhom irritabbli, dijarea, għaraq esaġerat jew vertigo.
Very common side effects (these can affect more than 10 in 100 patients treated) Feeling sick (nausea), somnolence, headache or dizziness.
Efetti sekondarji komuni ħafna (dawn jistgħu jaffettwaw iżjed minn pazjent 1 minn kull 10 pazjenti kkurati) Tħossok ma tiflaħx (tqalligħ), uġigħ ta ’ ras, nixfa fil- ħalq u tħossok bi ngħas,
Common side effects (these can affect from 1 to 10 users in 100 patients treated) • Tiredness, trouble sleeping, anxiety, feeling agitated or having abnormal dreams. • Dizziness, tremor or numbness, including numbness or tingling of the skin. • Diarrhoea, constipation, being sick (vomiting), heartburn, breaking wind, stomach pain. • Tinnitus (perception of sound in the ear when there is no external sound). • Blurred eyesight. • Feeling the heart pumping in the chest, flushing, increased sweating, night sweats • Problems getting an erection, less sex drive. • (Itchy) rash. • Muscle pain, muscle tightness, muscle spasm. • Increased yawning. • Lack of appetite, weight loss.
Effetti sekondarji komuni (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 100 pazjent ikkurat) • Għeja, diffikultà biex torqod, ansjetà, tħossok aġitat u jkollok ħolm mhux tas- soltu. • Sturdament, rogħda jew tirżiħ, inkluż it- tirżiħ jew tnemnin tal- ġilda • Dijarea, stitikezza, tħossok ma tiflaħx (rimettar), ħruq ta ’ l- istonku, tgħaddi l- arja, uġigħ fl - istonku. • Tinnitus (is- sensazzjoni ta ’ ħsejjes fil- widnejn meta m’ hemm ebda ħoss madwarek) • Vista mċajpra • Tħoss il- qalb tħabbat f’ sidrek, ħmura fil- wiċċ, tegħreq iżjed, tegħreq matul il- lejl. • Problemi biex ikollok erezzjoni, tnaqqis fil- ħajra għas- sess. • Raxx (bil- ħaqq) • Uġigħ fil- muskoli, riġidità fil- muskoli, spażmu fil- muskolu. • Tittewweb iżjed mis- soltu. • Imurlek l- aptit, tnaqqis fil- piż.
Uncommon side effects (these can affect from 1 to 10 users in 1,000 patients treated) • Throat inflammation. • Feeling disorientated, feeling sleepy, lack of motivation. • Tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking. • Poor sleep quality • Burping, indigestion, gastroenteritis • Vertigo, ear pain. • Inflammation of the liver that may cause abdominal pain 92 • Large pupils (the dark centre of the eye), visual disturbance. • Fast or irregular heart beat • Sexual problems, including changes in ejaculation, orgasm. • Abnormal periods, including heavy or prolonged periods. • Allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight • Increase in blood pressure, feeling cold in your fingers and/ or toes, feeling dizzy (particularly when standing up too quickly), cold sweats, shivering or fainting. • An increased level of sugar in the blood. • Need to pass more urine than normal, need to pass urine during the night, difficulty or inability to pass urine or having an urine flow decreased. • Grinding of teeth, feeling hot/ cold, thirst, throat tightness, nose bleeds. • Weight gain.
99 Effetti sekondarji mhux komuni( dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn 1, 000 pazjent ikkurat) • Infjammazzjoni tal- gerżuma. • Tħossok diżorjentat, tħossok bi ngħas, nuqqas ta ’ motivazzjoni. • Ttiegħem l- affarijiet differenti mis- soltu, disturbi ta ’ attenzjoni, ebusija, spażmi u movimenti involontarji tal- muskoli, ġbid involontarju tal- muskoli, timxi b’ mod mhux normali. • Kwalità hażina ta ’ irqad • Tfewwiq, indiġestjoni, gastroenterite. • Vertigo, uġigħ fil- widnejn. • Infjammazzjoni tal- fwied li tista ’ tkun il- kawża ta ’ uġigħ addominali. • Il- ħabba ta ’ l- għajn tkun kbira (iċ- centru skur ta ’ l- għajnejn), disturbi fil- vista. • Tħabbit mgħaġġel jew irregolari tal- qalb. • Problemi sesswali, li jinkludu bdil fl- eġakulazzjoni jew fl- orgażmu, • Pirjids mhux tas- soltu, li jinkludu pirjids b’ ħafna demm jew li jdumu • Reazzjonijiet allerġiċi, tendenza ogħla li titbenġel, infafet jew sensittività għad- dawl tax- xemx. • Żieda fil- pressjoni tad- demm, tħoss is- swaba ’ ta ’ idejk jew/ u ta ’ saqajk kesħin, tħossok se tistordi (speċjalment meta tqum bil- wieqfa malajr wisq), tħoss l- għaraq ixoqq għalik, tregħid jew ħass ħażin. • Jiżdied il- livell taz- zokkor fid- demm • Il- bżonn li tgħaddi iżjed awrina mis- soltu, il- bżonn li tgħaddi l- awrina matul il- lejl, diffikultà jew inabbiltà biex tgħaddi l- awrina jew ikun hemm tnaqqis fil- fluss ta ’ l- awrina. • Tagħżiż tas- snien, tħossok sħun/ kiesaħ, għatxan, rassa fil- gerżuma, tinfaraġ. • Żieda fil- piż.
Other possible side effects • Hallucinations, suicidal thoughts, behaviour aggression and anger. • A sensation of restlessness or an inability to sit or stand still or “ Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits. • Passing bright red blood in your stools, vomiting blood, or black tarry stools (faeces). • Having abnormal urine odour. • Chest pain. • Yellow colouration of the skin (jaundice), hepatic failure, Stevens-Johnson syndrome, sudden swelling of skin or mucosa (angioedema).
Effett sekondarji oħra li jista ’ jkollok • Alluċinazzjonijiet, imġiba jew ħsibijiet ta ’ suwiċidju, aggressjoni u rabja.. • Sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq jew “ Is- Sindromu ta ’ Serotonin ” (reazzjoni rari li tista ’ tikkawza sensazzjonijiet ta ’ kuntentezza kbira, ħedla, guffaġni, irrekwitezza, sensazzjoni bħallikieku fis- sakra, deni, muskoli riġidi jew għarqana), aċċessjonijiet. • Tgħaddi demm ta ’ kulur aħmar qawwi ma ’ l- ippurgar, tirremetti d- demm, jew l- ippurgar( il - feċi) ikun iswed bħall- qatran. • L- awrina jkollha riħa mhux tas- soltu. • Uġigħ fis- sider. • Il- ġilda tisfar (suffejra), insuffiċjenza epatika, sindromu ta ’ Stevens- Johnson, nefħa f’ daqqa tal- ġilda jew tal- mukoża (anġjoedima)
FURTHER INFORMATION
X’ fih ARICLAIM:
What ARICLAIM contains The active substance is duloxetine.
Is- sustanza attiva hi duloxetine.
What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule Each capsule of ARICLAIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Kull kapsula ta ’ ARICLAIM fiha pritkuni ta ’ duloxetine hydrochloride b’ kisja sabiex tipproteġihom mill- aċtu ta ’ l- istonku.
ARICLAIM is available in two strengths:
ARICLAIM issibu f’ żewġ dożi:
ARICLAIM 60 mg is available in packs of 28 and 98 capsules.
ARICLAIM 30mg issibu f’ pakketti ta ’ 7, 28 u 98 kapsula ARICLAIM 60 mg issibu f’ pakketti ta ’ 28 u 98 kapsula.
Manufacturer:
Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten, L- Olanda Manifattur:
België/ Belgique/ Belgien S. C. S.
101 België/ Belgique/ Belgien S. C. S.
95
102
What is Arixtra?
X’ inhu Arixtra?
Arixtra is a solution for injection in a prefilled syringe.
Arixtra hu soluzzjoni għall- injezzjoni f’ siringa mimlija bil- lest.
Arixtra contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).
Arixtra fih is- sustanza attiva fondaparinux sodium (1. 5, 2. 5, 5, 7. 5 jew 10 mg f’ kull siringa).
What is Arixtra used for?
Għal x’ hiex jintuża Arixtra?
Arixtra (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems caused by blood clots) in patients who are having major surgery to their legs, such as a hip replacement or surgery to repair a knee or hip fracture.
Arixtra (f’ dożi ta ’ 1. 5 u 2. 5 mg) jintuża fil- prevenzjoni ta ’ avvenimenti trombolitiċi venużi (VTEs, problemi kkawżati minn demm magħqud) f’ pazjenti li jkunu sa jagħmlu operazzjoni serja f’ riġlejhom, bħal sostituzzjoni ta ’ l- ingroppa jew operazzjonijiet għat- tiswija ta ’ ksur fl- irkoppa jew fl- ingroppa.
It can also be used in patients at high risk (because of their age or disease) when they have abdominal surgery, especially for cancer, or when they are forced to stay in bed because of an acute illness.
Jista ’ jintuża wkoll f’ pazjenti li jkollhom riskju kbir (minħabba l- età jew mard) meta jagħmlu operazzjonijiet addominali maġġuri, speċjalment għall- kanċer, jew meta jkollhom joqogħdu fis- sodda minħabba marda akuta.
At higher strengths (5, 7.5 and 10 mg), Arixtra is used to treat VTEs such as deep vein thrombosis (DVT, a blood clot in the leg) or pulmonary embolism (PE, blood clot in the lung).
F’ qawwiet iktar għolja (5, 7. 5 u 10 mg), Arixtra huwa wżat għall- kura tal- VTEs bħal ma huma trombożi fil- vini l- fondi (DVT, embolu fis- sieq) jew emboliżmu pulmonarju (PE, embolu fil- pulmun).
The 2.5 mg strength is also used to treat patients with unstable angina (a type of chest pain that changes in severity) or who are having a myocardial infarction (heart attack): • without ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG) in patients who are not going to undergo urgent angioplasty (within two hours): angioplasty or ‘ percutaneous coronary intervention ’ (PCI) is an operation to unblock the heart ’ s blood vessels, • with ‘ ST segment elevation’ in patients who are receiving thrombolytic medicines (‘ clot busters’) or who are not about to receive any other treatment to restore blood flow to the heart.
• Mingħajr ‘ l- elevazzjoni tas- segment ST ’ (qari mhux normali fuq l- elettrokardjogramma jew l - ECG) f ’ pazjenti li mhumiex ser jagħmlu anġjoplastija urġenti (urgent angioplasty) (fi żmien sagħtejn): anġjoplastija jew ‘ intervent perkutanju koronarju ’ (PCI) (percutaneous coronary intervention) hija operazzjoni li tiżblokka l- arterji u l- vini tal- qalb, • ‘ Bl- elevazzjoni tas- segment ST ’ f’ pazjenti li qed jirċievu mediċini trombolitiċi (‘ dawk li jeqirdu l- emboli ’) jew li mhumiex ser jirċievu xi tip ta ’ kura oħra immedjata biex il- fluss tad- demm jerġgħa lura lejn il- qalb.
How is Arixtra used?
Kif jintuża Arixtra?
In the prevention of VTEs, the recommended dose of Arixtra is 2.5 mg once a day by subcutaneous injection (under the skin).
Fil- prevenzjoni ta ’ VTEs, id- doża rakkomandata ta ’ Arixtra hija ta ’ 2. 5 mg darba kuljum amministrata permezz ta ’ injezzjoni taħt il- ġilda (subcutaneous injection).
For patients having surgery, the first dose should be given six hours after the end of the operation.
Għal pazjenti li jkunu se jagħmlu operazzjoni, l- ewwel doża għandha tingħata sitt sigħat wara tmiem l- operazzjoni.
Treatment should be continued until the risk of VTE has been reduced, usually at least five to nine days after surgery.
It- trattament għandu jitkompla sakemm jitnaqqas ir- riskju tal- VTE, ġeneralment minn ta ’ l- inqas bejn ħames u disat ijiem wara l- kirurġija.
For patients who have kidney problems, Arixtra may not be suitable, or the 1.5-mg dose may be used.
Għall- pazjenti li jbatu minn problemi fil- kliewi, Arixtra jista ’ ma jkunx adattat, jew inkella tista ’ tintuża doża iżgħar ta ’ 1. 5- mg.
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Id- doża tista ’ tiġi aġġustata, skond il- piż tal - ġisem.
Arixtra is not recommended in patients who are about to undergo certain types of PCI.
Arixtra mhuwiex rakkommandat f’ pazjenti li ser jgħaddu minn ċertu tipi ta ’ PCI.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal aktar informazzjoni, ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukol parti mill- EPAR).
How does Arixtra work?
Kif jaħdem Arixtra?
Blood clotting can be a problem when blood flow is disturbed in any way.
It- tagħqid tad- demm jista ’ jkun problema meta t- tnixxija tad- demm tiġi b’ xi mod imfixkla.
Arixtra is an anticoagulant: it prevents the blood from coagulating (clotting).
Arixtra hu antikoagulant: jipprevjeni d- demm milli jikkoagula (jagħqad).
The active ingredient in Arixtra, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, Factor Xa.
Is- sustanza attiva f’ Arixtra, fondaparinux sodium, twaqqaf waħda mis- sustanzi (fatturi) li jieħdu sehem fil- koagulazzjoni tad - demm, il- Fattur Xa.
When this is blocked, no thrombin (another factor) can be produced, and no clot can be formed.
Meta dan jiġi imblukkat, ma jkunx jista ’ jiġi prodott thrombin (fattur ieħor), u ma jkunx jista ’ jifforma embolu.
By using Arixtra after surgery, the risk of a blood clot forming is greatly reduced.
Bl- użu ta ’ Arixtra wara operazzjoni, ir- riskju ta ’ formazzjoni ta ’ embolu jitnaqqas drastikament.
By reducing blood clots, Arixtra can also help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack.
Peress illi huwa jnaqqas l- emboli, Arixtra jista ’ wkoll jgħin biex il- fluss tad - demm lejn il- qalb jinżamm f’ pazjenti li jbatu minn anġina jew li qegħdin isofru minn attakk tal- qalb.
How has Arixtra been studied?
Kif ġie studjat Arixtra?
The effectiveness of Arixtra has been studied for the prevention of and in the treatment of VTE.
L- effekaċja ta ’ Arixtra ġiet studjata fil- prevenzjoni ta ’ u fil- kura ta ’ VTE.
In the prevention studies, Arixtra was compared with other anticoagulants: enoxaparin (in hip or knee surgery; over 8,000 patients) or dalteparin (in abdominal surgery; 2,927 patients).
Fl- istudji tal- prevenzjoni, Arixtra tqabbel ma ’ antikoagulanti oħra: enoxaparin (fil- kirurġija fl- irkoppa jew fl- ingroppa; iktar minn 8, 000 pazjent) jew dalteparin (fil- kirurġija addominali; 2, 927 pazjent).
It was also compared with placebo (a dummy treatment) when looking at patients with an acute illness (839 patients) and patients treated for an additional 24 days following hip fracture surgery (656 patients).
Tqabbel ukoll ma ’ plaċebo (trattament finta) użat ma ’ pazjenti b’ marda akuta (839 pazjent) u ma ’ pazjenti ttrattati għal 24 jum ieħor wara kirurġija għal ksur fl- ingroppa (656 pazjent).
In the treatment of VTE, Arixtra was compared with enoxaparin (DVT:
Fit- trattament ta ’ VTE, Arixtra tqabbel ma ’ enoxaparin (DVT:
2,192 patients) or with unfractionated heparin (PE:
2, 192 pazjent) jew ma ’ eparina mhux frazzjonata (PE:
2,184 patients).
2, 184 pazjent).
In all studies, the main measure of effectiveness was the overall rate of thrombotic events (problems caused by blood clots).
Fl - istudji kollha, il- mezz prinċipali ta ’ effikaċja kien ir- rata globali ta ’ avvenimenti trombotiċi (problemi kkawżati minn emboli).
Arixtra has also been studied in two main studies of patients with unstable angina or myocardial infarction.
Arixtra ġie studjat ukoll f’ żewġ studji ewlenin ta ’ pazjenti li jbatu minn anġina mhux stabbli jew infart mijokardjali.
The first compared the effects of Arixtra with those of enoxaparin in over 20,000 patients with unstable angina or myocardial infarction without ST segment elevation, and the second compared Arixtra with standard care (unfractionated heparin in eligible patients, or placebo) in over 12,000 patients with myocardial infarction with ST segment elevation.
L- ewwel wieħed ikkumpara l- effetti ta ’ Arixtra ma dawk ta ’ enoxaparin f’ iktar minn 20, 000 – il pazjent li jbatu minn anġina mhux stabbli u infart mijokardjali mingħajr l- elevazzjoni tas - segment ST, u t- tieni wieħed ikkumpara Arixtra mal- kura standard (eparina mhux frazzjonata f’ pazjenti eliġibbli, jew plaċebo) f’ iktar minn 12, 000 – il pazjent li jbatu minn infart mijokardjali b ’ elevazzjoni tas- segment ST.
The main measure of effectiveness was the proportion of patients who died or had an ‘ ischaemic event’ (restriction of blood supply to an organ, including the heart).
Il- miżura prinċipali ta ’ effikaċja kienet il- proporzjon ta ’ pazjenti li mietu jew kellhom ‘ avveniment iskaemiku ’ (restrizzjoni tal- provvista tad- demm lejn xi organu, inkluż il - qalb).
What benefit has Arixtra shown during the studies?
X’ inhuma l- benefiċċji ta ’ Arixtra li ntwerew f’ dawn l- istudji?
The overall rate of thrombotic events in patients treated with Arixtra was significantly less than in patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin.
Ir- rata globali ta ’ avvenimenti trombotiċi f’ pazjenti ttrattati b’ Arixtra kienet ferm inqas minn dik f’ pazjenti ttrattati bi plaċebo jew b’ enoxaparin (għal pazjenti li kienu se jiġu operati f’ saqajhom), u kienet simili għal dik b’ enoxaparin (trattament tad- DVT), dalteparin jew eparina mhux frazzjonata.
Arixtra was at least as effective as enoxaparin in preventing death or an ischaemic event in patients with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days.
Arixtra kien minn ta ’ l- inqas effettiv daws enoxaparin fil- prevenzjoni tal- mewt jew avveniment iskaemiku f’ pazjenti li jbatu minn anġina mhux stabbli jew infart mijokarkjali mingħajr elevazzjoni tas- segment ST, b’ madwar 5% tal- pazjenti f’ kull grupp li mietu jew li kellhom avveniment iskaemiku wara disat ijiem.
In the study of myocardial infarction with ST segment elevation, Arixtra reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care.
Fl- istudju ta ’ l- infarti mijokardjali b’ elevazzjoni tas- segment ST, Arixtra naqqas ir - riskju ta ’ mewt jew attakk tal- qalb ieħor b’ 14% wara 30 jum, meta imqabbel mal- kura standard.
However, these results were insufficient to show whether Arixtra was more effective than unfractionated heparin or not.
Madankollu, dawn ir- riżultati ma kienux suffiċjenti biex juru jekk Arixtra kienx iktar effettiv mill - eparina mhux frazzjonata jew le.