qanastek/EMEA-V3 huggingface dataset:
Before you take CYMBALTA 3.
Qabel ma tieħu CYMBALTA 3.
How to take CYMBALTA 4.
Kif għandek tieħu CYMBALTA 4.
Possible side effects 5 How to store CYMBALTA 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen CYMBALTA 6.
WHAT CYMBALTA IS AND WHAT IT IS USED FOR
X’ INHU CYMBALTA U GĦALXIEX JINTUŻA
CYMBALTA increases the levels of serotonin and norepinephrine in the nervous system.
CYMBALTA jżid il- livelli ta ’ serotonin u ta ’ norepinephrine fis- sistema nervuża.
You have been given CYMBALTA to treat either 1) depression, 2) generalised anxiety disorder (chronic feeling of anxiety or nervousness) or 3) a condition called diabetic neuropathic pain.
Ġejt mogħti CYMBALTA bħala kura ta ’ jew 1) d- depressjoni, 2) disturb ta ’ l- ansjetà ġeneralizzata (sensazzjoni kronika ta ’ ansjetà jew nervożità) jew 3) kundizzjoni li tissejjaħ uġigħ newropatiku tad - dijabete.
Neuropathic pain is a medical condition in which the pain is commonly described as burning, stabbing, stinging, shooting or aching or like an electric shock.
L- uġigħ newropatiku huwa kundizzjoni medika fejn l- uġigħ huwa komunement deskritt bħala wieħed ta ’ ħruq, penetranti, ta ’ tingiż, li jxoqq l- għadam jew oppressiv jew bħal xokk elettriku.
There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain.
Jista ’ jkun hemm telf ta ’ sensibbilità fil- parti milquta jew is- sensazzjonijiet bħal ħass, sħana, kesħa jew tagħfis jistgħu jkunu kawża ta ’ wġigħ.
CYMBALTA starts to work in most people with depression or anxiety within two weeks of starting treatment.
Fil- parti l- kbira tan- nies li jbatu mid- depressjoni jew mill- ansjetà CYMBALTA jibda jaħdem fi żmien ħmistax minn mindu tibda l- kura.
Your doctor may continue to give you CYMBALTA when you are feeling better to prevent your depression or anxiety from returning.
It- tabib tiegħek jista ’ jkompli jagħtik CYMBALTA meta tkun qiegħed tħossok aħjar sabiex jimpedixxi milli tirritorna d- depressjoni jew l- ansjetà.
The effect of CYMBALTA 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 ’ CYMBALTA jista ’ jidher fi żmien ġimgħa minn mindu tibda l- kura..
BEFORE YOU TAKE CYMBALTA
QABEL MA TIEĦU CYMBALTA
Do not take CYMBALTA − If you are allergic (hypersensitive) to duloxetine or any of the other ingredients of CYMBALTA. − 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 are taking other medicines containing duloxetine. − 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 ’)
2 Take special care with CYMBALTA The following are reasons why CYMBALTA may not be suitable for you.
dipressjoni,, ciprofloxacine jew enoxacine li jintużaw għall- kura ta ’ xi infezzjonijiet.
If any of them apply to you, talk to your doctor before you take the medicine:
- Jekk qiegħed/ qiegħda tieħu mediċini oħra li fihom duloxetine
- If yYou are taking other medicines to treat depression.
- Jekk qiegħed/ qeiegħda tieħu mediċini oħra biex tikkura d- depressjoni.
- You are taking a herbal treatment containing St.
- Qiegħed/ qiegħda tieħu xi kura bbażata fuq il- ħxejjex li fiha St. John’ s Wort (Hypericum
John’ s Wort (Hypericum perforatum).
perforatum)
- You have kidney disease.
- Għandek mard tal- kliewi.
- You have had seizures (fits).
- Għandek passat ta 'aċċessjonijiet.
- You suffer from or have suffered from mania or bipolar disorder.
- Tbati jew għandek passat ta ’ manija jew mard bipolari.
- You have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
- Għandek problemi f' għajnejk bħal xi tip ta 'glawkoma (pressjoni għolja fl- għajn).
- You have a history of bleeding disorders (tendency to develop bruises).
- Għandek passat ta 'emorraġija (tendenza li tiżviluppa tbenġil).
- You are at risk of low sodium levels.
- Qiegħed/ qiegħda f’ riskju li jkollok livelli baxxi ta ’ sodium.
- If You have high blood pressure.
- Jekk ghandek pressjoni għolja tad- demm
- You are currently being treated with another medicine which may cause liver damage.
- Bħalissa qiegħed/ qiegħda tirċievi kura b’ mediċina oħra li tista ’ tikkawża ħsara fil- fwied.
- You are taking other medicines containing duloxetine.
- Qiegħed/ qiegħda tirċievi mediċini oħra li fihom duloxetine.
- You have intolerance to some sugars (see below).
- Għandek xi intolleranza għal xi zokkor (ara aktar ’ l isfel).
- You are considering stopping CYMBALTA (see section 3).
- Qiegħed/ qiegħda taħseb biex twaqqaf CYMBALTA (ara sezzjoni 3)
CYMBALTA may cause a sensation of restlessness or an inability to sit or stand still.
CYMBALTA jista ’ jikkawża sensazzjoni ta ’ irrekwitezza jew l- inkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq.
You should tell your doctor if this happens to you.
Għandek tgħid lit- tabib jekk jiġrilek hekk.
Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/ or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Jekk tbati mid - dipressjoni u/ jew għandek problemi ta ’ ansjetà, xi kultant jista ’ jkollok xi ħsibijiet li tweġġa ’ jew toqtol lilek innifsek.
These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Dawn jistgħu jiżdiedu fil- bidu li tibda tieħu l- antidipressivi, peress li dawn il - mediċini kollha jieħdu ż- żmien biex jibdew jaħdmu, issoltu xi ġimgħatejn iżda xi kultant iżjed.
You may be more likely to think like this:
Wisq probabbli taħseb iżjed b’ dan il- mod:
- If you have previously had thoughts about killing or harming yourself.
- Jekk diġà kellek xi ħsibijiet biex toqtol jew tweġġa ’ lilek innifsek
- If you are a young adult.
- Jekk inti adult/ a żgħir/ a.
Information from clinical trials has shown an increased risk of suicidal
Tagħrif minn studji kliniċi wera li hemm żieda fir- riskju ta ’ mġiba
behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
suwiċidali f’ adulti li għandhom inqas minn 25 sena, bi problemi psikjatriċi u li kienu kkurati b’ antidipressivi.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Jekk f’ xi kwalunkwe mument kellek xi ħsibijiet li tweġġa ’ jew toqtol lilek innifsek, tkellem mat- tabib tiegħek jew mur minnufih l- isptar.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Tista ’ tkun ta ’ għajnuna li tgħid lil xi ħadd li jiġi minnek jew lil xi ħabib tal- qalb li inti qed/ a tbati mid - dipressjoni jew li għandek xi problema ta ’ ansjetà, u għidilhom biex jaqraw dan il- fuljett.
You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Tista ’ tgħidilhom biex jgħidulek jekk jaħsbux li d- dipressjoni u l- ansjetà tiegħek m’ humiex sejrin għall- agħar jew jekk huma inkwetati dwar tibdil fl- imġiba tiegħek.
Use in children and adolescents under 18 years of age CYMBALTA should normally not be used for children and adolescents under 18 years.
Użu fit- tfal jew adolexxenti taħt it- tmintax- il sena Normalment CYMBALTA m’ għandux jintuza 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 suwiċidali u ostilità (l- iżjed aggressjoni, imġiba konfrontali u rabja) meta jieħdu dan it- tip ta ’ medicini.
Despite this, your doctor may prescribe CYMBALTA for patients under 18 because he/ she decides that this is in their best interests.
Madankollu, it- tabib tiegħek jista ’ jordna CYMBALTA lil pazjenti taħt it- 18 għax jiddeċiedi/ tiddeċiedi li huwa fl- aħjar interess għalihom.
If your doctor has prescribed CYMBALTA for a patient under 18 and you want to discuss this, please go back to your doctor.
Jekk it- tabib ordna CYMBALTA 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 CYMBALTA.
Għandek tavża lit- tabib tiegħek jekk jiżviluppaw jew jiggravaw xi sintomi li ssemmew hawn fuq, meta pazjenti taħt it- 18 ikunu qegħdin jieħdu CYMBALTA.
Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of CYMBALTA 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.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed/ qiegħda tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk ta ’ mingħajr riċetta.
The main ingredient of CYMBALTA, duloxetine, is used in other medicines for other conditions (diabetic neuropathic pain, depression, anxiety and urinary incontinence).
Is- sustanza l- aktar importanti f’ CYMBALTA, duloxetine, hija użata f’ medicini oħra għal kundizzjonijiet oħra (uġigħ newropatiku tad- dijabete,
Using more than one of these medicines at the same time should be avoided.
L- użu ta ’ iżjed minn wieħed minn dawn il- medicini fl - istess żmien għandu jkun evitat.
Check with your doctor if you are already taking other medicines containing duloxetine.
Ara mat- tabib tiegħek jekk qiegħed/ qiegħda diġà tieħu xi medicini oħra li fihom duloxetine.
Your doctor should decide whether you can take CYMBALTA with other medicines.
It- tabib tiegħek irid jiddeċiedi jekk għandekx tieħu CYMBALTA 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.
3 Monoamine Oxidase Inhibitors (MAOIs):
Inibituri ta ’ Monoamine Oxidase( MAOI):
You should not take CYMBALTA 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 CYMBALTA 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.
Taking a MAOI together with many prescription medicines, including CYMBALTA, can cause serious or even life-threatening side effects.
It- teħid ta 'xi MAOI flimkien ma' ħafna mill- mediċini mgħotija bir - riċetta, inkluż CYMBALTA, 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 CYMBALTA.
Għandek tistenna ta 'l- anqas 14- il ġurnata wara li tkun waqaft tieħu xi MAOI biex tkun tista' tieħu CYMBALTA.
Also, you need to wait at least 5 days after you stop taking CYMBALTA before you take a MAOI.
Għandek bżonn ukoll tistenna ta 'l- anqas 5 ijiem wara li tieqaf tieħu CYMBALTA biex tkun tista' tieħu xi MAOI.
Medicines that cause sleepiness:
Mediċini li jistgħu jikkawża n- ngħas:
Tell your doctor if you are taking any medicines which cause you to be sleepy.
Għid lit- tabib tiegħek jekk qiegħed/ qiegħda tieħu xi medicini li jġagħluk tkun bi ngħas.
These would include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, antihistamines.
Dawn jinkludu mediċini mgħotija mit- tabib tiegħek permezz ta ’ ricetta inklużi l- benżodijażepini, mediċini qawwijin kontra l- uġigħ, antipsikotiċi, phenobarbital u anti- istaminiċi.
Examples of these medicines include: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John’ s Wort and venlafaxine.
Sindromu ta ’ serotonin: għandek tgħid lit- tabib tiegħek jekk qiegħed/ qiegħda tieħu xi mediċini li l - mod kif jaħdmu jixbaħ dak ta ’ duloxetine. Eżempji ta ’ dawn il- medicini jinkludu: triptans, tramadol, tryptophan, SSRIs (bħal paroxetine u fluoxetine), triċikliċi (bħal clomipramine, amitriptyline), pethidine, St. John’ s Wort u venlafaxine.
These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with CYMBALTA, 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 ’ CYMBALTA, għandek tmur għand it- tabib tiegħek.
Oral -anticoagulants:
Antikoagulanti orali:
You should tell you doctor if you are taking oral – anticoagulants (medicines which thin the blood).
Għandek tgħid lit- tabib tiegħek jekk qiegħed/ qiegħda tieħu xi antikoagulanti orali (mediċini li jraqqu d- demm).
These medicines might increase the risk of bleeding.
Dawn il- mediċini jistgħu jżidu r- riskju ta ’ fsada.
Taking CYMBALTA with food and drink CYMBALTA may be taken with or without food.
Meta tieħu CYMBALTA ma ’ l- ikel u max- xorb CYMBALTA jista 'jittieħed ma' l- ikel jew fuq stonku vojt.
Care should be taken if you drink alcohol while you are being treated with CYMBALTA.
Għandek toqgħod attent jekk tixrob l - alkoħol waqt li tkun qiegħed/ qiegħda tirċievi l- kura b’ CYMBALTA.
You should use CYMBALTA 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 CYMBALTA. Ghandek biss tuża CYMBALTA wara li tkun iddiskutejt mat- tabib tiegħek il- benefiċċji possibbli u kull riskju possibbli għat- tarbija li għada ma twelditx.
You should ask your doctor or pharmacist for advice if you are breast-feeding.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek jekk qiegħda tredda ’.
The use of CYMBALTA while breastfeeding is not recommended.
Mhuwiex rakkomandat l- użu ta ’ CYMBALTA waqt it- treddigħ.
Do not drive or use any tools or machines until you know how CYMBALTA affects you.
Sewqan u tħaddim ta ’ magni Issuqx u tagħmilx użu minn għodda jew tħaddem magni sakemm tkun taf b’ liema mod jaffettwak CYMBALTA.
Important information about some of the ingredients of CYMBALTA CYMBALTA contains sucrose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ CYMBALTA CYMBALTA fih s- sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk ġejt mgħarraf mit- tabib tiegħek li għandek xi intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE CYMBALTA
KIF GĦANDEK TIEĦU CYMBALTA
Always take CYMBALTA exactly as your doctor has told you.
Dejjem għandek tieħu CYMBALTA skond il- parir tat- tabib.
For depression and diabetic neuropathic pain:
Għad- depressjoni u l- uġigħ newropatiku tad- dijabete:
The usual dose of CYMBALTA is one capsule (60 mg duloxetine) once a day, but your doctor will prescribe the dose that is right for you.
47 Id- doża ta ’ CYMBALTA li ssoltu tingħata hija ta ’ kapsula waħda (60 mg duloxetine) darba kuljum, iżda it- tabib jiktiblek ricetta skond id- doza li tgħodd għalik.
For generalised anxiety disorder:
Għad- disturb ta ’ l- ansjetà ġeneralizzata:
The usual starting dose of CYMBALTA is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Normalment id- doża inizjali ta ’ CYMBALTA hi ta ’ 30 mg darba kuljum, iżda maż- żmien il- parti l - kbira tal- pazjenti jibdew jirċievu 60 mg darba kuljum, madankollu t- tabib jiktiblek ricetta skond id - doza li tgħodd għalik.
The dose may be adjusted up to 120 mg a day based on your response to CYMBALTA.
Id- doża tista ’ tiġi aġġustata ’ l fuq sa 120 mg skond ir- rispons tiegħek għal CYMBALTA.
4 CYMBALTA is for oral use.
CYMBALTA għandu jittieħed mill- ħalq.
You should swallow your capsule whole with a drink of water.
Għandek tibla ’ l- kapsula tiegħek sħiħa, ma 'tazza ilma.
To help you remember to take CYMBALTA, you may find it easier to take it at the same times every day.
Biex tiftakar tieħu CYMBALTA, tista ’ ssibha aktar faċli li teħodha kuljum fl- istess ħinijiet.
Do not stop taking CYMBALTA without talking to your doctor.
Tkellem mat- tabib tiegħek dwar kemm trid iddum tieħu CYMBALTA. Tieqafx tieħu CYMBALTA mingħajr ma tkellem lit- tabib tiegħek.
If you have further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
If you take more CYMBALTA than you should Call your doctor or pharmacist immediately if you take more than the amount of CYMBALTA prescribed by your doctor.
Ċempel immedjatament lit- tabib jew lill- ispiżjar tiegħek jekk tieħu aktar ammont ta 'CYMBALTA minn kemm ordnalek it- tabib.
If you forget to take CYMBALTA Do not take a double dose to make up for a forgotten dose.
Jekk tinsa tieħu CYMBALTA M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu.
If you miss a dose, take it as soon as you remember.
Jekk tinsa tieħu doża, ħudha eżatt kif tiftakar.
However, if it is time for your next dose, skip the missed dose and take only a single dose as usual.
Madankollu, jekk sar il- ħin għad- doża li jmissek, aqbeż id- doża li nsejt tieħu u ħu doża waħda biss bħas- soltu.
Do not take more than the daily amount of CYMBALTA that has been prescribed for you in one day.
Tieħux iżjed mill- ammont ta 'CYMBALTA li ordnalek it- tabib għal ġurnata waħda.
If you stop taking CYMBALTA Do not stop taking your capsules without the advice of your doctor even if you feel better.
Jekk tieqaf tieħu CYMBALTA 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 CYMBALTA 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 CYMBALTA huwa se jgħidlek biex tnaqqas id- doża fuq perijodu ta ’ għallinqas ġimgħatejn qabel ma twaqqaf għal kollox il- kura.
Some patients who stop taking CYMBALTA suddenly have had symptoms such as dizziness, fatigue, 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 CYMBALTA f' daqqa kellhom sintomi bħal sturdament, għeja, 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.
These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.
Normalment dawn is- sintomi m’ humiex serji u jisparixxu fi ftit ġranet, imma jekk għandek sintomi li qegħdin idejquk għandek issaqsi lit- tabib għal parir.
Like all medicines, CYMBALTA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, CYMBALTA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These effects are normally mild to moderate and often disappear after a few weeks.
Normalment dawn l- effetti huma ħfief għal moderati u ħafna drabi jisparixxu wara ftit ġimgħat.
Very common side effects (these can affect more than 1 in 10 patients treated) Feeling sick (nausea), headache, dry mouth, feeling sleepy, fatigue, dizziness and constipation.
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, tħossok bi ngħas, għeja, sturdament u stitikezza.
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. • Tremor or numbness, including numbness or tingling of the skin. • Diarrhoea, 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) • Ħedla, diffikultà biex torqod, ansjetà, tħossok aġitat u jkollok ħolm mhux tas- soltu. • Rogħda jew tirżiħ, inkluż it- tirżiħ jew tnemnin tal- ġilda 48 • Dijarea, 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.
5 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 • 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
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.
Rare side effects (these can affect from 1 to 10 users in 10,000 patients treated) • Decrease of activity of the thyroid gland. • Dehydration. • Mania (a disorder which symptoms are over activity, racing thoughts and decrease need for sleep), experiencing aggression and anger. • Bad breath. • Increased pressure in the eye. • Menopausal symptoms. • Contraction of the jaw muscle. • Increased level of cholesterol 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).
Effetti sekondarji rari (dawn jistgħu jaffettwaw minn 1 sa 10 pazjenti minn kull 10, 000 pazjent ikkurat) • Tnaqqis fl- attività tal- glandola tat- tirojde. • Diżidratazzjoni • Manija (marda fejn is- sintomi huma li tkun attiv iżżejjed, ikollok ħsibijiet li jiġru bik u jonqos il- bżonn ta ’ l- irqad), tħossok aggressiv u rrabjat. • Togħma ħażina fil- ħalq. • Żieda tal- pressjoni fl- għajnejn. • Sintomi tal- menopawża. • Kontrazzjoni tal- muskolu tax- xedaq • Żieda fil- livell tal- kolesterol 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).
Other possible side effects • Hallucinations, suicidal thoughts, behaviour. • 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. • 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.
HOW TO STORE CYMBALTA
KIF TAĦŻEN CYMBALTA
Keep out of the reach and sight of children
Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
Do not use CYMBALTA after the expiry date which is stated on the carton.
Tużax CYMBALTA wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
6 Store in the original package.
6.
Do not store above 30°C.
AKTAR TAGĦRIF
FURTHER INFORMATION
X’ fih CYMBALTA:
The active substance is duloxetine.
Is- sustanza attiva hi duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride)
Kull kapsula fiha 30mg jew 60mg ta ’ duloxetine (bħala hydrochloride).
Capsule content: hypromellose, hydroxypropyl methylcellulose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate.
Kontenut tal- kapsula: hypromellose, hydroxypropyl methylcellulose acetate succinate, sucrose, sferi taz- zokkor, talkum, titanium dioxide (E171), triethyl citrate.
Capsule shell: gelatin, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Il- Qoxra tal- kapsula: ġelatina, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide isfar (E172) (għas- 60mg biss) u inkjostru aħdar li jittiekel (30mg) jew inkjostru abjad li jittiekel (60mg).
Edible green ink: black iron oxide-synthetic (E172), yellow iron oxide- synthetic (E172), propylene glycol, shellac.
Inkjostru aħdar li jittiekel: iron oxide sintetiku iswed (E172), iron oxide sintetiku isfar (E172), propylene glycol, shellac.
Edible White Ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
Inkjostru abjad li jittiekel: titanium dioxide (E171), propylene glycol, shellac, povidone.
What CYMBALTA looks like and contents of the pack CYMBALTA is a hard gastro-resistant capsule Each capsule of CYMBALTA contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Kull kapsula ta ’ CYMBALTA fiha pritkuni ta ’ duloxetine hydrochloride b’ kisja sabiex tipproteġihom mill- aċtu ta ’ l- istonku.
CYMBALTA is available in 2 strenghts:
CYMBALTA huwa disponibbli f’ żewġ dożi:
The 60 mg capsules are blue and green and are printed with ‘ 60 mg’ and the code ‘ 9542’.
30 mg u 60 mg Il- kapsuli ta ’ 30mg huma blu u abjad u huma stampati b ’ ‘ 30mg ’ u l- kodiċi ‘ 9543 ’ Il- kapsuli ta ’ 60mg huma blu u ħodor u huma stampati b ’ ‘ 60mg ’ u l- kodiċi ‘ 9542 ’
CYMBALTA 60 mg is available in packs of 28, 56, 84, 98, 100 and 500 capsules.
CYMBALTA 30mg issibu f’ pakketti ta ’ 7, 28 u 98 kapsula CYMBALTA 60 mg issibu f’ pakketti ta ’ 28, 56, 84, 98, 100 u 500 kapsula.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
Manufacturer:
50 Manifattur:
De la Industria, 30,28108 Alcobendas, Madrid, Spain.
De la Industria, 30, 28108 Alcobendas, Madrid, Spanja.
7 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
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 Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu.
EU/ 1/ 06/ 379/ 001
Numru ta ’ l- EU EU/ 1/ 06/ 379/ 001
Cystadane
Isem inventat Cystadane
1g
Qawwa 1g
Oral powder
Għamla farmaċewtika Trab għall- ħalq
Oral use
Mnejn jingħata Jittieħed mill- ħalq
bottle (HDPE)
Il- pakkett flixkun (HDPE)
180 g
Kontenut 180 g
1 bottle+3 measuring spoons (1g,150mg, 100mg)
Daqs tal- pakkett 1 flixkun +3 measuring spoons (1g, 150mg, 100mg)
Cystadane 1 g oral powder
Cystadane 1 g trab għall- ħalq
1 g of powder contains 1 g of betaine anhydrous.
1 g ta 'trab fih 1 g ta' betaine anidru.
Three measuring spoons dispense 1 g, 150 mg and 100 mg of betaine anhydrous.
Tliet kuċċarini bħala miżuri jagħtu 1 g, 150 mg u 100 mg ta 'betaine anidru.
For full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Oral powder White free flowing powder.
Trab għall- ħalq Trab abjad li faċilment jitħallat.
Adjunctive treatment of homocystinuria, involving deficiencies or defects in: • cystathionine beta-synthase (CBS), • 5,10-methylene-tetrahydrofolate reductase (MTHFR), • cobalamin cofactor metabolism (cbl).
Trattament miżjud għall- omoċistinurja, li jinvolvi defiċjenzi jew difetti f ’: • cystathionine beta- synthase (CBS), • 5, 10- methylene- tetrahydrofolate reductase (MTHFR), • cobalamin cofactor metabolism (cbl).
Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
Cystadane għandu jintuża bħala suppliment għal terapiji oħra bħala vitamina B6 (pyridoxine), vitamina B12 (cobalamin), folate u dieta speċifika.
Cystadane treatment should be supervised by a physician experienced in the treatment of patients with homocystinuria.
Trattament b’ Cystadane għandu jiġi sorveljat minn tabib b' esperjenza fit- trattamenti ta ’ pazjenti b’ omocistinurja.
The recommended total daily dose in adult and paediatric patients over 10 years of age is 6 g per day administered orally in divided doses of 3 g two times per day.
Id- doża globali ta ’ kuljum rakkomandata fl- adulti u f’ pazjenti tfal li għandhom ‘ il fuq minn 10 snin hija ta ’ 6 g kuljum li għandha tingħata oralment f’ dożi maqsuma ta ’ 3 g darbtejn kuljum.
However, dose titration may be preferable in paediatric patients.
Madankollu, titrazzjoni tad- doża tista ’ tkun ippreferuta f’ pazjenti tfal.
In paediatric patients less than 10 years of age, the usual effective dose regimen is 100 mg/ kg/ day given in 2 doses daily; increasing the frequency above twice daily and/ or the dose above 150 mg/ kg/ day does not improve the homocysteine-lowering effect.
F’ pazjenti tfal li għandhom anqas minn 10 snin t' età, ir- reġimen effettiv ġenerali hu ta ’ 100 mg/ kg/ kuljum mogħti f’ 2 dożi kuljum; żjieda fil- frekwenza għal aktar minn darbtejn kuljum u/ jew aktar minn 150 mg/ kg/ kuljum ma jtejjibx l- effett ta ’ tnaqqis fil- homocysteine.
Use in hepatic or renal impairment Experience with betaine therapy in patients with renal insufficiency or non-alcoholic hepatic steatosis has demonstrated no need to adapt the dose regimen of Cystadane.
Użu f’ indeboliment epatiku jew renali Esperjenza bit- terapija ta 'betaine f’ pazjenti b’ insuffiċjenza renali jew steatożi epatika mhux alkoħolika ma wriet l- ebda ħtieġa li r- reġimen tad- doża ta ’ Cystadane tiġi adattata.
The bottle should be lightly shaken before opening.
Il- flixkun għandu jitħallat b' mod ħafif qabel jinfetaħ.
It is recommended that a heaped measuring spoon is removed from the container and a flat surface e. g. base of a knife is drawn across the top of the measure.
Tliet kuċċarini bħala miżuri huma pprovduti li jidispensaw jew 100 mg, 150 mg jew 1 g ta ’ betaine anidru Huwa rakkomandat li kuċċarina mburġata tittella 'mir- reċipjent u superfiċje lixxa eż. il- bażi ta ’ sikkina tiġi mgħoddija minn fuq il- quċċata tal - miżura.
This will give the following doses: small measure 100 mg, middle size measure 150 mg and large measure 1 g of betaine anhydrous.
Dan jagħti d- dożi li ġejjin: kuċċarina żgħira 100 mg, kuċċarina tan- nofs 150 mg u kuċċarina kbira 1 g ta ’ betaine anidru.
The powder should be mixed with water, juice, milk, formula or food until completely dissolved and ingested immediately after mixing.
It- trab jista 'jiġi mħallat ma ’ l- ilma, il- meraq tal- frott, il- ħalib, it- trab tal- ħalib tat- trabi jew l- ikel sakemm jinħall kompletament u jittieħed immedjatament wara li jitħallat.
Therapeutic monitoring:
2 Monitoraġġ terapewtiku:
2 The aim of treatment is to keep plasma levels of total homocysteine below 15 µM or as low as possible.
L- għan tat- trattament hu li jżomm il- livelli ta 'homocysteine totali fil- plażma inqas minn15 µM jew baxx kemm jista' jkun.
The steady-state response usually occurs within a month.
Ir- rispons fi stat ta 'stadju fiss jseħħ fi żmien xahar.
Hypersensitivity to betaine.
Sensittività eċċessiva għal betaine.
Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine therapy (see section 4.8).
Każijiet mhux komuni ta ’ edema ċerebrali serja u ipermetjoninemija kienu rapportati fi żmien ġimgħatejn sa 6 xhur mill- bidu tat- terapija b' betaine (ara sezzjoni 4. 8).
Complete recovery was seen after treatment discontinuation:
Fejqan komplut deher wara li t- trattament twaqqaf:
- Plasma methionine level should be monitored, at start of treatment and periodically thereafter.
- Il- livell ta ’ methionine fil- plażma għandu jiġi monitorjat, fil- bidu tat- trattament u perijodikament
The plasma methionine concentrations should be kept below 1000 µM.
Il- konċentrazzjonijiet ta ’ methionine fil- plażma għandhom jinżammu taħt 1000 µM.
- If any symptoms of cerebral oedema like morning headaches with vomiting and/ or visual changes
- Jekk jidhru xi sintomi ta ’ edema ċerebrali bħal uġigħat ta ’ ras ta 'filgħodu b’ remettar u/ jew bidliet
appear, plasma methionine level and compliance to the diet should be checked and treatment with Cystadane interrupted.
fil- vista, il- livell ta ’ methionine fil- plażma u l- osservanza tad- dieta għandhom jiġu kontrollati u trattament b ’ Cystadane għandu jiġi interrott.
- If symptoms of cerebral oedema recur after re-introduction of treatment then betaine therapy
- Jekk sintomi ta ’ edema ċerebrali jerġgħu jidhru wara l- introduzzjoni mill- ġdid tat- trattament
should be discontinued indefinitely.
f’ dak il- każ terapija b’ betaine għandha tiġi mwaqqfa b ’ mod indefinit.
To minimize the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine and amino acids mixtures and/ or medicinal products containing vigabatrin and GABA analogues (see section 4.5).
Biex tnaqqas ir- riskju ta ’ interazzjonijiet potenzjali tal- mediċina, huwa rakkomandat li jitħallew 30 minuta bejn it- teħid ta ’ betaine u taħlitiet ta ’ aċidi amminiċi u/ jew prodotti mediċinali li fihom vigabatrin u analogi ta 'GABA (ara sezzjoni 4. 5).
Based on in vitro data, betaine might interact with amino acids mixtures and medicinal products containing vigabatrin and GABA analogues.
Ibbażat fuq dejta in vitro, betaine jista ’ jkollu effett ma ’ taħlitiet ta ’ aċidi amminiċi u prodotti mediċinali li fihom vigabatrin u analogi GABA.
Pregnancy Data on a limited number (7) of exposed pregnancies indicate no adverse event of betaine on pregnancy or on the health of the foetus/ newborn child.
Tqala Dejta minn fuq numru ristrett ta ’ (7) tqaliet esposti ma jindikaw l- ebda effett avversi ta ’ betaine fuq it - tqala jew fuq is- saħħa tal- fetu/ tarbija ġdida.
To date, no other relevant epidemiologic data are available.
Sal- lum, m' hemm l- ebda dejta epidemjoloġika rilevanti oħra.
Animal reproduction studies have not been conducted.
Studji dwar ir- riproduzzjoni fl- annimali ma sarux.
During pregnancy, administering betaine in addition to pyridoxine, folate, anticoagulant and diet under close monitoring of plasma homosysteine would be compatible with good maternal and foetal outcomes.
Waqt it- tqala, l- għoti ta ’ betaine flimkien ma ’ pyridoxine, folate, antikoagulant u dieta taħt sorveljanza stretta tal- homocysteine fil- plażma huwa kompatibbli ma ’ eżitu matern u fetali tajjjeb.
However, Cystadane should not be used during pregnancy unless clearly necessary.
Madankollu, Cystadane m' għandux jingħata waqt it- tqala għajr jekk ikun meħtieġ b' mod ċar.
Breast-feeding It is not known whether betaine is excreted in human milk (although its metabolic precursor, choline, occurs at high levels in human milk).
Treddigħ Mhux magħruf jekk betaine jiġix eliminat mal- ħalib uman (għalkemm il- prekursur metaboliku tiegħu, choline, jinsab f' livelli għoljin fil- ħalib uman).
Because of lack of data, caution should be exercised when prescribing Cystadane to breast-feeding women.
Minħabba nuqqas ta 'dejta, attenzjoni għandha tingħata meta Cystadane jiġi preskritt lin- nisa li jreddgħu.
No studies on the effects on the ability to drive and use machines have been performed.
Esperjenza meħuda minn esponiment għal betaine ta ’ 1, 000 pazjent.
3 4.8 Undesirable effects
3 Reazzjonijiet avversi rapportati huma elenkati hawn isfel, skond is- sistema tal- klassifika ta 'l- organi u l- frekwenza.
Experience derived from exposure to betaine in about 1,000 patients.
Disturbi marbuta mal- metaboliżmu u n - Mhux komuni: anoreksja nutrizzjon:
Reported adverse reactions are listed below, by system organ class and by frequency.
Disturbi psikjattriċi
Frequencies are defined as: 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).
Mhux komuni: agitazzjoni, depressjoni, irritabilità, disturbi fil- personalità, disturbi fl- irqadt
Metabolism and nutrition disorders Psychiatric disorders
Disturbi tas- sistema nervuża Disturbi gastrointestinali
Uncommon: anorexia Uncommon: agitation, depression, irritability, personality disorder, sleep disturbed
Mhux komuni: edema fil- moħħ * Mhux komuni: disturbi dentali, dijarrea, glossite, nawsea, skomfort fl- istonku, remettar
Nervous system disorders Gastrointestinal disorders
Disturbi tal- ġilda u tat- tessut subkutaneji
Uncommon: brain oedema* Uncommon: dental disorders, diarrhoea, glossitis, nausea, stomach discomfort, vomiting
Mhux komuni: telf tax- xagħar, ħorriqija, riħa anormali tal- ġilda
Skin and subcutaneous tissue disorders Renal and urinary disorder Investigations
Stħarriġ
Uncommon: hair loss, hives, skin odour abnormal Uncommon: urinary incontinence Very common: blood methionine increased*
Mhux komuni: inkontinenza urinarja Komuni ħafna: livell ogħla ta 'methionine fid- demm *
*Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine therapy, with complete recovery after treatment discontinuation.
* Każijiet mhux komuni ta ’ edema ċerebrali serja u ipermetjoninemija kienu rrapportati fi żmien ġimgħatejn sa 6 xhur mill- bidu ta ’ terapija b' betaine, b’ fejqan komplut wara t- twaqqif tat- trattament.
High increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients.
Żjidiet għoljin fil- livelli tal- methionine fil- plażma fuq firxa minn 1, 000 sa 3000 µM kienu notati f’ dawn il- pazjenti.
As cerebral oedema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine therapy has been postulated as a possible mechanism of action.
Billi edema ċerebrali kienet ukoll irrapportata f’ pazjenti b’ ipermetjoninemija, ipermetjoninemija sekondarja minħabba terapija b’ betaine ġiet postulata bħala mekkaniżmu t’ azzjoni possibbli.
For specific recommendations, refer to section 4.4.
Għar- rakkomandazzjonijiet speċifiċi, irreferi għal sezzjoni 4. 4.
Alimentary tract and metabolism product, ATC code:
Prodott għall- passaġġ alimentari u għall- metaboliżmu, Kodiċi ATC:
CBS deficiency; MTHFR deficiency and cbl defect.
Betaine kien muri li jbaxxi l- livelli ta 'ta ’ homocysteine fil- plażma fi tlett tipi ta ’ omoċistinurja, i. e. defiċjenza CBS; defiċjenza MTHFR u difett cbl.
The extent of this effect was dependent on the absolute degree of hyperhomocysteinemia, being higher in severe hyperhomocysteinemia.
L- estensjoni ta ’ dan l- effett kinet dipendenti fuq il - grad assolut ta ’ iperomocistinemija, u kienet ogħla f’ iperomocistinemija serja.
Betaine acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria.
Betaine jaġġixxi bħala donatur tal- grupp methyl f’ remethylation ta ’ homocysteine għal methionine f’ pazjenti b’ omoċistinurja.
As a result, plasma levels of homocysteine should decrease in these patients, to 20-30% of pre-treatment levels.
B’ riżultat ta ’ dan, il- livelli ta ’ homocysteine fil- plażma għandhom jonqsu f’ dawn il- pazjenti, għal 20- 30% tal- livelli ta ’ qabel it- trattament.
Elevated homocysteine plasma levels are associated with cardiovascular events such as thrombosis, osteoporosis, skeletal abnormalities, and optic lens dislocation.
Livelli għoljin ta ’ homocysteine fil- plażma huma assoċjati ma ’ każijiet kardjovaskulari bħal trombożi, osteoporożi, anormalitajiet skeletali, u żlogaturi tal- lenti ottika.
In observational studies, clinical improvement (cardiovascular and neurodevelopmental) was reported by the treating physician in about 75% of patients taking betaine.
Fi studji t’ osservazzjoni, titjib kliniku (kardjovaskulari u fi zvilupp newroloġiku) kienu irrapportati mit- tabib kuranti f’ madwar 75% tal- pazjenti li kienu fuq betaine.
Most of these patients were also receiving other treatments such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin) and folate with variable biochemical responses.
Fil- parti l- kbira dawn il- pazjenti kienu qed jieħdu wkoll mediċini oħrajn bħal vitamina B6 (pyridoxine), vitamina B12 (cobalamin) u folate b’ reazzjonijiet bijokemikali diversi.
In most cases, adding betaine resulted in a further reduction in plasma homocysteine level.
Fil- parti l- kbira tal- każijiet, żjieda ta ’ betaine irriżultat f’ aktar tnaqqis fil- livell ta ’ homocysteine fil- plażma.
It is likely that due to the multiple nature of therapy (dietary, pharmaceutical, supportive) in these patients, there may be an element of overestimation in the clinical effects of betaine treatment.
Huwa probabbli li minħabba n- natura multipla tat- terapija (tad- dieta, farmaċewtika u t’ appoġġ) f’ dawn il- pazjenti, jista ’ jkun hemm element ta ’ stima żejda fl- effetti kliniċi ta ’ trattament b ’ betaine.
Late detection of homocystinuria in symptomatic state is responsible for residual morbidity due to irreversible damage to connective tissue (ophtalmological, skeletal) that can not be corrected by further therapy.
4 morbidità residwali minħabba ħsara rriversibbli lit- tessuti konnettivi (oftalmoloġiċi, skeletali) li ma jistgħux jiġu kkorreġuti b’ aktar terapija.
The available clinical data do not allow correlating posology and clinical efficacy.
Id- dejta klinika disponibbli ma tħallix korelazzjoni bejn il - pożoloġija u l- effikaċja klinika.
There is no evidence of development of tolerance.
M’ hemm l- ebda evidenza ta ’ żvilupp ta ’ tolleranza.
4 Betaine has also been shown to increase plasma methionine and S-adenosyl methionine (SAM) levels in patients with MTHFR deficiency and cbl defects.
Betaine ġie muri li jżid il- methionine fil- plażma u l- livelli ta ’ S- adenosyl methionine (SAM) f’ pazjenti b’ defiċjenza MTHFR u difetti cbl.
In CBS-deficient patients without dietary restriction of methionine, excessive accumulation of methionine has been observed.
F’ pazjenti defiċjenti f’ CBS mingħajr restrizzjoni fid- dieta ta ’ methionine, akkumulazzjoni eċċessiva ta ’ methionine ġiet osservata.
In a few cases, increased plasma methionine levels were associated with cerebral oedema (see sections 4.4 and 4.8).
Fi ftit każijiet, livelli aktar ogħla ta ’ methionine kienu assoċjati ma ’ edema ċerebrali (ara sezzjoni 4. 4 u 4. 8).
Monitoring plasma homocysteine levels has demonstrated that the onset of action of betaine occurred within several days and that a steady-state response was achieved within one month.
Moniteraġġ ta ’ livelli ta ’ homocysteine fil- plażma wera li l- bidu t’ azzjoni ta ’ betaine seħħ fi żmien diversi jiem u li reazzjoni ta ’ stat fiss inkisbet fi żmien xahar.
In paediatric patients less than 3 years of age, the usual effective dose regimen is 100 mg/ kg/ day given in 2 doses daily; increasing the frequency above twice daily and/ or the dose above 150 mg/ kg/ day does not improve the homocysteine-lowering effect.
F’ pazjenti tfal li għandhom anqas minn 3 snin t' età, ir- reġimen effettiv tas- soltu huwa ta ’ doża ta '100 mg/ kg/ kuljum mogħti f’ 2 dożi kuljum; żjieda fil- frekwenza għal aktar minn darbtejn kuljum u/ jew aktar minn 150 mg/ kg/ kuljum ma jtejjibx l- effett ta ’ tnaqqis fil- homocysteine.
Betaine supplementation was shown to improve the metabolic abnormalities in the cerebrospinal fluid of patients with homocystinuria.
Iż- żieda ta 'Betaine wera titjib fl- abnormalitajiet metaboliċi tal- fluwidu ċerebrospinali ta' pazjenti b' omoċistinurja.