qanastek/EMEA-V3 huggingface dataset:
Sodium oxybate is a hydrophilic compound with an apparent volume of distribution averaging 190-384 ml/ kg.
Sodium oxybate huwa sustanza idrofilika li għandha volum ta ’ distribuzzjoni evidenti ta ’ medja bejn il- 190- 384 ml/ kg.
At sodium oxybate concentrations ranging from 3 to 300 μ g/ ml, less than 1% is bound to plasma proteins.
F’ konċentrazzjonijiet ta ’ sodium oxybate f’ medda ta ’ 3 sa 300 μg/ ml, inqas minn 1% huwa marbut mal- proteini tal- plażma.
Animal studies indicate that metabolism is the major elimination pathway for sodium oxybate, producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle and secondarily by β -oxidation.
Studji fl- annimali juri li l- mod if jiġi eliminat sodium oxybate huwa l- metaboliżmu, u jipproduċi carbon dioxide u ilma permezz taċ- ċiklu ta ’ tricarboxylic acid (Kreb’ s) u inqas importanti b ’ β- ossidazzjoni.
The primary pathway involves a cytosolic NADP+-linked enzyme, GHB dehydrogenase, that catalyses the conversion of sodium oxybate to succinic semialdehyde, which is then biotransformed to succinic acid by the enzyme succinic semialdehyde dehydrogenase.
Il- mod primarju jinvolvi enżim li huwa marbut ma ’ cytosolic NADP+, GHB dehydrogenase, li jikkataliżża l- konverżjoni ta ’ sodium oxybate f ’ succinic semialdehyde, li huwa imbagħad bijotrasformat f ’ succinic acid bl ’ enżim succinic semialdehyde dehydrogenase.
Succinic acid enters the Krebs cycle where it is metabolised to carbon dioxide and water.
Succinic acid jitħol fil- Krebs cycle fejn jiġi metaboliżżat f’ carbon dioxide u ilma.
A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyses the conversion to succinic semialdehyde in the presence of α -ketoglutarate.
Enżim tal- mitokondrion oxidoreductase ieħor, li hu transhydrogenase, jikkatalizza ukoll il- konverżjoni f ’ succinic semialdehyde fil- preżenza ta ’ α- ketoglutarate.
An alternate pathway of biotransformation involves β -oxidation via 3,4-dihydroxybutyrate to Acetyl CoA, which also enters the citric acid cycle to result in the formation of carbon dioxide and water.
Mod alternattiv ta ’ bijotrasformazzjoni jinvolvi β - ossidazzjoni billi jibel 3, 4- dihydroxybutyrate f ’ Acetyl CoA, li ukoll jitħol fiċ- ċiklu tas- citric acid u jirriżulta fil- formazzjoni ta ’ carbon dioxide u ilma.
No active metabolites have been identified.
Ebda prodott tal- metaboliżmu attiv ma ’ ġie identifikat.
Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes:
Studji in vitro b ’ mikrożomi miġbura minn fwied uman juru li sodium oxybate ma jinibixxix b’ mod sinifikanti l- attivita` ta ’ iżoenżimi umani::
CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 μ g/ ml).
CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, jew CYP3A sa konċentrazzjoni ta ’ 3 mM (378 μg/ ml).
These levels are considerably higher than levels achieved with therapeutic doses.
Dawn il- livelli huma konsiderevolment ogħla minn livelli li ntlaħqu b’ dożi terapewtiċi.
The clearance of sodium oxybate is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration.
Il- clearance ta ’ sodium oxybate jsir kważi kollu permeżż tal- bijotrasformazzjoni f’ carbon dioxide, li imbagħad jiġi eliminat b’ espirazzjoni.
On average, less than 5% of unchanged drug appears in human urine within 6 to 8 hours after dosing.
Fil- medda, inqas min 5% tal- mediċina tidher mhux mibdula fl- awrina fiż- żmien 6 sa 8 sigħat wara d- dożaġġ.
Faecal excretion is negligible.
L- eskrezzjoni fil- ħmieġ huwa negliġibli.
The pharmacokinetics of sodium oxybate in patients greater than the age of 65 years have not been studied.
Il- farmakokinetika ta ’ sodium oxybate f’ pazjenti li għandhom iżjed minn 65 sena ma ġewx kienux studjati.
The pharmacokinetics of sodium oxybate in paediatric patients under the age of 18 years have not been studied.
Il- farmakokinetika ta ’ sodium oxybate f’ pazjenti pedjatriċi taħt it- 18 il- sena ma ġewx studjati.
Renal Impairment:
Indeboliment tal- fwied:
Because the kidney does not have a significant role in the excretion of sodium oxybate, no pharmacokinetic study in patients with renal dysfunction has been conducted; no effect of renal function on sodium oxybate pharmacokinetics would be expected.
Ma sarux studji farmakokinetiċi f’ pazjenti b’ disfunzjoni renali għaliex il- kilwa m’ għandiex sehem sinifikanti fl- eskrezjoni ta ’ sodium oxybate; mhux mistenni li l- funzjoni renali jkollu xi effett fuq il- farmakokinetika ta ’ sodium oxybate.
Sodium oxybate undergoes significant presystemic (hepatic first-pass) metabolism.
Sodium oxybate tiġi metabolizzata sinifikament qabel ma jidħol fiċ- ċirkolazzjoni tad - demm (hepatic first- pass).
Elimination half-life was significantly longer in Class C and Class A patients than in control subjects (mean t1/ 2 of 59 and 32 versus 22 minutes).
Wara doża singola orali ta ’ 25mg/ kg, il- valuri ta ’ AUC kienu d- doppju f’ pażjenti b’ ċirrożi, b’ clearance orali evidenti li naqas minn 9. 1 minn f’ adulti f’ saħħithom sa 4. 5 u 4. 1 ml/ min/ kg f’ pazjenti b ’ Class A (mingħajr axxite) u b ’ Class C (b’ axxite) milli f’ pazjenti fil- kontrol (medja t1/ 2 ta ’ ta ’ 59 u 32 versus 22 minuti).
It is prudent to reduce the starting dose of sodium oxybate by one-half in patients with liver dysfunction (see Section 4.2).
Huwa prudenti li tnaqqas id- doża tal- bidu ta ’ sodium oxybate b’ nofs f’ pazjenti b ’ anormalita` fil- fwied (ara sezzjoni 4. 2).
Race The effect of race on metabolism of sodium oxybate has not been evaluated.
Razza L’ effett ta ’ razza fuq il- metaboliżmu ta ’ sodium oxybate ma ġiex stimat.
Repeat administration of sodium oxybate to rats (90 days and 26 weeks) and dogs (52 weeks) did not result in any significant findings in clinical chemistry and micro- and macro pathology.
Ma kienx hemm xi sejbiet sinifikanti fil- kimika klinika u fil- mikro - u makropatoloġija, wara li sodium oxybate ngħata ripetutament lil firien (90 ġurnata u 26 ġimgħat) u klieb (52 gimgħa).
Treatment- related clinical signs were mainly related to sedation, reduced food consumption and secondary changes in body weight, body weight gain and organ weights.
Sinjali kliniċi li kienu marbuta mat- trattament kienu relatati ma ’ sedazzjoni, konsum imnaqqas ta ’ l- ikel u tibil sekondarju fil- piz, żieda fil- piz tal- ġisem u tal- organi.
The rat and dog exposures at the NOEL were lower (~50%) than that in humans.
L- espożizzjoni fil- far u fil- kelb fin- NOEL kienu inqas (~50%) minn dak fil- bniedem.
Sodium oxybate was non-mutagenic and non-clastogenic in in vitro and in vivo assays.
Sodium oxybate ma kellux effetti mutaġeniċi u klastoġeniċi f’ assays in vitro u in vivo.
11 Gamma Butyrolactone (GBL), a pro-drug of GHB tested at exposures similar to the expected in man (1.21-1.64 times) has been classified by NTP as non-carcinogenic in rats and equivocal carcinogen in mice, due to slight increase of pheochromocytomas which was difficult to interpret due to high mortality in the high dose group.
11 Gamma Butyrolactone (GBL), pro- drug ta ’ GHB li kien ittestjat f ’ esponiment simili għal dak mistenni fil- bniedem (1. 21- 1. 64 l- darba) kien ikklassifikat minn NTP bħala mhux karċinoġeniku fil - far, minħabba żieda żgħira f ’ pheochromocytomas li huma diffiċli biex tinterpretahom minħabba l - mortalita` għolja fil- grupp tad- doża għolja.
In a rat carcinogenicity study with oxybate no compound-related tumours were identified.
F’ studju fuq karċenoġeniċita` fil- far b’ oxybate ma kienux identifikati tumuri li kienu relatati ma xi sustanza.
GHB had no effect on mating, general fertility or sperm parameters and did not produce embryo-foetal toxicity in rats exposed to up 1000 mg/ kg/ day GHB (1.64 times the human exposure calculated in nonpregnant animals).
GHB ma kellux effett fuq tgħammir, fertilita` ġenerali u parametri ta ’ l- isperma u ma kellux tossiċita` fuq l- embriju u l- fetu f’ firien esposti għal mhux iżjed minn 1000/ mg/ kg/ ġurnata ta ’ GHB (1. 64 l- darba iżjed minn l- esponiment fil- bniedem ikkalkulata f ’ annimali mhux tqal).
Perinatal mortality was increased and mean pup weight was decreased during the lactation period in high-dose F1 animals.
Il- mortalita` fiż- żmien immedjatament qabel jew wara t- twelid kienet iżjed u l- medja tal- piz tal- ġriewi kien inqas waqt iż - żmien tat- treddigħ fl- annimali tad- doża għolja F1.
The association of these developmental effects with maternal toxicity could not be established.
L- assoċjazzjoni ta ’ dawn l- effetti fl- iżvillup mat - tossiċita` fl- omm ma segħetx tkun stabbilita.
In rabbits, slight foetotoxicity was observed.
Fil- fniek kien osservat ftit tossiċita` fil- fetu.
Drug discrimination studies show that GHB produces a unique discriminative stimulus that in some respects is similar to that of alcohol, morphine and certain GABA-mimetic drugs.
Studji dwar drug discrimination urew li GHB jipproduċi stimulu uniku u diskriminattiv li f’ ċerti aspetti huwa simili għal dak tal- alkoħol, morfina u ċerti mediċini li jikkupjaw lil GABA.
Self-administration studies in rats, mice and monkeys have produced conflicting results, whereas tolerance to GHB as well as cross-tolerance to alcohol have been clearly demonstrated in rodents.
Studji fil - firien, fil- ġurdien u fix- xadini fejn kien it- teħid tal- mediċina sar minnhom stess, wrew risultati konfliġġenti, madanakollu t- tollerenza għal GHB kif ukoll cross- tolerance għall- alkoħol kien muri b’ mod ċar fil- ġrieden.
Purified water Malic acid for pH adjustment Sodium Hydroxide for pH adjustment
Ilma purifikat Malic acid għal aġġustament tal- pH Sodium hydroxide għal aġġustament tal- pH
6.3 Shelf life 5 years
5 snin
After First opening:
Wara li jinfetaħ l- ewwel darba:
40 days
40 ġurnata
After dilution in the dosing cups (see Section 4.2), the preparation should be used within 24 hours.
Wara li jiġi dilwit ġot- tazzi ta ’ dożaġġ (ara sezzjoni 4. 2), il- preparazzjoni għandha tintuża fi żmien 24 siegħa.
This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandha ebda kundizzjonijiet ta ’ ħażna speċjali.
Amber oval PET bottle with a child resistant closure composed of HDPE/ polypropylene with a LDPE liner fitted with a PVC tamper evident seal.
Flixkun tal- PET ovali ta ’ kulur ambra, b ’ tapp li ma ’ jinfetaħx mit- tfal magħmul minn HDPE/ polypropylene b ’ kisja ta ’ LDPE mgħammar b’ siġill tal- PVC li jidher jekk jiġi mbagħbas.
Each carton contains one bottle of 180ml Xyrem, a press-in bottle adaptor consisting of an LDPE bottle-well housing, a Silastic Biomedical ETR Elastomer valve, an acrylonitrile butadiene styrene terpolymer valve retainer and LDPE tubing, a graduated 10ml measuring device (polypropylene syringe), two polypropylene dosing cups and two HDPE child resistant screw closures.
Kull kaxxa fiha flixkun wieħed ta ’ 180 ml Xyrem, adapter li jiddaħħal ġol- flixkun li jikkonsisti f ’ LDPE bottle- well housing, valv tal- gomma EPDM, valve retainer tal- acrylonitrile butadiene styrene terpolymer u tubi ta ’ LDPE, għodda bil- marki tal- kejl ta ’ 10ml (siringa tal- polypropylene), żewġt tazzi ta ’ dożaġġ tal- polypropylene u żewġt tappijiet tal- kamin tal- HDPE li ma jinfetħux mit- tfal.
6.6 Special precautions for disposal
12 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE UK
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE Renju Unit
14 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Recipharm Limited Vale of Bardsley, Ashton under Lyne Lancashire OL7 9RR United Kingdom
Recipharm Limited Vale of Bardsley, Ashton under Lyne Lancashire OL7 9RR Renju Unit
UCB Pharma Ltd Unit 11 - 14 Foster Avenue Woodside Park Dunstable Bedfordshire LU5 5TA United Kingdom
UCB Pharma Ltd Unit 11 - 14 Foster Avenue Woodside Park Dunstable Bedfordshire LU5 5TA Ir- Renju Unit
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom
UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE Ir- Renju Unit
Medicinal product subject to special and restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
Carton
Kaxxa tal- kartun
Xyrem 500 mg/ ml oral Solution sodium oxybate
Xyrem 500 mg/ ml soluzzjoni orali sodium oxybate
500 mg/ ml sodium oxybate
500 mg/ ml sodium oxybate
Purified water Malic acid Sodium Hydroxide
Ilma purifikat Malic acid Soduim Hydroxide
One 180 ml bottle
Flixkun wieħed ta ’ 180 ml
Oral use.
Għal użu mill- ħalq.
There are no special storage instructions.
M ’ hemm ebda struzzjonijiet speċjali għal ħażna.
Return any unused product to your pharmacy.
Irritorna xi prodott mhux użati l- spiżerija tiegħek.
UK.
Renju Unit
< Batch >
< Lott >
19 MINIMUM PARTICULARS TO APPEAR BOTTLE
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FLIXKUN
Xyrem 500 mg/ ml oral solution Oral use
Xyrem 500 mg/ ml soluzzjoni orali Użu mill- ħalq
Keep out of the reach and sight of children.
Żomm fejn ma jidhirx u ma jintlaħaqx mit- tfal.
180 ml of a 500mg / ml sodium oxybate solution
180 ml ta ’ soluzzjoni ta ’ 500 mg/ ml ta ’ sodium oxybate
Xyrem 500 mg/ ml oral solution Sodium oxybate
Xyrem 500 mg/ ml soluzzjoni orali Sodium oxybate
What Xyrem is and what it is used for 2.
X’ inhu Xyrem u għalxiex jintuża 2.
Before you take Xyrem 3.
Qabel ma tieħu Xyrem 3.
How to take Xyrem 4.
Kif għandek tieħu Xyrem 4.
Possible side effects 5 How to store Xyrem 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Xyrem 6.
WHAT XYREM IS AND WHAT IT IS USED FOR
X’ INHU XYREM U GĦALXIEX JINTUŻA
Xyrem works by consolidating night-time sleep, though its exact mechanism of action is unknown.
Xyrem jaħdem billi jsaħħaħ l- irqad ta ’ bil- lejl, iżda l- mekkaniżmu eżatti ta ’ kif jaħdem mhux magħruf.
Xyrem is used to treat narcolepsy with cataplexy in adult patients.
Xyrem jintuża fit- trattament ta ’ narkolessija b’ katalessija f’ pazjenti adulti.
Narcolepsy is a sleep disorder that may include attacks of sleep during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations and poor sleep.
Narkolessija hija marda ta ’ l- irqad li tista ’ tinkludi attakki ta ’ l- irqad waqt il- ħin ta ’ bi nhar, kif ukoll kataplessija, paraliżi ta ’ l- irqad, alluċinazzjonijiet u irqad ħażin.
Cataplexy is the onset of sudden muscle weakness or paralysis without losing consciousness, in response to a sudden emotional reaction such as anger, fear, joy, laughter or surprise.
Kataplessija hija l- bidu ta ’ debolizza jew paraliżi fil- muskoli mingħajr ma ’ tintilef il- koxjenza, wara reazzjoni emozzjonali għall- għarrieda bħal rabbja, ferħ, daħk u ħasda.
BEFORE YOU TAKE XYREM
QABEL MA TIEĦU XYREM
Do not take Xyrem
Tieħux Xyrem
- if you are allergic (hypersensitive) to sodium oxybate or any of the other ingredients of Xyrem
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal sodium oxybate jew sustanzi oħra ta ’
- if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder)
- jekk tbati minn defiċjenza ta ’ succinic semialdehyde dehydrogenase (marda metabolika rari)
- if you are being treated with opoids or barbiturate agents
- jekk qiegħed fuq trattament b ’ opoids jew aġenti barbiturati.
Take special care with Xyrem
Oqgħod attent ħafna b’ Xyrem
- if you have breathing or lung problems
- jekk int għandek problemi fin- nifs jew fil- pulmun
- if you have or have previously had depressive illness
- jekk għandek jew kellek qabel xi mard depressiv
- if you have heart failure, hypertension (high blood pressure), liver or kidney problems as your
- jekk għandek insuffiċjenza tal- qalb, ipertensjoni (pressjoni għolja), problemi fil- fwied jew fil -
dose may need to be adjusted
kliewi għaliex id- doża tiegħek jista ’ jkun li trid tiġi aġġustata
- if you are taking other CNS depressants or alcohol
- jekk qiegħed tieħu depressanti tas- sistema nervuża ċentrali (CNS) jew alkoħol
- if you have previously had experience with drug abuse
- jekk kellek xi esperjenza fil- passat b’ abbuz tad- droga
- if you suffer from epilepsy the use of Xyrem is not recommended
- jekk tbati minn epilessija l- użu ta ’ Xyrem mhux rikkmandat
- if you have porphyria (an uncommon metabolic disorder)
- jekk għandek porfirja (mard metabolika mhux komuni)
If any of these apply to you, tell your doctor before you take Xyrem.
Jekk xi waħda minn dawn ta ’ fuq tapplika għalik, għid lit- tabib tiegħek qabel tieħu Xyrem.
While you are taking Xyrem, if you experience bed wetting and incontinence (both urine and faeces), confusion, hallucinations, episodes of sleepwalking or abnormal thinking you should tell your doctor straight away.
22 Waqt li qed tieħu Xyrem, jekk ikollok esperjenza ta ’ tpixxija fis- sodda w inkontinenza (kemm ta ’ l - awrina u kemm tal- ħmieġ), konfużjoni, alluċinazzjonijiet, episodji ta ’ sonnambulanza jew ħsibijiet abnormali, għandek tgħid lit- tabib tiegħek mall- ewwel.
Whilst these effects are uncommon, if they do occur they are usually mild-to-moderate in nature.
Dawn l- effetti m’ humiex komuni, u meta jiġru s- soltu jkunu ħfief u moderati.
22 If you are elderly, your doctor will monitor your condition carefully to check whether Xyrem is having the desired effects.
Jekk inti anzjan, it- tabib tiegħek ħa jsegwi l- kondizzjoni tiegħek b’ attenzjoni sabiex jara jekk Xyrem huwiex qed ikollu l- effett meħtieġ.
Xyrem should not be taken by children.
Xyrem m’ għandux jittieħed mit- tfal.
When you discontinue taking Xyrem you need to follow your doctor’ s instructions as it may result in side effects e. g. headache, lack of sleep, mood changes and hallucinations.
Meta tieqaf tieħu Xyrem għandek bżonn issegwi l- istruzzjonijiet tat- tabib għaliex jista ’ jkollok effetti mhux mixtieqa, eż: uġigħ ta ’ ras, nuqqas ta ’ rqad, tibdil fil- burdata u alluċinazzjonijiet.
Taking Xyrem with food and drink You must not drink alcohol while taking Xyrem, as its effects can be increased.
Meta tieħu Xyrem ma ’ l- ikel u max- xorb M’ għandekx tixrob alkoħol waqt li tkun qiegħed tieħu Xyrem, għaliex l- effett tiegħu jista ’ jiżdied.
Xyrem is to be taken at a set time well after a meal (two - three hours) as food decreases the amount of Xyrem that is absorbed by your body.
Xyrem għandu jittieħed f’ ħin fiss, xi ftit ħin mhux ħażin (sagħtejn – tlett sigħat) wara l- ikel, għaliex l - ikel inaqqas l- ammont ta ’ Xyrem li ġismek jassorbi.
Xyrem should be diluted only with water.
Xyrem jista ’ jiġi dilwit ma ’ l- ilma biss.
You need to monitor the amount of salt you take as Xyrem contains sodium (which is found in table salt) which may effect you if you have had blood pressure, heart or kidney problems in the past.
Għandek toqgħod attent ukoll għall- ammont ta ’ melħ li tieħu għaliex Xyrem fih is- sodium (li jinstab fil- melħ ta ’ l- ikel) li jista ’ jkollu effett jekk għandek pressjoni għolja, problemi fil- qalb u l- fwied fil - passat.
If you take two 2.25 g doses of sodium oxybate each night you will take 0.82g of sodium, or if you take two 4.5 g doses of sodium oxybate each night you will take in 1.6g sodium.
Jekk tieħu żewġ dożi ta ’ 2. 25 g ta ’ sodium oxybate kul lejl tkun qiegħed tieħu 0. 82g ta ’ sodium, jew jekk tieħu żewġt dożi ta ’ 4. 5 g ta ’ sodium oxybate kull lejl qiegħed tieħu 1. 6g ta ’ sodium.
You may need to moderate your intake of salt.
Jista ’ jkun li jkollok bżonn timmodera l- melħ li tieħu fl- ikel.
Pregnancy and breast-feeding The effects of Xyrem in pregnant women are not known, and so the use of Xyrem in pregnant women is not recommended.
Tqala u Treddigħ L- effetti ta ’ Xyrem fin- nisa tqal mhumiex magħrufin, u għalhekk l- użu ta ’ Xyrem fin- nisa tqal mhux rikkmandat.
Tell your doctor if you are pregnant or are planning to become pregnant.
Għid lit- tabib tiegħek jekk inti tqila jew qed tippjana li toħroġ tqila.
Xyrem is not recommended during pregnancy unless on the advice of your doctor
Xyrem mhux rikkmandat waqt it- tqala sakemm mhux fuq il- parir tat- tabib tiegħek.
It is not known whether Xyrem passes into breast milk.
Mhux magħruf jekk Xyrem jgħaddix fil- ħalib ta ’ l- omm.
Patients taking Xyrem should stop breast feeding.
Il- pazjenti li jkunu fuq Xyrem għandhom jiefqu jreddgħu.
Driving and using machines Xyrem will affect you if you drive or operate tools or machines.
Sewqan u tħaddim ta ’ magni Xyrem ser ikollu effett fuqek jekk issuq jew tagħmel użu minn għodda jew magni.
Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or that requires mental alertness for at least 6 hours after taking Xyrem.
Għal mill- inqas sitt sigħat wara li tieħu Xyrem, m’ għandekx issuq karozza, tħaddem magni kbar, jew tagħmel xi attivita` li hi perikoluża jew li għandha bżonn li wieħed ikun viġilanti.
HOW TO TAKE XYREM
KIF GĦANDEK TIEĦU XYREM
Always take Xyrem exactly as your doctor has instructed you.
Dejjem għandek tieħu Xyrem eżattament kif qallek it- tabib tiegħek.
The usual starting dose is 4.5 g/ day, given as two equally divided doses of 2.25 g/ dose.
Id- doża tal- bidu li ssoltu tingħata hija ta ’ 4. 5 g/ ġurnata, li tingħata f’ żewġt dożi maqsumin indaqs ta ’ 2. 25 g / doża.
Your doctor may gradually increase your dose up to a maximum of 9 g/ day given as two equally divided doses of 4.5g/ dose.
It- tabib għandu mnejn iżid id- doża tiegħek għall- massimu ta ’ 9 g / ġurnata li tingħata f’ żewġt dożi maqsumin indaqs ta ’ 4. 5 g / doża.
Take Xyrem orally two times each night.
Hu Xyrem mill- ħalq darbtejn kull lejl.
Take the first dose upon getting into bed and the second dose 2.5 to 4 hours later.
Hu l- ewwel doża kif titħol ġos- sodda u t- tieni doża minn 2. 5 sa 4 sigħat wara.
You may need to set an alarm clock to make sure you wake up to take the second dose.
L- ikel
Food decreases the amount of Xyrem that is absorbed by your body.
23 inaqqas l- ammont ta ’ Xyrem li ġismek jassorbi.
Therefore, it is best to take Xyrem at set times well after a meal (two-three hours).
Għalhekk, l- aħjar tieħu Xyrem f’ ħinijiet fissi, xi ftit ħin sew (sagħtejn – tlett siegħat) wara li tiekol.
Prepare both doses before bedtime.
Ipprepara iż- żewġt dożi qabel titħol torqod.
23 If you stop taking Xyrem for more than 14 consecutive days you should consult your doctor as you should restart taking Xyrem at a reduced dose.
Jekk tieqaf tieħu Xyrem għal iżjed minn 14 il- ġurnata konsekuttiva għandek tkellem lit- tabib tiegħek għaliex għandek terġa tibda tieħu Xyrem b’ doza mnaqqsa.
Instructions on how to dilute Xyrem
Struzzjonijiet ta ’ kif tiddilwa Xyrem
The following instructions explain how to prepare Xyrem.
L- istruzzjonijiet li ġejjin jispjegaw kif tipprepara Xyrem.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet b’ attenzjoni u imxi magħhom pas pas.
To help you, the Xyrem carton contains 1 bottle of medicine, a measuring syringe and two dosing cups with child-resistant caps.
Biex jgħinuk, il- kaxxa ta ’ Xyrem fiha flixkun wieħed ta ’ mediċina, siringa tal- kejl u żewġt tazzi tad - dożaġġ b’ tappijiet li ma jinfetħux mit- tfal.
The bottle will contain a tamper-evident seal that will need to be removed before using the bottle for the first time.
Il- flixkun jkollu siġill li juri jekk ikun imbagħbas u dan ikollu jitneħħa qabel ma tuża l- flixkun 1. għall- ewwel darba.
Remove the bottle cap by pushing down while turning the cap anticlockwise (to the left).
Neħħi it- tapp tal- flixkun billi timbotta l- isfel waqt li ddawwar it- tapp kontra l- arloġġ (lejn ix - xellug).
After removing the cap, set the bottle upright on a table-top.
Wara li tneħħi t- tapp, poġġi l- flixkun wieqaf fuq il- wiċċ tal- mejda.
While holding the bottle in its upright position, insert the press-in-bottle-adaptor into the neck of the bottle.
Waqt li żżomm il - flixkun fil- pożizzjoni wieqfa, daħħal l- adapter li jitħol ġol- flixkun f’ għonq il- flixkun.
This needs only to be done the first time that the bottle is opened.
Din hemm bżonn issir biss l- ewwel darba li jinfetaħ il- flixkun.
The adaptor can then be left in the bottle for all subsequent uses
L- adapter jista ’ jitħalla ġol- flixkun bil- lest għad- drabi l- oħra li jintuża.
Next, insert the tip of the measuring syringe into the centre opening of the bottle and press down firmly (See Figure 1).
Imbagħad, daħħal il- ponta tas- siringa tal- kejl fil- fetħa ċentrali tal- flixkun u mbotta bis- sod l - 2. isfel (Ara Figura 1).
While holding the bottle and syringe with one hand, draw up the prescribed dose with the other hand by pulling on the plunger.
Waqt li tkun qed iżżomm il- flixkun u s- siringa b’ idejk waħda, tella ’ d- doża preskritta bl’ id l - 3. oħra billi tiġbed il- planġer.
Medicine will not flow into the syringe unless you keep the bottle in its upright position (See Figure 2).
(Ara Figura 2).
Remove the syringe from the centre opening of the bottle.
Neħħi s- siringa mill- fetħa ċentrali tal- flixkun.
Empty the medicine from the syringe into one of the dosing cups provided by pushing on the plunger (See Figure 3).
Battal il- mediċina minn ġos- siringa għal ġo waħda mit- tazzi ta ’ dożaġġ provduti billi timbotta fuq il- planġer (Ara Figura 3).
Repeat this step for the second dosing cup.
Irrepeti dan il - pass għat- tieni tazza ta ’ dożaġġ.
Then add about 60 ml of water to each dosing cup (60 mls is about 4 tablespoons)
Imbagħad żid madwar 60 ml ta ’ ilma f ’ kull tazza ta ’ dożaġġ (60 ml huwa madwar 4 imgħaref)
Place the caps provided on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position (See Figure 4).
Poġġi t- tappijiet provduti fuq it- tazzi ta ’ dożaġġ u dawwar iż- żewġt tappijiet lejn il- lemin sakemm ifaqqa ’ u jissakkar fil- pożizzjoni li ma jistax jinfetaħ mit- tfal (Ara Figura 4).
Rinse out the syringe with water.
Laħlaħ is - siringa bl- ilma.
Just before going to sleep, place your second dose near your bed.
Qabel eżatt ma titħol torqod, poġġi t- tieni doża fejn is- sodda.
You may need to set an alarm so you wake up to take your second dose no earlier than 2.5 hours and no later than 4 hours after your first dose.
Jista ’ jkun li jkollok bżonn 6. tagħmel żveljarin sabiex tkun tista ’ tqum sabiex tieħu t- tieni doża tiegħek mhux qabel 2. 5 siegħa u mhux aktar tard minn 4 sigħat wara l- ewwel doża tiegħek.
Remove the cap from the first dosing cup by pressing down on the child- resistant locking tab and turning the cap anticlockwise (to the left).
Neħħi t- tapp minn fuq l- ewwel tazza ta ’ dożaġġ billi tagħfas l- isfel fuq l- ilsien li jagħlaq biex it- tapp ma jinfetaħx mit- tfal, u dawwar kontra l- arloġġ (lejn ix- xellug).
Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away
Ixrob l- ewwel doża kollha waqt li tkun fis- sodda, erġa ’ għalaq it- tazza, imbagħad imtedd mal- ewwel.
When you wake up 2.5 to 4 hours later, remove the cap from the second dosing cup.
Meta tqum 2. 5 sa 4 siegħat wara, neħħi it- tapp mit- tieni tazza ta ’ dożaġġ.
While sitting in bed, drink all of the second dose right before lying down to continue sleeping.
Waqt li tkun bil - qegħda fis- sodda, ixrob it- tieni doża kollha eżatt qabel ma tkun ser terġa ’ timtedd biex terġa torqod.
Recap the second cup.
Għalaq it- tieni tazza bit- tapp.
If you have the impression that the effect of Xyrem is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ Xyrem huwa qawwi wisq jew jew dgħajjef wisq, kellem lit- tabib jew lill - ispiżjar tiegħek.
If you take more Xyrem than you should Symptoms of Xyrem overdose may include agitation, confusion, impaired movement, impaired breathing, blurred vision, profuse sweating, headache, vomiting, decreased consciousness leading to coma and seizures.
Jekk tieħu Xyrem aktar milli suppost Is- sintomi meta jittieħed aktar Xyrem milli suppost jistgħu jinkudu aġitazzjoni, konfużjoni, moviment indebolit, nifs indebolit, viżjoni mċajpra, ħafna għaraq, uġigħ ta ’ ras, rimettar, koxjenza mnaqqsa li tista ’ twassal għal koma u attakk ta ’ puplesija.
If you take more Xyrem than you were told to take, or take it by accident, get emergency medical help right away.
Jekk tieħu iżjed Xyrem milli ġie ordnat lilek, jew tieħu iżjed bi żball, fittex li tieħu għajnuna medika ta ’ emerġenza mall- ewwel.
You should take the labelled medicine bottle with you, even if it is empty.
Għandek tieħu miegħek l - flixkun bit- tikketta tal- mediċina, anke jekk ikun vojt.
If you forget to take Xyrem If you forget to take the first dose, take it as soon as you remember and then continue as before.
Jekk tinsa tieħu Xyrem Jekk tinsa tieħu l- ewwel doża, ħudha kif tiftakar u imbagħad kompli bħal qabel.
If you miss the second dose, skip that dose and do not take Xyrem again until the next night.
Jekk tinsa tieħu t- tieni doża, aqbes dik id- doża u terġax tieħu Xyrem qabel l- għada bil- lejl.
If you stop taking Xyrem You should continue to take Xyrem for as long as instructed by your Doctor.
Jekk tieqaf tieħu Xyrem Għandek tibqa tieħu Xyrem sakemm jgħidlek it- tabib tiegħek.
You may find that your cataplexy attacks return if your medicine is stopped and you may experience insomnia, headache, anxiety, dizziness, sleeping problems, sleepiness, hallucination and abnormal thinking.
Jista ’ jkun li tinduna li l- attakki ta ’ kataplessija jerġgħu jibdew jekk titwaqqaf il- mediċina tiegħek u li jibda jkollok nuqqas ta ’ irqad, uġigħ ta ’ ras, anzjeta` sturdament, problemi ta ’ rqad, nagħas, alluċinazzjonijiet u ħsibijiet abnormali.
Like all medicines, Xyrem can have side effects.
Bħal kull mediċina oħra, Xyrem jista ’ jkollu effetti sekondarji.
These are usually mild to moderate.
Dawn normalment ikunu ħfief jew moderati.
If you experience any of these, tell your doctor straight away.
Jekk ikollok xi wieħed minn dawn, jekk jogħġbok, għid lit- tabib tiegħek mal- ewwel.
Sodium oxybate has a well known abuse potential.
Huwa magħruf sew li sodium oxybate għandu potenzjal għall- abbuż.
No cases of abuse are known among individuals treated for narcolepsy.
Mhux magħrufin każi ta ’ abbuż f ’ persuni trattati għal narkolessija.
However cases of dependency have occurred after the illicit use of sodium oxybate.
Madanakollu kien hemm każi ta ’ dipendenza wara l- użu illeċitu ta ’ sodium oxybate.
25 Common side effects include:
25 Effetti sekondarji komuni ħafna jinkludu:
Sleeping problems including insomnia, blurred vision, vomiting, stomach pains, diarrhoea, anorexia, weakness, abnormal dreams, tiredness, feeling drunk, sleep paralysis, sleepiness, trembling, confusion/ disorientation, nightmares, sleep walking, bed wetting, sweating, depression, muscle cramps, swelling, fall, joint pain, cataplexy, balance disorder, disturbance in attention, disturbed sensitivity particularly to touch, abnormal touch sensation, sedation, anxiety, difficulty in falling asleep in the middle of the night, nervousness, urinary incontinence, shortness of breath, snoring
Problemi ta ’ rqad inkluż insomnja, viżjoni mċajpra, rimettar, uġigħ fl- istonku, dijareja, anoressija, debollezza, ħolm abnormali, għajja, sensazzjoni ta ’ sakra, paraliżi ta ’ l- irqad, rogħda, konfużjoni/ disorjentazzjoni, inkubi, sonnambuliżmu, tpixxija fis- sodda, għaraq, waqgħat, uġigħ fil - ġogi, kataplessija, mard tal- bilanċ, disturbi fl- attenzjoni, sensittivita` mhux normali partikolarment għal mess, sensazzjoni abnormali tal- mess, sedazzjoni, anzjeta`, diffikulta` biex wieħed jorqod f’ nofs tal- lejl, nervożita`, inkontinenza urinarja, qtuħ ta ’ nifs, inħir
Uncommon side effects include:
Effetti sekondarji mhux komuni jinkludu:
Psychosis (a mental disorder that may involve hallucinations, incoherent speech, or disorganized and agitated behavior), paranoia, abnormal thinking, hallucination, agitation, suicide attempt, difficulty in falling asleep, restless legs, weight loss, forgetfulness, myoclonus (involuntary contractions of muscles), involuntary passage of feces, rash, increased blood pressure
Psikożi (marda mentali li jista ’ jinvolvi alluċinazzjonijiet, diskors li ma jinftehimx, jew imġieba diżorganizzata u aġitata), paranojja, ħsieb abnormali, alluċinazzjonijiet, aġitazzjoni, attentat ta ’ suwiċidju, diffikulta ’ biex wieħed jorqod, restless legs, telf ta ’ piz, nisi, myoclonus (kontrazzjoni involontarja tal- muskoli), inkontinenza tal- ħmieġ, żieda fil- pressjoni
Side effects with unknown frequency include:
Effetti sekondarji li mhux magħruf il- frekwenza tagħhom jinkludu:
Convulsion, decreased breathing depth or rate, hives, hypersensitivity, suicidal thoughts
Aċċessjoni, tnaqqis fil- profondita` jew ir- rata tan- nifs, urtikarja, ipersensitivita`, ħsibijiet ta ’ suwiċidju
If any of these affect you severely, tell your doctor.
Għarraf lit- tabib tiegħek, jekk xi wieħed minn dawn ikollu effett sever fuqek.
If you are concerned about any side effect, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE XYREM
KIF TAĦŻEN XYREM
Do not use Xyrem after the expiry date stated on the bottle.
Tużax Xyrem wara d- data ta ’ skadenza li tidher fuq il- flixkun.
Do not store Xyrem solutions diluted with water for more than 24 hours.
Taħżinx soluzzjonijiet ta ’ Xyrem diwiti bl- ilma għal iżjed minn 24 siegħa.
Once you open a bottle of Xyrem, any contents that you have not used with 40 days of opening should be disposed of.
Għandek tarmi dak li jkun fadal fil- flixkun, wara 40 ġurnata li tkun ftaħt flixkun ta ’ Xyrem.
Medicines should not be disposed of via wastewater or household waste.
Dawn il- miżuri jgħinu għall- protezzjoni ta ’ l- ambjent.
What Xyrem contains
X’ fih Xyrem:
- The active substance is sodium oxybate.
- Is- sustanza attiva hi sodium oxybate.
- The other ingredients are purified water, malic acid and sodium hydroxyde.
- Is- sustanzi l- oħra huma ilma purifikat, malic acid u sodium hydroxide.
Xyrem is supplied as an oral solution in a 180 ml tamper-evident amber plastic bottle.
Xyrem issibu bħala soluzzjoni orali fi flixkun tal- plastik ta ’ kulur ambra ta ’ 180 ml li jidher jekk xi ħadd ikun bgħabsu.
Each pack contains one bottle, a press-in-bottle-adaptor (PIBA), a plastic measuring syringe and two dosing cups with child-resistant caps.
Kull kaxxa fiha flixkun wieħed, adapter li jiġi mdaħħal ġol- flixkun (PIBA), siringa tal- kejl tal- plastik u żewġ tazzi għad- dożaġġ b’ tappijiet li ma jiftħuhomx it- tfal.
What Xyrem looks like and contents of the pack Xyrem is a clear to slightly opalescent solution.
Xyrem huwa soluzzjoni ċara għal kemmxejn tkanġi.
The amber plastic bottle contains 180 ml of oral solution.
Il- flixkun tal- plastik ta ’ kulur ambra fiħ 180 ml ta ’ soluzzjoni orali.
26 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom.
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, Renju Unit.
Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR, United Kingdom.
Recipharm Limited, Vale of Bardsley, Ashton- under- Lyne, Lancashire, OL7 9RR, Renju Unit.
UCB Pharma Ltd, Unit 11 - 14 Foster Avenue, Woodside Park, Dunstable, Bedfordshire LU5 5TA, United Kingdom UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom
UCB Pharma Ltd, Unit 11 - 14 Foster Avenue, Woodside Park, Dunstable, Bedfordshire LU5 5TA, Ir - Renju Unit UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire SL1 3WE, Ir- Renju Unit
Local representatives For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Rappreżentant Lokali Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
You should have received a Xyrem Information Pack from your physician, which includes a booklet all about Xyrem and a video showing you how to take the product.
Għandek tirċievi Pakkett ta ’ Informazzjoni minn għand it- tabib tiegħek, li tinkludi ktejjeb li fiħ kollox dwar Xyrem u vidjo li jurik kif tieħu l- prodott.
If you have not received this, please contact the local representative of the Marketing Authorisation Holder, below.
Jekk dan ma rċievejtux, jekk jogħġbok ikkuntatja lir - rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq, hawn taħt.
France UCB Pharma S. A.
27 France UCB Pharma S. A.
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What is Yentreve?
X' inhu Yentreve?
Yentreve is a medicine containing the active substance duloxetine.
Yentreve hija mediċina li fiha s- sustanza attiva duloxetine.
It is available as blue (20 mg) and orange (40 mg) capsules.
Huwa disponibbli f' kapsuli blu (20 mg) u oranġjo (40 mg).
What is Yentreve used for?
Għal xiex jintuża Yentreve?
Yentreve is used to treat moderate to severe stress urinary incontinence (SUI) in women.
Yentreve jintuża għat- trattament ta 'l- inkontinenza urinarja minn sforz (SUI - stress urinary incontinence) minn moderata għal gravi fin- nisa.
SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising.
SUI sseħħ meta l- awrina tiskappa involontarjament matul l- isforz fiżiku jew wara li tisgħol, tidħaq, tagħtas, tgħolli oġġetti jew tagħmel eżerċizzji fiżiċi.
How is Yentreve used?
Kif jintuża Yentreve?
The recommended dose of Yentreve is 40 mg twice a day.
Id- doża rrakkomandata ta 'Yentreve hi 40 mg darbtejn kuljum.
Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Xi pazjenti jistgħu jiksbu benefiċċju minn trattament inizjali b' doża ta '20 mg darbtejn kuljum għal ġimagħtejn qabel ma jgħaddu għad - doża rakkomandata ta' 40 mg, biex inaqqsu n- nawżea (dardir) u l- isturdament.
Combining Yentreve with pelvic floor muscle training may provide additional benefit.
Li tgħaqqad Yentreve ma 'programm ta' eżerċizzju tal- muskolatura tal- qiegħ pelviku (pelvic floor) jista 'jagħti aktar benefiċċju.
How does Yentreve work?
Kif jaħdem Yentreve?
The active substance in Yentreve, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor (SNRI).
Is- sustanza attiva f' Yentreve, duloxetine, hija inibitur ta 'l- assorbiment mill- ġdid tas- serotonina u tan - noradrenalina (SNRI, serotonin- noradrenaline reuptake inhibitor).
It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Dan jaħdem billi jipprevjeni lin - newrotrasmettituri 5- idrossitriptamina (imsejħa wkoll serotonina) u n- noradrenalina milli jerġgħu jiġu assorbiti fiċ- ċelluli nervużi fil- moħħ u fis- sinsla tad- dahar.
How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
L- azzjoni ta 'duloxetine fi SUI mhijiex ċara, iżda jitqies li, billi żżid il- livelli ta' 5- idrossitripamina e noradrenalina fil- livell tan- nervituri li jikkontrollaw il- muskolatura ta 'l- uretra (il- kanal li jgħaqqad il- bużżieqa ma' barra), duloxetine tikkawża għeluq ta 'l- uretra aktar bis- saħħa waqt il- bużżieqa timtela bl- awrina.
By closing the urethra more powerfully, Yentreve prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Billi jagħlaq l- uretra aktar bis- saħħa, Yentreve jipprevjeni t- telf involontarju ta 'awrina waqt sforz fiżiku bħas- sogħla jew id- daħk.
How has Yentreve been studied?
Kif ġie studjat Yentreve?
Yentreve has been studied in a total of 2,850 women with SUI.
Yentreve ġie studjat f' total ta '2, 850 mara b' SUI.
The four main studies involved 1,913 women and lasted 12 weeks, comparing Yentreve (mostly as 40 mg twice daily) with placebo (a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- erba 'studji prinċipali involvew 1, 913- il mara u damu 12- il ġimgħa u qabblu Yentreve (l- aktar bħala doża 40 mg darbtejn kuljum) mal- plaċebo 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. dummy treatment).
(trattament finta).
The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients’ scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
Il- kejl ewlieni ta 'l- effikaċja kienu l- frekwenza ta' l- episodji ta 'inkontinenza (IEF, jiġifieri l- għadd ta' episodji ta 'inkontinenza kull ġimgħa) imniżżla fuq djarju tal- pazjenti u l- punteġġ tal- pazjenti fuq il- bażi ta' kwestjonarju ta 'kwalità tal- ħajja speċifiku għall- inkontinenza (I- QOL).
What benefit has Yentreve shown during the studies?
X' benefiċċju wera Yentreve matul l- istudji?
In all four studies, the patients treated with Yentreve had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
Fl- erba 'studji kollha, il- pazjenti ttrattati b' Yentreve kellhom anqas episodji ta' inkontinenza wara 12- il ġimgħa, b' madwar erbgħa jew ħames episodji anqas kull ġimgħa meta mqabbel mal- frekwenza reġistrata l- istudju.
The IEF decreased by 52% in the Yentreve group, compared with a decrease of 33% in the placebo-treated group.
L- IEF naqset bi 52% fil- grupp ta 'Yentreve, kontra tnaqqis ta' 33% fil- grupp ittrattat bil- plaċebo.
The I-QOL questionnaire scores were also improved in the Yentreve group compared with the placebo group.
Il- punteġġi tal- kwestjonarju I- QOL tjiebu wkoll fil- grupp tal- pazjenti ttrattati b' Yentreve meta mqabbel mal- grupp ittrattat bil- plaċebo.
Yentreve was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Yentreve irriżulta aktar effikaċi mill- plaċebo biss fil- pazjenti li kellhom iktar minn 14- il episodju ta 'inkontinenza fil- ġimgħa (SUI minn moderata għal gravi) fil- bidu ta' l- istudju.
What is the risk associated with Yentreve?
X' inhu r- riskju assoċjat ma 'Yentreve?
The most common side effects with Yentreve (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
L- effetti sekondarji l- aktar komuni b' Yentreve (li dehru f' aktar minn pazjent 1 minn kull 10) huma nawżea, ħalq xott, stitikezza u għeja.
For the full list of all side effects reported with Yentreve, see the Package Leaflet.
Għal- lista sħiħ ta 'l- effetti sekondarji kollha rrappurtati b' Yentreve, ara l- Fuljett ta' Tagħrif.
Yentreve should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Yentreve ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal duloxetine jew għal xi ingredjenti oħra.
Yentreve should not be used in patients with certain types of liver disease or with severe kidney disease.
Yentreve ma għandux jintuża f' pazjenti b' ċerti tipi ta 'mard tal- fwied jew f' pazjenti b' mard gravi tal- kliewi.
Yentreve should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Yentreve ma għandux jintuża flimkien ma 'inibituri tal - monoaminoossidażi (monoamine oxidase inhibitors, grupp ta' antidepressivi), fluvoxamine (antidipressiv ieħor), jew ciprofloxacin jew enoxacin (tipi ta 'antibijotiċi).
Treatment with Yentreve should not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
It- trattament b' Yentreve ma għandux jinbeda f' pazjenti bi pressjoni tad- demm għolja mhux kontrollata, minħabba riskju ta 'kriżi ipertensiva (meta l- pressjoni tad- demm titla' f' daqqa u tkun perikoluża).
Why has Yentreve been approved?
Għaliex ġie approvat Yentreve?
The Committee for Medicinal Products for Human Use (CHMP) decided that Yentreve’ s benefits are greater than its risks for the treatment of moderate to severe SUI.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċju ta 'Yentreve huma ogħla mir- riskji tiegħu fit- trattament ta' l- inkontinenza urinarja minn sforz minn moderata għal gravi.
The Committee recommended that Yentreve be given marketing authorisation.
Il- Kumitat irrakkomanda li Yentreve jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Other information about Yentreve:
Aktar tagħrif dwar Yentreve:
The European Commission granted a marketing authorisation valid throughout the European Union for Yentreve to Eli Lilly Nederland B. V. on 11 August 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Yentreve lil Eli Lilly Nederland B. V. fil- 11 ta 'Awissu 2004.
The full EPAR for Yentreve is available here.
L- EPAR sħiħ għal Yentreve jista 'jiġi kkonsultat hawn.
Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules Hard gastro-resistant capsules
Kapsuli, gastro- re Kapsuli, gastro- re Kapsuli, gastro- re Kapsuli, gastro- re Kapsuli, gastro- re Kapsuli, gastro- re Kapsuli, gastro- re Kapsuli, gastro- re
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
U u orali U u orali U u orali U u orali U u orali U u orali U u orali U u orali
blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu) blister (PVC/ PE/ PCTFE/ alu)
folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu) folja (PVC/ PE/ PCTFE/ alu)
YENTREVE 40 mg hard gastro-resistant capsules.
YENTREVE 40 mg kapsuli ibsin gastro- reżistenti
Each capsule contains 40 mg of duloxetine (as hydrochloride).
Kull kapsula għandha 40 mg ta 'duloxetine (bħala hydrochloride).
Excipients: sucrose 11.5 mg.
Sucrose 11. 5 mg
The capsule has an Opaque orange body, imprinted with ’ 40mg’ and an opaque blue cap, imprinted with ‘ 9545’.
Il- kapsula għandha l- parti prinċipali oranġjo Opak, stampat b ’ '40 mg' u għatu ċelesti opak, stampat b ’ '9545'.
YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI), (see section 5.1).
YENTREVE huwa indikat għan- nisa għall- kura ta 'Inkontinenza Awrinarja minħabba Sforz – (SUI) ta ’ grad moderat għal wieħed gravi (ara sezzjoni 5. 1).
The recommended dose of YENTREVE is 40 mg twice daily without regard to meals.
Id- doża rrakkomandata ta ’ YENTREVE hija ta '40 mg darbtejn kuljum u mingħajr bżonn li tittieħed fuq l- ikel.
However, limited data are available to support the efficacy of YENTREVE 20 mg twice daily.
Madankollu, it- tagħrif disponibbli huwa limitat biex tkun aċċertata l- effikaċja ta ’ YENTREVE 20 mg darbtejn kuljum.
The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies.
L- effikaċja ta ’ YENTREVE ma kinitx evalwata għal tul ta ’ żmien ta ’ aktar minn 3 xhur fi studji kliniċi kkontrollati bil- plaċebo.
Combining YENTREVE with a pelvic floor muscle training (PFMT) program may be more effective than either treatment alone.
Jista ’ jkun aktar effettiv li tassoċja YENTREVE ma ’ programm ta ’ eżerċizzji biex jissaħħu l- muskoli tal- qiegħ tal- pelvis (PFMT), milli tuża wieħed minnhom biss.
It is recommended that consideration be given to concomitant PFMT.
Huwa rakkomandat li jkun ikkunsidrat li fl- istess żmien tal- kura b’ YENTREVE ikun hemm ukoll programm ta’ PFMT.