qanastek/EMEA-V3 huggingface dataset:
Breast-feeding must be discontinued during ALIMTA treatment.
It- treddigħ għandu jitwaqqaf waqt il- kura b’ ALIMTA.
Driving and using machines ALIMTA may make you feel tired.
Sewqan u tħaddim ta ’ magni Tista ’ tħossok għajjien b’ ALIMTA.
Be careful when driving a car or using machinery.
Ogħqod attent meta ssuq jew tħaddem magni.
HOW ALIMTA IS GIVEN
KIF GĦANDEK TIEĦU ALIMTA
The dose of ALIMTA is 500 milligrams for every square metre of your body’ s surface area.
Id- doża ta ’ ALIMTA hi 500 milligramma għal kull metru kwadru ta ’ l- erja tas- superfiċje tal- ġisem tiegħek.
Your height and weight are measured to work out the surface area of your body.
Jitkejjillek it- tul u jitteħidlek il- piż biex tinħadem l- erja tas- superfiċje tal- ġisem tiegħek.
Your doctor will use this body surface area to work out the right dose for you.
It - tabib tiegħek juża din l- erja tas- superfiċje tal- ġisem biex jaħdimlek id- doża korretta.
This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
Din id- doża tista ’ tiġi aġġustata, jew il- kura tista ’ tiġi ittardjata skond l- għadd taċ- ċelluli tad- demm tiegħek u l - kundizzjoni ġenerali tiegħek.
A hospital pharmacist, nurse or doctor will have mixed the ALIMTA powder with 9 mg/ ml (0.9%) sodium chloride solution for injection before it is given to you.
Qabel ma ’ jingħatalek, it- trab ta ’ ALIMTA jiġi mħallat ma ’ soluzzjoni għall- injezzjoni ta ’ 9 mg/ ml( 0. 9%) sodium chloride, mill- ispiżjar ta ’ l- isptar, infermier jew tabib.
You will always receive ALIMTA by infusion into one of your veins.
ALIMTA jingħatalek dejjem b’ infużjoni f’ waħda mill- vini tiegħek.
The infusion will last approximately 10 minutes.
L- infużjoni ddum madwar 10 minuti.
When using ALIMTA in combination with cisplatin:
Meta tuża ALIMTA flimkien ma ’ cisplatin:
The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
It- tabib jew spiżjar ta ’ l- isptar jaħdem id- doża li għandek bżonn skond it- tul u l- piż tiegħek.
Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of ALIMTA has finished.
Cisplatin ukoll jingħata b’ infużjoni f’ waħda mill- vini tiegħek, u jingħata madwar 30 minuta wara li tkun spiċċat l- infużjoni ta ’ ALIMTA.
The infusion of cisplatin will last approximately 2 hours.
L- infużjoni ta ’ cisplatin tieħu madwar sagħtejn.
You should usually receive your infusion once every 3 weeks.
Ġeneralment l- infużjoni tingħatalek darba kull 3 ġimgħat.
Additional medicines:
Mediċini oħra:
Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after ALIMTA treatment.
49 Kortikosterojdi: it- tabib tiegħek jordnalek pilloli ta ’ l- isterojdi (ekwivalenti għal 4 milligrammi ta ’ dexamethasone darbtejn kuljum) li jkollok bżonn tieħu l- ġurnata ta ’ qabel, dakinhar u l- ġurnata ta ’ wara l- kura b’ ALIMTA.
This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
Din il- mediċina tingħatalek sabiex titnaqqas il- frekwenza u s- severità ta ’ reazzjonijiet fil- ġilda li jista ’ jkollok waqt il- kura tiegħek kontra l- kanċer.
48 Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking ALIMTA.
Supplimentazzjoni b’ vitamini: it- tabib tiegħek jordnalek folic acid (vitamina) orali jew xi prodott multivitaminiku li fih folic acid (350 sa 1000 microgramma) li trid tieħu darba kuljum waqt it - trattament b’ ALIMTA.
You must take at least 5 doses during the seven days before the first dose of ALIMTA.
Trid tieħu mill- inqas 5 dożi matul is- sebat ijiem ta ’ qabel l- ewwel doża ta ’ ALIMTA.
You must continue taking the folic acid for 21 days after the last dose of ALIMTA.
Trid tkompli tieħu folic acid għal 21 ġurnata wara l- aħħar doża ta ’ ALIMTA.
You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of ALIMTA and then approximately every 9 weeks (corresponding to 3 courses of ALIMTA treatment).
Tingħatalek ukoll injezzjoni ta ’ vitamina B12 (1000 microgramma) fil- ġimgħa ta ’ qabel li tingħata ALIMTA u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta ’ kura b’ ALIMTA).
Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
Il- vitamina B12 u folic acid jingħatawlek sabiex jitnaqqsu l- effetti tossiċi possibbli tal- kura kontra l- kanċer.
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.
Like all medicines, ALIMTA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ALIMTA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In this leaflet, when a side effect is described as “ very common” this means that it has been reported in at least 1 in every 10 patients taking the medicine.
F' dan il- fuljett, meta xi effett sekondarju huwa deskritt bħala wieħed "komuni ħafna" dan ifisser li kien irrappurtat f’ mill- inqas pazjent 1 minn kull 10 pazjenti li ħadu l- mediċina.
When a side effect is described as “ common” this means that it has been reported in at least 1 in every 100 patients but less than 1 in every 10 patients.
Filwaqt li meta xi effett sekondarju huwa deskritt bħala wieħed "komuni" dan ifisser li kien irrappurtat f’ mill- inqas pazjent 1 minn kull 100 pazjent iżda inqas minn pazjent 1 minn kull 10 pazjenti.
When a side effect is described as “ uncommon”, this means it has been reported in at least 1 in every 1,000 patients, but less than 1 in every 100 patients.
Meta xi effett sekondarju huwa deskritt bħala wieħed "mhux komuni" dan ifisser li kien irrappurtat f’ mill- inqas pazjent 1 minn kull 1, 000 pazjent, iżda inqas minn pazjent 1 minn kull 100 pazjent.
When a side effect is described as “ rare”, this means it has been reported in at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients.
Meta xi effett sekondarju huwa deskritt bħala wieħed "rari" dan ifisser li kien irrappurtat f’ mill- inqas pazjent 1 minn kull 10, 000 pazjent, iżda inqas minn pazjent 1 minn kull 1, 000 pazjent.
You must contact your doctor immediately if you notice any of the following:
Għandek minnufih tgħid lit- tabib tiegħek jekk tinnota xi ħaġa minn dawn li ġejjin:
Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
Deni jew infezzjoni (komuni): jekk għandek temperatura ta '38ºC jew aktar, għarqan jew għandek sinjali oħra ta ’ infezzjoni (peress li jista ’ jkollok ċelluli bojod tad- demm inqas min - normal, li huwa komuni ħafna).
If you start feeling chest pain (common) or having a fast heart rate (uncommon).
Jekk tibda tħoss uġigħ f' sidrek (komuni) jew ikollok il- qalb tħabbat b' rata mgħaġġla (mhux komuni).
If you have pain, redness, swelling or sores in your mouth (very common).
Jekk tħoss uġigħ, ħmura, nefħa jew ġrieħi f' ħalqek (komuni ħafna).
Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Reazzjoni allerġika: jekk tiżviluppa raxx fil- ġilda (komuni ħafna) / sensazzjoni ta 'ħruq jew tingiż (komuni), jew deni (komuni).
If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
Jekk tħossok għajjien, tħossok li ġej xi ħass ħażin, tispiċċa bla nifs faċilment, jew jekk tidher pallidu (peress li jista 'jkollok inqas emoglobina min- normal, li huwa komuni ħafna).
If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
Jekk ikollok telf ta ’ demm mill- ħanek, mill- imnieħer jew mill- ħalq jew telf ta 'demm li ma jistax jieqaf, awrina li għandha kulur ħamrani jew jagħti fir- roża, ikollok tbenġil li mhux mistenni (peress li jista ’ jkollok inqas plejtlits fid- demm min- normal, li huwa komuni ħafna).
Side effects with ALIMTA may include:
Effetti sekondarji ta ’ ALIMTA jistgħu jinkludu:
Very common (occur in at least 1 in 10 patients) Low white blood cells Low haemoglobin level (anaemia) Low platelet count Diarrhoea Vomiting Pain, redness, swelling or sores in your mouth Nausea Loss of appetite Fatigue (tiredness) Skin rash Hair loss Constipation Loss of sensation Kidney: abnormal blood tests
Ammont baxx ta 'ċelluli bojod tad- demm Livell baxx ta' emoglobina (anemija) Għadd baxx ta 'plejtlits Dijarrea Rimettar Uġigħ, ħmura, nefħa u ġrieħi f' ħalqek Dardir Nuqqas ta ’ aptit Għeja (ħedla)
Common (occur in at least 1 in 100 patients but less than 1 in 10 patients) Allergic reaction: skin rash / burning or prickling sensation Infection
Komuni (jseħħu f' mill- inqas pazjent 1 minn kull 100 pazjent iżda f’ inqas minn pazjent 1 minn kull 10 pazjenti)
49 Fever Dehydration Kidney failure Irritation of the skin and itching Chest pain Muscle weakness.
Reazzjoni allerġika: raxx tal- ġilda / sensazzjoni ta 'tingiż jew ħruq Infezzjoni Deni Deidrazzjoni.
Conjunctivitis (inflamed eye) Upset stomach Pain in the abdomen Taste change Liver: abnormal blood tests
Insuffiċjenza tal- kliewi Irritazzjoni tal- ġilda u ħakk Uġigħ fis- sider Dgħjufija fil- muskoli Konġuntivite (għajn infjammata) Taqlib fl- istonku Uġigħ fl- addome Tibdil fit- togħma Fwied: testijiet tad- demm anormali
Uncommon (occur in at least 1 in 1000 patients but less than 1 in 100 patients) Fast heart rate Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (Excess fluid in body tissue, causing swelling).
Mhux komuni (jseħħu f’ mill- inqas pazjent 1 għal kull 1000 pazjent iżda f’ inqas minn pazjent 1 minn kull 100 pazjent) Tħabbit tal- qalb b' rata mgħaġġla Kolite (infjammazzjoni tar- rita tal- musrana l- kbira u li fl- istess ħin jista ’ jkun hemm ukoll fsada intestinali jew rettali) Pulmonite interstizjali (il- boroż ta ’ l- arja ġewwa ’ l pulmun irabbu qoxra) Edima (Fluwidu żejjed fit- tessuti tal- ġisem li jikkawża nefħa).
Rare (occur in more than 1 in 10000 patients but less than 1 in 1000 patients)
Rari ((jseħħu f’ aktar minn pazjent 1 għal kull 10000 pazjent iżda f’ inqas minn pazjent 1 minn kull 1000 pazjent)
Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Jerġa ’ jidher l- effett tar- radjazzjoni (raxx tal- ġilda bħal meta tinħaraq b’ mod sever minħabba tixmix żejjed), li jista ’ jseħħ fuq ġilda li tkun ġiet esposta qabel għar- radjoterapija, minn ġranet sa snin wara li tkun saret ir- radjazzjoni.
You might have any of these symptoms and/ or conditions.
Inti jista 'jkollok minn dawn is- sintomi u / jew kundizzjonijiet.
You must tell your doctor as soon as possible when you start experiencing any of these side effects.
Għandek tgħid lit- tabib tiegħek mill - aktar fis possibli malli tibda tinduna b’ xi wieħed minn dawn l- effetti sekondarji.
Uncommonly some patients have experienced a stroke or “ mini-stroke” while receiving ALIMTA usually in combination with another anticancer therapy.
M' huwiex komuni iżda xi pazjenti kellhom attakk ta 'puplesija jew "attakk żgħir ta' puplesija" meta rċevew ALIMTA, ħafna drabi meta dan ħaduh flimkien ma ’ terapija oħra. kontra l- kanċer.
Extremity pain, low temperature and discolouration have been reported.
Dawk il- pazjenti, li huma wkoll ikkurati permezz tar- radjazzjoni kemm qabel, kif ukoll waqt jew wara l- kura tagħhom b’ ALIMTA, jista ’ jkollhom pulmonite kawża ta ’ radjazzjoni (il- boroż ta ’ l- arja ġewwa ’ l pulmun irabbu qoxra minħabba t- terapija bir- radjazzjoni) Ġew irrapportati, uġigħ fl- estremitajiet, temperatura baxxa u tibdil fil- kulur.
If you are concerned about any side effects, talk to your doctor.
Kellem lit- tabib tiegħek jekk xi wieħed minn dawn l- effetti sekondarji qegħdin jinkwetawk.
If any of the side effects gets serious, 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 ALIMTA
KIF TAĦŻEN ALIMTA
Do not use after the expiry date shown on the pack.
Tużax wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Reconstituted and Infusion Solutions:
Soluzzjonijiet Rikostitwiti u ta 'Infużjoni:
The product should be used immediately.
Il- prodott għandu jintuża immedjatament.
When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature or 25°C.
Meta ppreparati kif suppost, l- istabbilità kimika u fiżika ta ’ waqt l- użu, tas- soluzzjonijiet rikostitwiti u ta ’ infużjoni ta ’ pemetrexed, ġiet ippruvata għal 24 siegħa f’ temperatura ta ’ friġġ jew ta ’ 25°C.
This medicinal product is for single use only, any unused solution should be discarded under the local requirements.
Kull fdal ta ’ soluzzjoni li ma jkunx intuża għandu jintrema kif jitolbu l- liġijiet lokali.
What ALIMTA contains
X’ fih ALIMTA
The active substance is pemetrexed.
Is- sustanza attiva hi pemetrexed.
Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium) ALIMTA 500 mg:
Kull kunjett fih 100 milligramm ta 'pemetrexed (bħala pemetrexed disodium) ALIMTA 500 mg:
Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium)
Kull kunjett fih 500 milligramm ta ’ pemetrexed (bħala pemetrexed disodium) Wara r- rikostituzzjoni, is- soluzzjoni jkun fiha 25 mg/ ml ta 'pemetrexed., Qabel ma tingħata, ikun hemm bżonn ta ’ iżjed dilwizzjoni mill- persuna inkarigata li tipprovdi l- kura.
The other ingredients are mannitol, hydrochloric acid and sodium hydroxide.
Is- sustanzi l- oħra huma mannitol, hydrochloric acid u sodium hydroxide.
What ALIMTA looks like and contents of the pack ALIMTA is a white to either light yellow or green-yellow lyophilised powder.
ALIMTA huwa trab lijofilizzat bejn abjad u isfar ċar jew isfar ħadrani.
ALIMTA is a powder for concentrate for solution for infusion in a vial.
ALIMTA huwa trab ġo kunjett għal konċentrat għal soluzzjoni għall- infużjoni.
Each pack of ALIMTA consists of one ALIMTA vial.
Kull pakkett ta 'ALIMTA fih kunjett wieħed ta' ALIMTA.
Lilly France S. A. S., rue du Colonel Lilly, F-67640, Fegersheim, France
Lilly France S. A. S., rue du Colonel Lilly, F- 67640, Fegersheim, Franza
51 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
52 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Tel: + 40 21 4023000 Slovenija Eli Lilly farmacevtska druž ba, d. o. o.
Tel: + 40 21 4023000 Slovenija Eli Lilly Farmacevtska družba, d. o. o Tel: +386 (0) 1 580 00 10
52 < ---------------------------------------------------------------------------------------------------------------
53 < ------------------------------------------------------------------------------------------------------------ It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Instructions for use, handling and disposal.
Istruzzjonijiet għall- użu, l- immaniġġar u rimi
Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Uża teknika asettika matul ir- rikostituzzjoni u għal iżjed dilwizzjoni ta ’ pemetrexed għall- għoti ta ’ l- infużjoni fil- vini.
Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
Kull kunjett fih ammont żejjed ta 'pemetrexed sabiex jiffaċilita l- għoti ta' l- ammont miktub fuq it- tikketta.
Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ ml pemetrexed.
ALIMTA 100 mg Irrikostitwixxi kull kunjett ta '100mg b' 4. 2 ml ta' soluzzjoni għall- injezzjoni ta '9mg/ ml (0. 9%) sodium chloride, mingħajr preservattiv, li jirriżulta f' soluzzjoni li jkollha 25 mg/ ml pemetrexed.
Reconstitute each 500 mg vial with 20 ml of 9 mg/ ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ ml pemetrexed.
ALIMTA 500 mg Irrikostitwixxi kull kunjett ta '500mg b' 20 ml ta' soluzzjoni għall- injezzjoni ta '9mg/ ml (0. 9%) sodium chloride, mingħajr preservattiv, li jirriżulta f' soluzzjoni li jkollha 25 mg/ ml pemetrexed.
The appropriate volume of reconstituted pemetrexed solution should be further diluted to 100 ml with 9 mg/ ml (0.9%) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Il- volum xieraq tas- soluzzjoni rikostitwita ta ’ pemetrexed għandu jerġa ’ jiġi dilwit sa 100ml b ’ soluzzjoni għall- injezzjoni ta ’ 9mg/ ml( 0. 9%) sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil- vini għal 10 minuti.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali
There have been a few reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator.
Ġew irrapportati xi każijiet ta ’ estravażjoni ta ’ pemetrexed, li ma ġewx meqjusa bħala serji mill- investigatur.
What is Alli?
X’ inhu Alli?
Alli is a medicine that contains the active substance orlistat.
Alli huwa mediċina li fiha s- sustanza attiva orlistat.
It is available as turquoise capsules (60 mg).
Huwa disponibbli bħala kapsuli turkważ (60 mg).
What is Alli used for?
Għal xiex jintuża Alli?
Alli is used to help patients lose weight.
Alli jintuża biex jgħin lill- pazjenti jitilfu l- piż.
It is used in adults who are overweight with a body mass index (BMI) greater than or equal to 28 kg per square metre, in combination with a low-calorie diet with reduced fat levels.
Jintuża f’ pazjenti b’ piż eċċessiv b’ Indiċi ta ’ Massa tal - Ġisem (Body Mass Index - BMI) ogħla minn jew ugwali għal 28 kg għal kull metru kwadru f’ kombinazzjoni ma ’ dieta ipokalorika (bi ftit kaloriji) bi tnaqqis fil- livelli tax- xaħam.
The medicine can be obtained without a prescription.
Il- mediċina tista ’ tinkiseb mingħajr riċetta tat- tabib.
How is Alli used?
Kif jintuża Alli?
Alli is taken as one capsule with water just before, during, or up to one hour after each main meal, three times a day.
Alli jingħata f’ doża ta ’ kapsula waħda mal- ilma eżattament qabel, matul, jew sa siegħa wara kull ikla prinċipali, tliet darbiet kuljum.
If a meal is missed or contains no fat, Alli should not be taken.
Jekk tinqabeż ikla jew jekk din ma jkunx fiha xaħam, Alli ma għandux jittieħed.
The patient should be on a diet in which about 30% of the calories come from fat.
Il- pazjent għandu jkun fuq dieta li fiha madwar 30% tal- kaloriji ġejjin mix- xaħam.
The food in the diet should be spread over three main meals.
L- ikel fid- dieta għandu jitqassam fuq tliet ikliet prinċipali.
Patients taking Alli should start a diet and exercise regime before beginning treatment.
Il- pazjenti li jkunu qed jieħdu Alli għandhom jibdew dieta u jagħmlu eżerċizzju fiżiku qabel ma jibdew it- trattament.
If patients taking Alli have been unable to lose weight after 12 weeks, they should speak to their doctor or pharmacist.
F’ każ li l- pazjenti li jkunu qed jieħdu Alli ma jkunux tilfu l- piż wara 12- il ġimgħa, għandhom ikellmu lit- tabib jew lill- ispiżjar tagħhom.
It may be necessary to stop treatment.
Hija possibbli l- interruzzjoni tat- trattament.
How does Alli work?
Kif jaħdem Alli?
The active substance in Alli, orlistat, is an anti-obesity medicine, which does not affect appetite.
Is- sustanza attiva f’ Alli, orlistat, hija mediċina kontra l- obeżità, li ma tolqotx l- aptit.
Orlistat blocks gastrointestinal lipases (enzymes that digest fat).
Orlistat jimblokka l- lipażi gastrointestinali (enzimi li jimmetabolizzaw ix- xaħam).
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to pass through the gut undigested.
Meta dawn l- enzimi jiġu mblukkati, ma jkunux jistgħu jiddiġerixxu xi wħud mix- xaħmijiet fid- dieta, u dan iħalli madwar kwart tax- xaħam li jkun ittiekel waqt l- ikel sabiex jgħaddi mill- imsaren mhux iddiġerut.
The body cannot use this dietary fat for energy or convert it into fat tissue.
Il- ġisem ma jistax juża dan ix - xaħam li ġej mill- ikel biex jipproduċi l- enerġija jew jaqilbu f’ tessut tax- xaħam.
This helps weight reduction.
Dan jgħin biex jonqos il- piż.
How has Alli been studied?
Kif ġie studjat Alli?
Because Alli is based on another medicine containing the same active substance already authorised in the EU (Xenical 120 mg capsules), some of the studies involved patients who took Xenical.
Billi Alli huwa bbażat fuq mediċina oħra li fiha l- istess sustanza attiva diġà awtorizzata fl- UE (Xenical 120 mg kapsuli), uħud mill- istudji involvew pazjenti ttrattati bi Xenical.
1 Previously known as Orlistat GSK.
1 Preċedentement magħruf bħala Orlistat GSK.
Alli has been studied in three main studies.
Alli ġie studjat fi tliet studji ewlenin.
Two of the studies involving a total of 1,353 overweight or obese patients with a BMI of 28 kg/ m2 or more and lasted from one to two years, comparing Alli given at different doses with placebo (a dummy treatment), in combination with dieting.
Żewġ studji minnhom involvew total ta ’ 1, 353 pazjent b’ piż eċċessiv jew bil- problema tal- obeżità b’ BMI ogħla minn jew ugwali għal 28 kg/ m2 u damu minn sena sa sentejn, qabblu Alli mogħti f’ dożaġġi differenti mal- plaċebo (trattament finta), flimkien ma ’ dieta.
Neither the patients nor the doctors knew which treatment each patient was taking until the end of the study.
Pazjenti u tobba saru jafu liema kien it- trattament mogħti biss meta l- istudju wasal fi tmiemu.
The third study compared Alli with placebo in 391 overweight patients with a BMI between 25 and 28 kg/ m2.
It- tielet studju qabbel Alli mal- plaċebo fi 391 pazjent b’ piż eċċessiv b’ BMI ivarja bejn 25 u 28 kg/ m2.
The study lasted four months.
L - istudji damu erba ’ xhur.
In all of the studies, the main measure of effectiveness was the change in weight.
Fl- istudji kollha, il- kejl ewlieni tal- effikaċja kien rappreżentat mill- bidla fil- piż.
What benefit has Alli shown during the studies?
X’ benefiċċju wera Alli waqt l- istudji mwettqa?
Alli was more effective than placebo in producing a reduction in weight in patients with a BMI of 28 kg/ m2 or more.
Alli rriżulta aktar effikaċi mill- plaċebo fil- produzzjoni ta ’ tnaqqis tal- piż f’ pazjenti b’ BMI ogħla minn jew ugwali għal 28 kg/ m2.
In the two studies of patients with a BMI of 28 kg/ m2 or more, patients taking Alli 60 mg had lost an average of 4.8 kg after a year, compared with 2.3 kg in those taking placebo.
Fiż- żewġ studji ta ’ pazjenti b’ BMI ogħla minn jew ugwali għal 28 kg/ m2, il- pazjenti ttrattati b’ Alli 60 mg, wara sena, tilfu medja ta ’ 4. 8 kg meta mqabbel ma ’ 2. 3 kg f’ dawk ittrattati bil- plaċebo.
The study of Alli in patients with a BMI between 25 and 28 kg/ m2 failed to show a degree of weight loss that would be relevant for patients.
L- istudju ta ’ Alli fil- pazjenti b’ BMI li jvarja bejn 25 u 28 kg/ m2 naqas milli juri livell ta ’ tnaqqis tal - piż rilevanti għall- pazjenti.
What is the risk associated with Alli?
X’ inhu r- riskju assoċjat ma ’ Alli?
Most of the side effects with Alli affect the digestive system and are less likely to occur with a low fat diet.
Il- maġġoranza tal- effetti sekondarji ta ’ Alli jolqtu s- sistima diġestiva u huwa inqas probabbli li jseħħu ma ’ dieta b’ kontenut baxx ta ’ xaħam.
In general, they are mild, and occur at the beginning of treatment, going away after some time.
Normalment, l- effetti sekondarji huma ħfief u jseħħu fil- bidu tat- trattament u jgħaddu wara ftit taż- żmien.
The most common side effects with Alli (seen in more than 1 patient in 10) are oily spotting, flatus (gas) with discharge, faecal urgency (urgent need to open the bowels), fatty oily stool, oily evacuation (faeces), flatulence (gas) and soft stools.
L- effetti sekondarji l- aktar komuni b’ Alli (li dehru f’ aktar minn pazjent 1 minn kull 10) huma ħruġ ta ’ qtar żejtni, flatulenza flimkien ma ’ tnixxija, urġenza biex jitbattlu l- imsaren, feċi li jidhru xaħmin jew żejtnin, evakwazzjoni żejtnija (feċi), flatulenza (gass) u feċi maħlula.
For the full list of all side effects reported with Alli, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b’ Alli, ara l- Fuljett ta ’ Tagħrif.
Alli should not be used in people who may be hypersensitive (allergic) to orlistat or any of the other ingredients.
Alli ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal orlistat jew għal xi sustanza oħra tiegħu.
It must not be used in people who are being treated with ciclosporin (used to prevent organ rejection in transplant patients) or with medicines used to prevent blood clots such as warfarin.
Ma għandux jintuża minn persuni li għaddejjin minn trattament biċ- ċiklosporina (użata għall- prevenzjoni ta ’ rifjut tal- organu fil- pazjenti trapjantati) jew flimkien ma ’ mediċini użati biex jipprevjenu li d- demm jagħqad bħall- warfarina.
It must also not be used in people with a long-term malabsorption disease (where nutrients from food are not easily absorbed during digestion) or cholestasis (a liver disorder), or in women who are pregnant or breast-feeding.
Ma għandux jintuża wkoll f’ persuni li jbatu mill - marda tal- assorbiment ħażin fuq perjodu ta ’ żmien twil (fejn in- nutrijenti li jinsabu fl- ikel mhumiex assorbiti faċilment matul id- diġestjoni), jew mill- kolestażi (disturb epatiku) jew f’ nisa tqal jew li qegħdin ireddgħu.
Why has Alli been approved?
Għaliex ġie approvat Alli?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Alli are greater than its risks for weight loss in adults who are overweight (BMI ≥ 28 kg/ m2), taken in conjunction with a mildly hypocalorific, lower-fat diet.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Alli huma ogħla mir- riskji tiegħu għat- telf tal- piż f’ adulti b’ piż eċċessiv (BMI ≥ 28 kg/ m2), meħud flimkien ma ’ dieta moderatament ipokalorika b’ kontenut iktar baxx ta ’ xaħam.
The Committee recommended that Alli be given marketing authorisation.
Il- Kumitat irrakkomanda li Alli jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Alli:
Aktar tagħrif dwar Alli:
The European Commission granted a marketing authorisation valid throughout the EU for Orlistat GSK to Glaxo Group Limited on 23 July 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- UE kollha għal Orlistat GSK lil Glaxo Group Limited fit- 23 ta ’ Lulju 2007.
This authorisation was based on the authorisation already granted in 1998 to Xenical capsules.
Din l- awtorizzazzjoni hija bbażata fuq l - awtorizzazzjonijiet diġà mogħtija fl- 1998 lil Xenical kapsuli.
The name of the medicine was changed to Alli on 12 September 2008.
Isem il- mediċina nbidel għal Alli fit- 12 ta ’ Settembru 2008.
The full EPAR for Alli can be found here.
L- EPAR sħiħ għal Alli jista ’ jiġi kkonsultat hawn.
This summary was last updated in 04-2009.
Dan is- sommarju kien aġġornat l- aħħar fi:
EU number EU/ 1/ 07/ 401/ 007 EU/ 1/ 07/ 401/ 008 EU/ 1/ 07/ 401/ 009 EU/ 1/ 07/ 401/ 0010
Numru ta ’ l- EU EU/ 1/ 07/ 401/ 007 EU/ 1/ 07/ 401/ 008 EU/ 1/ 07/ 401/ 009 EU/ 1/ 07/ 401/ 0010
Invented name alli alli alli alli
Isem inventat alli alli alli alli
Strength 60 mg 60 mg 60 mg 60 mg
Qawwa 60 mg 60 mg 60 mg 60 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard
G amla farma ewtika Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Route of administration Oral use Oral use Oral use Oral use
Mnejn jing ata G al u u mill - alq G al u u mill - alq G al u u mill - alq G al u u mill - alq
Packaging Bottle (HDPE) Bottle (HDPE) Bottle (HDPE) Bottle (HDPE)
Il- pakkett Fliexken (HDPE) Fliexken (HDPE) Fliexken (HDPE) Fliexken (HDPE)
Package size 42 60 84 90
Daqs tal- pakkett 42 60 84 90
alli 60 mg hard capsules
alli 60 mg kapsuli iebsa
Each hard capsule contains 60 mg orlistat.
Kull kapsula iebsa fiha 60 mg orlistat.
The capsule has a dark blue centre band, and a turquoise cap and body bearing the imprint of “ alli”.
Il- kapsula għandha faxxa blu skura fin- nofs, u għatu ta ’ lewn turkważ u għandha “ alli ” stampat fuqha.
alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥ 28 kg/ m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.
alli huwa ndikat għal użu minn adulti b’ piż żejjed (indiċi tal- massa tal- ġisem, BMI ≥25 kg/ m²) biex jitnaqqas il- piż u għandu jittieħed flimkien ma ’ dieta ta ’ kaloriji kemmxejn baxxi u b’ inqas xaħam.
The recommended dose of alli is one 60 mg capsule to be taken three times daily.
Id- doża rrakkomandata ta ’ alli hija kapsula waħda ta ’ 60 mg li għandha tittieħed tliet darbiet kuljum.
The capsule should be taken with water immediately before, during or up to 1 hour after each main meal.
Il- kapsula għandha tittieħed ma ’ l- ilma immedjatament qabel, waqt jew sa siegħa wara kull ikla prinċipali.
If a meal is missed or contains no fat, the dose of orlistat should be omitted.
Jekk tinqabeż xi ikla jew f’ każ ta ’ ikla bla ebda xaħam, id- doża ta ’ orlistat m’ għandhiex tittieħed.
No more than three 60 mg capsules should be taken in 24 hours.
M’ għandhomx jittieħdu aktar minn tliet kapsuli ta ’ 60 mg f’ 24 siegħa.
Treatment should not exceed 6 months.
Il- kura għandhiex taqbeż 6 xhur.
If patients have been unable to lose weight after 12 weeks of treatment with alli, they should consult their doctor or a pharmacist.
Jekk il- pazjenti ma jirnexxielhomx inaqqsu l- piż wara 12- il ġimgħa ta ’ kura b’ alli, għandhom ikellmu lit- tabib jew lill- ispiżjar tagħhom.
It may be necessary to discontinue treatment.
Jista ’ jkun meħtieġ li l- kura titwaqqaf.
Diet and exercise are important parts of a weight loss programme.
Dieta u eżerċizzju huma partijiet importanti ta ’ programm għal tnaqqis fil- piż.
It is recommended that a diet and exercise programme is started before beginning treatment with alli.
Huwa rrakkomandat li qabel il- bidu ta ’ kura b’ alli jinbeda programm ta ’ dieta u eżerċizzju.
While taking orlistat, the patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat (e. g. in a 2,000 kcal/ day diet, this equates to < 67 g of fat).
Meta jkun qed jieħu orlistat, il- pazjent għandu jkun fuq dieta ta ’ nutriment bilanċjat u b’ kaloriji kemmxejn baxxi li jkun fiha madwar 30% tal- kaloriji mix- xaħam (e. ż. f’ dieta ta ’ 2, 000 kcal/ kuljum, dan ikun ifisser < 67 g ta ’ xaħam).
The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
L- ammont ta ’ xaħam, karboidrati u proteini kkunsmati kuljum għandu jitqassam fuq tliet ikliet prinċipali.
The diet and exercise programme should continue to be followed when treatment with alli is stopped.
Il- programm ta ’ dieta u eżerċizzju għandu jitkompla meta l- kura b’ alli titwaqqaf.
alli should not be used in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
alli m’ għandux jintuża fi tfal u adoloxxenti taħt 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
There are limited data on the use of orlistat in the elderly.
Hemm tagħrif limitat dwar l- użu ta ’ orlistat fl- anzjani.
The effect of orlistat in individuals with hepatic and/ or renal impairment has not been studied.
2 L- effett ta ’ orlistat f’ individwi b’ indeboliment tal- fwied u/ jew tal- kliewi ma ġiex studjat.
2 However, as orlistat is minimally absorbed, no dosage adjustment is necessary in elderly and in individuals with hepatic and/ or renal impairment.
Madankollu, peress li orlistat huwa assorbit b’ mod minimu, l- ebda aġġustament fid- dożaġġ ma huwa meħtieġ fl- anzjani u f’ individwi b’ indeboliment tal- fwied u/ jew tal- kliewi.
• Hypersensitivity to the active substance or to any of the excipients • Concurrent treatment with ciclosporin (see section 4.5) • Chronic malabsorption syndrome • Cholestasis • Pregnancy (see section 4.6) • Breast-feeding (see section 4.6) • Concurrent treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8)
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi • Kura fl- istess waqt b’ ciclosporin (ara sezzjoni 4. 5) • Sindrome kronika ta ’ assorbiment ħażin • Kolestasi • Tqala (ara sezzjoni 4. 6) • Treddigħ (ara sezzjoni 4. 6) • Kura fl- istess waqt b’ warfarin jew b’ sustanzi orali oħra kontra il- koagulazzjoni tad- demm (ara sezzjonijiet 4. 5 u 4. 8)
Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).
Il- pazjenti għandhom jingħataw parir biex jimxu mar- rakkomandazzjonijiet tad- dieta li jingħatawlhom (ara sezzjoni 4. 2).
The possibility of experiencing gastrointestinal symptoms (see section 4.8) may increase when orlistat is taken with an individual meal or a diet high in fat.
Il- possibiltà ta ’ esperjenza ta ’ sintomi gastro- intestinali (ara sezzjoni 4. 8) tista ’ tiżdied meta orlistat jittieħed ma ’ xi ikla partikolari jew ma ’ dieta b’ ħafna xaħam.
Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K) (see section 4.5).
Kura b’ orlistat għandha mnejn tnaqqas l- assorbiment ta ’ vitamini li jinħallu fix- xaħam (A, D, E u K) (ara sezzjoni 4. 5).
For this reason, a multivitamin supplement should be taken at bedtime.
Għalhekk suppliment ta ’ multivitamini għandu jittieħed qabel l- irqad.
As weight loss may be accompanied by improved metabolic control in diabetes, patients who are taking a medicinal product for diabetes should consult a doctor or pharmacist before starting treatment with alli, in case it is necessary to adjust the dose of the antidiabetic medicinal product.
Peress li tnaqqis fil- piż jista ’ jkun akkompanjat minn titjib fil- kontroll metaboliku fil- każ ta ’ dijabete, pazjenti li qed jieħdu prodott mediċinali għad- dijabete għandhom ikellmu tabib jew spiżjar qabel jibdew kura b’ alli, għax jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża tal- prodott mediċinali kontra d- dijabete.
Weight loss may be accompanied by an improvement in blood pressure and cholesterol levels.
Telf fil- piż jista ’ jkun akkompanjat minn titjib fil- pressjoni tad- demm u fil- livelli tal- kolesterol.
Patients who are taking a medicinal product for hypertension or hypercholesterolaemia should consult a doctor or pharmacist when taking alli, in case it is necessary to adjust the dose of these medicinal products.
Pazjenti li qed jieħdu prodott mediċinali għall- pressjoni għolja jew għal kolesterol għoli għandhom ikellmu tabib jew spiżjar meta jkunu qed jieħdu alli, f’ każ li jkun hemm bżonn ta ’ aġġustament fid - doża ta ’ dawn il- prodotti mediċinali.
Patients who are taking amiodarone should consult a doctor or pharmacist before starting treatment with alli (see section 4.5).
Pazjenti li jkunu qed jieħdu amiodarone għandhom ikellmu tabib jew spiżjar qabel jibdew kura b’ alli (ara sezzjoni 4. 5).
Cases of rectal bleeding have been reported in patients taking orlistat.
F’ pazjenti li jieħdu orlistat kienu rrapportati każijiet ta ’ fsada mir- rektum.
If this occurs, the patient should consult a doctor.
Jekk iseħħ dan, il- pazjent għandu jikkonsulta tabib.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5).
L- użu ta ’ metodu kontraċettiv addizzjonali huwa rrakkomandat biex jipprevjeni l- possibiltà li kontraċezzjoni orali ma taħdimx, li tista ’ isseħħ f’ każ ta ’ dijarea severa (ara sezzjoni 4. 5).
A decrease in ciclosporin plasma levels has been observed in a drug-drug interaction study and also reported in several cases, when orlistat was administered concomitantly.
Fi studju dwar l- interazzjoni bejn mediċina u oħra, kien osservat tnaqqis fil- livelli ta ’ ciclosporin fil - plażma u dan kien irrapportat ukoll f’ diversi każijiet meta orlistat ingħata fl- istess waqt.
This could potentially lead to a decrease of immunosuppressive efficacy.
Dan jista ’ jwassal għal tnaqqis fl- effikaċja immunosoppressiva.
Concurrent use of alli and ciclosporin is contraindicated (see section 4.3).
L- użu ta ’ alli flimkien ma ’ ciclosporin huwa kontra- indikat (ara sezzjoni 4. 3).
Oral anticoagulants
Sustanzi orali kontra l- koagulazzjoni tad- demm
When warfarin or other oral anticoagulants are given in combination with orlistat, international normalised ratio (INR) values could be affected (see section 4.8).
3 Meta warfarin jew sustanzi orali oħra kontra l- koagulazzjoni tad- demm jingħataw flimkien ma ’ orlistat, il- valuri tal- proporzjon normalizzat internazzjonali (INR) jistgħu jiġu affettwati (ara sezzjoni 4. 8).
Concurrent use of alli and warfarin or other oral anticoagulants is contraindicated (see section 4.3).
L- użu ta ’ alli flimkien ma ’ warfarin jew sustanzi oħra kontra l- koagulazzjoni tad- demm huwa kontra- indikat (ara sezzjoni 4. 3).
Oral contraceptives
Kontraċettivi orali
3 The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies.
In- nuqqas ta ’ interazzjoni bejn kontraċettivi orali u orlistat intwera fi studji speċifiċi dwar l - interazzjoni bejn mediċina u oħra.
However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases.
Madankollu, orlistat jista ’ indirettament inaqqas id- disponibiltà ta ’ kontraċettivi orali u jwassal għal tqala mhux mistennija f’ xi każijiet individwali.
An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4).
Metodu addizzjonali ta ’ kontraċezzjoni huwa rrakkomandat f’ każ ta ’ dijarea severa (ara sezzjoni 4. 4).
Fat soluble vitamins
Vitamini li jinħallu fix- xaħam
Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K).
Kura b’ orlistat tista ’ tnaqqas l- assorbiment ta ’ vitamini li jinħallu fix- xaħam (A, D, E u K).
The vast majority of subjects receiving up to 4 full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range.
Fi studji kliniċi, l- biċċa l- kbira ta ’ individwi li rċevew kura b’ orlistat sa 4 snin sħaħ kellhom livelli ta ’ vitamini A, D, E u K u ta ’ beta- carotene li baqgħu fil- firxa normali.
However, patients should be advised to use a multivitamin supplement at bedtime to help ensure adequate vitamin intake (see section 4.4).
Madankollu, l- pazjenti għandhom jingħataw parir biex jieħdu suppliment ta ’ multivitamini qabel l- irqad biex ikun żgurat it- teħid adegwat ta ’ vitamini (ara sezzjoni 4. 4).
In the absence of pharmacokinetic interaction studies, alli is not recommended to be used by patients receiving acarbose.
Fin- nuqqas ta ’ studji farmakokinetiċi dwar l- interazzjoni, alli mhux irrakkomandat biex jintuża minn pazjenti li jkunu qed jieħdu acarbose.
A decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly.
F’ numru limitat ta ’ voluntiera f’ saħħithom li ħadu orlistat fl- istess waqt, kien osservat tnaqqis fil - livelli tal- plażma ta ’ amiodarone, meta ingħata bħala doża waħda.
The clinical relevance of this effect in patients receiving amiodarone treatment remains unknown.
F’ pazjenti li jkunu qed jieħdu amiodarone, ir- rilevanza klinika ta ’ dan l- effett għada mhux magħrufa.
Patients who are taking amiodarone should consult a doctor or pharmacist before starting treatment with alli.
Pazjenti li qed jieħdu amiodarone għandhom ikellmu tabib jew spiżjar qabel jibdew kura b’ alli.
The dose of amiodarone may need to be adjusted during treatment with alli.
Waqt kura b’ alli d- doża ta ’ amiodarone jista ’ jkollha bżonn tiġi aġġustata.
For orlistat, no clinical data on exposed pregnancies are available.
Għal orlistat m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, ħlas jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
alli is contraindicated in pregnancy (see section 4.3).
alli m’ għandux jingħata waqt it- tqala (ara sezzjoni 4. 3).
As it is not known whether orlistat is secreted into human milk, alli is contraindicated during breast- feeding (see section 4.3).
Peress li mhux magħruf jekk orlistat jgħaddix fil- ħalib tas- sider uman, alli huwa kontra- indikat waqt it- treddigħ (ara sezzjoni 4. 3).
Orlistat has no influence on the ability to drive and use machines.
Orlistat m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
Adverse reactions to orlistat are largely gastrointestinal in nature and related to the pharmacologic effect of the medicinal product on preventing the absorption of ingested fat.
Reazzjonijiet avversi għal orlistat fil- biċċa l- kbira huma ta ’ natura gastro- intestinali u huma relatati ma ’ l- effett farmakoloġiku tal- prodott mediċinali fuq il- prevenzjoni ta ’ l- assorbiment ta ’ xaħam li jkun ittiekel.
The gastrointestinal adverse reactions identified from clinical trials with orlistat 60 mg of 18 months to 2 years duration were generally mild and transient.
Dawn ġeneralment seħħew fil -
They generally occurred early in treatment (within 3 months) and most patients experienced only one episode.
4 bidu tal- kura (fi żmien tliet xhur) u l- biċċa l- kbira tal- pazjenti kellhom esperjenza ta ’ episodju wieħed biss.
Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal reactions (see section 4.4).
Il- konsum ta ’ dieta b’ ammont ta ’ xaħam baxx inaqqas il- probabilità ta ’ esperjenza ta ’ reazzjonijiet avversi gastro- intestinali (ara sezzjoni 4. 4).
Adverse reactions are listed below by system organ class and frequency.
Ir- reazzjonijiet avversi huma mniżżla taħt skond is- sistema tal- klassifika tal- organi u l- frekwenza.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000) and very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Il - frekwenzi huma definiti bħala: komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000) u rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
4 The frequencies of adverse reactions identified during post-marketing use of orlistat are not known as these reactions were reported voluntarily from a population of uncertain size.
Il- frekwenza ta ’ reazzjonijiet avversi identifikati waqt l- użu ta ’ wara t- tqegħid fis- suq ta ’ orlistat mhux magħrufa peress li dawn ir- reazzjonijiet kienu rrapportati b’ mod volontarju minn popolazzjoni ta ’ daqs mhux ċert.
System Organ Class and Frequency Blood and the lymphatic system disorders
Sistema tal- klassifika tal- organi u Frekwenza Disturbi tad- demm u tas- sistema limfatika
Adverse Reaction/ Event
Reazzjoni avversa/ avveniment
Decreased prothrombin and increased INR (see sections 4.3 and 4.5)
Prothrombin imnaqqas u INR miżjud (ara sezzjonijiet 4. 3 u 4. 5)
Hypersensitivity reactions including anaphylaxis, bronchospasm, angioedema, pruritus, rash, and urticaria
Reazzjonijiet ta ’ sensittività eċċessiva inkluż Mhux magħruf: anafilassi, bronkospażmu, anġjoedima, ħakk, raxx u urtikarja Disturbi psikjatriċi
Anxiety†
Ansejtà †
Oily spotting Flatus with discharge Faecal urgency Fatty oily stool Oily evacuation Flatulence Soft stools
Tbajja żejtnin mir- rektum Gass bil- ħruġ ta ’ ħmieġ Tħoss li għandek tmur tipporga bla telf ta ’ żmien Purgar xaħmi u żejtni Purgar żejtni Gass fl- istonku Purgar artab
Abdominal pain Faecal incontinence Liquid stools Increased defaecation
Uġigħ addominali Purgar mhux ikkontrollat Purgar likwidu Purgar aktar ta ’ spiss
Hepato-biliary disorders
Divertikulite Mhux magħruf:
Diverticulitis Mild rectal bleeding (see section 4.4)
Fsada ħafifa mir- rektum (ara sezzjoni 4. 4) Disturbi fil- fwied u fil- marrara
Skin and subcutaneous tissue disorders
Epatite Mhux magħruf:
Hepatitis Cholelithiasis Increase in transaminases and in alkaline phosphatase
Kolelitjasi Żjieda fit- transaminases u fl- alkaline phosphatase Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Not known:
Joħorġu l- imsiemer Mhux magħruf:
† It is plausible that treatment with orlistat can lead to anxiety in anticipation of or secondary to gastrointestinal adverse reactions.
5 † Huwa possibbli li kura b’ orlistat tista ’ twassal għall- ansjetà f’ antiċipazzjoni ta ’ jew sekondarja għall - reazzjonijiet gastro- intestinali avversi.
Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant clinical findings.
Dożi waħedhom ta ’ 800 mg orlistat u dożi multipli sa 400 mg tliet darbiet kuljum għal 15- il ġurnata ġew studjati f’ individwi b’ piż normali u f’ oħrajn bi ħxuna żejda mingħajr sejbiet kliniċi ta ’ sinifikanza.
In addition, doses of 240 mg three times daily have been administered to obese patients for 6 months.
Barra dan, dożi ta ’ 240 mg tliet darbiet kuljum ġew mogħtija għal 6 xhur lill- pazjenti bi ħxuna żejda.
The majority of orlistat overdose cases received during post-marketing reported either no adverse reactions or adverse reactions that are similar to those reported with recommended doses of orlistat.
Il- biċċa l- kbira ta ’ każijiet ta ’ dożi eċċessivi ta ’ orlistat meħuda wara t- tqegħid fis- suq jew ma rrapportaw l- ebda reazzjonijiet avversi jew irrapportaw reazzjonijiet avversi li huma simili għal dawk irrapportati bid- dożi rrakkomandati.
5 In the event of an overdose, medical advice should be sought.
F’ każ ta ’ doża eċċessiva, għandu jintalab parir mediku.
Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours.
Jekk isseħħ doża eċċessiva sinifikanti ta ’ orlistat, huwa rrakkomandat li l- pazjent jiġi osservat għal 24 siegħa.
Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.
Ibbażat fuq studji fil- bnedmin u l- annimali, kull effett sistematiku li jista ’ jkun attribwit għall- proprjetajiet li jimpedixxu l- lipase ta ’ orlistat għandu jkun riversibbli malajr.
Peripherally acting anti obesity products, ATC code A08AB01.
Prodotti kontra l- ħxuna żejda li jaħdmu b’ mod periferali, Kodiċi ATC A08AB01.
Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases.
Orlistat huwa impeditur potenti, speċifiku u li jaħdem fit- tul ta ’ lipases gastro- intestinali.
It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases.
Jeżerċita l - attività terapewtika tiegħu fil- lumen ta ’ l- istonku u tal- musrana ż- żgħira billi jifforma rabta kovalenti mas- sit serin attiv tal- lipases gastriċi u tal- frixa.