qanastek/EMEA-V3 huggingface dataset:
In Parkinson’ s disease levels of dopamine in the brain are low and Pramipexole Teva works by mimicking the action of dopamine.
Fil- marda tal- Parkinson il- livelli tad- dopamina fil- moħħ huma baxxi u Pramipexole Teva taġixxi billi timmimika l- azzjoni ta ’ dopamine.
Pramipexole Teva is used in the treatment of Parkinson’ s disease alone or in combination with another medicine called levodopa.
Pramipexole Teva tintuża biex tittratta s- sintomi tal- marda waħedha jew flimkien ma ’ levodopa.
BEFORE YOU TAKE PRAMIPEXOLE TEVA
QABEL MA TIEĦU PRAMIPEXOLE TEVA
Do NOT take Pramipexole Teva
TIEĦUX Pramipexole Teva
 If you are allergic (hypersensitive) to pramipexole or any of the other ingredients of this medicine.
 Jekk inti allerġiku (tbati minn sensittività eċċessiva) għal pramipexole jew sustanzi oħra ta ’ din il - mediċina.
Take special care with Pramipexole Teva
Oqgħod attent ħafna b’ Pramipexole Teva
Tell your doctor before you start to take this medicine if:  You have kidney problems (you may need a lower dose of Pramipexole Teva)  You have hallucinations (seeing, hearing or feeling things that are not there).
Għid lit- tabib tiegħek qabel ma tibda tieħu din il- mediċina jekk:  Jekk għandek problemi fil- kliewi (għandu mnejn ikollok bżonn doża aktar baxxa ta ’ Pramipexole Teva)  Jekk ikollok alluċinazzjonijiet (tara, tisma’ jew tħoss affarijiet li m’ humiex hemm).
Most hallucinations are visual.  You have dyskinesia (e. g. abnormal, uncontrolled movements of the limbs) If you have advanced Parkinson’ s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of Pramipexole Teva.  You have a mental illness such as schizophrenia or depression  You have heart problems (your doctor may decide to do check-ups more often during treatment to make sure that your blood pressure does not fall too low).
64 Jekk għandek il- marda ta ’ Parkinson avvanzata u qed tieħu wkoll levodopa, tista ’ tiżviluppa diskinesja, waqt it- tittrazzjoni ’ l fuq ta ’ Pramipexole Teva.  Jekk għandek mard mentali bħal skiżofrenja jew depressjoni  Jekk għandek problemi tal- qalb (it- tabib tiegħek għandu mnejn ikun irid jagħmilhek check- ups waqt it- trattament sabiex ikun żgur li l- pressjoni tad- demm tiegħek ma taqax iżżejjed).
You should tell your doctor if you experience sleepiness or episodes of suddenly falling asleep.
Għandek tinforma t- tabib tiegħek jekk tħoss ngħas jew ikollok episodji fejn torqod f’ daqqa.
60 You should tell your doctor if you (or your carer) notice any changes in your behaviour.
Għandek tinfurma lit- tabib tiegħek jekk int (jew min jieħu ħsiebek) tinduna b’ xi bidliet fl- imġieba tiegħek.
Such changes may be an abnormal desire to gamble, increased libido (sex drive) or excessive and uncontrollable overeating.
Dawn il- bidliet jistgħu jkunu xewqat abnormali biex tilgħab il- logħob tal- ażżard, żieda fit - tqanqil sesswali (żieda fix- xewqa għal sess) jew qed tiekol bl- addoċċ u mingħajr kontroll.
Your doctor may lower the dose of Pramipexole Teva or stop your treatment.
It- tabib tiegħek jista ’ jnaqqas id- doża tiegħek ta ’ Pramipexole Teva jew iwaqqaf it- trattament.
You should tell your doctor if you notice any changes to your eyesight.
Għandek tgħid lit- tabib tiegħek jekk tinduna b’ xi bidliet fil- vista tal- għajnejn.
Your eyes may need regular check-ups.
Għajnejk għandhom mnejn ikollhom bżonn jiġu invistati regolarment.
The effects of Pramipexole Teva may be altered or side effects may occur if you are also taking other medicines.
L- effetti ta ’ Pramipexole Teva jistgħu jiġu mibdula jew effetti kollaterali jistgħu jseħħu jekk qed tieħu mediċini oħra.
Talk to your doctor if you are taking any of the following:  Medicines which affect kidney function or are excreted by the kidneys, e. g. cimetidine (used to treat indigestion and other stomach problems) and amantidine (used to manage Parkinson’ s disease)  Levodopa (used to manage Parkinson’ s disease)  Medicines used to treat mental illnesses such as schizophrenia or depression  Other medicines which can cause drowsiness since the drowsiness may become worse in the combination with Pramipexole Teva.
Kellem lit- tabib tiegħek jekk qed tieħu xi wieħed minn dawn li ġejjin:  Mediċini li jaffettwaw il- funzjoni tal- kliewi jew li jiġu eliminati permezz tal- kliewi, eż. cimetidine (li jintuża biex jittratta l- indiġestjoni u problemi oħra tal- istonku) u amantidine (li jintuża biex jiġġestixxi l- marda ta ’ Parkinson)  Levodopa (li jintuża biex jiġġestixxi l- marda ta ’ Parkinson)  Mediċini li jintużaw biex jittrattaw il- mard mentali bħal skiżofrenja jew dipressjoni  Mediċini oħra jistgħu jikaġinaw ħedla peress li l- ħedla tista ’ taggrava bil- kombinazzjoni ta ’ Pramipexole Teva.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, li jinkludu mediċini li nkisbu mingħajr riċetta tat- tabib.
Taking Pramipexole Teva with food and drink
Meta tieħu Pramipexole ma ’ l- ikel u max- xorb
Pramipexole Teva can be taken with or without food and should be swallowed with a sufficient amount of water.
Pramipexole Teva tista ’ tittieħed kemm ma ’ l- ikel u mingħajr ikel u l- pilloli għandhom jinbelgħu b’ ammont suffiċjenti ta ’ ilma.
If you experience drowsiness this can be made worse if you drink alcohol.
Jekk tħoss ħedla din tista ’ taggrava jekk tixrob l- alkoħol.
If you are pregnant or planning to become pregnant Pramipexole Teva should only be used if your doctor considers it to be absolutely necessary.
Jekk inti tqila jew qed tippjana biex tinqabad tqila Pramipexole Teva għandha tintuża biss jekk it- tabib tiegħek jikkonsidra li hu assolutament meħtieġ.
The effects of Pramipexole Teva on the unborn child are not known.
L- effetti ta ’ Pramipexole Teva fuq it- tarbija mhux mwieled mhumiex magħrufin.
You should not take Pramipexole Teva if you are breast-feeding.
M’ għandekx tieħu Pramipexole Teva jekk int qed tredda ’.
Pramipexole Teva may stop milk production.
Pramipexole Teva tista ’ timpedixxi l - produzzjoni tal- ħalib.
Also, it can pass into the breast milk and can reach your baby and the effects of this are not known.
Anke minħabba li tista ’ tgħaddi fil- ħalib tas- sider u tilħaq it- tarbija tiegħek u l - effetti ta ’ dan mhumiex magħrufa.
Ask your doctor or pharmacist for advice before taking any medicine.
Staqsi lit- tabib jew lill- ispiżjar tiegħek għal pariri qabel ma tieħu xi mediċina.
Pramipexole Teva may cause hallucinations and sleepiness, and you may fall asleep suddenly without any warning.
Pramipexole Teva tista ’ tikkawża alluċinazzjonijiet u ħedla, u tista ’ torqod f’ daqqa mingħajr ma tkun taf.
If you experience these effects, do not drive, operate machinery or perform any other dangerous task that requires your full attention.
Jekk ikollok dawn l- effetti kollaterali, inti m’ għandekx issuq jew tħaddem magni jew twettaq xi attività perikoluża oħra li tkun teħtieġ l- attenzjoni kollha tiegħek.
You should also tell your doctor as he/ she may need to lower your dose of Pramipexole Teva or stop your treatment altogether.
Inti wkoll għandek tgħid lit- tabib tiegħek peress li hu/ hi għandha mnejn tkun trid tnaqqas id- doża tiegħek ta ’ Pramipexole Teva jew iwaqqaf/ twaqqaf it- trattament.
HOW TO TAKE PRAMIPEXOLE TEVA
KIF GĦANDEK TIEĦU PRAMIPEXOLE
Always take Pramipexole Teva exactly as your doctor has told you.
Dejjem għandek tieħu Pramipexole skont il- parir tat- tabib.
You should check with your doctor if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
Pramipexole Teva should be taken three times a day.
Pramipexole Teva għandha tittieħed tliet darbiet kuljum.
The tablets can be taken with or without food and should be swallowed with a glass of water.
Il- pilloli jistgħu jittieħdu kemm ma ’ l- ikel u mingħajru u għandhom jinbelgħu b’ tazza ilma.
You can break the tablets to make it easier to swallow them if necessary.
Tista taqsam il- pilloli biex jistaw jinbelghu aħjar jekk meħtieġ.
61 The treatment with Pramipexole Teva normally starts with a low dose which is gradually increased every 5 to 7 days until the right dose for your needs is reached (the “ maintenance dose”).
It- trattament b’ Pramipexole Teva ġeneralment jibda b’ doża baxxa li ġeneralment tiżdid b’ mod gradwali kull 5 sa 7 ijiem sakemm tintlaħaq l- aħjar doża għal ħtiġijiet tiegħek (id - “ doża ta ’ manteniment ”).
The normal starting dose is one Pramipexole Teva 0.088 mg tablet three times a day (a daily dose of 0.264 mg of pramipexole).
Id- doża li normalment jibda biha hija ta ’ pillola waħda ta ’ ta ’ Pramipexole Teva 0. 088 mg tliet darbiet kuljum (doża ta ’ kuljum ta ’ 0. 264 mg ta ’ pramipexole).
The usual maintenance dose is 1.1 mg per day.
Id- doża normali ta ’ manteniment hi ta ’ 1. 1 mg kuljum.
However, your dose may have to be increased even further.
Madankollu d- doża tiegħek għandu mnejn tkun teħtieġ tiżdid anke aktar minn hekk.
If necessary, your doctor may increase your tablet dose up to a maximum of 3.3 mg of pramipexole a day.
Jekk ikun meħtieġ it- tabib tiegħek jista ’ jżid id- doża tiegħek sa massimu ta ’ 3. 3 mg pramipexole kuljum.
A lower maintenance dose of three Pramipexole Teva 0.088 mg tablets a day is also possible.
Doża ta ’ manteniment aktar baxxa ta ’ tliet pilloli ta ’ Pramipexole Teva ta ’ 0. 088 mg kuljum hija wkoll possibbli.
Your doctor may decide to change your maintenance dose depending on your response to the treatment and any side effects that you experience.
It- tabib tiegħek jista ’ jiddeċiedi li jbiddel id- doża ta ’ manteniment tiegħek skont ir- rispons tiegħek għat- tratatment u għal kull effett kollaterali li tħoss.
If your doctor decides to stop your treatment, the dose will be reduced slowly until treatment is stopped.
Jekk it- tabib tiegħek jiddeċiedi li jwaqqaf it- tratatment, id- doża ser titnaqqas bil- mod sakemm it - tratatment jieqaf.
Patients with kidney disease If you have moderate or severe kidney disease, your doctor will prescribe a lower dose.
Pazjenti bil- mard tal- kliewi Jekk għandek mard minn moderat għal sever tal- kliewi, it- tabib tiegħek ser jippreskrivi doża aktar baxxa.
In this case, you will have to take the tablets only once or twice a day.
F’ każ bħal dan ikollok tieħu l- pilloli darba jew darbtejn kuljum.
If you have moderate kidney disease, the usual starting dose is 1 tablet Pramipexole Teva 0.088 mg twice a day.
Jekk għandek mard tal- kliewi moderat, id- doża li wieħed ġeneralment jibda biha hi ta ’ pillola 1 ta ’ Pramipexole Teva ta ’ 0. 088 mg darbtejn kuljum.
In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole Teva 0.088 mg a day.
F’ każ ta ’ mard tal- kliewi qawwi, id- doża li ġeneralment wieħed jibda biha hi biss ta ’ pillola 1 ta ’ Pramipexole Teva 0. 088 mg kuljum.
If you take more Pramipexole Teva than you should
Jekk tieħu Pramipexole Teva aktar milli suppost
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Jekk inti (jew xi ħadd ieħor) tibla ħafna mill- pilloli f’ daqqa, jew jekk taħseb li xi tifel/ tifla belgħu xi pilloli, ikkuntattja l- eqreb dipartiment tal- emerġenza fi sptar jew lit- tabib tiegħek minnufih.
An overdose is likely to cause nausea, vomiting, abnormal muscular movements, hallucinations, agitation and low blood pressure (which might cause light-headedness and dizziness).
Doża eċċessiva x’ aktarx tikkawża tqalligħ, remettar, movimenti muskolari mhux normali, alluċinazzjonijiet, aġitazzjoni u pressjoni tad- demm baxxa (li jista ’ jikkaġuna ħass ħażin jew sturdament).
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
Jekk jogħġbok ħu dan il- fuljett, kull pillola li tibqa u r- reċipjent miegħek l- isptar jew għand it- tabib sabiex ikunu jafu liema pilloli ttieħdu.
Medical treatment may be necessary.
Jista ’ jkun hemm bżonn ta ’ trattament mediku.
If you forget to take Pramipexole Teva
Jekk tinsa tieħu Pramipexole Teva
If you miss a tablet then you should take it as soon as you remember.
Jekk tonqos milli tieħu xi pillola ħudha malli tiftakar.
However, if it is nearly time for your next tablet then you should skip the dose you missed and take your next tablet as normal.
Madankollu, jekk ikun wasal il- ħin għal pillola li jmiss, allura għandek taqbeż id- doża li ma ħadtx u tieħu l- pillola li jmiss bħas- soltu.
Do not take a double dose to make up for a forgotten tablet.
M’ għandekx tieħu doża doppja biex tpatti għal kull pillola li nsejt tieħu.
If you stop taking Pramipexole Teva
Jekk tieqaf tieħu Pramipexole Teva
You should not stop taking your medicine or reduce your dose without discussing it with your doctor first.
Tieqafx tieħu Pramipexole Teva mingħajr ma ’ l- ewwel titkellem mat- tabib tiegħek.
It is dangerous to stop taking this medicine suddenly.
Huwa perikoluż li twaqqaf din il- mediċina f’ daqqa.
If you need to stop your treatment your doctor will reduce your dose slowly.
Jekk ikollok tieqaf tieħu din il- mediċina, it- tabib tiegħek ser inaqqas id- doża gradwalment.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI TISTA ’ JKOLLHA
Like all medicines, Pramipexole Teva can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Pramipexole Teva tista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Evaluation of the side effects is based on the following frequencies:
L- evalwazzjoni tal- effetti sekondarji huma bażati fuq il- frekwenzi li ġejjin:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data
jaffettwa aktar minn utent 1 f’ kull 10 Komuni ħafna: jaffettwa bejn utent 1 sa 10 f’ kull 100 Komuni: jaffettwa bejn utent 1 sa 10 f’ kull 1, 000 Mhux komuni: jaffettwa bejn utent 1 sa 10 f’ kull 10, 000 Rari: jaffettwa bejn utent 1 sa 10 f’ kull 10, 000 Rari Ħafna:
abnormal, uncontrolled movement of the limbs) pattern, such as sleepiness
Il- frekwenza ma setgħetx tiġi stmata mit- tagħrif disponibbli Mhux magħruf:
 Nausea (feeling sick)  Low blood pressure
Komuni ħafna:  Diskinesja (eż. moviment abnormali mhux kontrollat tad- dirgħajn u riġlejn)  Bidliet fix- xejriet ta ’ rqad  Sturdament  Tqalligħ (tħossok ma tiflaħx)  Pressjoni baxxa
Common:  Hallucinations (seeing, hearing or feeling things that are not there)  Confusion  Tiredness (fatigue)  Excess fluid, usually in the legs (peripheral oedema)  Headache  Abnormal dreams  Constipation  Sleeplessness (insomnia)
Komuni:  Alluċinazzjonijiet (tara, tisma ’ u tħoss affarijiet li m’ humiex hemm)  Konfużjoni  Għeja (tintelaq)  Fluwidu eċċessiv, ġeneralment fir- tiġlejn (edema periferali)  Uġigħ ta ’ ras  Ħolm mhux normali  Stitikezza  Nuqqas ta ’ rqad (insomnija)
Uncommon:  Paranoia (e. g. excessive fear for one’ s own well-being)  Delusion  Excessive daytime sleepiness and falling asleep suddenly  Hyperkinesia (increased movements and inability to keep still)  Weight increase  Increased sexual desire drive (e. g. increased libido)  Allergic reactions (e. g. rash, itching, hypersensitivity)
Mhux komuni:  Paranojja (eż. biża ’ żejda għal persuna nnifisha)  Delużjoni  Ngħas eċċessiv waqt il- jum jew torqod f’ daqqa waħda  Iperkinesja (żieda fiċ- ċaqlieq u ma tistax iżżomm kwiet)  Żieda fil- piż  Żieda fil- ġibda sesswali (il- ħajra sesswali)  Reazzjonijiet allerġiċi (eż. raxx, ħakk u ipersensittività)
Unknown frequency:  Pathological gambling, especially in patients taking high doses of Pramipexole Teva  Hypersexuality  Abnormal behaviour  Increased eating (binge eating, hyperphagia)
 Logħob tal- azzard patoloġiku, speċjalment f’ pazjenti li jieħdu dożi għoljin ta ’ Prampexole Teva  Ipersesswalità  Żieda mhux normali fl- ikel (tiekol bl- addoċċ, iperfaġja)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 PRAMIPEXOLE TEVA
KIF TAĦŻEN PRAMIPEXOLE TEVA
Do not use Pramipexole Teva after the expiry date that is stated on the outer packaging.
67 Tużax Pramipexole Teva wara d- data ta ’ skadenza li tidher fuq il- pakkett ta ’ barra.
Do not store above 25 ºC.
Taħżinx f’ temperatura ’ l fuq minn 25ºC.
What Pramipexole Teva contains
X’ fih Pramipexole Teva
The active substance is pramipexole.
Is- sustanza attiva hi pramipexole.
Pramipexole Teva 0.088 mg tablets: one tablet contains 0.088 mg pramipexole equivalent to 0.125 mg pramipexole dihydrochloride monohydrate Pramipexole Teva 0.18 mg tablets: one tablet contains 0.18 mg pramipexole equivalent to 0.25 mg of pramipexole dihydrochloride monohydrate Pramipexole Teva 0.35 mg tablets: one tablet contains 0.35 mg pramipexole equivalent to 0.5 mg pramipexole dihydrochloride monohydrate Pramipexole Teva 0.7 mg tablets: one tablet contains 0.7 mg pramipexole equivalent to 1.0 mg pramipexole dihydrochloride monohydrate
 Il- pilloli Pramipexole Teva 0. 088 mg: pillola waħda fiha 0. 088 mg ta ’ pramipexole li hu ekwivalenti għal 0. 125 mg ta ’ pramipexole dihydrochloride monohydrate  Il- pilloli Pramipexole Teva 0. 18 mg: pillola waħda fiha 0. 18 mg ta ’ pramipexole li hu ekwivalenti għal 0. 25 mg ta ’ pramipexole dihydrochloride monohydrate  Il- pilloli Pramipexole Teva 0. 35 mg: pillola waħda fiha 0. 35 mg ta ’ pramipexole li hu ekwivalenti għal 0. 5 mg ta ’ pramipexole dihydrochloride monohydrate  Il- pilloli Pramipexole Teva 0. 7 mg: pillola waħda fiha 0. 7 mg ta ’ pramipexole li hu ekwivalenti għal 1. 0 mg ta ’ pramipexole dihydrochloride monohydrate
The other ingredients are mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide.
Is- sustanzi l- oħra huma mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide.
What Pramipexole Teva looks like and contents of the pack  Pramipexole Teva 0.088 mg tablets are white, round tablets, embossed with "93" on one side and "P1" on the other side.  Pramipexole Teva 0.18 mg tablets are white round, scored tablets embossed with "P2" over "P2" on the scored side and "93" on the other side.
Id- dehra ta ’ Pramipexole Teva u l- kontenut tal- pakkett  Il- pilloli Pramipexole Teva ta ’ 0. 088 mg huma bojod, tondi u fuqhom hemm intaljat il- kodiċi "93" fuq naħa u "P1" fuq in- naħa l- oħra.  Il- pilloli Pramipexole Teva ta ’ 0. 18 mg huma bojod u tondi, u fuqhom hemm intaljat "P2" fuq "P2" fuq in- naħa bil- ferq u "93" fuq in- naħa l- oħra.
The tablet can be divided into equal halves.  Pramipexole Teva 0.35 mg tablets are white round, scored tablets embossed with "8023" over "8023" on the scored side and "93" on the other side.
Il- pillola tista ’ tinqasam f’ nofsijiet indaqs  Il- pilloli Pramipexole Teva ta ’ 0. 35 mg huma bojod u tondi, u fuqhom hemm intaljat il- kodiċi "8023" fuq "8023" fuq in- naħa bil- ferq u "93" fuq in- naħa l- oħra.
The tablet can be divided into equal halves.  Pramipexole Teva 0.7 mg tablets are white, round, scored tablets embossed with "8024" over "8024" on the scored side and "93" on the other side.
Il- pillola tista ’ tinqasam f’ nofsijiet indaqs  Il- pilloli Pramipexole Teva jiġu f’ pakketti ta ’ folji ta ’ 30, 50 u 100 pillola u fi flieken li fihom 90 pillola.
The tablet can be divided into equal halves.  Pramipexole Teva tablets are available in blister packs of 30, 50 and 100 tablets and bottles containing 90 tablets.
Il- pillola tista ’ tinqasam f’ nofsijiet indaqs Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Not all pack sizes may be marketed.
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Marketing Authorisation Holder and Manufacturer
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen, Hungary
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen, L- Ungerija
Or:
Jew:
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöll ő, Táncsics Mihály út 82 Hungary
68 TEVA Pharmaceutical Works Private Limited Company H- 2100 Gödöllő, Táncsics Mihály út 82 L- Ungerija
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne,
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ir- Renju Unit
This leaflet was last approved in Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Dan il- fuljett kien approvat l- aħħar f ’ Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
What is Prandin?
X’ inhu Prandin?
Prandin is a medicine that contains the active substance repaglinide.
Prandin huwa mediċina li fiha s- sustanza attiva repaglinide.
It is available as round tablets (white:
Tiġi bħala pilloli tondi (bojod:
What is Prandin used for?
Għal xiex jintuża Prandin?
Prandin is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Prandin jintuża f’ pazjenti li għandhom dijabete tat- tip 2 (dijabete mhux dipendenti fuq l- insulina).
It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Jintuża flimkien ma ’ dieta u eżerċizzju biex ibaxxi l- livelli ta ’ glukożju (zokkor) fid- demm f’ pazjenti li l- ipergliċemija (livelli għoljin ta ’ glukożju fid- demm) tagħhom ma tistax tiġi kkontrollata b’ dieta, tnaqqis fil- piż u eżerċizzju.
Prandin may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Prandin jista ’ jintuża wkoll ma ’ metformin (mediċina oħra kontra d - dijabete) f’ pazjenti b’ dijabete tat- tip 2 li l- livelli ta ’ glukożju fid- demm tagħhom m’ humiex ikkontrollati b’ mod sodisfaċenti b’ metaformin waħdu.
How is Prandin used?
Kif jintuża Prandin?
Prandin is taken before meals, normally up to 15 minutes before each main meal.
Prandin jittieħed qabel l- ikel, normalment sa 15- il minuta qabel kull ikla prinċipali.
A doctor should regularly test the patient ’ s blood glucose to find the lowest effective dose.
Tabib għandu jittestja regolarment il- glukożju fid- demm tal - pazjent sabiex isib l- inqas doża li tkun effikaċi.
Prandin can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Prandin jista ’ jintuża wkoll għal pazjenti b’ dijabete tat- tip 2 li l- livelli ta ’ glukożju fid- demm tagħhom huma normalment ikkontrollati sewwa b’ dieta, iżda li jkunu qegħdin jesperjenzaw telf temporanju ta ’ kontroll tal- glukożju fid- demm.
This dose may need to be increased after one or two weeks.
Jista ’ jkun hemm bżonn li din id- doża tiżdied wara ġimgħa jew ġimagħtejn.
If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.
Jekk il- pazjenti huma ttrasferiti minn mediċina kontra d- dijabete għal oħra, id- doża tal- bidu rakkomandata hija ta ’ 1 mg.
Prandin is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Prandin mhuwiex rakkomandat għal pazjenti li għandhom inqas minn 18- il sena minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja f’ dan il- grupp ta ’ età.
How does Prandin work?
Kif jaħdem Prandin?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Id- dijabete tat- tip 2 hija marda li fiha, il- frixa ma tipproduċix biżżejjed insulina biex tikkontrolla l - livell ta ’ glukożju fid- demm jew meta l- ġisem ma jkunx kapaċi juża l- insulina b’ mod effikaċi.
Prandin helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Prandin jgħin lill- frixa tipproduċi aktar insulina f’ ħinijiet l- ikel u jintuża biex jikkontrolla d- dijabete tat- tip 2.
The main studies compared Prandin with other medicines used in type 2 diabetes (glibenclamide, glipizide or gliclazide).
L- istudji ewlenin qabblu Prandin ma ’ mediċini oħrajn użati f’ dijabete tat- tip 2 (glibenclamide, glipizide jew gliclazide).
Another study looked at the effect of adding Prandin to metformin.
Studju ieħor ħares lejn l- effett taż- żieda ta ’ Prandin ma ’ metformin.
The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c) which gives an indication of how well the blood glucose is controlled.
L- istudji kejlu l- livell ta ’ sustanza fid- demm imsejħa emoglobina glikosilata (HbA1c) li jagħti indikazzjoni ta ’ kemm il- glukożju fid- demm ikun qiegħed jiġi kkontrollat tajjeb.
What benefit has Prandin shown during the studies?
Liema benefiċċju wera Prandin waqt l- istudji mwettqa?
In all studies, Prandin led to a decrease in the level of HbA1c, which showed that blood glucose levels had been controlled to a similar level to that seen with the comparator medicines.
Fl- istudji kollha, Prandin wassal għal tnaqqis fil- livell ta ’ HbA1c, li wera li l- livelli ta ’ glukożju fid - demm ġew ikkontrollati għal livell simili għal dak muri ma ’ mediċini ta ’ tqabbil.
In the study where Prandin was added to metformin, the effects of the two medicines were at least additive (equivalent to the effects of the two medicines added together).
Fl- istudju fejn Prandin ġie miżjud ma ’ metaformin, l- effetti taż- żewġ mediċini kienu talanqas addittivi (ekwivalenti għall- effetti taż- żewġ mediċini miżjuda flimkien).
Prandin produced a good insulin response to a meal within 30 minutes of being dosed in type 2 diabetes patients, leading to a blood glucose-lowering effect throughout the meal.
Prandin ipproduċa rispons tajjeb tal- insulina għal ikla fi żmien 30 minuta mid- dożaġġ f’ pazjenti b’ dijabete tat- tip 2, li wassal għal effett ta ’ tnaqqis tal- livell ta ’ glukożju fid- demm matul l- ikla.
The raised insulin levels returned to normal after the meal.
Il - livelli li kienu telgħu tal- insulina reġgħu marru lura għan- normal wara l- ikla.
What is the risk associated with Prandin?
X’ inhu r- riskju assoċjat ma ’ Prandin?
The most common side effects with Prandin (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels), abdominal (tummy) pain and diarrhoea.
L- aktar effetti sekondarji komuni ma ’ Prandin (li jidhru f’ bejn pazjent 1 u 10 minn kull 100) huma l - ipogliċemija (livelli baxxi ta ’ glukożju fid- demm), uġigħ addominali (ta ’ żaqq) u dijarrea.
For the full list of all side effects seen with Prandin, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji li jidhru ma ’ Prandin, ara l- Fuljett ta ’ Tagħrif.
Prandin should not be used in people who may be hypersensitive (allergic) to repaglinide or any of the other ingredients.
Prandin ma għandux jintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal repaglinide jew għal kwalunkwe sustanza oħra tiegħu.
It should also not be used in patients with type 1 (insulin-dependent) diabetes who do not have any ‘ C-peptide ’ in their blood (a marker of type 1 diabetes).
Ma għandux jintuża wkoll f’ pazjenti b’ dijabete tat- tip 1 (dipendenti fuq l- insulina) li ma għandhom l- ebda ‘ peptida Ċ ’ f’ demmhom (markatur ta ’ dijabete tat- tip 1).
It should also not be used in patients with diabetic ketoacidosis (high levels of ketones [acids] in the blood), in patients with severe liver problems or in patients also taking gemfibrozil (a medicine used to reduce blood fat levels).
Ma għandux jintuża wkoll f’ pazjenti b’ ketoaċidożi dijabetika (livelli għoljin ta ’ ketoni [aċidi] fid- demm), f’ pazjenti bi problemi serji fil- fwied jew f’ pazjenti li jkunu qegħdin jieħdu gemfibrozil ukoll (mediċina wżata biex tnaqqas il- livelli ta ’ xaħam fid- demm).
Prandin doses may also need to be adjusted when given with some medicines used in heart conditions, and to treat pain, asthma and other conditions.
Id- dożi ta ’ Prandin jistgħu jeħtieġu wkoll li jiġu aġġustati meta mogħtija ma ’ xi mediċini wżati f’ kundizzjonijiet tal- qalb, u sabiex jittrattaw uġigħ, ażżma u kundizzjonijiet oħrajn.
The full list is available in the Package Leaflet.
Il- lista sħiħa hija disponibbli fil- Fuljett ta ’ Tagħrif.
Why has Prandin been approved?
Għaliex ġie approvat Prandin?
The Committee for Medicinal Products for Human Use (CHMP) decided that Prandin’ s benefits are greater than its risks for the treatment of type 2 diabetes.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Prandin huma ikbar mir- riskji tiegħu għat- trattament ta ’ dijabete tat- tip 2.
The Committee recommended that Prandin be given marketing authorisation.
Il- Kumitat irrakkomanda li Prandin jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Prandin:
Informazzjoni oħra dwar Prandin:
The European Commission granted a marketing authorisation valid throughout the European Union for Prandin to Novo Nordisk A/ S on 29 January 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Prandin lil Novo Nordisk A/ S fid- 29 ta ’ Jannar 2001.
The marketing authorisation was renewed on 18 August 2003 and on 18 August 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 18 ta ’ Awwissu 2003 u fit- 18 ta ’ Awwissu 2008.
The full EPAR for Prandin is available here.
L- EPAR sħiħ għal Prandin jista ’ jiġi kkonsultat hawn.
Prandin 0.5 mg tablets
Prandin 0. 5 mg pilloli
In addition to the usual self-monitoring by the patient of blood and/ or urinary glucose, the patient’ s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Flimkien mas- soltu monitoraġġ tal- glucose fid- demm u/ jew fl- awrina min - naħa tal- pazjent stess, kull tant żmien, il- glucose fid- demm tal- pazjent għandu jiġi ċċekkjat mit- tabib biex tiġi determinata l- inqas doża effettiva għall- pazjent.
• Hypersensitivity to repaglinide or to any of the excipients in Prandin • Type 1 diabetes (Insulin-Dependent Diabetes Mellitus:
• Sensittività eċċessiva għal repaglinide jew għal xi sustanzi mhux attivi ta ’ Prandin. • Dijabete tat- tip 1 (Dijabete Mellitus li Tiddependi fuq l- insulina:
No clinical studies have been performed in children and adolescents< 18 years of age or in patients > 75 years of age.
Ma sarux studji kliniċi fuq tfal u adolexxenti < 18- il sena jew fuq pazjenti > 75 sena.
One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide
Studju epidemjoloġiku wieħed wera żieda fir- riskju tas- sindromu koronarju akut f’ pazjenti kkurati b’ repaglinide meta mqabbla ma ’ pazjenti kkurati b’ sulfonylureas (ara sezzjonijiet 4. 4 u 4. 8).
EU/ 1/ 00/ 162/ 003-005, EU/ 1/ 00/ 162/ 021
9 EU/ 1/ 00/ 162/ 003- 005, EU/ 1/ 00/ 162/ 021
29 January 2001 Date of last renewal:
29 ta ’ Jannar 2001 Data ta ’ l- aħħar tiġdid:
23 July 2008
23 ta ’ Lulju 2008
Prandin 1 mg tablets
Prandin 1 mg pilloli
Initial dose The dosage should be determined by the physician, according to the patient’ s requirements.
11 Doża inizjali Id- doża għandha tiġi determinata mit- tabib, skond il- ħtiġijiet tal- pazjent.
The blood glucose-lowering effect of oral hypoglycaemic agents decreases in many patients over time.
12 L- effett ta 'sustanzi ipogliċemiċi, orali, li jbaxxu l- glucose fid- demm maż- żmien jonqos f' ħafna pazjenti.
The following substances may enhance and/ or prolong the hypoglycaemic effect of repaglinide:
13 Is- sustanzi li ġejjin jistgħu jżidu u/ jew itawlu l- effett ipogliċemiku ta ’ repaglinide:
Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, other antidiabetic agents, monoamine oxidase inhibitors (MAOI), non selective beta blocking agents, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Gemfibrozil, clarithromycin, itraconazole, ketoconazole, trimethoprim, ciclsporin, sustanzi oħra kontra d- dijabete, inibituri ta ’ monoamine oxidase (MAOIs), sustanzi beta blokkanti mhux selettivi, inibituri ta ’ angiotensin converting enzyme (ACE), saliċilati, NSAIDs, octreotide, alkoħol, u sterojdi anaboliċi.
Co-administration of cimetidine, nifedipine, oestrogen, or simvastatin with repaglinide, all CYP3A4 substrates, did not significantly alter the pharmacokinetic parameters of repaglinide.
14 It- teħid fl- istess ħin ta ’ cimetidine, nifedipine, oestrogen, jew simvastatin ma ’ repaglinide, kollha sustanzi li fuqhom jaġixxi CYP3A4, ma bidlux b’ mod sinifikanti l- parametri farmakokinetiċi ta ’ repaglinide.
During post marketing experience, cases of hypoglycaemia have been reported in patients treated with repaglinide in combination with metformin or thiazolidinedione.
15 ipogliċemija f' pazjenti li kienu trattati b’ repaglinide flimkien ma 'metformin jew ma ’ thiazolidinedione.
Gastro-intestinal complaints such as abdominal pain, diarrhoea, nausea, vomiting and constipation have been reported in clinical trials.
Tqalligħ Ilmenti gastrointestinali bħal uġigħ addominali, dijarea, dardir, rimettar u stitikezza ġew irrappurtati fi studji kliniċi.
Repaglinide is a novel short-acting oral secretagogue.
16 Repaglinide huwa prodott ġdid li jikkawża s- sekrezzjoni ta ’ l- insulina, jittieħed mill- ħalq u jaħdem għal ħin qasir.
15 One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
Studju epidemjoloġiku wieħed wera żieda fir- riskju tas- sindromu koronarju akut f’ pazjenti kkurati b’ repaglinide meta mqabbla ma ’ pazjenti kkurati b’ sulfonylureas (ara sezzjonijiet 4. 4 u 4. 8).
Repaglinide and its metabolites are excreted primarily via the bile.
17 Repaglinide u l- metaboli tiegħu jiġu mneħħija primarjament permezz tal- bile.
EU/ 1/ 00/ 162/ 009-11, EU/ 1/ 00/ 162/ 020
18 EU/ 1/ 00/ 162/ 009- 11, EU/ 1/ 00/ 162/ 020
Prandin 2 mg tablets
Prandin 2 mg pilloli
Drugs that inhibit OATP1B1 may likewise have the potential to increase plasma concentrations of repaglinide, as has been shown for ciclosporin (see below).
22 OATP1B1 jistgħu jkollhom il- potenzjal li jżidu l- konċentrazzjonijiet ta ’ repaglinide fil- plażma kif ġie muri għal ciclosporin (ara aktar ’ l isfel).
Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided.
Jekk jidher li l- użu flimkien
If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
23 ikun bżonnjuż, għandu jkun hemm monitoraġġ mill- viċin kemm mil- lat kliniku u kemm taz- zokkor fid- demm (ara sezzjoni 4. 4).
Allergy Generalised hypersensitivity reactions (e. g. anaphylactic reaction), or immunological reactions such as vasculitis.
Allerġija Reazzjonijiet ta ’ sensittività eċċessiva ġeneralizzati (eż. reazzjoni anafilattika), jew reazzjonijiet immunoloġiċi bħal vaskulite
If severe, requiring third party assistance, infusion of glucose may be necessary.
Jekk ikunu serji, tant li tkun meħtieġa l- assistenza minn persuni oħra, jista ’ jkun hemm bżonn
Prandin 0.5 mg tablets Repaglinide
Prandin 0. 5 mg pilloli Repaglinide
Prandin 1 mg tablets Repaglinide
Prandin 1 mg pilloli Repaglinide
Prandin 2 mg tablets Repaglinide
Prandin 2 mg pilloli Repaglinide
Prandin 0.5 mg tablets 1 mg tablets 2 mg tablets
Prandin Pilloli ta ’ 0. 5 mg Pilloli ta ’ 1 mg Pilloli ta ’ 2 mg
What Prandin is and what it is used for 2.
X’ inhu Prandin u għalxiex jintuża 2.
Before you take Prandin 3.
Qabel ma tieħu Prandin 3.
How to take Prandin 4.
Kif għandek tieħu Prandin 4.
How to store Prandin 6.
Kif taħżen Prandin 6.
WHAT PRANDIN IS AND WHAT IT IS USED FOR
X’ INHU PRANDIN U GĦALXIEX JINTUŻA
Prandin is an oral antidiabetic agent containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Prandin hu sustanza orali kontra d- dijabete li fih repaglinide, li jgħin il- frixa tiegħek tipproduċi iżjed insulina u b’ hekk tnaqqas il- livell taż- żokkor (glucose) fid- demm.
Prandin is used to control type 2 diabetes as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar.
Prandin jintuża bħala żieda mad- dieta u l- eżerċizzju biex tiġi ikkontrollata d- dijabete tat- tip 2: normalment il- kura tinbeda jekk id- dieta, l- eżerċizzju u t- tnaqqis fil- piż waħidhom ma kinux kapaċi jikkontrollaw (jew inaqqsu) il- livelli taz- zokkor fid- demm tiegħek.
Prandin can also be given with metformin, another medicine for diabetes.
Prandin jista ’ wkoll jingħata flimkien ma ’ metformin, mediċina oħra għad- dijabete.
BEFORE YOU TAKE PRANDIN
QABEL MA TUŻA PRANDIN
Do not take Prandin:
Tieħux Prandin:
If any of these apply to you, tell your doctor and do not take Prandin.
Jekk xi waħda minn dawn tapplika għalik, għid lit- tabib tiegħek u tieħux Prandin.
Take special care with Prandin:
Oqgħod attent ħafna b’ Prandin:
Prandin is not recommended in patients with moderate liver disease.
Prandin m’ huwiex rakkomandat f’ pazjenti li għandhom mard moderat fil- fwied.
Prandin should not be taken if you have a severe liver disease (see Do not take Prandin). • If you have kidney problems.
Prandin m’ għandux jittieħed jekk għandek mard sever tal- fwied (ara Tieħux Prandin). – Jekk għandek problemi fil- kliewi.
Prandin should be taken with caution. • If you are about to have major surgery or you have recently suffered a severe illness or infection.
Prandin għandu jittieħed b’ kawtela. – Jekk dalwaqt ser ikollok operazzjoni maġġuri jew jekk dan l- aħħar kellek xi marda jew infezzjoni severa.
Prandin is not recommended.
F’ dawn iż- żminijiet jista ’ jintilef il- kontroll dijabetiku. – Jekk għandek inqas minn 18- il sena jew iżjed minn 75 sena, Prandin m’ huwiex rakkomandat..
Prandin may not be suitable for you.
Kellem lit- tabib tiegħek, jekk xi waħda minn dawn ta ’ hawn fuq tapplika għalik, Prandin jista ’ ma jkunx adattat għalik.
This may happen: • If you take too much Prandin • If you exercise more than usual • If you take other medicines or suffer from liver or kidney problems (see other sections of 2.
Dan jista ’ jiġri: • Jekk tieħu wisq Prandin • Jekk tagħmel aktar eżercizzju mis- soltu. • Jekk tieħu mediċini oħra jew tbati minn problemi fil- fwied jew fil- kliewi (ara sezzjonijiet oħra ta ’ 2.
Before you take Prandin).
Qabel ma tieħu Prandin)
When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue Prandin treatment.
Meta s- sintomi ta ’ l- ipogliċemija jkunu għebu jew meta l- livelli taz- zokkor fid- demm ikunu stabbli, kompli l- kura b’ Prandin.
The amount of Prandin, food or exercise may need to be adjusted.
Jista ’ jkun hemm bżonn li jiġi aġġustat l- ammont ta ’ Prandin, ikel jew eżerċizzju.
This may happen: • If you take too little Prandin • If you have an infection or a fever • If you eat more than usual • If you exercise less than usual.
Dan jista ’ jiġri: • Jekk tieħu ftit wisq ta ’ Prandin • Jekk għandek infezzjoni jew deni • Jekk tiekol aktar mis- soltu • Jekk tagħmel inqas eżerċizzju mis- soltu
The amount of Prandin, food or exercise may need to be adjusted.
Jista ’ jkun hemm bżonn li jiġi aġġustat l- ammont ta ’ Prandin, ikel jew eżerċizzju
You can take Prandin with metformin, another medicine for diabetes, if your doctor prescribes it.
Tista ’ tieħu Prandin ma ’ metformin, mediċina oħra għad- dijabete, jekk jiktiblek riċetta għaliha t- tabib.
If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Prandin.
Jekk tieħu gemfibrozil (użat biex inaqqas livelli għoljin ta ’ xaħam fid- demm) m’ għandekx tieħu Prandin.
John’ s wort (herbal medicine).
44 Il- mod kif il- ġisem tiegħek jirrispondi għal Prandin jista ’ jinbidel jekk tieħu mediċini oħrajn, speċejalment dawn: • Inibituri ta ’ monoamine oxidase (MAOI) (użati għall- kura tad- dipressjoni) • Beta blokkanti (użati għall- kura ta ’ pressjoni tad- demm għoli jew kundizzjonijiet tal- qalb) • Inibituri ACE (użati għall- kura ta ’ kundizzjonijiet tal- qalb) • Salicylates (eż. aspirina) • Octreotide (użat għall- kura tal- kanċer) • Mediċini antiinfjammatorji li m’ humiex sterojdi (NSAIDS) (tip ta ’ mediċina għal kontra l - uġigħ) • Sterojdi (sterojdi anaboliċi u kortikosterojdi - użati għall- anemija jew għall- kura ta ’ l - infjammazzjoni) • Kontraċettivi orali (pilloli użati għall- kontroll tat- tqala) • Thiazides (dijuretiċi jew “ pilloli biex tneħħi l- ilma żejjed ”) • Danazol (użat għall- kura ta ’ ċisti fis- sider u l- endometrjożi) • Prodotti tat- tirojde (użati għall- kura ta ’ livelli baxxi ta ’ l- ormoni tat- tirojde) • Simpatomimetiċi (jintużaw biex jikkuraw l- ażma) • Clarithromycin, trimethoprim, rifampicin (mediċini antibijotiċi) • Itraconazole, ketoconazole (mediċini antifungali) • Gemfibrozil (użat għall- kura ta ’ xaħam għoli fid- demm) • Ciclosporin (jintuża biex ibaxxi s- sistema immuni) • Phenytoin, carbamazepine, Phenobarbital (użati għall- kura ta ’ l- epilessija) • St. John’ s wort (mediċina magħmula mill- ħxejjex)
Using Prandin with food and drink
Meta tuża Prandin ma ’ l- ikel u max- xorb
Take Prandin before main meals.
Ħu Prandin qabel l- ikliet prinċipali.
Alcohol can change the ability of Prandin to reduce the blood sugar.
L- alkoħol jista ’ jbiddel il- kapaċità ta ’ Prandin li jnaqqas iz- zoqqor fid- demm.
You should not take Prandin if you are pregnant or you are planning to become pregnant.
M’ għandekx tieħu Prandin jekk inti tqila jew jekk qed tippjana li toħroġ tqila.
You should not take Prandin if you are breast-feeding.
M’ għandekx tieħu Prandin jekk inti qed tredda ’.
HOW TO TAKE PRANDIN
KIF GĦANDEK TIEĦU PRANDIN
Do not take more Prandin than your doctor has recommended.
45 Tiħux Prandin aktar milli rrakkomandalek it- tabib tiegħek.
Always take Prandin exactly as your doctor has told you.
Dejjem ħu Prandin eżatt kif qallek it- tabib tiegħek.
If you take more Prandin than you should
Jekk tieħu aktar Prandin milli suppost
Please see If
Jekk tieħu żżejjed pilloli, iz- zokkor fid- demm tiegħek jista ’ jinżel ħafna, u dan iwassal għal ipo.
42 you get a hypo on what a hypo is and how to treat it.
Jekk jogħġbok ara Jekk ikollok ipo jew x’ inhi ipo u kif għandek tikkuraha.
If you forget to take Prandin
Jekk tinsa tieħu Prandin
If you stop taking Prandin
Jekk tieqaf tieħu Prandin
Be aware that the desired effect is not achieved if you stop taking Prandin.
Kun af li l- effett mixtieq ma jkunx milħuq jekk tieqaf tieħu Prandin.
If you have any further questions on the use of Prandin, 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, Prandin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Prandin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE PRANDIN
KIF TAĦŻEN PRANDIN
Medicines should not be disposed of down the drain or in household rubbish.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Prandin contains
X’ fih Prandin
What Prandin looks like and contents of the pack
Id- Dehra ta ’ Prandin u l- kontenuti tal- pakkett
Prandin tablets are round and convex and engraved with the Novo Nordisk logo (Apis bull).
Il- pilloli Prandin huma tondi u konvessi u mnaqqxa bil- logo ta ’ Novo Nordisk (Apis bull).
Further Information For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Aktar tagħrif Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
sa Novo Nordisk Pharma nv Boulevard International 55 B-1070 Bruxelles Tél/ Tel: + 32 2556 0580 Magyarország
Boulevard International 55 B- 1070 Bruxelles Tél/ Tel: + 32 2556 0580 Magyarország
35 H-1025 Budapest Tel.: +36 1 3259 161 Malta
35 H- 1025 Budapest Tel.: +36 1 3259 161 Malta (immaniġjata minn NNF Italy)
DK-2880 Bagsværd Tlf: + 45 45 88 08 00 Deutschland
Novo Nordisk A/ S Novo Allé DK- 2880 Bagsværd Tlf: + 45 45 88 08 00 Deutschland
Laboratorios Menarini, S. A. c/ Alfonso XII, 587 E-08918 Badalona (Barcelona) Tel: + 34 93 4628800
Laboratorios Menarini, S. A. c / Alfonso XII, 587 E- 08918 Badalona (Barcelona) Tel: + 34 93 4628800 France Novo Nordisk Pharmaceutique S. A.
Ireland Novo Nordisk Limited 3/ 4 Upper Pembroke Street
Novo Nordisk Limited 3/ 4 Upper Pembroke Street
IRL - Dublin 2 Tel: + 353 1 678 5989
IRL - Dublin 2 Tel: + 353 1 678 5989 Ísland
11
11 Bucharest 010031 – RO
Bucharest 010031 – RO Tel: + 40 2 1312 3674
Tel: + 40 2 1312 3674
IS-210 Garðabæ Sími: + 354 535 7000
IS- 210 Garðabæ Sími: + 354 535 7000 Italia
Š martinska cesta 140
Šmartinska cesta 140 SI- 1000 Ljubljana
SI-1000 Ljubljana Tel: + 386 1 585 1900
48
I-00144 Roma Tel: + 39 06 500 881
I- 00144 Roma Tel: + 39 06 500 881 Κύπρος
Ž ilinská 7-9
Žilinská 7- 9 SK- 811 05 Bratislava
Κύπρος Generica Pharmaceutical Products Trading Co Ltd.
Generica Pharmaceutical Products Trading Co Ltd.
NAME OF THEMEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI
Preotact 100 micrograms powder and solvent for solution for injection.
Preotact 100 mikrogramm trab u solvent għal soluzzjoni għall- injezzjoni.
Preotact contains parathyroid hormone manufactured using a strain of Escherichia coli modified by recombinant DNA technology.
Preotact fih ormon tal- paratirojde prodott bl- użu ta ’ razza ta ’ Escherichia coli modifikata bit - teknoloġija tad- DNA rikombinanti.
The medicinal product is supplied in a dual-chamber cartridge.
Dan l- prodott mediċinali huwa fornut fi skartoċċ ta ’ żewġ kompartimenti.
The first chamber contains 1.61 mg parathyroid hormone.
L- ewwel kompartiment fih 1. 61 mg ta ’ ormon tal- paratirojde.
Each dose of 71.4 microliter contains 100 micrograms parathyroid hormone.
Kull doża ta ’ 71. 4 mikrolitru fiha 100 mikrogramm ta ’ ormon tal- paratirojde.
Each cartridge contains 14 doses.
Kull skartoċċ fih 14- il doża.
The second chamber contains a sterile solvent for reconstitution.
It- tieni kompartiment fih solvent sterili għar- rikostituzzjoni.
White to off-white powder and clear, colourless solvent.
Trab abjad għal offwajt u solvent ċar, bla kulur.
Treatment of osteoporosis in postmenopausal women at high risk of fractures (see section 5.1).
Trattament ta ’ osteoporożi f’ nisa li qabżu l- menopawsa f’ riskju għoli ta ’ ksur (ara sezzjoni 5. 1).
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Ġie muri tnaqqis sinifikanti fl- inċidenza ta ’ ksur tal- vertebra iżda mhux tal- ġenb.
The recommended dose is 100 micrograms of parathyroid hormone administered once-daily as a subcutaneous injection into the abdomen.
Id- doża rakkomandata hija 100 mg ta ’ ormon tal- paratirojde mogħtija darba kuljum bħala injezzjoni taħt il- ġilda fl- addome.
Patients must be trained to use the proper injection techniques (see section 6.6).
Il- pazjenti jridu jiġu mħarrġa biex jużaw il- metodi korretti ta ’ injezzjoni (ara sezzjoni 6. 6).
A user manual is available with the Preotact pen to instruct patients on the correct use of the pen.
Manwal għall- utent huwa disponibbli mal- pinna Preotact biex jgħallem lill- pazjenti dwar l- użu korrett tal - pinna.
The pen is not included in the packs with cartridges.
Il- pinna mhix inkluża fil- pakketti ma ’ l- iskrataċ.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
Il- pazjenti għandhom jirċievu kalċju u vitamina D supplimentari jekk l- ammont li jieħdu fid- dieta tagħhom ma jkunx biżżejjed.