qanastek/EMEA-V3 huggingface dataset:
62 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTONS – PACK SIZES 30 AND 100 TABLETS
61 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT – KARTUN - PAKKETTI TA ’ QISIEN TA ’ 30 U 100 PILLOLA
Rapamune 2 mg coated tablets Sirolimus
Rapamune 2 mg pilloli miksija Sirolimus
Each Rapamune tablet contains 2 mg sirolimus
Kull pillola ta ’ Rapamune fiha 2 mg sirolimus.
30 coated tablets 30 x 2 mg 100 coated tablets 100 x 2 mg
30 pillola miksija 30 x 2 mg 100 pillola miksija 100 x 2 mg
Do not store above 25˚ C.
Taħżinx f’ temperatura ’ l fuq minn 25˚C.
EU/ 1/ 01/ 171/ 009 30 tablets EU/ 1/ 01/ 171/ 010 100 tablets
EU/ 1/ 01/ 171/ 009 30 pillola EU/ 1/ 01/ 171/ 010 100 pillola
64 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
63 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Rapamune 2 mg tablets Sirolimus
Rapamune 2 mg pilloli Sirolimus
PACKAGE LEAFLET
65 FULJETT TA ’ TAGĦRIF:
Rapamune 1mg/ ml oral solution Sirolimus
Rapamune 1 mg/ ml soluzzjoni orali (Sirolimus)
Please read all of this leaflet carefully before you start taking this medicine.  Keep this leaflet.
Aqra sew dan il- fuljett kollu sewwa qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mgħotija lilek.
It may harm them, even if their symptoms are the same as yours.  If any of the side effects gets serious, or if you notice any other effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • 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.
What Rapamune is and what it is used for 2.
X’ inhu Rapamune u għalxiex jintuża 2.
Before you take Rapamune 3.
Qabel ma ’ tieħu Rapamune 3.
How to take Rapamune 4.
Kif għandek tieħu Rapamune 4.
How to store Rapamune 6.
Kif taħżen Rapamune 6.
WHAT RAPAMUNE IS AND WHAT IT IS USED FOR
X’ INHU RAPAMUNE U GĦALXIEX JINTUŻA
Rapamune belongs to a group of medicines called immunosuppressants.
Rapamune jappartjeni għal grupp ta ’ mediċini li jissejħu.
It helps to control your body’ s immune system after you have received an organ transplant.
Huwa jgħin biex jikkontrolla s- sistema tal- immunità tal- ġisem wara li tkun irċevejt trapjant ta ’ organu.
It is used to prevent your body from rejecting transplanted kidneys and is normally used with medicines called corticosteroids and initially with ciclosporin.
Huwa użat biex ma jħallix il- ġisem tiegħek jirrifjuta t- trapjant tal- kliewi u hu normalment użat ma ’ mediċini li jissejħu kortikosterojdi u fil- bidu ma ’ ciclosporin.
BEFORE YOU TAKE RAPAMUNE
QABEL MA TIEĦU RAPAMUNE
Do not take Rapamune  if you are allergic (hypersensitive) to sirolimus or any of the other ingredients of Rapamune.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal sirolimus jew sustanzi oħra ta ’
Take special care with Rapamune  if you have any liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive.  immunosuppressive medicines may decrease your body ’ s ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.
jogħġbok għid lit- tabib tiegħek għaliex din tista ’ taffettwa d- doża ta ’ Rapamune li ser tirċievi.
Your doctor will perform tests to monitor the levels of Rapamune in your blood.
It- tabib tiegħek ser jagħmillek testijiet sabiex jistudja l- livelli ta ’ Rapamune fid- demm tiegħek.
Your doctor will also perform tests to monitor your kidney function and, possibly, your liver function, during therapy with Rapamune.
Ukoll, it- tabib tiegħek ser jagħmillek ukoll testijiet sabiex jara kif il- kliewi qegħdin jiffunzjunaw u, possibilment, kif il- fwied jiffunzjona, matul it- terapija b’ Rapamune.
Exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.
L- espożizzjoni għad- dawl tax- xemx u d- dawl UV għandha tiġi ristretta billi tilbes ħwejjeġ protettiv u tuża krema li għandha fattur għoli ta ’ protezzjoni minħabba li r- riskju tal- kanċer tal- ġilda jiżdied.
Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including those obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Some medicines can interfere with the action of
Xi mediċini jistgħu jinterferixxu mal- azzjoni ta ’ Rapamune.
In particular, you should inform your doctor or pharmacist if you are taking any of the following:  any other immunosuppressive agents excluding ciclosporin or corticosteroids.  antibiotics or antifungal medicines used to treat infection e. g. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole and voriconazole.  high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem.  anti-epileptic medicines including carbamazepine, phenobarbital, phenytoin.  medicines used to treat-ulcers or other gastrointestinal disorders such as cisapride, cimetidine, metoclopramide.  bromocriptine (used in the treatment of Parkinsons’ disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (used in the treatment of HIV).  St.
66 − antibijotiċi jew mediċini antifungali użati biex jittrattaw l- infezzjonijiet eż. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole u voriconazole. − mediċini għal pressjoni tad- demm għolja jew mediċini għal problemi tal- qalb li jinkludu nicardipine, verapamil u diltiazem. − mediċini antiepilettiċi li jinkludu carbamazepine, phenobarbital, phenytoin. − mediċini użati biex jittrattaw ulċeri jew disturbi gastriontestinali oħra bħal cisapride, cimetidine, metoclopramide. − bromocriptine (użat biex jittratta l- marda ta ’ Parkinson u disturbi ormonali diversi), danazol (użat fit- trattatment ta ’ disturbi ginekoloġiċi), jew inibituri tal- protease (użat għat- trattament ta ’ HIV). − St.
John’ s Wort (Hypericum perforatum).
John’ s Wort (Hypericum perforatum).
The use of Rapamune may lead to increased blood concentrations of cholesterol and triglycerides that may require treatment.
L- użu ta ’ Rapamune jista ’ jwassal għal konċentrazzjonijiet ogħla fid- demm ta ’ kolesterol u trigliċeridi li jistgħu jinħtieġu trattament.
Medicines known as “ statins” and “ fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis).
Mediċini magħrufa bħala "statins ” u “ fibrates ” użati biex jittrattaw kolesterol u trigliċeridi elevati ġew assoċjati ma ’ riskju ogħla ta ’ kollass muskolari (rabdomajoliżi).
Please inform your doctor if you are taking drugs to lower your blood fats.
Jekk jogħġbok informa lit- tabib tiegħek jekk qed tieħu mediċini biex jitnaqqas ix- xaħam fid- demm tiegħek.
Taking Rapamune with food and drink Rapamune should be taken consistently, either with or without food.
Meta tieħu Rapamune mal- ikel u max- xorb Rapamune għandu jittieħed b’ mod konsistenti jew mal- ikel jew fuq stonku vojt.
Rapamune should be diluted only with water or orange juice.
Rapamune għandu jiġi mħallat mal- ilma jew mal- meraq tal- larinġ.
Do not take Rapamune with grapefruit juice.
Tieħux Rapamune mal- meraq tal- grejpfrut.
Pregnancy and breast feeding You must use effective contraception methods during treatment with Rapamune and for 12 weeks after treatment has stopped.
Tqala u treddigħ Għandek tuża metodi effettivi ta ’ kontraċezzjoni meta tkun qed tieħu Rapamune u għal 12- il ġimgħa wara li jitwaqqaf it- trattament.
If you are unsure, or think you may have become pregnant, talk to your doctor.
Jekk inti m’ intiex żgur, jew jekk taħseb li nqbadt tqila, tkellem mat- tabib tiegħek.
Decreased sperm count has been associated with the use of Rapamune and usually resolves after discontinuation.
Tnaqqis fl- għadd ta ’ sperma huwa assoċjat mal- użu ta ’ Rapamune u ġeneralment jirriżolvi ruħu malli dan jitwaqqaf.
It is not known whether Rapamune passes into breast milk.
Mhux magħruf jekk Rapamune jgħaddiex mill- ħalib tas- sider.
Patients taking Rapamune should discontinue breast-feeding.
Pazjenti li qegħdin fuq Rapamune għandhom jieqfu jreddgħu.
Use in children and adolescents There is limited experience with the administration of Rapamune in children and adolescents.
L- użu fit- tfal u fl- adoloxxenti L- esperjenza dwar l- amministrazzjoni ta ’ Rapamune fit- tfal u fl- adoloxxenti hi limitata.
Driving and using machines No specific studies on the effects of Rapamune on the ability to drive and use machines have been conducted.
Sewqan u tħaddim ta ’ magni Ma sar l- ebda studju speċifiku dwar l- effetti ta ’ Rapamune fuq il- ħila biex issuq u tħaddem magni.
Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.
Għalkemm it- trattament ta ’ Rapamune mhux mistenni li jaffettwa l- abiltà tiegħek biex issuq, jekk għandek xi dubji staqsi lit- tabib tiegħek.
Important information about one of the ingredients of Rapamune WARNING:
Tagħrif importanti dwar wieħed mis- sustanzi ta ’ Rapamune TWISSIJA:
This medicine contains 1.5% to 2.5% ethanol.
Il- mediċina għandha bejn 1. 5% u 2. 5% ethanol.
Each 2 mg dose contains up to 50 mg of alcohol.
Kull doża ta ’ 2 mg għandha sa 50 mg ta ’ alkoħol.
Alcohol may be harmful for those suffering from alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
L- alkoħol jista ’ jkun ta ’ ħsara għal dawk li jbatu mill- alkoħoliżmu, mill- epilessija, minn ħsara jew mard fil- moħħ kif ukoll f’ nisa tqal u fit- tfal.
Alcohol may modify or increase the effect of other medicines.
L- alkoħol jista ’ jimmodifika jew iżid l- effett ta ’ mediċini oħra.
HOW TO TAKE RAPAMUNE
KIF GĦANDEK TIEĦU RAPAMUNE
Rapamune is for oral use only.
Rapamune qiegħed għall- użu orali biss.
Always take Rapamune exactly as your doctor has told you.
Dejjem għandek tieħu Rapamune skont il- parir eżatt tat- tabib.
Your doctor will decide exactly what dose of Rapamune you must take and how often to take it.
67 It- tabib tiegħek se jiddeċiedi kemm għandha tkun id- doża ta ’ Rapamune li għandek tieħu u kemm- il darba għandek teħodha.
Follow your doctor’ s instructions exactly and never change the dose yourself.
Imxi eżatt mal- istuzzjonijiet li tak it- tabib tiegħek u qatt tbiddel id- doża minn jeddek.
Do not stop taking your medicine unless your doctor tells you to.
Tieqafx tieħu d- doża jekk it- tabib ma jgħidlekx biex tieqaf.
If you stop taking your medicine, you risk losing your transplant.
Jekk tieqaf tieħu l- mediċina tiegħek, qed tirriskja li titlef it- trapjant.
Usually for an adult your doctor will give you an initial dose of 6 mg at the time of the kidney transplant operation.
Ġeneralment fil- każ tal- adulti t- tabib tiegħek jagħtik doża inizjali ta ’ 6 mg fiż- żmien li saret l- operazzjoni tat- trapjant tal- kliewi.
Then you will need to take 2 mg of Rapamune each day, unless otherwise directed by your doctor.
Wara tkun trid tieħu 2 mg ta ’ Rapamune kuljum, sakemm it- tabib ma jordnax xorta oħra.
Your dose will be adjusted depending on the level of Rapamune in your blood.
Id- doża tieghek tista ’ tkun aġġustjata skont il- livell ta ’ Rapamune fid- demm tiegħek.
Your doctor will need to perform a blood test to measure Rapamune concentrations.
It- tabib tiegħek ikun irid jagħmel testijiet tad- demm biex ikejjel il- konċentrazzjoni ta ’ Rapamune.
If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart.
Jekk inti qed tieħu ciclosporin, inti trid tieħu ż- żewġ mediċini f’ ħin ta ’ madwar 4 sigħat differenza bejniethom.
Instructions on how to dilute Rapamune
Istruzzjonijiet kif tħallat Rapamune
Remove the safety cap from the bottle by squeezing the tabs on the cap and twisting.
Neħħi t- tapp mill- flixkun billi tagħfas it- tiketta ta ’ fuq it- tapp u ddawwar.
Insert the syringe adapter into the bottle until it is flush with the top of the bottle.
Daħħal l- adapter tas- siringa fil- flixkun sakemm ikun eżatt ma ’ għonq il- flixkun.
Do not attempt to remove the syringe adapter from the bottle once inserted.
Tipruvax tneħħi l- adapter tas- siringa mill- flixkun ġaladarba tkun daħħaltu.
With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter.
Bil- planġer magħfus kollu, deffes waħda mis- siringi tad- doża fil- bokka tal- adapter.
Withdraw the exact amount of Rapamune oral solution as prescribed by your doctor by gently pulling out the plunger of the dosing syringe until the bottom of the black line of the plunger is level with the appropriate mark on the dosing syringe.
Dan tagħmlu billi tiġbed ’ il barra bil- mod il- parti ta ’ wara tas- siringa tad- doża sakemm il- qiegħ tal- linja s- sewda li hemm fuq il- parti ta ’ wara tas- siringa tkun livell mal- marka propja ta ’ fuq is- siringa tad- doża.
The bottle should remain in an upright position when withdrawing the solution.
Il- flixkun għandu jinżamm f’ pożizzjoni wieqfa meta jinġibed il- likwidu minnu.
If bubbles form in the dosing syringe during withdrawal, empty the Rapamune solution back into the bottle and repeat the withdrawal procedure.
Jekk tara xi bżieżaq fis- siringa tad- doża waqt li tkun qed tiġbed, erġa ’ battal Rapamune fil- flixkun u irrepeti l- proċedura.
You may have been instructed to take your Rapamune oral solution at a particular time of day.
Tista ’ tkun mitlub biex tieħu Rapamune soluzzjoni orali f’ ħin partikulari tal- ġurnata.
If it is necessary to carry your medication with you, fill the dosing syringe to the appropriate mark and place a cap securely on it – the cap should snap into place.
Jekk ikollok bżonn iġġorr il- mediċina miegħek, imla s- siringa tad- doża sal- marka propja u poġġi t- tapp magħluq tajjeb fuqha – it- tapp irid jidħol f’ postu.
Then place the capped dosing syringe in the carrying case provided.
Wara poġġi s- siringa tad- doża magħluqa fil- but tal- ġarr ipprovdut.
Once in the syringe the medication may be kept at room temperature (not exceeding 25 C) or refrigerated and should be used within 24 hours.
Din għandha tittieħed fi żmien 24 siegħa.
Empty the contents of the dosing syringe into only a glass or plastic container holding at least 60 ml of water or orange juice.
68 Battal il- mediċina li hemm fis- siringa tad- doża f’ reċipjent tal- ħġieġ jew tal- plastik li jesa ’ mill- inqas 60 ml ta ’ ilma jew meraq tal- larinġ.
Stir well for one minute and drink immediately.
Ħawwad sewwa għal minuta u ixorbu mill- ewwel.
Refill the glass with at least 120 ml of water or orange juice, stir well, and drink immediately.
Erġa ’ imla t- tazza mill- inqas 120 ml ta ’ ilma jew meraq tal- larinġ, ħawwad tajjeb u ixrob mill- ewwel.
The dosing syringe and cap are to be used once and then discarded.
L- ebda likwidu ieħor inkluż il- meraq tal- grejpfrut m’ għandu jintuża għat- taħlita. Is- siringa tad- doża u t- tapp għandhom jintużaw darba biss u wara jiġu mormija.
When refrigerated the solution in the bottle may develop a slight haze.
Meta l- mediċina titpoġġa fil- friġġ jista ’ jkun li l- flixkun jsir mċajpar.
If this occurs, simply bring your Rapamune 1 mg/ 1 ml oral solution to room temperature and shake gently.
Jekk jiġri dan, ġib Rapamune 1 mg/ 1 ml soluzzjoni orali għat- temperatura tal- kamra u ċaqalqu bil- mod.
The presence of this haze does not affect the quality of Rapamune.
Il- preżenza ta ’ dan iċ- ċpar ma taffettwax il- kwalità ta ’ Rapamune.
If you take more Rapamune than you should If you have taken more medicine than you were told contact a doctor or go to the nearest hospital emergency department straight away.
Jekk tieħu Rapamune aktar milli suppost Jekk ħadt aktar mediċina milli għaliha ngħatajt ir- riċetta, ikkuntattja tabib jew mur mill- ewwel fl- eqreb sptar fid- dipartiment tal- emerġenza.
Always take the labelled medicine bottle with you, even if it is empty.
Dejjem ħu miegħek il- flixkun tal- mediċina bit- tiketta fuqu anke jekk ikun vojt.
If you forget to take Rapamune If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin.
Jekk tinsa tieħu Rapamune Jekk tinsa tieħu Rapamune, ħudu malli tiftakar, iżda mħux fiż- żmien ta ’ 4 sigħat li jmissek tieħu id- doża ta ’ ciclosporin.
After that, continue to take your medicines as usual.
Wara dan, kompli ħu l- mediċini bħas- soltu.
Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża Rapamune li tkun insejt tieħu, u ftakar dejjem li jridu jgħaddu madwar 4 sigħat bejn Rapamune u ciclosporin.
If you miss a dose of Rapamune completely, you should inform your doctor.
Jekk tonqos li tieħu doża kompleta ta ’ Rapamune, għandek tgħarraf b’ dan lit- tabib tiegħek.
Like all medicines, Rapamune can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Rapamune jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
However, since Rapamune is taken in combination with other medicines, the side effects cannot always be attributed with absolute certainty to Rapamune.
Madanakollu, peress li Rapamune jittieħed flimkien ma ’ mediċini oħra, l- effetti sekondarji ma jistgħux dejjem jiġu attribwiti b’ ċertezza assoluta lil Rapamune.
When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts with or without rash (thrombocytopenic purpura/ haemolytic uraemic syndrome).
Meta jittieħed ma ’ mediċini li jissejħu inibituri ta ’ calcineurin (ciclosporin jew tacrolimus), Rapamune jista ’ jkabbar ir- riskju ta ’ ħsara tal- kliewi bi plejtlets tad- demm baxxi u b’ għadd baxx fin- numru ta ’ ċelluli ħomor tad- demm bi jew mingħajr raxx (purpura tromboċitopenika/ sindromu uremiku emolitiku).
Immunosuppressants, including Rapamune, reduce your body’ s own defence mechanisms to stop you rejecting your transplanted organ.
Immunosoppressanti, li jinkludu Rapamune, inaqqsu l- mekkaniżmu tad- difiża ta ’ ġismek biex iwaqqfuk milli tirrifjuta l- organu trapjantat.
Consequently your body will not be as good as normal at fighting infections.
Konsegwentement, ġismek mhux ser ikun tajjeb daqs is - soltu biex jiġġieled kontra l- infezzjonijiet.
So if you are taking Rapamune you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
Għalhekk, meta tkun qed tieħu Rapamune, inti jista ’ jkollok aktar infezzjonijiet mis- soltu bħal infezzjonijiet tal- ġilda, il- ħalq, l- istonku u l- imsaren, il- pulmun u l - apparat urinarju.
70 Possible side effects of Rapamune are listed according to the following categories:
L- effetti sekondarji possibbli b’ Rapamune huma elenkati skont il- kategoriji li ġejjin:
Very common: more than 1 per 10 Common: less than 1 per 10 but more than 1 per 100 Uncommon: less than 1 per 100 but more than 1 per 1000 Rare: less than 1 per 1000
Komuni ħafna: aktar minn 1 f’ kull 10 Komuni: inqas minn 1 f’ kull 10 imma aktar minn 1 f’ kull 100 Mhux komuni: inqas minn 1 f’ kull 100 imma aktar minn 1 f’ kull 1, 000 Rari: inqas minn 1 f’ kull 1, 000
 Body as a whole:
• Il- ġisem kollu:
Fluid collection around the kidney, swelling of the extremities, fever, pain Impaired healing (this may include separation of the layers of a surgical wound or suture line), swelling, infections (including life-threatening infections)
Jinġabar fluwidu madwar il- kilwa, infiħ f’ partijiet estremi tal- ġisem, deni, uġigħ Fejqan indebolit (li jinkludi s- seperazzjoni tas- saffi tal- ferita tal- operazzjoni jew fejn saru l- ponti), infiħ, infezzjonijiet (li jinkludu infezzjonijiet li jistgħu jkunu ta ’ 69
 Nervous system
theddida għal ħajja)
disorders:
• Disturbi tas- sistema nervuża:
 Cardiac disorders:
• Disturbi fil- qalb:
Rapid heart rate Fluid collection in the sac around the heart that, in some cases, may decrease the heart's ability to pump blood
Il- qalb tħabbat mgħaġġla Jinġabar fluwidu fil- borża ta ’ madwar il- qalb, li f’ xi każijiet, jista ’ jnaqqas l- ħila tal- qalb li tippompja d- demm
 Blood vessel disorders:
• Disturbi assoċjati mal- vaskulaturi tad- demm:
Increased blood pressure Blood clots in the legs Blood clots in the lung
Żieda fil- pressjoni tad- demm Demm magħqud fir- riġlejn Demm magħqud fil- pulmun.
 Gastrointestinal reactions:
• Disturbi gastrointestinali:
Abdominal pain, diarrhoea, constipation, nausea Mouth sores Inflammation of the pancreas
Uġigħ addominali, dijarea, stitikezza, tqalligħ Ġrieħi fil- ħalq Infjammazzjoni tal- frixa
 Blood and lymph disorders:
• Disturbi tad- demm u tas- sistema limfatika:
Low red blood cells, low blood platelets Kidney damage with low blood platelets and low red blood cell counts with or without rash (thrombocytopenic purpura/ haemolytic uraemic syndrome), a reduced number of infection fighting cells in the blood (white blood cells), low levels of a type of white blood cells called neutrophils
Livell baxx ta ’ ċelluli ħomor tad- demm, livell baxx ta ’ plejtlets fid- demm Ħsara lill- kliewi b’ livell baxx ta ’ plejtlets u b’ għadd baxx ta ’ ċelluli ħomor tad- demm b’ raxx jew mingħajr raxx (purpura tromboċitopenika/ sindromu uremiku emolitiku), għadd imnaqqas ta ’ ċelluli li jikkumbattu l- infezzjonijiet fid- demm (ċelluli bojod tad- demm), għadd baxx ta ’ ċelluli bojod tad- demm imsejħa newtrofili
Cancer of the lymph tissue (lymphoma/ post-transplant lympho-proliferative disorder), combined lowering of red blood cells, white blood cells and blood platelets
Kanċer tat- tessut limfatiku (limfoma/ proliferazzjoni tas- sistema limfatika wara t- trapjant), flimkien mat- tnaqqis ta ’ ċelluli ħomor fid- demm, ċelluli bojod fid- demm u plejtlets.
Too much fluid collecting in the tissues due to irregular lymph function
Jinġabar ħafna fluwidu fit- tessuti minħabba funzjoni irregolari tal- limfa
 Immune system disorders:
• Disturbi fis- sistema immuni:
Allergic reactions including those that are life-threatening
Reazzjonijiet allerġiċi li jinkludu dawk li huma ta ’ perikolu għall- ħajja
71  Metabolism and nutrition disorders:
• Disturbi fil- metaboliżmu u n- nutrizzjoni:
Elevated cholesterol, elevated blood sugar, elevated fat in the blood, low blood potassium, low blood phosphorus, elevated lactate dehydrogenase protein in the blood, elevated creatinine in the blood
Kolesterol għoli, zokkor għoli fid- demm, xaħam għoli fid- demm, potassju baxx fid- demm, fosforu baxx fid- demm, livell għoli tal- proteina lactate dehydrogenase fid- demm, kreatinina għolja fid- demm
Abnormal tests of liver function, elevated AST and/ or ALT liver enzymes
Testijiet anormali tal- funzjoni tal- fwied, livelli għoljin tal- enzimi tal- fwied AST u/ jew ALT
 Bone and joint disorders:
• Disturbi tal- għadam u l- ġogi:
Joint pain Deterioration of bone
Uġigħ tal- ġogi Deterjorazzjoni tal- għadam
 Respiratory tract
• Disturbi tas- sistema respiratorja:
Common:
70 Komuni:
Pneumonia and other causes of inflammation that may lead to lung damage, fluid around the lung, nose bleeds
Pulmonite u kawżi oħra ta ’ infjammazzjonijiet li jistgħu jwasslu għal ħsara pulmonari, fluwidu madwar il- pulmun, tifriġ
Bleeding from the lung.
Emorraġija mill- pulmun.
Protein build-up in the air sacs of the lungs that may interfere with breathing
Il- formazzjoni ta ’ proteini fil- bżieżaq tal- arja tal- pulmun li jistgħu jinterferixxu mat- teħid tan- nifs.
 Skin disorders:
• Disturbi tal- ġilda:
Acne Skin cancer, rash
Akni Kanċer tal- ġilda, raxx
 Kidney disorders:
• Disturbi tal- kliewi:
Urinary tract infection Kidney infection; protein in the urine Protein in the urine, occasionally severe and associated with side effects such as swelling
Proteina fl- awrina, xi kultant severa u assoċjata b’ effetti sekondarji bħal tinfiħ
Serious liver damage has also been reported.
Kienet irrapportata wkoll ħsara serja fil- fwied.
Scarring in the kidney that may reduce kidney function has been reported.
Ġew irrappurtati ġrieħi fil- kliewi li jistgħu jnaqqsu l- funzjoni tal- kliewi.
The above side effects may require medical intervention and some may be life-threatening or fatal.
L- effetti mhux mixtieqa ta ’ hawn fuq jista ’ jkollhom bżonn ta ’ interventi mediċi u xi wħud jistgħu jkunu ta ’ perikolu għall- ħajja jew fatali.
You should see your doctor immediately if you experience symptoms such as swollen face, tongue and/ or pharynx (back of the mouth) and/ or difficulties in breathing (angioedema), or a skin condition whereby the skin can peel off (exfoliative dermatitis).
Għandek tara lit- tabib tiegħek minnufih jekk tesperjenza sintomi bħal nefħa fil- wiċċ, fl- ilsien u/ jew fil- farinġi (in- naħa ta ’ wara tal- ħalq) u/ jew diffikultajiet fit- teħid tan- nifs (anġjodema), jew kundizzjoni fil- ġilda fejn il- ġilda tista ’ titqaxxar (dermatite eksfoljattiva).
If you are concerned about any side effect or if you notice any other effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tkun imħasseb dwar xi effett mhux mixtieq li jidher jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew l- ispiżjar tiegħek.
HOW TO STORE RAPAMUNE
KIF TAĦŻEN RAPAMUNE
Do not use Rapamune after the expiry date which is stated on the carton after EXP:
Tużax Rapamune wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS:.
Keep Rapamune oral solution in its original bottle in order to protect from light.
Żomm is- soluzzjoni orali ta ’ Rapamune fil- flixkun oriġinali sabiex tilqa ’ mid- dawl.
Store in a refrigerator (2 C -8 C).
Aħżen fi friġġ (2°C – 8°C).
Once the bottle has been opened, the contents should be kept refrigerated and used within 30 days.
Wara li jinfetaħ il- flixkun, il- kontenut għandu jiġi jinżamm fi friġġ u jiġi użat fi żmien 30 jum.
If necessary, you may store the bottles at room temperature up to 25 C for a short period of time (no longer than 24 hours).
Jekk ikun hemm bżonn żommu f’ temperatura tal- kamra f’ temperatura sa 25°C għal żmien qasir (mhux aktar minn 24 siegħa).
72 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew mal- ilma tad- dranaġġ jew mal- iskart domestiku.
What Rapamune contains The active substance is sirolimus.
X’ fih Rapamune Is- sustanza attiva hi sirolimus.
Each ml of Rapamune contains 1 mg of sirolimus.
Kull ml ta ’ Rapamune fih 1 mg ta ’ sirolimus.
Polysorbate 80 and phosal 50 PG (phosphatidylcholine, propylene glycol, monodiglycerides, ethanol (1.5% to 2.5%), soya fatty acids, and ascorbyl palmitate).
Polysorbate 80 and phosal 50 PG (phosphatidylcholine, propylene glycol, monodiglycerides, ethanol (1. 5% to 2. 5%), soya fatty acids, u ascorbyl palmitate).
What Rapamune looks like and contents of the pack
71 Id- dehra ta ’ Rapamune u l- kontenuti tal- pakkett
Rapamune oral solution is supplied in 60 ml amber glass bottles.
Is- soluzzjoni orali ta ’ Rapamune tiġi fi fliexken tal- ħġieġ ta ’ kulur ambra ta ’ 60 ml.
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq:
United Kingdom.
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH Ir- Renju Unit.
Ireland.
Little Connell Newbridge Co.
Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG United Kingdom
Kildare L- Irlanda. jew Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG Ir- Renju Unit.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ireland Wyeth Pharmaceuticals Tel: +353 1 449 3500 Fax: +353 1 679 3773
Portugal Ísland Česká Republika Wyeth Lederle Portugal (Farma) Lda.
Č eská Republika Wyeth Whitehall Czech s. r. o.
Icepharma hf Wyeth Whitehall Czech s. r. o.
Tel: +420 2 67 294 111 Fax: +420 2 67 294 199
Tel: +351 21 412 82 00 Tel: +354 540 8000 Tel: +420 2 67 294 111 Fax: +351 21 412 01 11 Fax: +354 540 8001 Fax: +420 2 67 294 199
Tel: +351 21 412 82 00 Fax: +351 21 412 01 11
Slovenská Republika Italia Danmark Wyeth Whitehall Export GmbH, Wyeth Lederle S. p. A.
Danmark Wyeth Danmark Tlf: +45 44 88 88 05 Fax: +45 44 88 88 06
Wyeth Danmark organizačná zložka Tel: +39 06 927151 Tlf: +45 44 88 88 05 Tel: +42 1 2 654 128 16 Fax: +39 06 23325555 Fax: +45 44 88 88 06 Fax: +42 1 2 654 128 17
Italia Wyeth Lederle S. p. A.
Deutschland
Tel: +39 06 927151 Fax: +39 06 23325555
Kύπρος
Slovenská Republika Wyeth Whitehall Export GmbH, organizač ná zlož ka Tel: +42 1 2 654 128 16 Fax: +42 1 2 654 128 17
Suomi/ Finland
Suomi/ Finland Wyeth Puh/ Tel: +358 20 7414 870 Fax: + 358 20 7414 879
Wyeth
Eesti/ Latvija/ Lietuva/ Österreich / Slovenija/ България / România Wyeth-Lederle Pharma GmbH Tel/ Tãlr/ Teл: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax/факс: +43 1 89 114600
Tel: +49 180 2 29 93 84 Fax: +49 251 204 1128 Eesti/ Latvija/ Lietuva / Österreich / Slovenija / България / România Wyeth- Lederle Pharma GmbH Tel/ Tãlr/ Teл: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax/ факс: +43 1 89 114600
Magyarország Wyeth Kft Tel: +36 1 453 33 30 Fax: +36 1 240 4632
AEBE Tηλ: +357 22 817690 Φαξ: +357 22 751855 Magyarország Wyeth Kft Tel: +36 1 453 33 30 Fax: +36 1 240 4632
Sverige Wyeth AB Tel: +46 8 470 3200 Fax: +46 8 730 0666
Puh/ Tel: +358 20 7414 870 Fax: +358 20 7414 879 Sverige Wyeth AB Tel: +46 8 470 3200 Fax: +46 8 730 0666
Norge Wyeth Tlf: +47 40 00 23 40 Fax: +47 40 00 23 41
Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website tal- Aġenzija Ewropea dwar il- mediċini (EMEA) http: // www. emea. europa. eu.
Rapamune 1 mg coated tablets Sirolimus
Rapamune 1 mg pilloli miksija (Sirolimus)
You may need to read it again.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet oħra, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mgħotija lilek.
Rapamune belongs to a group of medicines called immunosuppressants.
Rapamune jappartjeni għal grupp ta ’ mediċini li jissejħu immunosoppressanti.
Do not take Rapamune  if you are allergic (hypersensitive) to sirolimus or any of the other ingredients in the tablet.
sustanzi l- oħra misjuba fil- pillola.
In particular, you should inform your doctor or pharmacist if you are taking any of the following:  any other immunosuppressive agents excluding ciclosporin or corticosteroids.  antibiotics or antifungal medicines used to treat infection e. g. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole and voriconazole.  high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem.  anti-epileptic medicines including carbamazepine, phenobarbital, phenytoin.  medicines used to treat ulcers or other gastrointestinal disorders such as cisapride, cimetidine, metoclopramide.  bromocriptine (used in the treatment of Parkinsons’ disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (used in the treatment of HIV).  St.
74 − antibijotiċi jew mediċini antifungali użati biex jittrattaw l- infezzjonijiet eż. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole u voriconazole. − mediċini għal pressjoni tad- demm għolja jew mediċini għal problemi tal- qalb li jinkludu nicardipine, verapamil u diltiazem. − mediċini antiepilettiċi li jinkludu carbamazepine, phenobarbital, phenytoin. − mediċini użati biex jittrattaw ulċeri jew disturbi gastriontestinali oħra bħal cisapride, cimetidine, metoclopramide. − bromocriptine (użat biex jittratta l- marda ta ’ Parkinson u disturbi ormonali diversi), danazol (użat fit- trattatment ta ’ disturbi ginekoloġiċi), jew inibituri tal- protease (użat għat- trattament ta ’ HIV). − St.
Rapamune should not be taken with grapefruit juice.
Tieħux Rapamune mal- meraq tal- grejpfrut.
Pregnancy and breast feeding You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped.
Tqala u treddigħ Għandek tuża metodi effettivi ta ’ kontraċezzjoni meta tkun qed tieħu Rapamune u għal 12- il ġimgħa wara li jitwaqqaf it- trattament.
Use in children and adolescents There is limited experience of the use of Rapamune in children and adolescents.
L- użu fit- tfal u fl- adoloxxenti L- esperjenza dwar l- użu ta ’ Rapamune fit- tfal u fl- adoloxxenti hi limitata.
Driving and using machines No specific studies on the effects of Rapamune on the ability to drive and operate machines have been conducted.
Sewqan u tħaddim ta ’ magni Ma sar l- ebda studju speċifiku dwar l- effetti ta ’ Rapamune fuq il- ħila biex issuq u tħaddem magni.
Important information about some of the ingredients of Rapamune If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Rapamune Jekk it- tabib tiegħek qallek li għandek xi intolleranza għal xi zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Your doctor will decide exactly what dose of Rapamune you must take and how often to take it.
It- tabib tiegħek se jiddeċiedi kemm għandha tkun id- doża ta ’ Rapamune li għandek tieħu u kemm- il darba għandek teħodha.
Do not crush, chew, or split the tablets.
M’ għandekx titħan, tomgħod jew taqsam il- pilloli.
Inform your doctor if you have difficulty taking the tablet.
Informa lit- tabib tiegħek jekk ikollok 75 diffikultà meta tieħu l- pillola.
Then you will need to take 2 mg of Rapamune each day, until otherwise directed by your doctor.
Wara tkun trid tieħu 2 mg ta ’ Rapamune kuljum, sakemm it- tabib ma jordnax xorta oħra.
If you take more Rapamune than you should If you have taken more medicine than you were told contact a doctor or go to the nearest hospital emergency department as soon as possible.
Jekk tieħu Rapamune aktar milli suppost Jekk ħadt aktar mediċina milli għaliha ngħatajt ir- riċetta, ikkuntattja tabib jew mur mill- aktar fis fl- eqreb sptar fid- dipartiment tal- emerġenza.
Always take the labelled blister with you, even if it is empty.
Dejjem ħu miegħek il- folja bit- tiketta, anke jekk tkun vojta.
Possible side effects of Rapamune are listed according to the following categories:
L- effetti sekondarji possibbli b’ Rapamune huma elenkati skont il- kategoriji li ġejjin:
Impaired healing (this may include separation of the layers of a surgical wound or suture line), swelling, infections (including life-threatening infections)
Jinġabar fluwidu madwar il- kilwa, infiħ f’ partijiet estremi tal- ġisem, deni, uġigħ Fejqan indebolit (li jinkludi s- seperazzjoni tas- saffi tal- ferita tal- operazzjoni jew fejn saru l- ponti), infiħ, infezzjonijiet (li jinkludu infezzjonijiet li jistgħu jkunu ta ’ theddida għal ħajja)
 Nervous system disorders:
• Disturbi tas- sistema nervuża:
Very common:
76 Komuni ħafna:
 Metabolism and nutrition disorders:
• Disturbi fil- metaboliżmu u n- nutrizzjoni:
Elevated cholesterol, elevated blood sugar, elevated fat in the blood, low blood potassium, low blood phosphorus, elevated lactate dehydrogenase protein in the blood, elevated creatinine in the blood
Kolesterol għoli, zokkor għoli fid- demm, xaħam għoli fid- demm, potassju baxx fid- demm, fosforu baxx fid- demm, livell għoli tal- proteina lactate dehydrogenase fid- demm, kreatinina aktar għolja fid- demm Komuni:
 Bone and joint
• Disturbi tal- għadam u l- ġogi:
 Respiratory tract disorders:
• Disturbi tas- sistema respiratorja:
78 Common:
Komuni:
Protein build-up in the air sacs of the lungs that may interfere with breathing
77
Each tablet contains 1 mg of sirolimus.
Kull pillola fiha l mg ta ’ sirolimus.
Tablet core: lactose monohydrate, macrogol, magnesium stearate, talc
Il- qalba tal- pillola: lactose monohydrate, macrogol, magnesium stearate, talc.
Tablet Coating: macrogol, glyceryl monooleate, pharmaceutical glaze, anhydrous calcium sulphate, microcrystalline cellulose, sucrose, titanium dioxide, poloxamer 188,  -tocopherol, povidone, carnauba
Il- kisja tal- pillola: macrogol, glyceryl monooleate, pharmaceutical glaze, anhydrous calcium sulphate, microcrystalline cellulose, sucrose, titanium dioxide, poloxamer 188, α- tocopherol, povidone, carnauba wax: red opacode S- 1- 15095 (shellac glaze ~45% f’ ethanol, red iron oxide (E172), isoproply alcohol, n- butyl alcohol, propylene glycol, ammonium hydroxide, simethicone).
What Rapamune looks like and contents of the pack
Id- dehra ta ’ Rapamune u l- kontenuti tal- pakkett
Rapamune is supplied to you as white coloured, triangular-shaped coated tablets marked “ RAPAMUNE 1 mg ” on one side
Rapamune jasallek bħala pilloli bojod miksija, f’ għamla trijangulari u mmarkati “ RAPAMUNE 1 mg ” fuq naħa waħda.
The tablets are supplied in blister packs of 30 and 100 tablets.
Il- pilloli jiġu f’ pakketti b’ folji ta ’ 30 u 100 pillola.
Marketing authorisation holder:
78 Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq:
United Kingdom.
Berkshire, SL6 0PH Ir- Renju Unit.
Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG United Kingdom.
Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG Ir- Renju Unit.
Suomi/ Finland Wyeth Puh/ Tel: +358 20 7414 870 Fax: +358 20 7414 879
Wyeth Puh/ Tel: +358 20 7414 870
80 Eesti/ Latvija/ Lietuva/ Österreich / Slovenija/ България / România Wyeth-Lederle Pharma GmbH Tel/ Tãlr/ Teл: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax/факс: +43 1 89 114600
Tel: +49 180 2 29 93 84 Fax: +49 251 204 1128 Eesti/ Latvija/ Lietuva / Österreich / Slovenija / България / România Wyeth- Lederle Pharma GmbH Tel/ Tãlr/ Teл: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax/ факс: +43 1 89 114600
Sverige Wyeth AB Tel: +46 8 470 3200 Fax: +46 8 730 0666
Fax: +358 20 7414 879 Sverige Wyeth AB Tel: +46 8 470 3200 Fax: +46 8 730 0666
81 PACKAGE LEAFLET:
80 FULJETT TA ’ TAGĦRIF:
Rapamune 2 mg coated tablets Sirolimus
Rapamune 2 mg pilloli miksija (Sirolimus)
In particular, you should inform your doctor or pharmacist if you are taking any of the following:  any other immunosuppressive agents excluding ciclosporin or corticosteroids.  antibiotics or antifungal medicines used to treat infection e. g. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole and voriconazole.  high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem.  anti-epileptic medicines including carbamazepine, phenobarbital, phenytoin.  medicines used to treat ulcers or other gastrointestinal disorders such as cisapride, cimetidine, metoclopramide.  bromocriptine (used in the treatment of Parkinsons’ disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (used in the treatment of HIV).  St.
81 − antibijotiċi jew mediċini antifungali użati biex jittrattaw l- infezzjonijiet eż. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole u voriconazole. − mediċini għal pressjoni tad- demm għolja jew mediċini għal problemi tal- qalb li jinkludu nicardipine, verapamil u diltiazem. − mediċini antiepilettiċi li jinkludu carbamazepine, phenobarbital, phenytoin. − mediċini użati biex jittrattaw ulċeri jew disturbi gastriontestinali oħra bħal cisapride, cimetidine, metoclopramide. − bromocriptine (użat biex jittratta l- marda ta ’ Parkinson u disturbi ormonali diversi), danazol (użat fit- trattatment ta ’ disturbi ginekoloġiċi), jew inibituri tal- protease (użat għat- trattament ta ’ HIV). − St.
Inform your doctor if you have difficulty taking the tablet.
Informa lit- tabib tiegħek jekk ikollok 82 diffikultà meta tieħu l- pillola.
Usually for an adult your doctor will give you an initial dose of 6mg at the time of the kidney transplant operation.
Ġeneralment fil- każ tal- adulti t- tabib tiegħek jagħtik doża inizjali ta ’ 6 mg fiż- żmien li saret l- operazzjoni tat- trapjant tal- kliewi.
Immunosuppressants, including Rapamune, reduce your body’ s own defence mechanisms to stop you rejecting your transplanted organ.
Immunosoppressanti, li jinkludu Rapamune, inaqqsu l- mekkaniżmu ta ’ difiża ta ’ ġismek biex iwaqqfuk milli tirrifjuta l- organu trapjantat.
So if you are taking Rapamune you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
Għalhekk, meta tkun qed tieħu Rapamune, inti jista ’ jkollok aktar infezzjonijiet mis- soltu bħal infezzjonijiet tal- ġilda, il- ħalq, l- istonku u l- imsaren, il- pulmun u l - apparat urinarju
Impaired healing (this may include separation of the layers of a surgical wound or suture line), swelling, infections (including life-threatening infections)
Jinġabar fluwidu madwar il- kilwa, infiħ f’ partijiet estremi tal- ġisem, deni, uġigħ Fejqan indebolit (li jinkludi s- seperazzjoni tas- saffi tal- ferita tal- operazzjoni jew fejn saru l- ponti), infiħ,, infezzjonijiet (li jinkludu infezzjonijiet li jistgħu jkunu ta ’ theddida għal ħajja)
Very common:
83 Komuni ħafna:
Elevated cholesterol, elevated blood sugar, elevated fat in the blood, low blood potassium, low blood phosphorus, elevated lactate dehydrogenase protein in the blood, elevated creatinine in the blood
Kolesterol għoli, zokkor għoli fid- demm, xaħam għoli fid- demm, potassju baxx fid- demm, fosforu baxx fid- demm, livell għoli tal- proteina lactate dehydrogenase fid- demm, kreatinina aktar għolja fid- demm
85 Common:
Komuni:
Bleeding from the lung.
Emorraġija mill- pulmun
Protein build-up in the air sacs of the lungs that may interfere with breathing
Il- formazzjoni ta ’ proteini fil- bżieżaq tal- arja tal- pulmun li jistgħu jinterferixxu mat- teħid tan- nifs
Do not use after the expiry date which is stated on the carton after EXP:
Tużax Rapamune wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS:.
Each tablet contains 2 mg of sirolimus.
Kull pillola fiha 2 mg ta ’ sirolimus.
Tablet Coating: macrogol, glyceryl monooleate, pharmaceutical glaze, anhydrous calcium sulphate, microcrystalline cellulose, sucrose, titanium dioxide, brown iron oxide (E172), yellow iron oxide (E172), poloxamer 188,  -tocopherol, povidone, carnauba wax: red opacode S-1-15095 (shellac glaze ~45% in
Il- kisja tal- pillola: macrogol, glyceryl monooleate, pharmaceutical glaze, anhydrous calcium sulphate, microcrystalline cellulose, sucrose, titanium dioxide, brown iron oxide (E172), yellow iron oxide (E172) poloxamer 188, α- tocopherol, povidone, carnauba wax: red opacode S- 1- 15095 (shellac glaze ~45% f’ ethanol, red iron oxide (E172), isoproply alcohol, n- butyl alcohol, propylene glycol, ammonium hydroxide, simethicone).
Rapamune is supplied to you as yellow to beige coloured, triangular-shaped coated tablets marked “ RAPAMUNE 2 mg ” on one side
Rapamune jasallek bħala pilloli miksija ta ’ lewn isfar fil- bex, f’ għamla trijangulari u mmarkati “ RAPAMUNE 2 mg ” fuq naħa waħda.
The tablets are supplied in blister packs of 30 and 100 tablets.
85 Il- pilloli jiġu f’ pakketti b’ folji ta ’ 30 u 100 pillola.
Marketing authorisation holder:
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid Wyeth Medica Ireland fis- Suq:
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH
Little Connell Wyeth Europa Ltd Newbridge Huntercombe Lane South Co.
United Kingdom.
Kildare Taplow, Maidenhead Berkshire, SL6 0PH Ir- Renju Unit.
Suomi/ Finland Wyeth Puh/ Tel: +358 20 7414 870 Fax: +358 20 7414 879
Wyeth
87 Eesti/ Latvija/ Lietuva/ Österreich / Slovenija/ България / România Wyeth-Lederle Pharma GmbH Tel/ Tãlr/ Teл: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax/факс: +43 1 89 114600
Tel: +49 180 2 29 93 84 Fax: +49 251 204 1128 Eesti/ Latvija/ Lietuva / Österreich / Slovenija / България / România Wyeth- Lederle Pharma GmbH Tel/ Tãlr/ Teл: +43 1 89 1140 Faks/ Fakss/ Faksas/ Fax/ факс: +43 1 89 114600
EU Number
Numru tal - Isem proċedura ta ’ l - EMEA
Pharmaceutical form Route of administration Packaging
Għamla farmaċewtika
Content (concentration)
Mnejn jingħata
Package size
Il- pakkett
EU/ 1/ 96/ 018/ 001
Kontenut (konċentrazzjoni)
Rapilysin
Daqs tal- pakkett
10 U
10 ml
Powder and solvent for Intravenous use Powder: vial (glass) solution for injection Solvent: prefilled syringe (glass)
Trab: fjala (tal -
10 U 10 ml (1 U/ ml)
ħġieġ)
2 vials 2 prefilled syringes 2 reconstitution devices and 2 needles 19 G l
2 mezzi għar - rikostituzzjoni/ labar
Rapilysin 10 U powder and solvent for solution for injection.
Trab u solvent ta ’ Rapilysin 10 U għal soluzzjoni għall- injezzjoni.
1 vial contains 10 U* reteplase ** in 0.56 g powder 1 prefilled syringe contains 10 ml water for injections.
Kunjett wieħed fih 10 U * reteplase ** f’ 0. 56 g trab Siringa waħda mimlija għal- lest fiha 10 ml ilma għall- injezzjonijiet.
The reconstituted solution contains 1 U reteplase per ml.
Is- soluzzjoni rikostitwita fiha 1 U reteplase kull ml.
* Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents.
* Il- potenza ta ’ reteplase hija rapreżentata f’ unitajiet (U) billi tintuża referenza standard li hija speċifika għal reteplase u li mhix komparabbli ma ’ unitajiet użati għall- aġenti trombolitiċi oħra.
** Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology.
** Attivatur rikombinanti ta ’ plasminogen prodott f’ Echerichia coli permezz ta ’ teknoloġija ta ’ DNA rikombinata.
White powder and clear colourless liquid (water for injections).
Trab abjad u likwidu ċar u bla kulur (ilma għall- injezzjonijiet).
Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 12 hours after the onset of acute myocardial infarction AMI symptoms.
Rapilysin huwa indikat għat- trattament trombolitiku ta ’ infart mijokardjali suspettat ma ’ elevazzjoni ta ’ l- ST persistenti jew ostruzzjoni reċenti tal- Bundle Branch (Bundle Branch Block) tax- xellug fi żmien 12- il siegħa wara l- bidu tas- sintomi ta ’ infart mijokardjali akut AMI.
Treatment with reteplase should be initiated as soon as possible after the onset of AMI symptoms.
It- trattament b’ reteplase għandu jinbeda kemm jista ’ jkun malajr wara l- bidu tas- sintomi ta ’ AMI.
Rapilysin should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor its use.
Rapilysin għandu jiġi preskritt minn tobba b’ esperjenza fl- użu ta ’ kura trombolitika u bil- faċilitajiet li jissorveljaw l- użu tagħha.
Reteplase is supplied as a freeze-dried substance in vials.
Reteplase huwa pprovdut bħala sustanza imnixxfa permezz ta ’ friża f’ kunjetti.
The lyophilisate is reconstituted with the contents of the accompanying syringe (see section 6.6).
It- trab imnixxef permezz ta ’ friża huwa rikostitwit mal- kontenut tas- siringa li tiġi miegħu (ara sezzjoni 6. 6).
Rapilysin should be injected preferably through an intravenous line whose sole purpose is the injection of Rapilysin.
Preferibilment Rapilysin għandu jiġi injettat minn pajp għal ġol- vini, li l- uniku skop tiegħu hija l - injezzjoni ta ’ Rapilysin.