qanastek/EMEA-V3 huggingface dataset:
Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne Billancourt cedex France
Pierre Fabre Médicament 45, place Abel Gance, F- 92654 Boulogne Billancourt cedex, Franza
MARKETING AUTHORISATION NUMBERS
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Lot
Lott
Medicinal product subject to restricted medical prescription.
Prodott mediċinali jingħata bir- riċetta ristretta tat- tabib
Justification for not including Braille accepted.
Il- Gustifikazzjoni biex ma jkunx inkuz il- Braille hija aċċettata
21 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT INTERMIDJARJU
{box containing 4 vials of 10ml)
(Kaxxa li fiha 4 kunjetti ta ’ 10ml)
Concentrate 10 ml
Konċentrat 10 ml
Intravenous use (IV) Must be diluted before use
Użu għal ġol- vini (IV) Irid ikun imħallat bl- ilma qabel ma tużah
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( JIET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
Store in a refrigerator (2°C – 8°C)
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
Read the leaflet before use
Aħżen fi friġġ (2°C – 8°C) Aqra l- fuljett ta ’ tagħrif qabel l- użu
MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 03/ 254/ 002
Justification for not including Braille accepted.
Il- ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata.
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI ŻGĦAR EWLENIN
{10ml type I glass vial}
{Kunjett ta ’ 10 ml tip I tal- ħġieġ}
Busilvex 6 mg/ml sterile concentrate IV
Busilvex 6 mg/ ml konċentrat sterili IV
METHOD OF ADMINISTRATION
METODU TA 'KIF GĦANDU JINGĦATA
Lot
LOTT
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM JEW PARTI INDIVIDWALI
PACKAGE LEAFLET
24 FULJETT TA ’ TAGĦRIF
25 PACKAGE LEAFLET:INFORMATION FOR THE USER
25 FULJETT TA ’ TAGĦRIF:
Busilvex 6 mg/ml concentrate for solution for infusion. busulfan.
INFORMAZZJONI INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Busilvex 6 mg/ ml konċentrat għal soluzzjoni għall- infużjoni. busulfan
Read all of this leaflet carefully before you start using this medicine.
Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina.
- If you have further questions, ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek
please tell your doctor or pharmacist
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
1.
F' dan il- fuljett 1.
What Busilvex is and what it is used for 2.
X’ inhu Busilvex u għalxiex jintuża 2.
Before you use Busilvex 3.
Qabel ma tuża Busilvex 3.
How to use Busilvex 4.
Kif għandek tuża Busilvex 4.
Possible side effects 5 How to store Busilvex 6.
X’ effetti oħra li jista ’ jkollu 5 Kif taħżen Busilvex 6.
WHAT BUSILVEX IS AND WHAT IT IS USED FOR
X’ INHU BUSILVEX U GĦALXIEX JINTUŻA
Busilvex contains the substance busulfan, which belongs to a group of medicines called alkylating agents.
Busilvex fih is- sustanza busulfan, li tappartjeni għall- grupp ta ’ mediċini msejħa aġenti alkilatini.
Busilvex destroys the original bone marrow before the transplant.
Busilvex ikisser il- mudullun oriġinali qabel it- trapjant.
Busilvex is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation.
Busilvex jintuża fil- każ ta ’ l- adulti, tfal li għadhom kemm twieldu, tfal u adoloxxenti bħala trattament qabel it- trapjant.
In adults Busilvex is used in combination with cyclophosphamide.
Fl- adulti Busilvex jintuża flimkien ma ’ ċiklofosfamid.
In new-born infants, children and adolescents, Busilvex is used in combination with cyclophosphamide or melphalan.
Fit- trabi ta ’ l- idejn, fit- tfal u fl- adoloxxenti, Busilvex jintuża b’ taħlita maċ- ċiklofosfamidi jew mal - melfalan.
You will receive this preparative medicine before receiving a transplant of either bone marrow or haematopoietic progenitor cell.
Int ser tirċievi din il- mediċina preparattiva qabel ma tirċievi t- trapjant tal- mudulun ta ’ l- għadma jew ta ’ ċelluli ematopojetiċi proġenitriċi.
BEFORE YOU USE BUSILVEX
QABEL MA TUŻA BUSILVEX
Do not use Busilvex: − if you are allergic (hypersensitive) to busulfan or any of the other ingredients of Busilvex − if you are pregnant, or think you may be pregnant.
Tużax Busilvex: − jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal busulfan jew sustanzi oħra ta ’ Busilvex − jekk int tqila, jew taħseb li għandek mnejn int tqila
Take special care with Busilvex:
Oqgħod attent ħafna b’ Busilvex:
Busilvex is a potent cytotoxic medicine that results in profound decrease of blood cells.
Busilvex hi mediċina citotossika qawwija li tikkaġuna tnaqqis sostanzjali taċ- ċelluli tad- demm.
At the recommended dose, this is the desired effect.
Meta tingħata d- doża rrakkomandata, dan hu l- effett mixtieq.
Therefore careful monitoring will be performed.
Għalhekk ser isir monitoraġġ bir- reqqa.
It is possible that use of Busilvex may increase the risk of suffering another malignancy in the future.
Jista ’ jiġri li l- użu tal- Busilvex għandu mnejn iżied ir- riskju li int tbagħti minn malinnjità oħra fil - futur.
You should tell your doctor if: − you have a liver, kidney, heart or lung problem − you have a history of seizures, − you are currently taking other medicines.
Int għandek tinforma lit- tabib tiegħek jekk: − int għandek problema tal- fwied, tal- kilwa, tal- qalb jew tal- pulmun − għandek passat ta ’ puplessiji − bħalissa qed tieħu mediċini oħra.
It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with busulfan.
Għandu mnejn jagħti l- każ li ma tkunx tista ’ iżjed issir tqila (infertilità) wara t- trattament bil- busulfan.
If you are concerned about having children, you should discuss this with your doctor before treatment.
Jekk int inkwetata dwar jekk tridx ikollok tfal, int għandek tkellem lit- tabib tiegħek dwar dan qabel il- bidu tat- trattament.
Busilvex can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Busilvex jista ’ ukoll jipproduċi sintomi ta ’ menopawsa u fil- każ ta ’ bniet ta ’ qabel l- adolexxenza, jista 'jitwaqqaf il- bidu tal- pubertà.
Men treated with Busilvex are advised not to father child during and up to 6 months after treatment.
26 Irġiel li jingħataw il- Busilvex huma mwissija li m' għandhomx ikollhom tifel/ tifla sa 6 xhur wara t- trattament.
26 Taking other medicines:
Meta tieħu mediċini oħra:
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Busilvex may interact with other medicines.
Busilvex jista ’ jirreaġixxi ma ’ mediċini oħra.
Particular caution should be taken if you use itraconazol (used for certain types of infections) or ketobemidone (used to treat pain), because this may increase the side-effects.
Għandha tingħata attenzjoni partikolari jekk inti tagħmel użu minn itraconazol (użat għal ċerti tipi ta ’ infezzjonijiet) jew ketobemidone (użat għall- fejqan ta ’ l- uġigħ), għax dan jista ’ jżid il- probabilità ta ’ l - effetti mhux mixtieqa.
The use of paracetamol during the 72 hours prior to or with Busilvex administration should be used with caution.
L- użu ta ’ paracetamol 72 siegħa qabel it- teħid jew ma ’ Busilvex għandu jsir b’ attenzjoni kbira.
Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding, before you receive treatment with Busilvex.
Tqala u treddigħ Għarraf lit- tabib tiegħek jekk int tqila, taħseb li int tqila jew qed tredda ', qabel ma tirċievi t- trattament bil- Busilvex.
Women must not be pregnant during treatment with Busilvex and up to 6 months after treatment.
In- nisa m’ għandhomx isiru tqal matul it- trattament bil- Busilvex u sa 6 xhur wara l- kura.
Women must stopbreast-feeding before starting their treatment with Busilvex.
In- nisa għandhom jieqfu jreddgħu qabel ma jibdew it- trattament bil- Busilvex.
Adequate contraceptive precautions should be used when either partner is receiving Busilvex.
Għandhom jittieħdu prekawzjonijiet bil- kontraċettivi meta is- sieħeb jew is- sieħba jkunu qed jieħdu l- Busilvex.
HOW TO USE BUSILVEX
KIF JINTUŻA BUSILVEX
The dose will be calculated according to your body weight.
Dożaġġ Fl- adulti Id- doża ser tkun maħduma skond il- piż ta 'ġismek.
The recommended dose of Busilvex is 0.8 mg per kg of body weight, in combination with cyclophosphamide.
Id- doża rrakkomandata ta ’ Busilvex b’ taħlita ma ’ ċiklofosfamidi jew melfalan hija ta ’ 0. 8 mg kull kg ta ’ piż tal- ġisem, flimkien ma ’ ċilofosfamid.
The recommended dose of Busilvex in combination with cyclophosphamide or melphalan is based on your body weight varying between 0.8 and 1.2 mg/kg.
Fi tfal li għandhom kemm twieldu, tfal u adoloxxenti (minn 0 sa 17- il sena) Ir- rata rakkomandata hi bbażata fuq il- piż ta ’ ġismek u tvarja bejn 0. 8 u 1. 2 mg/ kg.
Administration: − Busilvex is administered by a qualified healthcare professional as a central intravenous infusion, after dilution of the individual vial.
L- Għoti − Busilvex jingħata minn professjonist kwalifikat fit- trattament tas- saħħa bħala infużjoni minn ġol- vina ċentrali, wara d- dilwazzjoni tal- kunjett individwali.
Each infusion will last 2 hours. − Busilvex will be administered every 6 hours during 4 consecutive days prior to transplant.
Kull infużjoni ser iddum 2 sigħat. − Busilvex ser jingħata kull 6 sigħat matul 4 ġranet konsekuttivi qabel it- trapjant.
Medicines before you receive Busilvex:
Mediċini qabel ma tibda tirċievi l- Busilvex:
Before receiving Busilvex, you will be medicated with − anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and − antiemetic medicines to prevent vomiting.
Qabel ma tibda tieħu l- Busilvex int ser tingħata l- mediċini li ġejjin: − mediċini antikonvulsivi biex jimpedixxu puplessiji (fenitojn jew benżodjażepini) u − mediċini antjemetiċi biex jimpedixxu r- ramettar.
POSSIBLE SIDE EFFECTS
EFFETT OĦRA LI JISTGĦU JINĦASSU
Like all medicines, Busilvex can cause side effects, although not every body gets them.
Bħal kull mediċina oħra, Busilvex jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Serious side effects:
Effetti oħra serji:
The most serious side effects of Busilvex therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications.
L- aktar effetti oħra serji tat- terapija Busilvex jew tal- proċedura tat- trapjant għandhom mnejn jinkludu tnaqqis fil- għadd taċ- ċelluli tad- demm li jkunu qed jiċċirkulaw (l- effett intiż tal- mediċina biex jippreparak għall- infużjoni tiegħek tat- trapjant), infezzjoni, mard tal- fwied inkluż l- imblokkar tal- vina tal- fwied, marda tat- trapjant kontra r- riċevitur (it- trapjant jattakka l- ġismek) u komplikazzjonijiet pulmonari.
Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
It- tabib tiegħek ser jimmonitorja il- għadd tiegħek tad- demm u l- enżimi tiegħek tal- fwied regolarment biex josserva u jimmaniġġja dawn il- każi.
Very common side effects (affects more than 1 user in 10):
Effetti oħra komuni ħafna (jaffettwa iktar minn utent 1 minn kull 10) Demm: tnaqqis fiċ- ċelluli tad- demm li jkunu qed jiċċirkulaw (ħomor u bojod) u pjastrini.
Blood: decrease of blood circulating cells (red and white) and platelets.
Sistema nervuża: insomnja, ansjetà, stordament, u dipressjoni.
Nervous system: insomnia, anxiety, dizziness, and depression.
Nutriment: nuqqas ta ’ aptit, tnaqqis fil- manjesju, kalċju, potassju, fosfat fid- demm, u żjieda taz- zokkor fid- demm.
Nutrition: loss of appetite, decrease in magnesium, calcium, potassium, phosphate in blood, and increase in blood sugar.
Kardijaku: żjieda fir - rata tal- qalb, żjieda jew tnaqqis fil- pressjoni tad- demm, vażodilatatazzjoni (stat ta ’ kalibru ogħla fil- vini/ arterji tad- demm) u każi fejn jagħqad id- demm.
Cardiac: increase in heart rate, increase or decrease of blood pressure, vasodilatation (a state of increased calibre of the blood vessels), and blood clots.
Respiratorji: qtugħ ta ’ nifs, tnixxija mill - imnieħer (rinite), mard tal- gerżuma, sogħla, sulluzzu, ħruġ ta ’ demm mill- imnieħer, ħsejjes annormali tan- nifs.
Gastro-intestinal: nausea, inflammation of the mucosa of the mouth, vomiting, abdominal pain, diarrhoea, constipation, heart burn, anus discomfort, liquid in the abdomen.
Gastro- intestinali: dardir, infjammazzjoni tal- mukoża tal- ħalq, rammettar, uġigħ abdominali, dijarea, xedda, ħruq ta ’ stonku, uġigħ fit- toqba tas- sorm, likwidu fiż- żaqq.
Hepatic: enlarged liver, jaundice,.
Epatiku: fwied imkabbar, suffejra.
Skin: rash, itching, loss of hairs.
Ġilda: raxx, ħakk, jaqagħlek ix- xaghar.
Muscle and bone: back, muscle and joint pain.
Muskoli u għadam: uġigħ fid- dahar, fil- muskoli u fil- ġogi.
Renal: increase in creatinine elimination, discomfort in urination, and decrease in urine output.
Renali: żjieda fit- tkeċċija tal- kreatinina, tħossok skomdu meta tagħmel l- awrina, u tnaqqis fil- kwantità ta ’ awrina.
General:, fever, headache,, weakness, chills, pain, allergic reaction, oedema, general pain or inflammation at injection site, chest pain, inflammation of the mucosa.
Ġenerali: deni, uġigħ ta ’ ras, debbolezza, tkexkix tal- bard, uġigħ, reazzjoni allerġika, oedema, uġigħ ġenerali jew infjammazzjoni fis- sit fejn issir l- injazzjoni, uġigħ fis- sider, infjammazzjoni tal- mukoża.
Investigations: elevated liver enzymes, weight increased
Investigazzjonijiet: enżimi elevati tal- fwied, tnaqqis fil- piż
Common side effects (affects 1 to 10 users in 100 patients):
Effetti oħra komuni (jaffettwa 1 sa 10 utent f’ 100 pazjent):
Cardiac: changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output.
Sistema nervuża: konfużjoni Nutriment: sodjum baxx fid- demm Kardijaku: tibdil u annormalitajiet fir- ritmu tal- qalb, żamma tal- fluwidu jew infjammazzjoni madwar il- qalb, tnaqqis fil- produzzjoni tal- qalb.
Respiratory: increase in breath rhythm, respiratory failure, alveolar haemorrhages, asthma, collapse of small portions of the lung, fluid around the lung.
Respiratorji: żjieda fir- ritmu tan- nifs, falliment respiratorju, emoraġiji alveolari, ażma, kollass ta ’ parti żgħira tal- pulmun, fluwidu madwar il- pulmun.
Gastro-intestinal: inflammation of the mucosa of oesophagus, paralysis of the gut, vomiting blood..
Gastro- intestinali: infjammazzjoni tal - mukoża ta ’ l- esofagu, paraliżi ta ’ l- imsaren, rammettar tad- demm.
Skin:
Ġilda:
Skin colour disorder, redness of the skin, skin desquamation Renal: increase in the amount of nitrogen components in the blood stream, blood in urines, moderate renal insufficiency.
Mard tal- kulur tal- ġilda, ħmura tal- ġilda, tqaxxir tal- ġilda Renali: żjieda fl- ammont ta ’ komponimenti ta 'nitroġenu fid- demm, demm fl- awrina, insuffiċjenza moderata renali.
Uncommon side effects (affects 1 to 10 users in 1,000 patients):
Effetti oħra rari (jaffettwa 1 sa 10 utent f’ 1000 pazjent):
Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Sistema nervuża: delirjum, nervożità, alluċinazzjoni, aġitazzjoni, funzjoni annormali tal- moħħ, emoraġija ċerebrali, u puplessija.
Gastro-intestinal: bleeding in the stomach and/or the gut.
Kardijaku: sadd ta ’ l- arterja femorali, trombożi, taħbit ekstra tal- qalb, tnaqqis fir- rata tal- qalb, tqattir diffuż tal- fluwidu mill- kapillari (vini żgħar tad- demm) Respiratorji: tnaqqis fl- ossiġenu fid- demm Gastro- intestinali: ħruġ ta 'demm fl- istonku u/ jew l- imsaren.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effetti sekondarji jisserjaw jew tinduna b’ xi effetti oħrajn li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
STORING BUSILVEX
KIF TAĦŻEN BUSILVEX
Do not use Busilvex after the expiry date which is stated on the carton.
− Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. − Tużax busilvex wara d- data ta ’ skadenza li hi miktuba fuq il- kartuna. − − Aħżen fi friġġ (2°C- 8°C).
Diluted solution:
Soluzzjoni dilwita:
28 when stored at 20 °C ± 5 °C or 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C ± 5 °C (including infusion time).
28 Stabilita kimika u fiżika stabbilita wara d- dilwizzjoni ta ’ soluzzjoni għall- injezzjoni ta ’ glucose 5% jew sodium chloride 9 mg/ ml (0. 9%) ġiet murija għal 8 sigħat (inkluż il- ħin ta ’ l- infużjoni) wara d - dilwizzjoni meta maħżuna f’ temperaturi ta ’ 20 °C ± 5 °C jew 12- il siegħa wara d- dilwizzjoni meta maħżuna f’ temperaturi bejn 2 °C- 8 °C segwiti bi ħżin ta ’ tliet sigħat f’ temperaturi ta ’ bejn 20 °C ± 5 °C (inkluż il- ħin ta ’ l- infużjoni).
Do not freeze
Tiffriżaħx.
One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
AKTAR TAGĦRIF
After dilution: one ml of solution contains approximately 0.5 mg of busulfan.
Millilitru wieħed ta ’ konċnetrat fih 6 mg busulfan (60 mg fil - kunjett).
- The other ingredients are dimethylacetamide and macrogol 400
- Is- sustanzi l- oħra huma dimethylacetamide u macrogol 400
What Busilvex looks like and contents of the pack Busilvex consists of a concentrate for solution for infusion and is supplied in colourless glass vials, each vial containing 60 mg of busulfan.
Id- Dehra ta ’ Busilvex u l- kontenuti tal- pakkett Busilvex huwa konċentrat għal soluzzjoni għall- infużjoni u jingħata f’ kunjetti tal- ħġieġ, b’ kull kunjett li jkun fih 60 mg ta ’ busulfan.
When diluted Busilvex is a clear colourless solution.
Meta jkun dilwit, Busilvex ikun ċar u mingħajr kulur.
Busilvex is available in a box containing 8 vials.
Busilvex huwa disponibbli f’ kaxex li jkun fihom 8 kunjetti.
Marketing Authorisation Holder Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne-Billancourt cedex France
Pierre Fabre Médicament 45, place Abel Gance F- 92654 Boulogne- Billancourt cedex Franza
Manufacturer Pierre Fabre Médicament Production, site Aquitaine Pharm International Avenue du béarn F-64320 Idron France
Pierre Fabre Médicament Production, site Aquitaine Pharm International Avenue du béarn F- 64320 Idron Franza
This leaflet was last approved on:
Dan il- fuljett kien approvat l- aħhar f ’:
PREPARATION GUIDE
GWIDA TA ’ PREPARAZZJONI
Busilvex 6 mg/ml concentrate for solution for infusion Busulfan
Busilvex 6 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Busulfan
Read this guide prior to the preparation and administration of Busilvex.
Aqra din il- gwida qabel ma tipprepara u tagħti l- Busilvex.
PRESENTATION
PREŻENTAZZJONI
Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Busilvex jingħata bħala soluzzjoni ċara u bla kulur f’ kunjetti ta ’ 10 ml ċari tal- ħġieġ (tip I).
Busilvex must be diluted prior to administration.
Busilvex irid ikun miżjud bl- ilma qabel ma jingħata.
RECOMMENDATION FOR SAFE HANDLING
RAKKOMANDAZZJONIJIET DWAR L- IMMANIĠĠJAR MINGĦAJR PERIKULU
Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Il- proċeduri għall- immaniġġjar sew u r- rimi ta ’ prodotti mediċinali antikanċer għandhom ikunu meqjusa.
29 All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood
Il- proċeduri kollha ta ’ trasferiment jirrikjedu osservanza stretta ta 'tekniċi aseptiċi, preferabbilment barnuża tas- sigurtà vertikali bi fluss laminari.
Calculation of the quantity of Busilvex to be diluted and of the diluent Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Busilvex għandu jkun miżjud bl- ilma qabel ma jintuża jew b’ soluzzjoni tal- klorid tas- sodju ta ’ 9 mg/ ml (0. 9%) għall- injezzjoni jew soluzzjoni tal- glukows ta ’ 5% għall- injezzjoni.
The quantity of the diluent must be 10 times the volume of Busilvex ensuring the final concentration of busulfan remains at approximately 0.5 mg/ml.
Pereżempju:
• Quantity of Busilvex:
• Kwantità ta ’ Busilvex:
Y (kg) x D (mg/kg) = A ml of Busilvex to be diluted 6 (mg/ml)
Y (kg) x D (mg/ kg) = A ml ta ’ Busilvex li għandu jkun miżjud bl- ilma 6 (mg/ ml)
Y: body weight of the patient in kg D: dose of Busilvex (see SPC section 4.2)
Y: piż tal- ġisem tal- pazjent f’ kg D: id- doża ta ’ Busilvex (ara SPC sezzjoni 4. 2) • Kwantità ta ’ dilwent:
To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%)
Biex tipprepara s- soluzzjoni finali għall- infużjoni, żied (A) ml ta 'Busilvex ma' (B) ml tad- dilwent (soluzzjoni ta ’ klorid tas- sodju ta ’ 9 mg/ ml (0. 9%) għall- injezzjoni jew is- soluzzjoni tal- glukows għall- injezzjoni ta ’ 5%)
Preparation of the solution for infusion Busilvex must be prepared by a healthcare professional using sterile transfer techniques. • Using a non polycarbonate syringe fitted with a needle:
Preparazzjoni tas- soluzzjoni għall- infużjoni • Busilvex għandu jitħejja minn professjonist fil- qasam tas- saħħa bl- użu ta ’ tekniċi sterili għat - trasferiment
- the calculated volume of Busilvex must be removed from the vial.
- il- volum ikkalkulat tal- Busilvex għandu jitneħħa mill- kunjett.
Busilvex must always be added to the diluent, not the diluent to Busilvex.
Il- Busilvex għandu dejjem jiżdied mad- dilwent, mhux id- dilwent ma 'Busilvex.
Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Il- Busilvex m’ għandux jitpoġġa ġo borza li tintuża għal ġol- vini li ma fihiex soluzzjoni ta ’ klorid tas- sodju ta ’ 9 mg/ ml (0. 9%) għall- injezzjoni jew soluzzjoni ta ’ glukows ta ’ 5% għall- injezzjoni.
After dilution, 1 ml of solution for infusion contains 0.5 mg of busulfan
30 Wara li tkun miżjuda bl- ilma, 1 ml tas- soluzzjoni għall- infużjoni fiha 0. 5 mg ta ’ busulfan.
30 The residual medicinal product must be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
Il- mediċina li tibqa ’ fit- tubi ta ’ l- amministrazzjoni m’ għandiex tiġi fflaxxjata għax qatt ma sar test ta ’ l- infużjoni rapida tal- Busilvex u dan mhux irrakkomandat.
The entire prescribed Busilvex dose should be delivered over two hours.
Id- doża kollha preskritta tal- Busilvex għandha tingħata fuq firxa ta ’ sagħtejn.
In that case infusion sets with minimal priming space should be used (i.e 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
F' dan il- każ infużjoni issettjata bi spazju minimali pprajmjat għandha tintuża (i. e. 0. 3- 0. 6 ml), ippramjat b' soluzzjoni tal- prodott mediċinali qabel il- bidu ta ’ l- infużjoni attwali tal- Busilvex u mbagħad tkun ifflaxxjata b’ soluzzjoni tal- klorid tas- sodju ta ’ 9 mg/ ml (0. 9%) għall- injezzjoni jew soluzzjoni tal- glukows (5%) għall- injezzjoni.
Busilvex must not be infused concomitantly with another intravenous solution.
Busulvex m’ għandux jiġi nfużat konkomitament ma ’ taħlit likwidi ieħor mill- ġol vini.
Polycarbonate syringes must not be used with Busilvex.
Is- sirinġi polikarbonati m’ għandhomx jintużaw mal- Busilvex.
Only a clear solution without particles should be used.
Soluzzjoni ċara biss għandha tintuża mingħajr fdal.
PROCEDURE FOR PROPER DISPOSAL
PROĊEDURI GĦAR- RIMI KIF SUPPOST
Any unused product or waste should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali dwar prodotti mediċinali ċitotossiċi.
What is Byetta?
X’ inhu Byetta?
Byetta is a solution for injection that contains the active substance exenatide.
Byetta huwa soluzzjoni għall- injezzjoni li fiha s- sustanza attiva exenatide.
It is available as prefilled injection pens that provide either 5 or 10 micrograms of exenatide in each dose.
Tiġi bħala pinen tal - injezzjoni mimlijin għal- lest li jipprovdu 5 jew 10 mikrogrammi ta ’ exenatide f’ kull doża.
What is Byetta used for?
Għal xiex jintuża Byetta?
Byetta is used to treat type 2 diabetes together with other antidiabetes medicines (metformin and/ or sulphonylureas) in patients whose blood glucose (sugar) levels are not adequately controlled with the maximum tolerated doses of the other medicines.
Byetta jintuża fit- trattament tad- dijabete tat- tip 2 flimkien ma ’ mediċini antidijabetiċi oħra (metformin u/ jew sulphonylureas) f’ pazjenti li l- livelli ta ’ glukożju (zokkor) fid- demm tagħhom ma jkunux qed jiġu kkontrollati tajjeb bid- dożi massimi tollerati tal- mediċini l- oħrajn.
Type 2 diabetes is also known as non-insulin- dependent diabetes.
Id- dijabete tat- tip 2 hija magħrufa wkoll bħala dijabete mhux dipendenti fuq l- insulina.
How is Byetta used?
Kif jintuża Byetta?
Byetta is given by injection under the skin of the thigh, the abdomen (tummy) or the upper arm, using the injection pen.
Byetta jingħata b’ injezzjoni taħt il- ġilda fil- koxxa, fiż- żaqq jew fin- naħa ta ’ fuq tad- driegħ, bl- użu ta ’ pinna tal- injezzjoni.
The pen has a user manual.
Il- pinna tiġi flimkien ma ’ manwal għall- utent.
Treatment with Byetta should start at a dose of 5 micrograms twice a day for at least a month.
It- trattament b’ Byetta għandu jinbeda b’ doża ta ’ 5 mikrogrammi darbtejn kuljum għal mill- inqas xahar.
The dose can then be increased to 10 micrograms twice a day.
Id- doża tista ’ tiżdied għal 10 mikrogrammi darbtejn kuljum.
A dose higher than 10 micrograms twice a day is not recommended.
Doża ogħla minn 10 mikrogrammi darbtejn kuljum mhijiex rakkomandata.
The first dose of the day is administered within the one hour before the morning meal, and the second dose within the one hour before the evening meal.
L- ewwel doża tal- ġurnata għandha tingħata mhux iktar minn siegħa qabel l- ikla ta ’ filgħodu, u t- tieni doża mhux iktar minn siegħa qabel l- ikla ta ’ filgħaxija.
Byetta should never be given after a meal.
Byetta m’ għandu qatt jingħata wara l- ikel.
Care is needed when adding Byetta to sulphonylureas, as there is a risk of hypoglycaemia (low blood sugar levels).
Wieħed irid joqgħod attent meta jżid Byetta ma ’ sulphonylureas, għax ikun hemm riskju ta ’ ipogliċemija (livelli baxxi ta ’ zokkor fid- demm).
Adding Byetta to metformin is not associated with this risk.
Iż- żieda ta ’ Byetta ma ’ metformin mhijiex assoċjata ma ’ dan ir- riskju.
Byetta should not be used in patients who have severe problems with their kidneys.
Byetta mgħandux jingħata lil pazjenti li jkollhom problemi serji bil- kliewi tagħhom.
Patients being treated with Byetta should continue to follow their diet and exercise plans.
Il- pazjenti li jkunu qegħdin jiġu ittrattati b’ Byetta għandhom jibgħqu isegwu l- pjanijiet għad- dieta.
The safety and effectiveness of Byetta have not been established in patients below 18 years of age.
Is - sigurtà u l- effikaċja ta ’ Byetta ma ġewx stabbiliti għal pazjenti li jkollhom inqas minn 18- il sena.
How does Byetta work?
Kif jaħdem Byetta?
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 tagħmilx biżżejjed insulina biex tikkontrolla l- livell ta ’ glukożju fid- demm jew meta l- ġisem ma jkunx jista ’ juża l- insulina b’ mod effettiv.
The active substance in Byetta, exenatide, is an ‘ incretin mimetic’.
Is- sustanza attiva f’ Byetta, exenatide, hija ‘ sustanza li timita lill- inkretin ’.
This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food.
Dan ifisser li taġixxi bl- istess mod bħall- inkretins (ormoni prodotti fl- imsaren) billi żżid l- ammont ta ’ insulina prodotta mill- frixa b’ rispons għall- ikel.
This helps with the control of blood glucose levels.
Dan jgħin fil- kontroll tal- livelli tal- glukożju fid- demm.
How has Byetta been studied?
Kif ġie studjat Byetta?
The effects of Byetta were first tested in experimental models before being studied in humans.
L- effetti ta ’ Byetta għall- ewwel ġew ittestjati f’ mudelli esperimentali qabel ma ’ ġew ittestjati fuq il - bnedmin.
Byetta has been studied in five main studies involving almost 2,400 patients.
Byetta ġie studjat f’ ħames studji ewlenin li fihom ħadu sehem kważi 2, 400 pazjent.
In three of these studies, Byetta was compared with placebo (a dummy treatment), when they were given as an ‘ add-on’ to metformin (336 patients), sulphonylureas (377 patients) or both types of medicine (733 patients).
Fi tlieta minn dawn l- istudji, Byetta tqabbel ma ’ plaċebo (trattament finta), fejn l- ewwel ingħataw bħala ‘ żieda ’ ma ’ metformin (336 pazjent), sulphonylureas (377 pazjent) jew iż- żewġ tipi ta ’ mediċini (733 pazjent).
The other two studies compared adding Byetta or adding an insulin to existing treatment with metformin and sulphonylureas.
Iż- żewġ studji l- oħra qabblu ż- żieda ta ’ Byetta jew iż- żieda ta ’ xi insulina mat- trattament eżistenti b’ metformin u sulphonylureas.
In one study, Byetta was compared with insulin glargine in 456 patients and in the other study it was compared with biphasic insulin in 483 patients.
Fi studju minnhom, Byetta tqabbel ma ’ insulin glargine f’ 456 pazjent u fl- istudju l- ieħor tqabbel ma ’ insulina bifażika f’ 483 pazjent.
In all studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c).
Fl- istudji kollha, il- mezz ewlieni tal- kejl tal- effikaċjà kien it- tibdil fil- livelli ta ’ sustanza fid- demm magħrufa bħala glycosylated haemoglobin (HbA1c).
HbA1c levels give an indication of how well the blood glucose is controlled.
Il- livelli tal- HbA1c jagħtu idea ta ’ kemm qed ikun ikkontrollat tajjeb il- glukosju fid- demm.
What benefit has Byetta shown during the studies?
Liema benefiċċji ta ’ Byetta ntwerew f’ dawn l- istudji?
Byetta was more effective than placebo in reducing the levels of HbA1c when used in combination with other antidiabetic medicines.
Byetta kien iktar effettiv mill- plaċebo fit- tnaqqis tal- livelli ta ’ HbA1c meta jintuża flimkien ma ’ mediċini antidijabetiċi oħra.
After 30 weeks, the 5-microgram twice-daily dose decreased HbA1c levels by 0.46 to 0.66% and the 10-microgram twice-daily dose decreased it by 0.86 to 0.91%.
Wara 30 ġimgħa, id- doża ta ’ 5 mikrogrammi darbtejn kuljum naqqset il - livell ta ’ HbA1c b’ bejn 0. 46 u 0. 66% u d- doża ta ’ 10 mikrogrammi darbtejn kuljum naqqsitu b’ bejn 0. 86 u 0. 91%.
Little or no effect was seen with placebo.
Bil- plaċebo ftit li xejn kien hemm effett.
Byetta was as effective as injected insulin.
Byetta kien effettiv daqs l- insulina injettata.
The 10-microgram twice-daily dose of Byetta decreased HbA1c by 1.13%, compared to 1.10% with insulin glargine after six months.
Id- doża ta ’ 10 mikrogrammi darbtejn kuljum naqqset l - HbA1c b’ 1. 13%, meta mqabbel ma ’ 1. 10% b’ insulin glargine wara sitt xhur.
In the final study, the 10-microgram twice-daily dose of Byetta decreased HbA1c by 1.01% after a year, compared to 0.86% with biphasic insulin.
Fl- istudju finali, id- doża ta ’ 10 mikrogrammi darbtejn kuljum ta ’ Byetta naqqset l- HbA1c b’ 1. 01% wara sena, meta mqabbel ma ’ 0. 86% bl- insulina bifażika.
What is the risk associated with Byetta?
Liema riskji huma assoċjati ma ’ Byetta?
In clinical studies, the most common side effects with Byetta (seen in more than 1 patient in 10) were hypoglycaemia (when it was taken with a sulphonylurea), nausea (feeling sick), vomiting and diarrhoea.
Fl- istudji kliniċi, l- iktar effetti sekondarji komuni ma ’ Byetta (li dehru f’ iktar minn pazjent wieħed minn kull 10) kienu l- ipogliċemija (meta jittieħed flimkien ma ’ sulphonylurea), dardir, rimettar u dijarea.
For the full list of all side effects reported with Byetta, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati ma ’ Byetta, ara l- Fuljett ta ’ Tagħrif.
Byetta should not be used in people who may be hypersensitive (allergic) to exenatide or any of the other ingredients.
Byetta m’ għandux jintuża f’ persuni li jisgħu jkunu allerġiċi għal exenatide jew għal xi sustanza oħra tiegħu.
Why has Byetta been approved?
Għaliex ġie approvat Byetta?
The Committee for Medicinal Products for Human Use (CHMP) decided that Byetta’ s benefits are greater than its risks for the treatment of type 2 diabetes mellitus in combination with metformin and/ or sulphonylureas in patients who have not achieved adequate control on maximum tolerated doses of these medicines.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Byetta huma ikbar mir- riskju tiegħu meta użat għat- trattament tad- dijabete tat- tip 2 flimkien ma ’ metformin u/ jew sulphonylureas f’ pazjenti li ma jkollhomx kontroll adegwat fuq dożi massimi tollerati ta ’ dawn il- mediċini.
The Committee recommended that Byetta be given marketing authorisation.
Il- Kumitat irrakkomanda li Byetta jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Byetta:
Tagħrif ieħor dwar Byetta:
The European Commission granted a marketing authorisation valid throughout the European Union for Byetta to Eli Lilly Nederland B. V. on 20 November 2006.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Byetta lil Eli Lilly Nederland B. V. fl- 20 ta ’ Novembru 2006.
The full EPAR for Byetta can be found here.
L- EPAR sħiħ ta ’ Byetta jista ’ jinstab hawn.
This summary was last updated in 12-2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ 12- 2008.
Pharmaceutical Form Solution for injection Solution for injection Solution for injection Solution for injection
Pinna mimlija għal - 1, 2 ml lest (ħāieā)
Route of administration subcutaneous use subcutaneous use subcutaneous use subcutaneous use
Pinna mimlija għal - 1, 2 ml lest (ħāieā)
Packaging Pre-filled pen (glass) Pre-filled pen (glass) Pre-filled pen (glass) Pre-filled pen (glass)
Pinna mimlija għal - 2, 4 ml lest (ħāieā)
Content 1,2 ml 1,2 ml 2,4 ml 2,4 ml
Pinna mimlija għal - 2, 4 ml lest (ħāieā)
Package size 1 pre-filled pen 3 pre-filled pens 1 pre-filled pen 3 pre-filled pens
3 pinen mimlijin għal- lest
BYETTA 5 micrograms solution for injection, prefilled pen
BYETTA 5 mikrogrammi soluzzjoni għall- injezzjoni, pinna mimlija għal- lest.
Each dose contains 5 micrograms(µg) synthetic exenatide in 20 microlitres(µl), (0.25 mg exenatide per ml).
Kull doża fiha 5 mikrogrammi (µg) exenatide sintetiku f’ 20 mikrolitru (µl), (0. 25 mg exenatide kull ml).
Each dose contains 44 µg metacresol.
Kull doża fiha 44 µg metacresol.
This medicinal product contains less than 1mmol sodium per dose, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih anqas minn 1mmol sodium kull doża, jiġifieri tista ’ tgħid “ bla sodium ”.
Solution for injection, pre-filled pen.
Soluzzjoni għall- injezzjoni, pinna mimlija għal- lest.
Clear, colourless solution.
Soluzzjoni ċara, bla kulur.
BYETTA is indicated for treatment of type 2 diabetes mellitus in combination with metformin, and/ or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
BYETTA hija indikata fil- kura tad- dijabete mellitus tip 2 flimkien ma ’ metformin, u/ jew sulphonylureas f’ pazjenti li ma kisbux kontroll gliċemiku xieraq b’ dożi massimi tollerabbli ta ’ dawn it- terapiji orali.
BYETTA therapy should be initiated at 5 µg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability.
It- terapija b’ BYETTA għandha tinbeda b’ doża ta ’ 5 µg exenatide mogħtija darbtejn kuljum (BID) għal mill- anqas xahar bil- għan li titjieb it- tollerabbilità.
The dose of exenatide can then be increased to 10 µg BID to further improve glycaemic control.
Id- doża ta ’ exenatide imbagħad tista ’ tiżdied għal 10 µg biex jitjieb aktar il- kontroll gliċemiku.
Doses higher than 10µg BID are not recommended.
Mhux irrakkomandati dożi ta ’ aktar minn 10 µg BID.
BYETTA is available as either a 5 µg or a 10 µg exenatide per dose pre-filled pen.
BYETTA tinstab bħala pinna mimlija għal- lest ta ’ 5 µg jew ta ’ 10 µg exenatide kull doża.
BYETTA can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart).
BYETTA tista ’ tingħata f’ kwalunkwe ħin fil- perijodu ta ’ 60 minuta qabel l- ikla ta ’ filgħodu jew ta ’ filgħaxija (jew ż- żewġ ikliet prinċipali tal- ġurnata, madwar 6 sigħat jew aktar bejn ikla u oħra).
BYETTA should not be administered after a meal.
BYETTA m’ għandiex tingħata wara ikla.
If an injection is missed, the treatment should be continued with the next scheduled dose.
Jekk tinqabeż injezzjoni, il- kura għandha titkompla mad - doża skedata li tmiss.
Each dose should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm.
Kull doża għandha tingħata bħala injezzjoni taħt il- ġilda fil- koxxa, fl- addome, jew fil- parti ta ’ fuq tad - driegħ.
BYETTA is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin and/ or a sulphonylurea.
BYETTA hija rrakkomandata għall- użu f’ pazjenti bid- dijabete mellitus tip 2 li diġà qegħdin jieħdu metformin u/ jew xi sulphonylurea.
When BYETTA is added to existing metformin therapy, the current dose of metformin can be continued as no increased risk of hypoglycaemia is anticipated, compared to metformin alone.
Meta BYETTA tiżdied ma ’ kura eżistenti b’ metformin, tista ’ titkompla d- doża attwali ta ’ metformin billi mhux mistenni riskju akbar ta ’ ipogliċemija meta mqabbel ma ’ użu ta ’ metformin waħdu.
When BYETTA is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4.).
Meta BYETTA tiżdied ma ’ kura b’ sulphonylurea, għandu jiġi kkunsidrat tnaqqis fid- doża ta ’ sulphonylurea biex jitnaqqas ir- riskju ta ’ ipogliċemija (ara sezzjoni 4. 4).
The dose of BYETTA does not need to be adjusted on a day-by-day basis depending on self- monitored glycaemia.
2 M’ hemmx bżonn ta ’ aġġustament fid- doża ta ’ BYETTA ġurnata b’ ġurnata skond il- monitoraġġ gliċemiku magħmul mill- pazjent innifsu.
However, blood glucose self-monitoring may become necessary to adjust the dose of sulphonylureas.
Madanakollu, il- monitoraġġ magħmul mill- pazjent innifsu ta ’ glucose fid- demm jista ’ jkun neċessarju biex tiġi aġġustata d- doża ta ’ sulphonylureas.
2 Limited experience exists concerning the combination of BYETTA with thiazolidinediones (see section 5.1).
L- esperjenza dwar l- użu ta ’ BYETTA flimkien ma ’ thiazolidinediones hija limitata (ara sezzjoni 5. 1).
Specific patient groups Elderly BYETTA should be used with caution and dose escalation from 5 µg to 10 µg should proceed conservatively in patients > 70 years.
Anzjani BYETTA għandha tintuża b’ attenzjoni u żieda fid- doża minn 5 µg għal 10 µg għandha tingħata b’ mod kawt f’ pazjenti > 70 sena.
The clinical experience in patients > 75 years is very limited.
L- esperjenza klinika f’ pazjenti > 75 sena hija limitata ħafna.
Patients with renal impairment No dosage adjustment of BYETTA is necessary in patients with mild renal impairment (creatinine clearance 50 – 80 ml/ min).
50 – 80 ml/ min).
In patients with moderate renal impairment (creatinine clearance:30-50 ml/ min), dose escalation from 5 µg to 10 µg should proceed conservatively (see section 5.2).
30 – 50 ml/ min), żieda fid- doża minn 5 µg għal 10 µg għandha tingħata b’ mod kawt (ara sezzjoni 5. 2).
BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.4).
BYETTA m’ hijiex irrakkomandata għall- użu f’ pazjenti b’ mard renali fl- aħħar stadju jew b’ indeboliment renali qawwi (tneħħija tal- krejatinina: < 30 ml/ min) (ara sezzjoni 4. 4).
Patients with hepatic impairment No dosage adjustment of BYETTA is necessary in patients with hepatic impairment (see section 5.2).
Pazjenti b’ indeboliment epatiku M’ hemmx bżonn ta ’ aġġustament fid- doża ta ’ BYETTA f’ pazjenti b’ indeboliment epatiku (ara sezzjoni 5. 2).
(see section 5.2).
Tfal u adolexxenti Is- sigurtà u l- effikaċja ta ’ exenatide ma ġewx stabbiliti f’ pazjenti taħt it- 18- il sena. (ara sezzjoni 5. 2).
BYETTA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
BYETTA m’ għandiex tintuża f’ pazjenti b’ dijabete mellitus tip 1 jew fil- kura ta ’ ketoaċidożi dijabetika.
BYETTA should not be used in type 2 diabetes patients who require insulin therapy due to betacell failure.
BYETTA m’ għandiex tintuża f’ pazjenti b’ dijabete mellitus tip 2 li jeħtieġu kura bl- insulina minħabba insuffiċjenza fil- funzjoni taċ- ċelluli beta.
Intravenous or intramuscular injection of BYETTA is not recommended.
Mhux irrakkomandat li l- injezzjoni ta ’ BYETTA ssir fil- vina jew fil- muskolu.
In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 µg increased frequency and severity of undesirable gastrointestinal effects.
Doża waħda ta ’ BYETTA 5 µg żiedet l- frekwenza u s- severità ta ’ effetti mhux mixtieqa gastro - intestinali f’ pazjenti b’ mard renali fl- aħħar stadju u li qegħdin fuq dijalisi.
BYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/ min).
BYETTA m’ hijiex irrakkomandata għall- użu f’ pazjenti b’ mard renali fl- aħħar stadju jew b’ indeboliment renali qawwi (tneħħija tal- krejatinina < 30 ml/ min).
The clinical experience in patients with moderate renal impairment is very limited.
L- esperjenza klinika f’ pazjenti b’ indeboliment renali moderat hija limitata ħafna.
There have been rare, spontaneously reported events of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis.
Ġew irrapportati avvenimenti rari u spontanji ta ’ kambjament fil- funzjoni renali li jinkludu żieda fil - krejatinina fis- serum, indeboliment renali, insuffiċjenza renali kronika li tmur għall- agħar u insuffiċjenza renali akuta li xi kultant teħtieġ l- emodijalisi.
Some of these events occurred in patients experiencing events that may affect hydration, including nausea, vomiting, and/ or diarrhoea and/ or receiving pharmacological agents known to affect renal function/ hydration status.
Xi wħud minn dawn l- avvenimenti seħħew f’ pazjenti li kellhom avvenimenti li jistgħu jkollhom effett fuq l- idratazzjoni, li jinkludu tqalligħ, rimettar, u/ jew dijarea u/ jew qegħdin jirċievu sustanzi farmakoloġiċi magħrufa li jkollhom effett fuq il- funzjoni renali/ stat ta ’ idratazzjoni.
Concomitant agents included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, nonsteroidal anti-inflammatory medicinal products and diuretics.
Sustanzi li ttieħdu flimkien kienu jinkludu inibituri ta ’ l- enzimi li jikkonvertu l- anġjotensin, antagonisti ta ’ anġjotensin- II, prodotti mediċinali antinfjammatorji li m’ humiex sterojdi u dijuretiċi.
Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative agents, including BYETTA.
Ġie osservat li b’ kura ta ’ sosteniment u bit- twaqqif tas- sustanzi potenzjalment kawżattivi, li jinkludu BYETTA, tista ’ treġġa ’ lura l- kambjament fil- funzjoni renali.
BYETTA has not been studied in patients with severe gastrointestinal disease, including gastroparesis.
3 BYETTA ma ġietx studjata f’ pazjenti b’ mard gastro- intestinali qawwi, fosthom il- gastroparesi.
Its use is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhoea.
L- użu tiegħu huwa spiss assoċjat ma ’ reazzjonijiet avversi gastro- intestinali, fosthom it- tqalligħ, r- rimettar, u d- dijarrea.
Therefore, the use of BYETTA is not recommended in patients with severe gastrointestinal disease.
Għaldaqstant, mhux irrakkomandat l- użu ta ’ BYETTA f’ pazjenti b’ mard gastro- intestinali qawwi.
3 There have been rare, spontaneously reported events of acute pancreatitis.
Ġew irrapportati avvenimenti rari u spontanji ta ’ pankreatite akuta.
Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Il- pazjenti għandhom ikunu mgħarrfa dwar is- sintomu karateristiku ta ’ pankreatite akuta: uġigħ addominali sever u persistenti.
Resolution of pancreatitis has been observed with supportive treatment.
Ġie osservat li b’ kura ta ’ sosteniment, il- pankreatite tirriżolva ruħa.
If pancreatitis is suspected, BYETTA and other potentially suspect medicinal products should be discontinued.
Jekk ikun hemm is- suspett ta ’ pankreatite, BYETTA u prodotti mediċinali oħra li jistgħu jkunu ta ’ suspett, għandhom jiġu mwaqqfa.
The concurrent use of BYETTA with insulin, D-phenylalanine derivatives(meglitinides), or alpha-glucosidase inhibitors has not been studied and cannot be recommended.
L- użu fl- istess ħin ta ’ BYETTA ma ’ l- insulina, derivattivi ta ’ D- phenylalanine (meglitinides) jew inibituri ta ’ alpha- glucosidase ma ġiex studjat u ma jistax jiġi rrakkomandat.
The experience in patients with BMI ≤ 25 is limited.
L- esperjenza f’ pazjenti b’ BMI ≤25 hija limitata.
This medicinal product contains metacresol, which may cause allergic reactions.
Dan il- prodott mediċinali fih metacresol, li jista ’ jikkaġuna reazzjonijiet allerġiċi.
Hypoglycaemia When BYETTA was used in combination with a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo in combination with a sulphonylurea.
Ipogliċemija Meta BYETTA ntużat flimkien ma ’ xi sulphonylurea, l- inċidenza ta ’ l- ipogliċemija żdiedet fuq dik ta ’ plaċebo flimkien ma ’ xi sulphonylurea.
In the clinical studies patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
Fl- istudji kliniċi, pazjenti b’ indeboliment renali ħafif u li qegħdin jirċievu BYETTA flimkien ma ’ xi sulphonylurea kellhom żieda fl- inċidenza ta ’ l- ipogliċemija meta mqabbla ma ’ pazjenti b’ funzjoni renali normali.
To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea should be considered.
Biex jitnaqqas ir- riskju ta ’ l- ipogliċemija assoċjata ma ’ l- użu ta ’ xi sulphonylurea, għandu jiġi kkunsidrat it- tnaqqis fid- doża ta ’ sulphonylurea.
Interactions The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
Kif jaġixxi ma ’ prodotti mediċinali oħra L- effett ta ’ BYETTA li ttawwal il- ħin biex l- istonku jitbattal jista ’ jnaqqas il- livell u r- rata ta ’ assorbiment ta ’ prodotti mediċinali meħuda b’ mod orali.
BYETTA should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption and medicinal products with a narrow therapeutic ratio.
BYETTA għandha tintuża b’ attenzjoni f’ pazjenti li jieħdu prodotti mediċinali orali li jeħtieġu assorbiment gastro- intestinali rapidu u meta jieħdu prodotti mediċinali b’ indiċi terapewtiċi dojoq.
Specific recommendations regarding intake of such medicinal products in relation to BYETTA is given in section 4.5.
Rakkomandazzjonijiet speċifiċi dwar it- teħid ta ’ dawn il- prodotti mediċinali fir- rigward ta ’ BYETTA jingħataw f’ sezzjoni 4. 5.
The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
L- effett ta ’ BYETTA li ttawwal il- ħin biex l- istonku jitbattal, jista ’ jnaqqas il- livell u r- rata ta ’ assorbiment ta ’ prodotti mediċinali meħuda b’ mod orali.