qanastek/EMEA-V3 huggingface dataset:
Bridion can affect hormonal contraceptives • Bridion can make hormonal contraceptives - including the ‘ Pill’, vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone.
Bridion jista ’ jaffettwa l- kontraċettivi ormonali • Bridion jista ’ jagħmel il- kontraċettivi ormonali - li jinkludu l - ’ Pillola ’, ċirku vaġinali, impjanti jew IntraUterine System (IUS) ormonali - inqas effettivi għax inaqqas kemm inti tirċievi mill - ormon tal- progestogen.
The amount of progestogen lost by using Bridion is about the same as missing one oral contraceptive Pill. → If you are taking the Pill on the same day as Bridion is given to you, follow the instructions for a missed dose in the Pill’ s package leaflet. → If you are using other hormonal contraceptives (for example a vaginal ring, implant or IUS) you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the advice in the package leaflet.
L- ammont ta ’ progestogen li jintilef bl- użu ta ’ Bridion hu bejn wieħed u ieħor l- istess bħal dak meta ma tiħux Pillola kontraċettiva orali waħda. → Jekk tieħu l- Pillola fl- istess jum meta jingħatalek Bridion, segwi l- istruzzjonijiet għal meta ma tiħux doża fil- fuljett ta ’ tagħrif tal- Pillola. → Jekk qed tuża kontraċettivi ormonali oħrajn (per eżempju ċirku vaġinali, impjant jew IUS) għandek tuża metodu ieħor kontraċettiv mhux ormonali (bħal kondom) għas- 7 t’ ijiem li jkun imiss, u segwi l- parir fil- fuljett ta ’ tagħrif.
Effects on blood tests In general, Bridion does not have an effect on laboratory tests.
Effetti fuq it- testijiet tad- demm B’ mod ġenerali, Bridion m’ għandu l- ebda effett fuq it- testijiet tal- laboratorju.
However, it may affect the results of a blood test for a hormone called progesterone and some blood clotting tests.
Madankollu, jista ’ jaffettwa r- riżultati ta ’ test tad- demm għal ormon imsejjaħ progesterone u xi testijiet għat- tagħqid tad- demm.
Pregnancy and breast-feeding → Tell your anaesthetist if you are pregnant or might be pregnant.
Tqala u treddigħ → Għid lill- anestetista tiegħek jekk inti tqila jew jekk tista ’ tkun tqila.
You may still be given Bridion, but you need to discuss it first.
Xorta waħda tista ’ tingħata Bridion, iżda l- ewwel trid tiddiskuti dan il- fatt.
Driving and using machines Your doctor will tell you when it is safe to drive or operate machinery after you have been given Bridion.
Sewqan u tħaddim ta ’ magni It- tabib tiegħek ser għidlek meta ma jibqax periklu li ssuq jew tħaddem il- makkinarju wara li tingħata Bridion.
Bridion is not known to have an effect on alertness or concentration.
Bridion mhux magħruf li għandu xi effett fuq l- attenzjoni jew il- konċentrazzjoni.
HOW BRIDION IS GIVEN
KIF JINGĦATA BRIDION
The dose Your anaesthetist will work out the dose of Bridion you need based on: • your weight • how much the muscle relaxant medicine is still affecting you.
Id- doża L- anestetista tiegħek ser jikkalkula d- doża ta ’ Bridion li teħtieġ ibbażat fuq: • il- piż tiegħek • kemm il- mediċina tar- rilassant tal- muskoli għadha qed taffettwak.
The usual dose is 2-4 mg per kg body weight.
Id- doża normali hi ta ’ minn 2 sa 4 mg għal kull kg ta ’ piż tal- ġisem.
A higher dose may be given if the anaesthetist wants you to recover faster.
Tista ’ tingħata doża ogħla jekk l- anestetista jkun iridek tirkupra iktar malajr.
The dose of Bridion for children is 2 mg/ kg (children and adolescents between 2-17 years old).
Id- doża ta ’ Bridion għat- tfal hi ta ’ 2 mg/ kg (tfal u adolexxenti bejn l- età ta ’ 2- 17).
How Bridion is given Bridion will be given to you by your anaesthetist.
Kif jingħata Bridion Bridion ser jingħatalek mill- anestetista tiegħek.
It is given into a vein (intravenously) as a single injection.
Jingħata ġo vina (minn ġol- vina) bħala injezzjoni waħda.
If more Bridion is given to you than recommended As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Bridion.
Jekk jingħatalek aktar Bridion minn dak irrakkomandat Billi l- anestetista tiegħek ser ikun qed jimmonitorja l- kundizzjoni tiegħek bir- reqqa, mhux mistenni li ser tingħata żżejjed Bridion.
But even if this happens, it is unlikely to cause any problems.
Iżda anki jekk jiġri dan, mhux mistenni li jikkawża xi problema.
If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.
27 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott mediċinali, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Bridion can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Bridion jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
26 If these side effects occur while you are under anaesthesic, they will be seen and treated by your anaesthetist.
Jekk dawn l- effetti sekondarji jseħħu waqt li tkun taħt l- effett tal- loppju, dawn ser ikunu ċċekkajti u kkurati mill- anestetista tiegħek.
Very common side effects (in more than 1 user in 10) • A temporary unpleasant taste in your mouth.
Effetti sekondarji komuni ħafna (li jseħħu f’ iktar minn 1 minn kull 10 utenti) • Togħma temporanja mhux pjaċevoli f’ ħalqek.
Common side effects (in 1 to 10 users in 100) • Light anaesthesia - you may start to come out of deep sleep, so need more anaesthetic.
Effetti sekondarji komuni (f’ minn 1 sa 10 utenti minn kull 100) • Loppju ħafif - tista ’ tħossok li qed tqum minn raqda fil- fond, u għalhekk ikollok bżonn ta ’ aktar loppju.
This might cause you to move or cough at the end of the operation. • Your muscles may turn weak again after the operation (if a too low dose is administered).
Dan jista ’ jikkawża lil inti tiċċaqlaq jew tisgħol fit- tmiem ta ’ l- operazzjoni. • Il- muskoli tiegħek jistgħu jiddgħajfu mill- ġdid wara l- operazzjoni (jekk tingħata doża baxxa wisq).
Uncommon side effects (in 1 to 10 users in 1,000) • Being awake during the operation (anaesthesia awareness) • Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of asthma • Allergic (hypersensitivity) reactions - such as a rash or red skin.
Effetti sekondarji mhux komuni (li jseħħu f’ minn 1 sa 10 utenti minn kull 1, 000) • Li tkun imqajjem waqt l- operazzjoni (tkun konxju tal- loppju) • Qtugħ ta ’ nifs minħabba bugħawwieġ fil- muskoli tal- passaġġi tan- nifs (bronkospażmu) seħħ f’ pazjenti b’ passat mediku ta ’ ażżma. • Reazzjonijiet allerġiċi (sensittività eċċessiva) - bħal raxx jew ġilda ħamra.
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 wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW BRIDION IS STORED
KIF JINĦAŻEN BRIDION
Do not use Bridion after the expiry date which is stated on the vial and the carton.
Tużax Bridion wara d- data ta ’ skadenza li tidher fuq il- kunjett u fuq il- kartuna.
After first opening and dilution, store at 2 to 8 °C and use within 24 hours.
Wara l- ewwel darba li tinfetaħ il- mediċina u d- dilwizzjoni, aħżen f’ temperatura ta ’ 2- 8 °C u uża fi żmien 24 siegħa.
What Bridion contains
X’ fih Bridion
- The active substance is sugammadex.
- Is- sustanza attiva hi sugammadex.
1 ml solution for injection contains 100 mg sugammadex (as sodium salt)
1 ml soluzzjoni għall- injezzjoni fih 100 mg ta ’ sugammadex (bħala melħ tas- sodium).
- The other ingredients are water for injections, hydrochloric acid 3.7% and/ or sodium hydroxide
- Is- sustanzi l- oħra huma ilma għall- injezzjonijiet, hydrochloric acid 3. 7% u/ jew
(to adjust pH).
sodium hydroxide (għal aġġustament tal- pH)
What Bridion looks like and contents of the pack Bridion is a clear and colourless to slightly yellow solution for injection.
Id- dehra ta ’ Bridion u l- kontenuti tal- pakkett Bridion hu soluzzjoni bejn ċara u bla kulur jew sa kemm kemm safra għall- injezzjoni.
It comes in two different pack sizes, containing either 10 vials with 2 ml or 10 vials with 5 ml solution for injection.
Jiġi f’ żewġ daqsijiet ta ’ pakketti differenti, li jkun fihom jew 10 kunjetti ta ’ 2 ml jew 10 kunjetti b’ soluzzjoni għall- injezzjoni ta ’ 5 ml.
Not all pack sizes may be marketed.
28 Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq.
Marketing Authorisation Holder and Manufacturer N. V.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur N. V.
Manufacturers • N. V.
Manifatturi • N. V.
Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands • Organon (Ireland) Ltd., Drynam Road, Swords, Co.
Organon, Kloosterstraat 6, 5349 AB Oss, L- Olanda • Organon (L- Irlanda) Ltd., Drynam Road, Swords, Co.
Dublin, Ireland
Dublin, L- Irlanda
This leaflet was last approved in {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}
27 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
---------------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
For detailed information refer to the Summary of Product Characteristics of BRIDION.
Jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott ta 'BRIDION.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TA 'VALUTAZZJONI PUBBLIKA EWROPEW (EPAR)
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport ta 'Valutazzjoni Pubblika Ewropew (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex jaslu għar- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet ta 'CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Busilvex?
X' inhu Busilvex?
Busilvex is a concentrate to be made up into a solution for infusion (drip into a vein).
Busilvex huwa konċentrat li jitħallat f' soluzzjoni għall- infużjoni (drip ġol- vina).
It contains the active substance busulfan.
Fih is- sustanza attiva busulfan.
What is Busilvex used for?
Għalxiex jintuża Busilvex?
Busilvex is used in adults and children as a ‘ conditioning’ (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Busilvex jintuża fl- adulti u tfal fit- trattament ta 'kundizzjonament (preparatorju) qabel it- trapjant ta' ċelluli ematopojetiċi proġenitriċi (iċ- ċelluli li jiġġeneraw ċ- ċelluli tad- demm).
This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Dan it- tip ta 'trapjant jintuża f' pazjenti li jeħtieġ ibiddlu ċ- ċelluli li jagħmlu d- demm tagħhom, għaliex għandhom disturb tad- demm (bħalma hija tip rari ta' anemija) jew kanċer tad- demm.
Busilvex treatment is followed by treatment with another medicine (cyclophosphamide in adults, and cyclophosphamide or melphalan in children).
It- trattament b' Bulsivex huwa segwit minn trattament b' mediċina oħra (cyclophosphamide fl- adulti, u cyclophosphamide jew melphalan fit- tfal).
Because of the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, busulfan was designated as an ‘ orphan medicine’ (a medicine used in rare diseases) on 29 December 2000.
Minħabba li n- numru ta 'pazjenti fl- Unjoni Ewropea (UE) li jsirilhom dan it- tip ta' kundizzjonament u trapjant huwa wieħed baxx, busulfan ġie kklassifikat bħala 'mediċina orfni' (mediċina li tintuża f' mard rari) fid- 29 ta 'Diċembru 2000.
The medicine can only be obtained with a prescription.
Il- mediċina tista 'tinkiseb biss b' riċetta tat- tabib.
How is Busilvex used?
Kif jintuża Busilvex?
Busilvex should be used by a doctor who has experience in treatments given before transplantation.
Busilvex għandu jintuża minn tabib li għandu esperjenza fi trattamenti mogħtija qabel trapjant.
The recommended dose of Busilvex in adults is 0.8 mg per kilogram body weight.
Id - doża rakkomandata ta 'Busilvex fl- adulti hija 0. 8 mg kull kilogramm piż tal- ġisem.
In children up to 17 years of age, the recommended dose of Busilvex is based on the weight of the child and varies between 0.8 and 1.2 mg/ kg.
Fi tfal ta 'età sa 17 - il sena, id- doża rakkomandata ta' Busilvex hija bbażata fuq il- piż tat- tifel jew tifla u tvarja bejn 0. 8 u 1. 2 mg/ kg.
Busilvex is given as a central intravenous infusion (drip into a central vein in the chest).
Busilvex jingħata bħala infużjoni intravenuża ċentrali (dripp ġewwa vina ċentrali fis- sider).
Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Kull infużjoni ddum sagħtejn u tingħata lil pazjent kull sitt ġimgħat fuq erbat ijiem konsekuttivi qabel trattament b' cyclophosphamide jew b' melphalan u t- trapjant.
Before receiving Busilvex, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Qabel ma jingħataw Busilvex, il- pazjenti għandhom ikunu ttrattati minn qabel b' mediċini antikonvulsivanti (għall- prevenzjoni ta 'kriżijiet epilettiċi) u mediċini antiemetiċi (għall- prevenzjoni ta' remettar).
How does Busilvex work?
Kif jaħdem Busilvex?
The active substance in Busilvex, busulfan, belongs to a group of medicines called ‘ alkylating agents’.
Is- sustanza attiva f' Busilvex, busulfan, tappartjeni għall- grupp ta 'mediċini msejħin' aġenti alkilanti '(alkylating agents).
These substances are ‘ cytotoxic’.
Dawn is- sustanzi huma 'ċitotossiċi'.
This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (or ‘ stem ’) cells (cells that make other types of cell).
Dan ifisser li joqtlu ċ- ċelluli, speċjalment ċelluli li jiżviluppaw malajr, bħalma huma ċelluli tal- kanċer jew proġenitriċi (jew 'stem') (ċelluli li jipproduċu tipi ta 'ċelluli oħrajn).
Busulfan is used before transplantation to destroy abnormal cells and the patient ’ s existing haematopoietic progenitor cells.
Busulfan jintuża qabel it- trapjant biex jeqred ċelluli anomali u ċ - ċelluli ematopojetiċi proġenitriċi eżistenti.
This is called ‘ myeloablation’.
Dan il- proċess jissejjaħ 'mjeloablazzjoni' (myeloablation).
Reproduction is authorised provided the source is acknowledged. immune system, so that the body ’ s natural defences are decreased.
It- trattament b' cyclophosphamide jew b' melphalan imbagħad jintuża biex iġiegħel l - immunosoppressjoni, biex jitnaqqsu d- difiżi naturali tal- ġisem.
This helps the transplanted cells to ‘ engraft ’ (when they start to grow and produce normal blood cells).
Dan jgħin iċ- ċelluli trapjantati biex jibdew jikbru u jipproduċu ċelluli tad- demm normali (engrafting).
How has Busilvex been studied?
Kif ġie studjat Busilvex?
The effects of Busilvex were first tested in experimental models before being studied in humans.
L- effetti ta 'Busilvex għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The applicant also presented data from the scientific literature.
L- applikant ippreżenta wkoll dejta mil- letteratura xjentifika.
Busilvex has been studied in patients, mainly with blood cancer, who needed transplantation of haematopoietic progenitor cells.
Busilvex ġie studjat f' pazjenti, prinċipalment b' kanċer tad- demm, li kellhom bżonn ta 'trapjant ta' ċelluli ematopojetiċi proġenitriċi.
There were two main studies involving 103 adults and one involving 55 children.
Twettqu żewġ studji ewlenin li involvew 103 adulti u wieħed li involva 55 tifel u tifla.
The main measures of effectiveness were the number of patients with myeloablation (with reduced counts of white blood cells and platelets) and ‘ engraftment’ (the time for the white blood cells to return to higher levels).
Il- kejl ewlieni ta 'l- effikaċja kienu n- numru ta' pazjenti bi mjeloablazzjoni (tnaqqis ta 'l- għadd ta' ċelluli tad- demm bojod u platelets) u 'engraftment' (iż- żmien meħtieġ għaċ - ċelluli tad- demm bojod biex imorru lura għal- livelli ogħla).
What benefit has Busilvex shown during the studies?
Liema benefiċċju wera Busilvex waqt l- istudji mwettqa?
All adults and children achieved myeloablation.
Fl- adulti u fit- tfal kollha, ġiet osservata mjeloablazzjoni.
On average, engraftment was reached in 10 days in adults and 11 days in children with ‘ autotransplantation’ (when the patient receives their own cells, harvested and stored before the transplant).
Bħala medja, l- engraftment intlaħaq f' 10 ijiem fl- adulti u 11- il jum fit- tfal bi trapjant awtologu (jiġifieri trapjant ta 'ċelluli tal- pazjent stess, miġbura u miżmuma qabel it- trattament).
Engraftment was obtained in 13 days in adults and 21 days in children with ‘ allotransplantation’ (when the patient receives cells from a donor).
L- engraftment inkiseb fi żmien 13- il jum fl- adulti u fi żmien 21 jum fi tfal bi trapjanti alloġeniċi (trapjant ta 'ċelluli minn donatur).
What is the risk associated with Busilvex?
X' inhu r- riskju assoċjat ma 'Busilvex?
Apart from the decrease in blood cell counts, which this is the intended effect of the medicine, the most serious side effects of Busilvex are infection, liver disorders including blocking of a liver vein, graft versus host disease (when the transplanted cells attack the body) and respiratory (lung) disorders.
Apparti t- tnaqqis fl- għadd taċ- ċelluli tad- demm, li huwa l- effett intenzjonat tal- mediċina, l- iktar effetti sekondarji gravi b' Busilvex huma infezzjoni, disturbi tal- fwied li jinkludu l- imblokkar ta 'vina epatika, marda minn trapjant lejn l- ospitu (meta t- trapjant jattakka l- ġisem tal- pazjent) u disturbi respiratorji (tal- pulmun).
For the full list of all side effects reported with Busilvex, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Busilvex, ara l- Fuljett ta' Tagħrif.
Busilvex should not be used in people who may be hypersensitive (allergic) to busulfan or any of the other ingredients.
Busilvex ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal busulfan jew għal xi sustanza oħra tiegħu.
It must not be used in women who are pregnant.
Ma għandux jintuża f' nisa tqal.
Breast-feeding should be stopped when treatment with Busilvex is started.
Meta jinbeda trattament b' Busilvex għandu jieqaf it- treddigħ.
Busilvex can affect fertility in both sexes.
Busilvex jista 'jaffettwa l- fertilità fiż- żewġ sessi.
Because of this, female patients should not become pregnant during treatment and for up to six months afterwards, and male patients are advised not to father a child during and for up to six months after treatment with Busilvex.
Minħabba dan, il- pazjenti nisa m' għandhomx joħorġu tqal waqt it- trattament u sa sitt xhur wara, u pazjenti rġiel jingħataw parir biex ma jnisslux tarbija waqt u sa sitt xhur wara t- trattament b' Busilvex.
Caution is needed when Busilvex is used at the same time as other medicines, such as itraconazole (used to treat some infections), ketobemidone (used to treat pain) and paracetamol.
Meta Busilvex jintuża fl- istess waqt ma 'mediċini oħrajn, bħalma huwa itraconazole (użat għat - trattament ta' xi infezzjonijiet), ketobemidone (użat għat- trattament ta 'l- uġigħ) u paracetamol, jeħtieġ li dan isir b' kawtela.
See the Package Leaflet for full details.
Ara l- Fuljett ta 'Tagħrif għal dettalji sħaħ.
Why has Busilvex been approved?
Għaliex ġie approvat Busilvex?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of Busilvex had been shown, and that it provides an alternative to busulfan tablets, which have disadvantages such as the large number of tablets that need to be taken.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- effikaċja ta 'Busilvex intweriet, u li huwa jipprovdi alternattiva għal pilloli ta' busulfan, li għandhom żvantaġġi bħal, per eżempju, in- numru kbir ta 'pilloli li jridu jittieħdu.
The Committee decided that Busilvex’ s benefits are greater than its risks as conditioning treatment prior to haematopoietic progenitor cell transplantation.
Il- Kumitat iddeċieda li l- benefiċċji ta 'Busilvex huma ogħla mir- riskji tiegħu għat- trattament ta' kundizzjonament qabel it- trapjant ta 'ċelluli ematopojetiċi proġenitriċi.
The Committee recommended that Busilvex be given marketing authorisation.
Il- Kumitat irrakkomanda li Busilvex jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Busilvex:
Aktar tagħrif dwar Busilvex:
The European Commission granted a marketing authorisation valid throughout the EU for Busilvex to Pierre Fabre Médicament on 9 July 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha għal Busilvex lil Pierre Fabre Médicament fid- 9 ta 'Lulju 2003.
The marketing authorisation was renewed on 9 July 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 9 ta 'Lulju 2008.
The record of Busilvex’ s designation as an orphan medicine is available here.
Ir- reġistrazzjoni tal- kwalifika ta 'Busilvex bħala mediċina orfni hija disponibbli minn hawn.
The full EPAR for Busilvex can be found here.
L- EPAR sħiħ għal Busilvex jista 'jiġi kkonsultat hawn.
This summary was last updated in 07-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Pharmaceutical Form Concentrate for solution for infusion
Konċentrat għal soluzzjoni għal infużjoni
Route of Administration Intravenous use
Użu ġol- vini
Packaging vial (glass)
Vjala (ħġieġ)
Package size 8 vials
8 Vjala
Busilvex 6 mg/ ml concentrate for solution for infusion
Busilvex 6 mg/ ml konċentrat għal soluzzjoni għall- infużjoni
One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Millilitru wieħed ta ’ ċonċentrat fih 6 mg ta 'busulfan (60 m f' 10 ml).
After dilution:
Wara lis- sustanza tkun dilwita:
1 ml of solution contains 0.5 mg of busulfan For a full list of excipients see section 6.1
1 ml tat- soluzzjoni fih 5 mg ta ’ busulfan Għal- lista sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Clear, colourless solution.
Konċentrat għal soluzzjoni għall- infużjoni (konċentrat sterili) Soluzzjoni ċara u bla kulur.
4.1 Therapeutic indications
4. 1Indikazzjonijiet terapewtiċi
Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Busilvex li jingħata qabel il- ċiklofosfamid (BuCy2) hu indikat bħala trattament kondizzjonarju qabel it- trapjant konvenzjonali taċ- ċelluli ematopojetiċi proġenitriċi (HPCT) f’ pazjenti adulti meta din it- taħlita hi meqjusa bħala l- aħjar għażla li hemm.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Il- Busilvex li jingħata qabel iċ- ċiklofosfamid (BuCy4) jew melfalan (BuMel) hu indikat bħala trattament kondizzjonarju qabel it- trapjant konvenzjonali taċ- ċelluli ematopojetiċi proġenitriċi f’ pazjenti pedjatriċi.
4.2 Posology and method of administration
4. 2Pożoloġija u metodu ta ’ kif għandu jingħata
Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
L- għoti tal- Busilvex għandu jkun taħt is- sorveljanza ta ’ tabib li għandu esperjenza fit- trattament kondizzjonarju qabel it- trapjant taċ- ċelluli ematopojetiċi proġenitriċi.
Busilvex is administered prior the conventional haematopoietic progenitor cell transplantation (HPCT).
Busilvex għandu jittieħed qabel it- trapjant taċ- ċelluli ematopojetiċi proġenitriċi convenzjonali (HPCT).
Dosage in adults The recommended dosage and schedule of administration is:
Dożaġġ fl- adulti Id- dożaġġ irrakkomandat u l- iskeda ta ’ l- għoti hi:
- 0.8 mg/ kg body weight (BW) of busulfan as a two-hour infusion every 6 hours over 4
0. 8 mg/ kg piż tal- ġisem (BW) ta ’ busulfan bħala infużjoni ta ’ sagħtejn kull 6 sigħat fuq medda ta ’ 4 ġranet konsekuttivi għal total ta ’ 16- il doża
- followed by cyclophosphamide at 60 mg/ kg/ day over 2 days initiated for a least 24 hours
segwit miċ- ċiklofosfamid b’ 60mg/ kg/ jum għal jumejn li jibdew mhux inqas minn 24 siegħa wara s- 16- il doża ta ’ Busilvex (ara sezzjoni 4. 5).
following the 16th dose of Busilvex (see section 4.5).
Id- dożaġġ f’ pazjenti pedjatriċi (minn 0 sa 17- il sena)
Dosage in paediatric patients (0 to 17 years) The recommended dose of Busilvex is as follows:
Id- doża rrakkomandata ta ’ Busilvex hi kif tidher hawn taħt:
Actual
Piż attwali
body weight (kg) < 9 9 to < 16 16 to 23
tal- ġisem (kg) < 9
Busulfex
Dożaġġ Busulfex (mg/ kg) 1. 0
dose (mg/ kg) 1.0 1.2 1.1
9 sa < 16 16 sa 23
> 23 to 34 > 34
> 23 sa 34 > 34
0.95 0.8
0. 95 0. 8
2 followed by:
2 u wara ikun hemm:
- 4 cycles of 50 mg/ kg body weight (BW) cyclophosphamide (BuCy4) or
- 4 ċikli ta ’ 50 mg/ kg piż tal- ġisem (BW) ċiklofosfamid (BUCy4) jew
- one administration of 140 mg/ m² melphalan (BuMel)
- għotja waħda ta '140 mg/ m² melfalan (BuMel) li jibdew mill- 24 siegħa wara s- 16- il doża ta ’
initiated for a least 24 hours following the 16th dose of Busilvex. (see section 4.5).
Busilvex (ara sezzjoni 4. 5).
Busilvex is administered as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses prior to cyclophosphamide or melphalan and conventional haematopoietic progenitor cell transplantation (HPCT)
Busilvex jingħata bħala infużjoni ta ’ sagħtejn kull 6 sigħat fuq medda ta ’ 4 ġranet konsekuttivi għal total ta ’ 16- il doża qabel iċ- ċiklofosfamid jew il- melfalan u t- trapjant konvenzjonali taċ- ċelluli ematopojetiċi proġenitriċi (HPCT).
Administration Busilvex must be diluted prior to administration (see section 6.6).
L- Amministrazzjoni Busilvex għandu jkun dilwit qabel l- għoti (ara sezzjoni 6. 6).
A final concentration of approximately 0.5 mg/ ml busulfan should be achieved.
Għandha tintlaħaq konċentrazzjoni finali ta ’ madwar 0. 5 mg/ ml busulfan.
Busilvex should be administered by intravenous infusion via central venous catheter.
Busilvex għandu jingħata permezz ta ’ infużjoni minn ġol- ġilda permezz ta ’ kateter ġol- vina ċentrali.
Busilvex should not be given by rapid intravenous, bolus or peripheral injection.
Busilvex m’ għandux jingħata permezz ta ’ injezzjoni minn ġol- vina, bolus jew injezzjoni periferali.
All patients should be pre-medicated with anticonvulsant medicinal products to prevent seizures reported with the use of high dose busulfan.
Il- pazjenti kollha għandhom ikunu premedikati permezz ta ’ prodotti mediċinali antikonvulżivi biex jimpedixxu attakki ta ’ puplesija liema attakki kienu rrapurtati meta tingħata doża għolja ta ’ busulfan.
It is recommended to administer anticonvulsants 12 h prior to Busilvex to 24 h after the last dose of Busilvex.
Hu rrakkomandat li għandhom jingħataw antikonvulżivi 12- il s. qabel il- Busilvex sa 24 s. wara l- aħħar doża ta 'Busilvex.
In adults all studied patients received phenytoin.
Fil- każ ta ’ l- adulti, il- pazjenti kollha li ġew studjati ngħataw fenitojin.
There is no experience with other anticonvulsant agents such as benzodiazepines (see sections 4.4 and 4.5).
M’ hemmx esperjenza dwar aġenti oħra antikonvulżivi bħal ngħidu aħna benżodjażepini (ara sezzjonijiet 4. 4 u 4. 5).
In children studied patients received either phenytoin or benzodiazepines.
Fil- każ tat- tfal, il- pazjenti studjati rċevew jew il- fenitojin jew il- benżodjażepini.
Antiemetics should be administered prior to the first dose of Busilvex and continued on a fixed schedule according to local practice through its administration.
L- antjemetiċi għandhom jingħataw qabel l- ewwel doża ta ’ Busilvex u jibqgħu jingħataw skond skeda fissa skond il- prattika lokali matul l- għoti tiegħu.
Obese patients
Pażjenti ħoxnin iżżejjed
In adults For obese patients, dosing based on adjusted ideal body weight (AIBW) should be considered.
Fl- adulti Fil- każ ta ’ pazjenti ħoxnin iżżejjed, wieħed għandu jara jekk id- dożaġġ għandux ikun ibbażat fuq piż idejali aġġustat tal- ġisem (AIBW).
Ideal body weight (IBW) is calculated as follows:
Piż idejali tal- ġisem (IBW) hu maħdum kif ġej:
IBW men (kg)=50 + 0.91x (height in cm-152); IBW women (kg)= 45 + 0.91x (height in cm-152).
IBW irġiel (kg) = 50 + 0. 91x (tul f’ ċentimetri- 152); IBW nisa (kg) = 45 + 0. 91x (tul f’ ċentimetri- 152).
Adjusted ideal body weight (AIBW) is calculated as follows:
Piż aġġustat idejali tal- ġisem (AIBW) hu maħdum kif ġej:
AIBW= IBW+0.25x (actual body weight - IBW).
AIBW=IBW+0. 25x (piż attwali tal- ġisem – IBW).
In paediatric patients The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/ (m)² > 30 kg/ m² until further data become available.
Fil- każ ta ’ pazjenti pedjatriċi Dan il- prodott mediċinali mhux rakkomandat fi tfal u adoloxxenti ħoxnin iżżejjed li għandhom piż ta 'l- indiċi tal- massa tal- ġisem (kg) / (m) ² > 30 kg/ m² sakemm aktar data tkun disponnibbli.
Renally impaired patient:
Pazjent li jbati minn indeboliment tal- kliewi:
Studies in renally impaired patients have not been conducted, however, as busulfan is moderately excreted in the urine, dose modification is not recommended in these patients.
Ma sarux studji f’ pazjenti li jbatu minn indeboliment tal- kliewi, peress li kien hemm tkeċċija moderata tal- busulfan fl- awrina, l- aġġustament tad- doża mhux irrakkomandat fil- każ ta ’ dawn il- pazjenti.
However, caution is recommended (see sections 4.8 and 5.2).
Imma tkun ħaġa għaqlija li wieħed joqgħod attent (ara sezzjonijiet 4. 8 u 5. 2).
Hepatically impaired patient:
Pazjent li jbati minn indeboliment tal- fwied:
Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Ma sarx studju dwar il- Busilvex u l- busulfan f’ pazjenti li jbatu minn indeboliment tal- fwied.
Caution is recommended, particularly in those patients with severe hepatic impairment (see section 4.4).
Wieħed għandu joqgħod attent, aktar u aktar fil- każ ta 'dawk il- pazjenti li jbatu minn indeboliment sever tal- fwied (ara sezzjoni 4. 4).
3 Elderly patient:
Pazjenti anzjani:
Patients older than 50 years of age (n=23) have been successfully treated with Busilvex without dose- adjustment.
3 Pazjenti li għandhom aktar min 50 sena (n=23) ġew ikkurati b’ suċċess bil- Busilvex mingħajr aġġustament tad- doża.
However, for the safe use of Busilvex in patients older than 60 years only limited information is available.
Imma hemm biss tagħrif limitat dwar l- użu mingħajr periklu tal- Busilvex fil - każ ta ’ pazjenti akbar minn 60 sena.
Same dose (see section 5.2) for elderly as for adults (< 50 years old) should be used.
Għandha tingħata l- istess doża (ara sezzjoni 5. 2) għall- anzjani bħal dik ta ’ l- adulti (< 50 sena).
Hypersensitivity to the active substance or to any of the excipients Pregnancy (see section 4.6)
Tqala u treddigħ (ara sezzjoni 4. 6)
4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
The consequence of treatment with Busilvex at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Il- konsegwenza ta ’ trattament bil- Busilvex bid- doża u l- iskeda rrakkomandata hi mijelosuppressjoni profonda li seħħet fil- pazjenti kollha.
Severe granulocytopenia, thrombocytopenia, anaemia, or any combination thereof may develop.
Granuloċitopenija, tromboċitopenija, anemja jew għandhom mnejn jiżviluppaw taħlita ta ’ dawn kollha.
Frequent complete blood counts, including differential white blood cell counts, and platelet counts should be monitored during the treatment and until recovery is achieved.
L- għadd tad- demm ta ’ spiss u sħaħ, inklużi għadd taċ - ċelluli tad- demm bojod differenzjali, u l- għadd tal- pjastrini għandhom ikunu mgħassa matul it - trattament u sakemm ikun hemm fejqan.
Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
L- użu profilaktiku jew empiriku ta ’ l- anti- infettivi (batterjali, fungali, virali) għandhom jiġu meqjusa għall- fini tal- prevenzjoni u l- immaniġġjar ta ’ l- infezzjonijiet matul il- perijodu newtropeniku.
Platelet and red blood cell support, as well as the use of growth factors such as granulocyte colony stimulating agent (G-CSF), should be employed as medically indicated.
Għandha tintuża terapija ta ’ appoġġ għall- pjastrini u ċelluli eritroċiti flimkien ma ’ l- użu tal- fatturi ta ’ l- iżvilupp bħal ngħidu aħna l- aġent stimulanti kolonja granuloċite (G- CSF), skond l- indikazzjoni medika.
In adults, absolute neutrophil counts < 0.5x109/ l at a median of 4 days post transplant occurred in 100% of patients and recovered at median day 10 and 13 days following autologous and allogeneic transplant respectively (median neutropenic period of 6 and 9 days respectively).
Fl- adulti kien hemm għadd assolut newtrofil < 0. 5x109/ l fil- medjan ta ’ 4 ġranet wara t- trapjant f’ 100% tal- pazjenti u kien hemm fejqan fil- gurnata medjana 10 u 13- il ġurnata wara t- trapjant awtologuż u alloġenejiku rispettivament (perijodu medjan newtropeniku ta '6 u 9 ġranet rispettivament).
Thrombocytopenia (< 25x109/ l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Tromboċitopenia (< 25x109/ l jew li għandhom bżonn transfużjoni tal- pjastrini) seħħet fil- medjan ta ’ bejn 5- 6 ġurnata f’ 98% tal- pazjenti.
Anaemia (haemoglobin < 8.0 g/ dl) occurred in 69% of patients.
Anemja (emoglobina < 8. 0 g/ dl) seħħet f’ 69% tal- pazjenti.
In paediatric patients, absolute neutrophil counts < 0.5x109/ l at a median of 3 days post transplant occurred in 100% of patients and lasted 5 and 18.5 days in autologous and allogeneic transplant respectively.
Fil- pazjenti pedjatriċi, l- għadd assolut newtrofil < 0. 5 x 109/ 1 f’ medjan ta ’ 3 ġranet ta ’ wara t- trapjant ġie irreġistrat f’ 100% tal- pazjenti u dam 5 u 18. 5 ġranet fi trapjant awtologuż u alloġenejiku rispettivament.
In children, thrombocytopenia (< 25x109/ l or requiring platelet transfusion) occurred in 100% of patients.
Fit- tfal, it- tromboċitopenija (< 25x109/ l jew kien hemm bżonn ta ’ transfużjoni tal - pjastrini) irriżultat f’ 100% tal- pazjenti.
Anaemia (haemoglobin < 8.0 g/ dl) occurred in 100% of patients.
Anemja (emoglobina < 8. 0 g/ d) irriżultat f’ 100% tal- pazjenti.
The Fanconi anaemia cells have hypersensitivity to cross-linking agents.
Iċ- ċelluli ta ’ l- anemja Fanconi għandhom sensittività eċċessiva għall- aġenti li għandhom rabta inkroċjata.
There is limited clinical experience of the use of busulfan as a component of a conditioning regimen prior to HSCT in children with Fanconi’ s anaemia.
L- esperjenzi kliniċi huma limitati dwar l- użu tal- busulfan bħala komponiment tar- regimen kondizzjonarju qabel l- HSCT fit- tfal li għandhom anemja Fanconi.
Therefore Busilvex should be used with caution in this type of patients.
Mela il- Busilvex għandu jintuża bil- kawtela f’ dawn it- tip ta ’ pazjenti.
Since busulfan is mainly metabolized through the liver, caution should be observed when Busilvex is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment.
Peress li l- busulfan hu prinċipalment metabolizzat minn ġol- fwied, wieħed għandu joqgħod attent meta il- Busilvex jkun użat f' pazjenti li diġà għandhom indeboliment tal- funzjoni tal- fwied aktar u aktar fil- każ ta ’ dawk li jbatu minn indeboliment sever epatiku.
It is recommended when treating these patients that serum transaminase, alkaline phosphatase, and bilirubin should be monitored regularly 28 days following transplant for early detection of hepatotoxicity.
Hu rrakkomandat li meta dawn il- pazjenti jkunu qed jiġu kkurati, għandu jkun hemm monitoraġġ regolari tas- serum transaminas, tal- fosfatas alkaliniku u tal- bilirubin għal 28 ġurnata wara t- trapjant għall- iskoperta bikrija tal- epatotossiċità.
Hepatic veno-occlusive disease is a major complication that can occur during treatment with Busilvex.
Matul it- trattament bil- Busilvex pazjent jista ’ jimrad bil- marda epatika veno- okklusiva li hi komplikazzjoni serja.
Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk (see section 4.8).
Pazjenti li kienu rċevew qabel terapija tar- radjazzjoni, li hi akbar jew daqs tlett ċikli ta ’ kemoterapija jew trapjant ta ’ celluli proġenitriċi minn qabel għandhom mnejn ikunu f’ riskju akbar (ara sezzjoni 4. 8).
Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with Busilvex due to a possible decrease in the metabolism of busulfan (See section 4.5).
Wieħed għandu joqgħod attent meta jieħu l- paracetamol qabel (inqas minn 72 siegħa) jew fl- istess ħin mal- Busilvex minħabba l- possibilità ta ’ tnaqqis fil- metaboliżmu tal- busulfan (ara sezzjoni 4. 5).
As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to Busilvex.
Hekk kif ġie dokumentat fi studji kliniċi, l- ebda pazjent li ngħata t- trattament ma esperjenza tamponad kardijaku jew tossiċitajiet kadijaċi oħra speċifiċi li għandhom x’ jaqsmu mal- Busilvex.
However cardiac function should be monitored regularly in patients receiving Busilvex (see section 4.8).
Biss il- funzjoni kardijaka għandha tiġi mgħassa regolarment f' pazjenti li qed jirċievu l- Busilvex (ara sezzjoni 4. 8).
4 Occurrence of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis was reported in Busilvex studies in one patient who died, although, no clear aetiology was identified.
4 Skond rapport dwar studji dwar il- Busilvex kien hemm każ ta ’ sindrom ta 'periklu respiratorju akut u falliment respiratorju assoċjat ma ’ fibrożi pulmonari interstizjali, dan il- pazjent miet, għalkemm, ma kienet identifikata l- ebda etjoloġija ċara.
In addition, busulfan might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents.
Barra minn dan, il- busulfan għandhom mnejn iwassal għal tossiċità pulmonari li għandha mnejn tkun addizzjonali ma ’ l- effetti ipproduċuti minn aġenti oħra ċitotossiċi.
Therefore, attention should be paid to this pulmonary issue in patients with prior history of mediastinal or pulmonary radiation (see section 4.8).
Għalhekk, wieħed irid jieħu ħsieb il- kwistjoni pulmonari f' pazjenti li diġà għandhom passat ta 'radjazzjoni medjastinali jew pulmonari (ara sezzjoni 4. 8).
Periodic monitoring of renal function should be considered during therapy with Busilvex (see section 4.8).
Wieħed għandu jqies jekk għandux ikun hemm monitoraġġ perjodiku tal- funzjoni renali matul it - terapija bil- Busilvex (ara sezzjoni 4. 8).
Seizures have been reported with high dose busulfan treatment.
Kien hemm rapporti ta ’ puplesiji meta ngħata trattament ta 'doża għolja ta ’ busulfan.
Special caution should be exercised when administering the recommended dose of Busilvex to patients with a history of seizures.
Wieħed għandu joqgħod attent ħafna meta jagħti d- doża rrakkomandata ta ’ Busilvex lill- pazjenti b’ passat ta ’ puplesiji.
Patients should receive adequate anti-convulsant prophylaxis.
Pazjenti għandhom jirċievu profilassi anti- konvulsanti adegwata.
In adults, all data with Busilvex were obtained using phenytoin.
Fl- adulti, id- dejta kollha bil- Busilvex kienu nkisbu waqt l- użu tal- fenitojin.
There are no data available on the use of other anticonvulsant agents such as benzodiazepines.
M’ hemm l- ebda dejta disponibbli dwar l- użu ta ’ aġenti oħra antikonvulsanti bħal ngħidu aħna benżodijażepini.
Thus, the effect of anticonvulsant agents (other than phenytoin) on busulfan pharmacokinetics is not known.
Mela, m’ hemmx tagħrif dwar l- effett ta ’ l- aġenti antikonvulżanti (barra l- fenitojin) fuq il- farmakokinetiċi busulfan.
(see sections 4.2 and 4.5).
(ara sezzjonijiet 4. 2 u 4. 5).
In paediatric patients, data with Busilvex were obtained using benzodiazepines or phenytoin.
Fil- każ ta ’ adulti pedjatriċi, id- dejta bil- Busilvex kienu nkisbu waqt l- użu tal- benżodijażepini u tal- fenitojin.
The increased risk of a second malignancy should be explained to the patient.
Ir- riskju ogħla ta ’ malinnjanza sekondarja għandu jkun spjegat lill- pazjent.
On the basis of human data, busulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen.
Skond il- bażi ta ’ dejta umana, il- busulfan ġie kklasifikat mill- Aġenzija Internazzjonali tar- Riċerka fuq il- Kanċer (IARC) bħala karċinoġen uman.
The World Health Association has concluded that there is a causal relationship between busulfan exposure and cancer.
L- Assoċjazzjoni Dinija tas- Saħħa ikkonkludiet li hemm relazzjoni kawżali bejn l- esponiment għall- busulfan u l- kanċer.
Leukaemia patients treated with busulfan developed many different cytological abnormalities, and some developed carcinomas.
Pazjenti li jbatu mill- lewkimja li ġew ikkurati bil - busulfan żviluppaw ħafna annormalitajiet differenti ċitoloġikali, u wħud żviluppaw karċinomi.
Busulfan is thought to be leukemogenic.
Il - busulfan hu meqjus bħala lewkemoġeniku.
Fertility: busulfan can impair fertility.
Fertilità: busulfan jista ’ jfixkel il- fertilità.
Therefore, men treated with Busilvex are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Busilvex.
Mela, irġiel li jkunu kkurati bil- Busilvex jingħataw parir li ma jnisslu l- ebda tarbija matul u sa 6 xhur wara t- trattament u jiksbu pariri fuq iċ- ċrijo- konservazzjoni ta ’ l- isperma qabel il- kura minħabba l- possibilità ta ’ infertilità irreversibbli kaġun tat- terapija bil - Busilvex.
Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients.
Pazjenti premenopawsali spiss ikollhom suppressjoni ovariana u amenorrea b' sintomi menopawsali.
Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
It- trattament bil- Busulfan f’ tifla preadoloxxenti fixkel il- bidu tal- pubertà minħabba l - falliment ovarjan.
Impotence, sterility, azoospermia, and testicular atrophy have been reported in male patients.
Kien irrapportat li pazjenti maskili esperjenzaw impotenza, sterilità, ażoospermja, u atrofija testikulari.
The solvent dimethylacetamide (DMA) may also impair fertility.
Is- solvent dimetilaċetamide (DMA) għandu mnejn ifixkel il- fertilità.
DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3)
DMA inaqqas il- fertilità ta 'l- annimali gerriema maskili u femminili (ara sezzjonijiet 4. 6 u 5. 3)
No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole.
Ma sar l- ebda esperiment speċifiku kliniku biex jassessja l- interazzjoni bejn mediċina u oħra bejn busulfan mogħti ġol- vini u itrakonażol.
From published studies, in adults administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.
Skond studji ppubblikati, fl- adulti, l- għoti tal- itrakonażol lill - pazjenti li qed jirċievu doża għolja ta 'busulfan għandu mnejn iwassal għat- tkeċċija mnaqqsa tal - busulfan.
Patients should be monitored for signs of busulfan toxicity when itraconazole is used as an antifungal prophylaxis with intravenous busulfan.
Pazjenti għandhom ikunu mgħassa għal sinjali ta 'tossiċità tal- busulfan meta jintuża l - itrakonażol bħala profilasi antifungali bil- busulfan mogħti ġol- vini.
Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
Studji ppubblikati dwar adulti ddiskrivew li ketobemidon (analġesiku) għandu mnejn ikun assoċjat ma ’ livelli għoljin plażmatiċi ta ’ busulfan.
Therefore special care is recommended when combining these two compounds.
Mela hu rrakkomandat li għandha tingħata kura speċjali meta ikun hemm taħlit taż- żewġ kompożizzjonijiet.
In adults, for the BuCy2 regimen it has been reported that the time interval between the last oral busulfan administration and the first cyclophosphamide administration may influence the development of toxicities.
Fl- adulti, għar- regimen BuCy2 ġie rrapportat li l- intervall tal- ħin bejn l- aħħar għotja mill- ħalq tal - busulfan u l- ewwel għotja tal- ċiklofosfamid għandu mnejn jinfluwenza l- iżvilupp tat- tossiċitajiet.
A reduced incidence of Hepatic Veino Occlusive Disease (HVOD) and other regimen- related toxicity have been observed in patients when the lag time between the last dose of oral busulfan and the first dose of cyclophosphamide is > 24hours.
Inċidenza mnaqqsa tal- Marda Okklussiva Vejina Epatika (HVOD) u ta ’ regimen- relattat mat- tossiċità kien nnotat f’ pazjenti meta l- perijodu ta ’ żmien bejn l- aħħar doża tal- busulfan mill- ħalq u l- ewwel doża ta ’ ċiklofosfamid hu > 24 siegħa.
In paediatric patients, for the BuMel regimen it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities.
Fil- pazjenti pedjatriċi, għar- regimen BuMel, kien innutat li l- għoti tal- melfalan inqas minn 24 siegħa wara l- aħħar għotja mill- ħalq tal- busulfan għandu mnejn influwenza l- iżvilupp tat- tossiċitajiet.
Paracetamol is described to decrease glutathione levels in blood and tissues, and may therefore decrease busulfan clearance when used in combination (see section 4.4).
5 Il- paracetamol hu deskritt li kapaċi jnaqqas il- livelli tal- glutatijon fid- demm u fit- tessuti, u għalhekk għandu mnejn inaqqas it- tkeċċija tal- busulfan meta jintużaw flimkien (ara sezzjoni 4. 4).
5 Phenytoin or benzodiazepines were administered for seizure prophylaxis in all patients in the clinical trials conducted with intravenous busulfan.
Fenitojin u l- benżodijażepini ngħataw għall- profilasi tal- puplesija fil- pazjenti kollha fl- istudji kliniċi li saru bil- busulfan mogħti ġol- vini.
The concomitant systemic administration of phenytoin to patients receiving high-dose busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase.
L- għoti sistematiku konkomitanti tal- fenitojin lill- pazjenti li ngħataw doża għolja tal- busulfan kien irrapportat li wassal għal żjieda fit- tkeċċija tal- busulfan, minħabba l- induzzjoni tal- glutatijon- S- transferas.
However no evidence of this effect has been seen in intravenous data. (see section 4.4) No interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan (see sections 4.2 and 4.4).
(ara sezzjoni 4. 4) Ma kienet irrapportata l- ebda interazzjoni meta l- benżodijażepini bħal ngħidu aħna dijażepam, klonażepam jew lorażepam kienu wżati biex jimpedixxu l- puplessiji b’ doża għolja ta ’ busulfan (ara sezzjonijiet 4. 2 u 4. 4).