qanastek/EMEA-V3 huggingface dataset:
Before starting with Zevalin following chemotherapy, the number of your blood platelets should be more than 150,000/ mm3 and the number of your white blood cells should be more than 1,500/ mm3.
Qabel ma tibda Zevalin wara kimoterapija, in- numru ta ’ plejtlits fid- demm tiegħek għandu jkun aktar minn 150, 000/ mm3 u n- numru ta ’ ċelluli bojod tad- demm tiegħek għandu jkun aktar minn 1, 500/ mm3.
Your doctor will need to think carefully whether to give you Zevalin in some cases:
It- tabib tiegħek irid jaħsibha sew jekk jużax Zevalin f’ każi fejn:
If more than a quarter of your bone marrow contains malignant abnormal cells.
Jekk aktar minn kwart mill- mudullun tiegħek fih ċelluli malinni mhux normali Jekk diġà ħadt kura ta ’ raġġi minn barra (ċertu tip ta ’ radjuterapija) fuq iktar minn kwart mill- mudullun tiegħek
If you have had external beam radiation (a type of radiotherapy) to more than a quarter of your bone marrow.
Jekk tirċievi Zevalin waħdu u n- numru ta ’ plejtlits fil- ġisem hu inqas min 100, 000 / mm3
If you receive Zevalin alone and the number of your blood platelets is fewer than 100,000/ mm3
• •
If the number of your blood platelets is fewer than 150,000/ mm3 after chemotherapy
Jekk wara kimoterapija n- numru ta ’ plejtlits fid- demm tiegħek huwa inqas minn 150, 000/ mm3 Jekk in- numru ta ’ ċelluli bojod tiegħek huma inqas minn 1500 / mm3
If you have had a bone marrow transplant or have received blood stem cells in the past.
Jekk sarlek trapjant tal- mudullun jew ingħatajt ċelluli staminali fil- passat.
If you have had certain other types of antibody treatment before starting Zevalin, you may be more likely to have an allergic reaction (hypersensitivity).
Jekk diġà ingħatajt xi kura bl- antikorpi qabel ma bdejt tieħu Zevalin, għandek iktar ċans li tiżviluppa allerġija (sensittività eċċessiva).
You may therefore need to be tested for special antibodies.
Għalhekk jaqbel li tagħmel testijiet biex tiċċekkja jekk fid - demm hemmx ċertu tip speċjali ta ’ antikorpi.
Your doctor will tell you if this applies to you.
B’ hekk, it- tabib tiegħek ikun jista ’ jgħidlek jekk dan jgħoddx għalik.
After treatment with Zevalin, and if you your doctor plans to treat you with some other antibody, please tell the doctor about your treatment with Zevalin.
Wara l- kura b’ Zevalin u jekk it- tabib tiegħek għandu f’ moħħu li jikkurak b’ xi antikorp ieħor, jekk jogħġbok għid lit- tabib bil- kura li kellek b’ Zevalin.
This will help avoid a possible allergic reaction (hypersensitivity).
Dan jgħin biex jiġu evitati allerġiji (sensittività eċċessiva).
31 During or after you are treated with rituximab severe infusion reactions may occur.
Waqt jew wara l- kura tiegħek b’ rituximab jistà jkun hemm reazzjonijiet qawwija għall - infuzjoni.
Rituximab is the medication which is given to you on day 1 or directly before Zevalin treatment (see 3.
Rituximab huwa mediċina li tingħatalek fl- ewwel ġurnata jew eżatt qabel kura b’ Zevalin (ara 3.
How to use Zevalin).
Kif jintuża Zevalin).
Symptoms associated with such infusion reactions may include pain in the breast, heart failure, heart attack, breathing difficulties, severe breathlessness, bronchospasm, accumulation of tissue fluid causing swelling mostly in the face (angioneurotic edema), flushing, reduction of blood pressure.
Sintomi assoċjati mà dawn ir- reazzjonijet għall- infuzjoni jistu jinkludu uġigħ fis- sider, insuffiċjenza tal- qalb, attakk tal- qalb, diffikultajiet biex tieħu n- nifs, qtugħ tà nifs qawwi, akkumulazzjoni ta ’ fluwidu tat- tessuti li jikkawża nefħa l- aktar fil- wiċċ (edima anġionewrotika), fwawar, titbaxxa il- pressjoni tad- demm.
If you get any of these symptoms, inform your doctor immediately.
Jekk ikollok xi sintomi minn dawn, kellem lit- tabib tiegħek minnufiħ.
The appearance of such infusion-related symptoms during or after you are treated with Zevalin is less frequent and less severe.
31 Il- probabbilità li jkollok sintomi bħal dawn relatati mà l- infuzjoni waqt jew wara l- kura tiegħek b’ Zevalin hija inqas u s- sintomi jkunu anqas qawwija.
If you notice a skin and mucous membrane reaction during or after treatment with the Zevalin regimen, tell your doctor immediately.
Jekk tinnota xi rejazzjoni fil- ġilda u fil- membrana mukosa waqt jew wara kors ta ‘ kura b’ Zevalin għarraf lit- tabib tiegħek immedjatament.
This is because in rare instances such reactions have been reported to develop into severe cases, even with the possibility of death.
Dan iseħħ minħabba li f’ każijiet rari rejazzjonijiet bħal dawn ġew irrappurtati li żviluppaw f’ każijiet severi, sa ’ possibilita ’ ta ’ mewt.
Such a reaction may occur days or months after you have been given Zevalin and/ or rituximab.
Reazzjoni bħal din tista ’ sseħħ jiem jew xhur wara li tkun ingħatajt Zevalin u/ jew rituximab.
If you experience a reaction of your skin and mucous membrane, your doctor should stop to give you any further components of the Zevalin regimen.
Jekk ikollok reazzjoni tal- ġilda u tal - membrana mukuża, it- tabib tiegħek għandu jieqaf milli jagħtik kwalunkwe komponenti oħrajn tal- kors ta ’ Zevalin.
The safety of immunisation with any vaccine, particularly live viral vaccines, following therapy with Zevalin has not been studied.
Is- sigurtà ta ’ l- immunizzazzjoni bi kwalunkwe vaċċin, l- aktar vaċċini b’ virus ħaj, wara terapija b’ Zevalin, għadha ma ġietx studjata.
The ability of the body to respond to any vaccine has also not been studied.
Il- ħila tal- ġisem li jirrispondi għal kull tip ta ’ vaċċini wkoll ma ġietx studjata.
If you notice pain, burning, stinging or another reaction at the infusion site during the Zevalin treatment, tell your doctor.
Jekk tinnota uġigħ, ħruq, tingiż jew reazzjoni oħra fis- sit ta ’ l- infużjoni waqt kura b’ Zevalin, għid lit- tabib tiegħek.
He will immediately stop the infusion and restart it using another vein.
Huwa jwaqqaflek immedjatament l- infużjoni u jerġa ’ jibdijielek billi juża vina oħra.
Your doctor will closely monitor you during the infusion of Zevalin to avoid that leakage to the surrounding tissue (extravasation).
It- tabib tiegħek ser jissorvejlak mill- viċin waqt l- infużjoni ta ’ Zevalin biex jevita ’ dik it- tnixxija got - tessut tal- madwar (ekstravasazzjoni).
There is no experience with Zevalin in patients with lymphoma of the brain and/ or spinal cord.
M’ hemm l- ebda esperjenza b’ Zevalin f’ pazjenti b’ limfoma tal- moħħ u/ jew sinsla tad - dahar.
Using any other medicines:
Meta tuża xi mediċini oħra:
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tuża jew użżajt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
This includes especially: • growth factor such as G-CSF, as your doctor should interrupt this therapy already (two weeks) before giving you Zevalin
Dan jinkludi b’ mod speċjali: • Fattur tat- tkabbir bħal G- CSF, għax it- tabib tiegħek għandu jwaqqaf din it- terapija minn qabel (ġimagħtejn), qabel jagħtik Zevalin
Taking Zevalin with food and drink:
Meta tieħu Zevalin ma ’ l- ikel u max- xorb:
Zevalin is infused into a vein.
Zevalin jingħata ġo vina.
An influence by food or drinks is thus not to be expected.
Għalhekk, ma huwa mistenni l- ebda effett mill- ikel jew mix- xorb.
Pregnancy should be excluded before you start treatment, during treatment and for a year after treatment.
Jekk hemm ċans li tinqabad tqila, uża kontraċezzjoni affidabbli (eżempju: pilloli, impjanti, tappijiet, kondom jew IUD) Qabel ma tibda l- kura, waqt il- kura u għal sena wara l- kura t- tqala trid tiġi eskluża.
Men who have been given Zevalin and who could become fathers must use reliable contraception during and for a year after stopping treatment.
Irġiel li jingħataw Zevalin u li jista ’ jkollom it- tfal għandhom jużaw il- kontraċezzjoni meħtieġa kemm matul il- kura kif ukoll għal sena wara l- kura.
Talk to your doctor before starting breast-feeding after the end of treatment because antibodies are excreted in human milk.
Kellem it- tabib qabel tibda tredda ’ għaliex wara l- kura, l- antikorpi jsibu ruħhom fil- ħalib ta ’ l- omm ukoll.
It is possible that Zevalin will affect your ability to drive and to operate any tools or machines as dizziness is a common side effect.
Hu possibli li Zevalin jaffettwa l- ħila tiegħek li ssuq jew li tħaddem magni, minħabba li wieħed mill - effetti mhux mixtieqa komuni hu li tista ’ tħossok stordut.
Please take care, and do not try to drive or operate machines until you are sure you are not affected.
Jekk jogħġbok oqgħod attent u tippruvax issuq jew tħaddem magni jekk ma tkunx ċert li m’ intix stordut.
32 Children and adolescents:
Tfal u adoloxxenti:
Children and adolescents should not be given Zevalin.
It- tfal u l- adoloxxenti m' għandhomx jingħataw Zevalin.
The safety and how it works in them have not yet been tested.
Għadhom ma sarux studji dwar is- sigurtà u l- mod kif Zevalin jaħdem fuqhom.
How to use Zevalin
KIF GĦANDEK TUŻA ZEVALIN
You will only be given Zevalin by an experienced professional and it will only be handled by properly qualified staff in hospital.
Inti tingħata Zevalin biss minn professjonisti li għandhom esperjenza fuq l- użu ta ’ din il- mediċina u din tkun immaniġġjata fl- isptar biss minn persuni li huma kkwalifikati jagħmlu hekk.
Before you are given Zevalin itself, you are given another medicine – called rituximab – to improve the effect of Zevalin.
Qabel ma tingħata Zevalin, inti tingħata mediċina oħra li jisimha rituximab, biex Zevalin jaħdem aħjar.
The first two infusions of your treatment are actually rituximab.
L- ewwel żewġ infużjonijiet tal- kura tiegħek fil- fatt huma ta ’ rituximab.
You will make 2 hospital visits, a week apart.
Inti jkollok tmur l- isptar darbtejn, ġimgħa l- bogħod minn xulxin.
On your first visit (day 1) you will be given o One rituximab infusion
Fl- ewwel żjara (1 jum) inti tingħata: o Infużjoni waħda ta ’ rituximab
On your second visit (day 7, 8, or 9) you will be given o One rituximab infusion o One Zevalin infusion straight afterwards.
Fit- tieni żjara (7, 8 jew 9 jum) inti tingħata: o Infużjoni waħda ta ’ rituximab o U infużjoni ta ’ Zevalin eżatt warajha
You will be given a total of 3 infusions.
B’ kollox tingħata 3 infużjonijiet.
That will be the end of the treatment.
B’ hekk il- kura tispiċċa.
An infusion means that the medicine is given by a drip into a vein.
Infużjoni tfisser li l- mediċina tingħata minn dripp ġol- vina.
Zevalin infusions usually take about 10 minutes.
L- infużjoni ta ’ Zevalin is- soltu tieħu madwar 10 minuti.
Rituximab infusions can take an hour or two.
Infużjoni ta ’ rituximab tieħu bejn siegħa u sagħtejn.
The doctor will calculate your individual dose.
Kemm jingħata Zevalin It- tabib jikkalkola d- doża għalik.
This depends on your body weight and the number of your blood platelets.
Din tiddependi fuq il- piż u fuq in- numru ta ’ plejtlits fid- demm tiegħek.
The amount of radiation that your body will be exposed to during a course of Zevalin is smaller than it would be in radiotherapy.
Wara li tkun ingħatajt Zevalin L- ammont ta ’ radjazzjoni li ġismek jiġi espost għaliha tul il- kura b’ Zevalin hu inqas minn dik ta ’ meta wieħed jingħata r- radjuterapija.
With this type of radioactivity, there is no direct effect of radiation outside the body.
B’ din it- tip ta ’ radjuattivita, ma hemmx effett dirett tar- radjazzjoni barra mill- ġisem.
You are not exposing other people to radiation.
M’ intiex qed tesponi nies oħra għar- radjazzjoni.
A small part of the radioactivity will leave your body through your urine.
Parti żgħira mir- radjazzjoni tiġi mneħħija minn ġismek fl- awrina.
The remainder will decay within the body, leaving no radioactive remains.
Il- bqija, tinqered f’ ġismek bla ma tħalli ebda attività radjuattiva.
There is one simple precaution because of the radioactivity:
Trid tieħu prekawzjoni waħda minħabba r- radjuattivita:
Wash your hands especially thoroughly after urinating for a week after the Zevalin infusion.
Aħsel idejk sew ħafna wara li tgħaddi l- awrina għal ġimgħa wara l- infużjoni ta ’ Zevalin.
Your doctor will be taking small samples of blood at regular intervals in order to monitor blood-platelet and white-blood-cell counts.
F’ intervalli regolari it- tabib jibda jeħodlok kampjuni żgħar ta ’ demm biex ikun jista ’ jiċċekkja l - għadd ta ’ plejtlits u ta ’ ċelluli bojod fid- demm.
These tend to show shortages around day 60 after start of treatment.
Dawn il- livelli għandhom mnejn ikunu baxxi madwar jum 60 ta ’ wara l- bidu tal- kura.
In connection with this, your physician will ensure that all measures are taken in case of infectious events.
Minħabba dan, it- tabib għandu jaċċerta ruhu li jieħu l- passi meħtieġa f’ każi ta ’ infezzjonijiet.
In case you have had too much Zevalin administered, your doctor will stop the administration of Zevalin and treat your symptoms (e. g. with growth factors).
Jekk tirċievi Zevalin aktar milli suppost F’ każ li inti ġejt mogħtija wisq aktar Zevalin, it- tabib tiegħek ser iwaqqaf l- għotja ta ’ Zevalin u jikkura s- sintomi tiegħek (e. ż. b’ fattur ta ’ tkabbir).
In such a case you also may receive stem cells to manage the toxic effects on your blood cells.
F’ każ b dan int tista ’ tirċievi wkoll ċelluli staminali biex jimmaniġġjaw l- effetti tossiċi fuq iċ- ċelluli tad- demm teigħek.
In case you may have received only the radioactive substance yttrium, your doctor will treat you as described in the product information of yttrium-90.
F’ każ li forsi inti rċevejt biss is - sustanza radjuattiva yttrium, it- tabib tiegħek ser jikkurak kif deskritt fl- iformazzjoni tal- prodott ta ’ yttrium- 90.
Possible side effects
X’ EFFETTI OĦRA JISTA ’ JKOLLU
Like all medicines, Zevalin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Zevalin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Because many side effects resemble the effects of the illness, it is not always clear if a reaction seen in clinical trials was due to Zevalin or not.
Peress li ħafna minn dawn l- effetti sekondarji jixbhu lil dawk tal- marda minnha nfisha, mhux dejjem ċar jekk ir- reazzjoni li ġrat waqt il- provi kliniċi kienetx minħabba l- użu ta ’ Zevalin.
If you are worried by any of these side effects, ask your doctor for advice.
Jekk qed tħossok inkwetat/ a dwar dawn l- effetti sekondarji, ħu parir mingħand it- tabib tiegħek.
For a few side effects even death has been reported either in clinical trials or in post marketing experience.
33 Għal xi ftit mill- effetti sekondarji, anke l- mewt kienet irrappurata, kemm fil- provi kliniċi kif wkoll fl - esperjenza ta ’ wara t- tqegħid fis- suq.
These side effects are marked with an asterisk (*).
Dawn l- effetti sekondarji huma mmarkati b' asterisk (*).
You should tell your doctor immediately, if you notice any of the symptoms of these side effects as described below.
Għandek tkellem lit- tabib tiegħek immedjatment jekk tinnota xi wieħed mis- sintomi ta 'dawn l- effetti sekondarji kif deskritt hawn taħt.
► Tell your doctor immediately:
► Għid lit- tabib tiegħek immedjatament:
if you notice an infection (e.g. fever, chills), symptoms of blood poisoning (e.g. fever and chills, changes in mental status, rapid breathing, increased heart rate, decreased urine output, low blood pressure, shock, problems with bleeding or clotting), or breathing difficulties.
Jekk tinnota xi infezzjoni (e. ż. deni, tertir), sintomi ta ’ vvalenar tad- demm (e. ż. deni u tertir, tibdil fl- istat mentali, nifs mgħaġġel, rata tal- qalb miżjuda, tnaqqis fit- tneħħija ta ’ l - awrina, pressjoni tad- demm baxxa, xokk, problemi bil- fsada, jew tagħqid), jew diffikultajiet biex tieħu n- nifs.
if you notice any unusual bruising, more bleeding then usual after injury, fever, or if you feel unusually tired or breathless.
Jekk tinnota xi tbenġil mhux tas- soltu, aktar fsada milli suppost wara korriment, deni, jew jekk tħossok għajjien jew bla nifs aktar mis- soltu.
In a small percentage of cancer patients participating in certain Zevalin studies, other types of cancer have been reported that relate to the blood: myelodysplastic syndrome or acute myeloid leukaemia (AML), which can even lead to death.
F’ persentaġġ żgħir ta ’ pazjenti bil- kanċer li pparteċipaw f’ ċertu studji b’ Zevalin, tipi oħra ta ’ kanċer ġew irrappurtati li jirrelataw mad- demm: sindromu mjelodisplastiku jew lewkimja mjelojda akuta (AML), li tista ’ twassal ukoll għal mewt.
The risk of these secondary cancers occurring after therapy with alkylating agents is already well- known to doctors.
Ir- riskju ta ’ dawn il- kanċers sekondarji li jseħħu wara terapija b’ sustanzi alkylating hija diġà magħrufa sew mit- tobba.
However, as previous treatment with alkylating agents is widespread prior to Zevalin treatment, one does not know the exact role of Zevalin when these cancers occur after treatment with Zevalin, since radiation may potentially also cause these cancers.
Iżda, minħabba li kura minn qabel b’ sustanzi alkylating hija komuni qabel kura b’ Zevalin, wieħed ma jafx ir- rwol eżatt ta ’ Zevalin meta dawn il- kanċers iseħħu wara kura b’ Zevalin, minħabba li radjazzjoni tista ’ potenzjalment ukoll tikkawża dawn il- kanċers.
Your doctor will carefully balance the potential risks with Zevalin against the expected benefits before treating your disease with Zevalin.
It- tabib tiegħek jibbilanċja b’ attenzjoni r- riskji potenzjali b’ Zevalin kontra l- benefiċċji mistennija qabel jikkura l - marda tiegħek b’ Zevalin.
Below we list possible side effects by the parts of the body they affect and by how common they are.
Taħt inniżżlu l- effetti sekondarji possibbli bil- parti tal- ġisem li jaffettwawu b’ kemm huma komuni.
• Very common means 10 or more in every 100 patients are likely to get these:
• Komuni ħafna tfisser bejn 10 jew aktar minn kull 100 pazjent huma probabbli li jkollhom dawn:
- bruising, low numbers of platelets, red or white blood cells*,
tbenġil, numru baxx ta ’ plejtlits, ċelluli tad- demm ħomor jew bojod *,
- feeling sick (nausea),
tħossok ma tiflaħx (tqalligħ),
- weakness, fever, chills (rigor).
debbulizza, deni, tkexkix ta ’ bard (rogħda).
• Common means between 1 and 10 in every 100 patients are likely to get these.
• Komuni tfisser bejn 1 u 10 minn kull 100 pazjent huma probabbli li jkollhom dawn:
- -infection*, blood poisoning*, infection in the lungs which can lead to breathing difficulties
infezzjoni *, ivvalenar tad- demm *, infezzjoni fil- pulmuni li tista ’ twassal għal diffikutajiet biex
(pneumonia)*, urinary tract infection, which can cause pain when passing urine, fungal infections in the mouth such as oral thrush,
tieħu n- nifs (pnewmonja) *, infezzjoni fl- apparat unrinarju li tista ’ tikkawża uġigħ meta tgħaddi l - awrina, infezzjoni tal- moffa fil- ħalq bħal infezzjoni tal- moffa fil- ħalq, uġigħ tat- tumur, sindromu mjelodisplastiku / lewkimja mjelojda akuta (ara isfel) *,
- white blood-cell depletion leading up to fever (febrile neutropenia), decreased levels of all blood
tnaqqis taċċelluli tad- demm l- bojod li jwassal għal deni (newtropenja febrili), livelli mnaqqsa taċ -
cells possibly leading to tiredness, frequent infections, bleeding and fever (pancytopenia)*; lower number of lymphocytes (lymphocytopenia),
ċelluli tad- demm kollha li possibilment iwasslu għal għejja, infezzjonijiet frekwenti, fsada u deni (panċitopenja) *; numru mnaqqas tal- limfoċiti (limfoċitopenja), reazzjonijiet ta ’ sensittività eċċessiva,
- severe loss of appetite leading to weight loss (anorexia),
telf qawwi ta ’ l- aptit li jwassal għal telf fl- aptit (anoressija),
- feeling anxious, trouble sleeping,
tħossok ansjuż, problemi biex torqod,
- dizziness, headache,
sturdament, uġigħ ta ’ ras,
- bleeding due to lower platelet count*,
fsada minħabba għadd aktar baxx ta ’ plejtlits *,
- cough, runny nose,
sogħla, mnieħer inixxi,
- being sick (vomiting), stomach pain, diarrhea, indigestion, throat irritation, constipation,
tħossok ma tiflaħx (rimettar), uġigħ ta ’ żaqq, indiġestjoni, irritazzjoni tal- griżmejn, stitikezza,
- rash, itching.
raxx, ħakk.
- joint pain, aching muscles, back pain, neck pain,
uġigħ fil- ġogi, uġigħ fil- muskoli, uġiġħ fid- dahar, uġigħ fl- għonq,
- pain, flu-like symptoms, generally feeling unwell, swelling caused by build-up of fluid in the arms
uġigħ, sintomi bħal tar- riħ, tħossok ġeneralment mhux tajjeb, nefħa kkawżata minn
and legs and other tissues, increased sweating.
akkumulazzjoni ta ’ fluwidu fid- dirgħajn u fir- riġlejn u f’ tessuti oħra, żieda fl- għaraq.
• Uncommon means between 1 and 10 in every 1,000 patients are likely to get these.
34 • Mhux komuni tfisser bejn 1 u 10 minn kull 1, 000 pazjent huma probabbli li jkollhom dawn:
- f ast heart rate.
rata tal- qalb mgħaġġla,
• Rare means between 1 and 10 in every 10,000 patients are likely to get these.
• Rari tfisser bejn 1 u 10 minn kull 10, 000 pazjent huma probabbli li jkollhom dawn: ċertu tumur beninju fil- moħħ (meninġjoma),
- bleeding in the head due to lower platelet count*.
fsada fir- ras minħabba għadd aktar baxx tal- plejtlits *,
In patients where Zevalin is used following remission induction therapy, infections were observed more frequently than described above (very common).
F’ pazjenti fejn Zevalin jintuża wara terapija ta ’ induzzjoni ta ’ remissjoni, infezzjonijiet kienu osservati aktar frekwenti minn kif deskritt fuq (komuni ħafna).
In addition, the following side effects were observed in these patients:
Barra minn hekk, f’ dawn il- pazjenti kienu osservati l- effetti sekondarji li ġejjin:
• Very common:
• Komuni ħafna: għeja
- red spots under the skin (petechia)
dbabar ħomor taħt il- ġilda (petikja)
• Common:
• Komuni: pressjoni għolja
- high blood pressure
-
- low blood pressure
pressjoni baxxa
- suppression of menstrual periods
soppressjoni tal- pirjids menstrwali
Skin and subcutaneous system
Ġilda u fit- tessuti ta ’ taħt il- ġilda
Reaction of the skin and/or mucous membranes with fatal outcome has been reported (Stevens- Johnson Syndrome).
Rejazzjoni fil- ġilda u/ jew membrani mukożi b’ riżultat fatali ġew irrappurati (Sindromu Stevens - Johnson).
A few cases have been reported where Zevalin leaked from the vein to the surrounding tissue, which then inflamed (infusion site dermatitis) and scars develop (infusion site desquamation) of the skin at the infusion site.
Ftit każijiet ġew irrapurtati fejn Zevalin nixxa mill- vina għal ġot- tessuti tal- madwar, li wara ffjammaw (dermatite fis- sit ta ’ l- infużjoni) u żviluppaw ċikatriċi (derskwamazzjoni fis- sit ta ’ l- infużjoni) tal- ġilda fis- sit ta ’ l- injezzjoni.
Radiation due to Zevalin might cause damage to tissue around tumors of the lymph system and might cause complications due to swelling of such tumors of the lymph system.
Radjazzjoni minħabba Zevalin tista ’ tikkawża ħsara lit- tessut ta ’ madwar it- tumuri tas- sitema limfatika u tista ’ tikkawża kumplikazzjonijiet minħabba nefħa f’ tumuri tas- sistema limfatika bħal dawn.
How to store Zevalin
KIF TAĦŻEN ZEVALIN
35 Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Zevalin after the expiry date which is stated on the pack.
Tużax Zevalin wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Store in a refrigerator (2°C - 8°C) Do not freeze.
Tagħmlux fil- friża.
Store in the original package in order to protect from light.
Aħżen fil- kontenitur oriġinali biex tipproteġih mid- dawl.
After radiolabeling:
Wara r- radjo- tikkettar:
Store at 2°C - 8°C and protect from light.
Aħżen f’ temperatura ta ’ bejn 2°C – 8°C u ipproteġih mid- dawl.
Storage should be in accordance with national regulations for radioactive materials.
Dan il- prodott għandu jinħażen skond ir- regolamenti nazzjonali fuq il- ħażna ta ’ materjali radjuattivi.
What Zevalin contains
X’ fih Zevalin
• The active substance is ibritumomab tiuxetan (3.2 mg/ 2 ml).
• Is- sustanza attiva hi Ibritumomab tiuxetan (3. 2mg/ 2ml)
dodecahydrate, sodium hydroxide, potassium dihydrogen phosphate, potassium chloride, pentetic acid, hydrochloric acid (diluted), water for injection
• Sustanzi oħra jinkludu: - fil- kunjett ta ’ ritumomab tiuxetan: sodium chloride, ilma għall- injezzjoni - fil- kunjett ta ’ sodium acetate: sodium acetate, ilma għall- injezzjoni - fil- kunjett tal- baffer tal- preparazzjoni: soluzzjoni ta ’ l- albumina umana, sodium chloride, disodium phosphate dodecahydrate, sodium hydroxide, potassium dihydrogen phosphate, potassium chloride, pentetic acid, hydrochloric acid (dilwit), ilma għall- injezzjoni
What Zevalin looks like and contents of the pack:
Id- Dehra ta ’ Zevalin u l- kontenuti tal- pakkett:
Zevalin is a kit for radiopharmaceutical preparation for infusion.
Zevalin huwa pakkett għall- preparazzjoni radjufarmaċewtika għall- infużjoni.
Clear, colourless solution.
Soluzzjoni mingħajr kulur u ċara.
- One ibritumomab tiuxetan vial
- Vjala waħda b’ ibritumomab tiuxetan
- One sodium acetate vial
- Vjala waħda b’ sodium acetate
- One formulation buffer vial
- Vjala waħda ta ’ formulazzjoni ta ’ buffer
- One empty reaction vial
- Vjala waħda tar- reazzjoni wieħed vojt
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
What is Ziagen?
X’ inhu Ziagen?
Ziagen is a medicine containing the active substance abacavir.
Ziagen hija mediċina li fiha s- sustanza attiva abacavir.
It is available as yellow capsule-shaped tablets (300 mg) and as an oral solution (20 mg/ ml).
Tiġi bħala pilloli forma ta ’ kapsuli sofor (300 mg) u bħala soluzzjoni orali (20 mg/ ml).
What is Ziagen used for?
Għal xiex jintuża Ziagen?
Ziagen is an antiviral medicine.
Ziagen hija mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults and children who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Tintuża flimkien ma ’ mediċini antivirali oħra biex tittratta adulti u tfal li jkunu infettati bil- virus ta ’ l- immunodefiċjenza umana (HIV), il- vajrus li jikkawża s- sindromu tad - defiċenza immunitarja (l- AIDS).
How is Ziagen used?
Kif jintuża Ziagen?
Treatment with Ziagen should be prescribed by a doctor who has experience in the management of HIV infection.
It- trattament b’ Ziagen għandu jiġi preskritt minn tabib li jkollu esperjenza fil- ġestjoni ta ’ infezzjoni ta ’ l- HIV.
The recommended dose of Ziagen for patients over 12 years of age is 600 mg daily, either as 600 mg once a day or 300 mg twice a day.
Id- doża rakkomandata ta ’ Ziagen għal pazjenti ta ’ iktar minn 12- il sena hija ta ’ 600 mg kuljum jew 300 mg darbtejn kuljum.
In children aged below 12 years, the dose depends on body weight.
Fi tfal ta ’ inqas minn 12- il sena d- doża tiddependi fuq il- piż tal- ġisem.
Children taking Ziagen tablets should be closely monitored for side effects.
Tfal li jieħdu l- pilloli Ziagen għandhom jiġu osservati mill- qrib għal effetti sekondarji.
Information on the use of Ziagen in children aged below three months is very limited.
Tagħrif dwar l- użu ta ’ Ziagen fit- tfal bl- età ta ’ inqas minn 3 xhur huwa limitat.
Ziagen tablets should ideally be swallowed without crushing.
Ziagen jista ’ jittieħed mal- ikel jew fuq stonku vojt u dawn il- pilloli għandhom jinbelgħu mingħajr ma jinkissru.
Patients who cannot swallow tablets should use the oral solution, or they may crush and add the tablets to a small amount of food or drink, before taking the dose immediately.
Pazjenti li ma jistgħux jibilgħu pilloli għandhom jieħdu s- soluzzjoni orali, jew jistgħu jidħnu l- pilloli u jżiduhom ma ’ ammont żgħir ta ’ ikel jew xorb dritt qabel ma jieħdu d- doża.
Before starting treatment with Ziagen, all patients should have a test to find out if they have a specific gene called ‘ HLA-B (type 5701 )’.
Qabel ma jinbeda trattament b’ Ziagen, il- pazjenti kollha għandu jkollhom test għall- identifikazzjoni ta ’ ġene speċifika ‘ HLA- B (type 5701) ’.
Patients with this gene have an increased risk of having an allergic reaction to abacavir, so they should only take Ziagen if there are no other treatment options.
Pazjenti b’ din il- ġene għandhom riskju ikbar li jkunu allerġiċi għal abacavir u, għalhekk għandhom jieħdu biss Ziagen jekk m’ hemm l- ebda trattament alternattiv ieħor.
Patients who take Ziagen must be given the special alert card that summarises the key safety information about the medicine.
Il- pazjenti li jieħdu Ziagen għandhom jingħataw il- kard ta ’ twissija speċjali li tagħti it- tagħrif ewlieni fil- qosor dwar is- sigurtà tal- mediċina.
How does Ziagen work?
Kif jaħdem Ziagen?
The active substance in Ziagen, abacavir, is a nucleoside reverse transcriptase inhibitor (NRTI).
Is- sustanza attiva f’ Ziagen, abacavir, hu nucleoside reverse transcriptase inhibitor (NRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Jimblokka l- attività tar- reverse transcriptase, enzim prodott mill- HIV li jippermettilu li jinfetta ċ- ċelloli u jagħmel iktar vajrusis.
Ziagen does
Billi jimblokka dan l- enzim, Ziagen, meħud flimkien ma ’ mediċini antivirali oħra, inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell baxx.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Ziagen ma jfejjaqx l- infezzjoni ta ’ l- HIV 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
©European Medicines Agency, 2008 Reproduction is authorised provided the source is acknowledged jew l- AIDS, iżda jista ’ jbiegħed il- ħsara lis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mardiet marbuta ma ’ l- AIDS.
How has Ziagen been studied?
Kif ġie studjat Ziagen?
Ziagen has been studied in six main studies including 1,843 HIV-infected adults.
Ziagen ġie studjat f’ sitt studji ewlenin li fihom ħadu sehem 1, 843 adult infettati bl- HIV.
Ziagen was taken alone, or added to the combination of lamivudine and zidovudine (other antiviral medicines) or the patients’ existing HIV treatment.
Ziagen ittieħed waħdu, jew flimkien ma ’ kombinazzjoni ta ’ lamivudine u zidovudine (mediċini antivirali oħra) jew mat- trattament eżistenti ta ’ l- HIV tal- pazjent.
One study compared the effects of Ziagen taken once and twice a day, in combination with lamivudine and efavirenz (other antiviral medicines) in 784 patients.
Studju wieħed qabbel l- effetti ta ’ Ziagen meħud darba jew darbtejn kuljum, flimkien ma ’ lamivudine u efavirenz (mediċini antivirali oħra) f’ 784 pazjent.
Ziagen has also been studied in three studies including 489 HIV-infected children aged between three months and 18 years.
Ziagen ġie studjat ukoll fi tliet studji li fihom ħadu sehem 489 tifel u tifla infettati bl - HIV bl- età ta ’ bejn tliet xhur u 18- il sena.
Ziagen’ s effects were compared with other antiviral medicines, placebo (a dummy treatment) or no treatment.
L- effetti ta ’ Ziagen tqabblu ma ’ mediċini antivirali oħra, ma ’ plaċebo (trattament finta) jew ma ’ ebda trattament.
The main measures of effectiveness were the effect of Ziagen on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count).
Il- mezzi ewlenin tal- kejl ta ’ l- effikaċja kienu l- effetti ta ’ Ziagen fuq il- livelli ta ’ l- HIV fid- demm (tagħbija virali) u n- numru ta ’ CD4 T- cells fid - demm (CD4 cell count).
CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Is- CD4 T- cells huma ċelloli tad- demm bojod li huma importanti biex jgħinu fil- ġlieda kontra l- infezzjoni iżda li jinqatlu mill- HIV.
What benefit has Ziagen shown during the studies?
X’ inhu l- benefiċċju ta ’ Ziagen li ntwera f’ dawn l- istudji?
In all studies, Ziagen caused a decrease in viral loads, particularly when taken with other antiviral medicines.
Fl- istudji kollha, Ziagen wassal għal tnaqqis fit- tagħbijiet virali, partikolarment meta ttieħed ma ’ mediċini antivirali oħra.
It was more effective than placebo, and as effective as other antiviral medicines in reducing viral loads.
Kien iktar effettiv mill- plaċebo, u effettiv daqs mediċini antivirali oħra fit - tnaqqis tat- tagħbijiet virali.
Patients receiving Ziagen also had increases in their CD4 cell counts.
Il- pazjenti li kienu qed jingħataw Ziagen ukoll kellhom żidiet fl- għadd ta ’ ċelloli ta ’ CD4 fid- demm.
After 16 weeks of treatment, 77% of the adults taking Ziagen with lamivudine and zidovudine had viral loads below 400 copies/ ml (67 out of 87), compared with 38% of the adults taking lamivudine and zidovudine alone (33 out of 86).
Wara 16- il ġimgħa trattament, 77% mill- adulti li kienu qed jieħdu Ziagen ma ’ lamivudine u zidovudine kellhom tagħba virali ta ’ inqas minn 400 kopja/ ml (67 minn 87), meta mqabbla ma ’ 38% tal- adulti li kienu qed jieħdu lamivudine u zidovudine weħidhom (33 minn 86).
Ziagen was of similar effectiveness to indinavir, with around two thirds of the patients having viral loads below 400 copies/ ml after 16 weeks.
Ziagen kien similarment effikaċi għal indinavir, b’ madwar żewġ terzi tal- pazjenti jkollhom tagħbija virali ta ’ inqas minn 400 kopja/ ml wara 16- il ġimgħa.
Once- and twice-daily Ziagen had similar effects on viral load, with around two thirds of patients having viral loads below 50 copies/ ml after 48 weeks.
Ziagen meħud darba u darbtejn kuljum kellu effetti simili fuq it- tagħbija virali, b’ madwar żewġ terzi tal- pazjenti jkollhom tagħbija virali ta ’ inqas minn 50 kopja/ ml wara 48 ġimgħa.
The studies in children showed that Ziagen, in combination with other antiviral medicines, reduced viral loads to a similar extent to other combinations after 24 weeks.
L- istudji fit- tfal urew li Ziagen, flimkien ma ’ mediċini antivirali oħra, naqqas it- tagħbija virali f’ livelli simili għal kombinazzjonijiet oħra wara 24 ġimgħa.
What is the risk associated with Ziagen?
X’ inhu r- riskju assoċjat ma ’ Ziagen?
The most common side effects when taking Ziagen (seen in between 1 and 10 patients in 100) are anorexia (loss of appetite), headache, nausea (feeling sick), vomiting, diarrhoea, rash, fever, lethargy (lack of energy) and fatigue (tiredness).
L- iktar effetti sekondarji komuni tat- teħid ta ’ Ziagen (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma l- uġigħ ta ’ ras, id- dardir, id- dijarrea, raxx, deni, għeja u telqa.
For the full list of all side effects reported with Ziagen, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Ziagen, ara l- Fuljett ta ’ Tagħrif.
Hypersensitivity reactions (allergic reactions) occur in about 5% of patients taking Ziagen, usually within the first six weeks of treatment.
Iseħħu reazzjonijiet allerġiċi f’ madwar 5% tal- pazjenti li jieħdu Ziagen, ġeneralment fl- ewwel sitt ġimgħat ta ’ trattament.
The risk of hypersensitivity is higher in patients who have the HLA-B (type 5701) gene.
Ir- riskju tal- ipersensittività hija ogħla f’ pazjenti li jkollhom il- ġene HLA- B (tat- tip 5701).
Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain, dyspnoea (difficulty breathing), cough, fever, lethargy, malaise (feeling unwell), headache, signs of liver damage in the blood and myalgia (muscle pain).
Fost is- sintomi dejjem ikun hemm deni jew raxx, iżda ħafna drabi jinkludu wkoll dardir, remettar, dijarea, uġigħ ta ’ żaqq, deni, uġigħ ta ’ ras, sinjali fid- demm ta ’ ħsara fil- fwied, uġigħ fil- muskoli, qtugħ ta ’ nifs, sogħla u telqa.
Patients treated with Ziagen receive a card detailing these symptoms so that they are aware of them, and must contact their doctor immediately if they develop a reaction.
Il- pazjenti ttrattati b’ Ziagen jingħataw kard li fiha jkunu mniżżla dawn is- sintomi sabiex ikunu konxji tagħhom, u għandhom jikkuntattjaw lit- tabib tagħhom immedjatament jekk jiżviluppaw xi reazzjoni.
Ziagen should not be used in patients with severe liver disease or who may be hypersensitive (allergic) to abacavir or any of the other ingredients.
Ziagen m’ għandux jintuża f’ pazjenti li jkollhom mard sever fil- fwied jew li jkunu allerġiċi għal abacavir jew għal xi sustanzi oħra tiegħu.
As with other anti-HIV medicines, patients taking Ziagen may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal fil- każ ta ’ mediċini oħra kontra l- HIV, il- pazjenti li jkunu qed jieħdu Ziagen jistgħu jkunu f’ riskju li jiżviluppaw lipodistrofija (tibdiliet fid- distribuzzjoni tax- xaħam fil- ġisem), is- sindromu tar - riattivazzjoni immunitarja (reazzjonijiet għal organiżmi li jikkawżaw mard mis- sistema immunitarja li tkun qed tirkupra), u osteonekrożi (mewt ta ’ ċelloli fl- għadam, li jagħmel l- għadam iktar fraġli).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Ziagen.
Il - pazjenti li jkollhom problemi bil- fwied (inkluż infezzjoni ta ’ l- epatite B jew Ċ) jista ’ jkollhom riskju ikbar għal ħsara fil- fwied meta jieħdu Ziagen.
As with all other NRTIs, Ziagen may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Ziagen during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Bħal fil- każ ta ’ l- NRTIs kollha, Ziagen jista ’ jikkawża wkoll l- aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fil- ġisem) u, fit- trabi ta ’ ommijiet li jkunu qed jieħdu Ziagen waqt it- tqala, disfunzjoni mitokondrijaka (ħsara fil- komponenti ta ’ ġoċ- ċelloli li jipproduċu l- enerġija li jistgħu jikkawżaw problemi fid- demm).
Why has Ziagen been approved?
Għaliex ġie approvat Ziagen?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ziagen’ s benefits are greater than its risks for use in antiretroviral combination therapy for the treatment of HIV-infected patients.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Ziagen’ s huma ikbar mir- riskji tiegħu fit- terapija antiretrovirali kombinata għat- trattament ta ’ pazjenti infettati bl- HIV.
2/ 3 in adults who had not taken HIV treatment before.
Il- Kumitat innota li l- wiri tal- benefiċċju ta ’ Ziagen kien ibbażat fuq ir- riżultati ta ’ studji li saru primarjament bil- mediċina tittieħed darbtejn kuljum flimkien ma ’ mediċini oħra fl- adulti 2/ 3 li ma kinux ħadu trattament għall- HIV qabel.
The Committee recommended that Ziagen be given marketing authorisation.
Il- Kumitat irrakkomanda li Ziagen jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Ziagen:
Tagħrif ieħor dwar:
The European Commission granted a marketing authorisation valid throughout the European Union for Ziagen to Glaxo Group Ltd on 8 July 1999.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq, valida madwar l- Unjoni Ewropea kollha, għal Ziagen lil Glaxo Group Ltd fit- 8 ta ’ Lulju ta ’ l- 1999.
The marketing authorisation was renewed on 8 July 2004.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fit- 8 Lulju ta ’ l- 2004.
The full EPAR for Ziagen can be found here.
L- EPAR sħiħ għal Ziagen jista ’ jiġi kkonsultat hawn.
Ziagen 300 mg film-coated tablets
Ziagen 300 mg pillola miksija b`rita
Each film-coated tablet contains 300 mg of abacavir (as sulfate).
Kull pillola miksija b`rita fiha 300 mg ta ’ abacavir bħala abacavir sulfate.
For a full list of excipients see section 6.1.
Għal lista sħiħa ta ’ sustanzi mhux attivi ara sezzjoni 6. 1.
Film-coated tablet
Pillola miksija b`rita
The scored tablets are yellow, biconvex, capsule shaped and are engraved with GX 623 on both sides.
Il- pilloli b’ sinjal imnaqqax biex tkun tista ’ taqsamhom huma sofor, ibbuzzati fuq iż- żewġ naħat, b`forma ta` kapsoli u huma mnaqqxa b’ GX 623 fuq iż- żewġ naħat.
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.
Ziagen hu indikat għal kombinazzjoni ta` terapija antiretrovirali għall- kura ta` l- infezzjoni bil- Vajrus ta ’ Immunodefiċjenza Umana (HIV).
The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy (see section 5.1).
Il- benefiċċju għall- użu ta` Ziagen huwa bbażat l- aktar minn riżultati li ħarġu minn studji fuq pazjenti adulti naïve għall- kura u li bdew jieħdu terapija kombinata darbtejn kuljum (ara sezzjoni 5. 1).
Ziagen should be prescribed by physicians experienced in the management of HIV infection.
Ziagen għandu jiġi preskritt minn tobba b`esperjenza fil- kura ta` l- infezzjoni ta` l- HIV.
Ziagen can be taken with or without food.
Ziagen jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Biex tassigura li d- doża tkun ittieħdet kollha, għandek idealment tibla ’ il- pillola( i) mingħajr ma tfarrakhom.
Ziagen is also available as an oral solution for use in children over three months of age and weighing less than 14 kg and for those patients for whom the tablets are inappropriate.
Ziagen issibu wkoll bħala soluzzjoni orali għall- użu fit- tfal ta ’ ‘ l fuq minn tlett xhur u li jiżnu anqas minn 14kg u għal dawk il- pazjenti li ma jistgħux jieħdu pilloli.
Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2).
Inkella, għal pazjenti li ma jistgħux jibilgħu pilloli, il- pillola( i) jistgħu jkunu mfarrka u miżjuda ma ’ ammont żgħir ta ’ ikel semi- solidu jew likwidu, u kollha għandhom jiġu kkunsmati mill- ewwel (ara sezzjoni 5. 2)
Adults and adolescents (over 12 years of age): the recommended dose of Ziagen is 600 mg daily.
Id- doża rakkomandata ta` Ziagen hija 600mg kuljum.
This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily (see sections 4.4 and 5.1).
Din tista ’ tingħata jew 300 mg (pillola waħda) darbtejn kuljum, jew 600mg (żewġ pilloli) darba kuljum (ara sezzjonijiet 4. 4 u 5. 1).
Patients changing to the once daily regimen should take 300 mg twice a day and switch to 600 mg once a day the following morning.
Pazjenti li jaqilbu fuq is- sistema ta ’ darba kuljum, għandhom jieħdu 300mg darbtejn kuljum u jaqilbu fuq 600mg darba kuljum ‘ l għada filgħodu.
When changing
Meta is- sistema ta ’ darba kuljum filgħaxija tkun
2 back to a twice daily regimen, patients should complete the day's treatment and start 300 mg twice a day the following morning.
2 ippreferuta, 300mg ta ’ Ziagen għandhom jittieħdu biss fl- ewwel għodwa, imbagħad jittieħdu 600mg filgħaxija.
A dosing according to weight bands is recommended for Ziagen tablets.
Huwa rakkomandat dożaġġ skond kategoriji ta ’ piż għal pilloli ta ’ Ziagen.
This dosing regimen for paediatric patients weighing 14-30 kg is based primarily on pharmacokinetic modelling.
Din is- sistema ta ’ kura għal pazjenti pedjatriċi li jiżnu minn 14- 30kg hija bbażata primarjament fuq mudell farmakokinetiku.
A pharmacokinetic overexposure of abacavir can occur since accurate dosing can not be achieved with this formulation.
Jista ’ jkun hemm espożizzjoni farmakokinetika żejda ta ’ abacavir minħabba li ma jistax jintlaħaq dożaġġ eżatt b’ din il- formulazzjoni.
Therefore a close safety monitoring is warranted in these patients.
Għalhekk għandu jkun hemm osservazzjoni mill- qrib f’ dawn il - pazjenti.
Children weighing at least 30 kg: the adult dosage of 300 mg twice daily should be taken.
Għal tfal li jiżnu mill- anqas 30kg: għandha tittieħed id- doża ta ’ l- adulti ta ’ 300mg darbtejn kuljum.
Children weighing > 21 kg to < 30 kg: one half of a Ziagen tablet taken in the morning and one whole tablet taken in the evening.
Għal tfal li jiżnu > 21kg u < 30kg: nofs pillola Ziagen filgħodu u pillola sħiħa filgħaxija.
Children weighing 14 to 21 kg: one half of a Ziagen tablet twice daily.
Għal tfal li jiżnu minn 14 sa 21kg: nofs pillola Ziagen darbtejn kuljum.
Children less than three months: the data available on the use of Ziagen in this age group are very limited (see section 5.2).
L- informazzjoni fuq l- użu ta` Ziagen f`din il- kategorija ta ’ età huma limitati ħafna (ara sezzjoni 5. 2).
Renal impairment: no dosage adjustment of Ziagen is necessary in patients with renal dysfunction.
Mard tal- kliewi: m`hemmx bżonn tibdil fid- doża ta` Ziagen f`pazjenti li jbgħatu minn xi ħsara tal - kliewi.
However, Ziagen should be avoided in patients with end-stage renal disease (see section 5.2).
(ara sezzjoni 5. 2).
Hepatic impairment: abacavir is primarily metabolised by the liver.
Indeboliment tal- fwied: abacavir huwa fil- parti l- kbira metabolliżżat mill- fwied.
No dose recommendation can be made in patients with mild hepatic impairment.
Ma tista tingħata l - ebda rakkomandazzjoni ta ’ doża lill- pazjenti li jbgħatu minn indeboliment epatiku ħafif.
No data are available in patients with moderate hepatic impairment, therefore the use of abacavir is not recommended unless judged necessary.
Ma teżisti l - ebda informazzjoni għall- pazjenti b`indeboliment epatiku moderat, għalhekk l- użu ta ’ abacavir mhux rakkomandat sakemm mhux ġustifikat.
In patients with mild and moderate hepatic impairment close monitoring is required, and if feasible, monitoring of abacavir plasma levels is recommended (see section 5.2).
Abacavir huwa kontra- indikat f’ pazjenti li jsofru minn indeboliment epatiku sever.
Abacavir is contraindicated in patients with severe hepatic impairment (see section 4.3 and 4.4).
(ara sezzjoni 4. 3, 4. 4 u 5. 2).
Elderly: no pharmacokinetic data is currently available in patients over 65 years of age.
Anzjani: fil- preżent m’ hemmx tagħrif farmakokinetiku f`pazjenti ta ’ età ’ l fuq minn 65 sena.
See BOXED INFORMATION ON HYPERSENSITIVITY REACTIONS in sections 4.4. and 4.8.
Ziagen m`għandux jingħata lill- pazjenti li jbgħatu minn sensittività eċċessiva għas- sustanza attiva jew għall xi sustanzi mhux attivi Ara L- KAXXA TA`L- INFORMAZZJONI FUQ REAZZJONIJIET TA ’ SENSITTIVITÀ EĊĊESSIVA f`sezzjonijiet 4. 4. u 4. 8.
Ziagen is contraindicated in patients with severe hepatic impairment.
Ziagen m`għandux jingħata lill- pazjenti li jbgħatu minn indeboliment epatiku sever.
Hypersensitivity Reaction (see also section 4.8):
Reazzjoni ta ’ sensittività eċċessiva (ara wkoll sezzjoni 4. 8):
In clinical studies approximately 5% of subjects receiving abacavir develop a hypersensitivity reaction; some of these cases were life-threatening and resulted in a fatal outcome despite taking precautions.
Fi studji kliniċi li saru nstab li bejn wieħed u ieħor 5% tal- pazjenti li rċevew abacavir żviluppaw reazzjonijiet ta ’ sensittività eċċessiva; xi wħud minn dawn il- każijiet kienu ta` periklu għall- ħajja u kienu fatali minkejja li ttieħdu prekawzjonijiet.
Based on the prospective study CNA106030 (PREDICT-1), use of pre-therapy screening for the HLA-B*5701 allele and subsequently avoiding abacavir in patients with this allele significantly reduced the incidence of abacavir hypersensitivity reactions.
Skond l- istudju prospettiv CNA106030 (PREDICT- 1), l- użu ta ’ investigazzjoni għal preżenza ta ’ l- allel HLA- B* 5701 qabel il- kura u li tevita l- użu ta ’ abacavir f’ pazjenti b’ dan l- allel, naqqas b’ mod sinifikanti ir- reazzjonijiet ta ’ sensittività eċċessiva għal abacavir.
3 These results are consistent with those of prior retrospective studies.
3 Dawn ir- riżultati huma konsistenti ma ’ dawk ta ’ studji retrospettivi li saru qabel.
As a consequence, before initiating treatment with abacavir, screening for carriage of the HLA- B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin.
B’ konsegwenza ta ’ dan, qabel tibda l- kura b’ abacavir, għanda ssir investigazzjoni għall- ġarr ta ’ l- allel HLA- B* 5701 f’ kull pazjent infettat bl- HIV, irrispettivament mir- razza.
Hypersensitivity reactions are characterised by the appearance of symptoms indicating multi-organ system involvement.
Reazzjonijiet ta ’ sensittività eċċessiva huma karatteriżżati mid- dehra ta ’ sintomi li jinvolvu s- sistema ta ’ l- organi kollha tal- ġisem.