qanastek/EMEA-V3 huggingface dataset:
63 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON TEXT AND BOTTLE LABEL TEXT (BOTTLE PRESENTATION)
KITBA FUQ IL- KARTUNA TA 'BARRA U KLIEM FUQ IT- TIKKETTA TAL- FLIXKUN (PREŻENTAZZJONI TAL- FLIXKUN)
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
70 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Zerit 20 mg hard capsules Stavudine
Zerit 20 mg kapsuli iebsin Stavudine
Each hard capsule contains 20 mg stavudine.
Kull kapsula iebsa fiha 20 mg ta ’ stavudine.
67 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
72 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Zerit 30 mg hard capsules Stavudine
Zerit 30 mg kapsuli iebsin Stavudine
Each hard capsule contains 30 mg stavudine.
Kull kapsula iebsa fiha 30 mg ta ’ stavudine.
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
77 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Zerit 40 mg hard capsules Stavudine
Zerit 40 mg kapsuli iebsin Stavudine
Each hard capsule contains 40 mg stavudine.
Kull kapsula iebsa fiha 40 mg ta ’ stavudine.
77 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
78 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
83 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
80 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING OUTER CARTON TEXT AND BOTTLE LABEL TEXT
85 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT KITBA FUQ IL- KARTUNA TA 'BARRA U KLIEM FUQ IT- TIKKETTA TAL- FLIXKUN
Zerit 200 mg powder for oral solution Stavudine
Zerit 200 mg trab għal soluzzjoni orali Stavudine
Stavudine 200 mg The reconstituted solution contains 1 mg of stavudine per ml.
Stavudine 200 mg Is- soluzzjoni rikostitwita fiha 1 mg ta 'stavudine kull ml.
Sucrose and preservatives (E218 and E216)
Sucrose u preservattivi (E218 u E216)
Powder for oral solution, 200 mg (stavudine)
Trab għal soluzzjoni orali, 200 mg (stavudine)
Stable for 30 days after reconstitution, when stored in a refrigerator (2°C-8°C).
Stabbli għal 30 ġurnata wara rikostituzzjoni, meta maħżun fi friġġ (2°C- 8°C).
83 PACKAGE LEAFLET:
88 FULJETT TA 'TAGĦRIF:
This medicine has been prescribed for you.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħal - tiegħek.
What Zerit is and what it is used for 2.
X' inhu Zerit u għalxiex jintuża 2.
Before you take Zerit 3.
Qabel ma tieħu Zerit 3.
How to take Zerit 4.
Kif għandek tieħu Zerit 4.
How to store Zerit 6.
Kif taħżen Zerit 6.
WHAT Zerit IS AND WHAT IT IS USED FOR
X’ INHU Zerit U GĦALXIEX JINTUŻA
Zerit belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs).
Zerit jagħmel parti minn grupp ta ’ mediċini kontra l- virus, magħrufa wkoll bħala antiretrovirali, msemmijin nukleosidi inibituri tat- traskrittażi nversi (NRTIs).
These are used to treat Human Immunodeficiency Virus (HIV) infection.
Dawn jintużaw biex jittrattaw il- virus ta ’ l- Immunodefiċenza Umana (HIV).
This medicinal product, in combination with other antiretrovirals, reduces the HIV viral load and keeps it at a low level.
Dan il- prodott mediċinali, flimkien ma ’ antiretrovirali oħra, inaqqas il- piz tal- virus ta ’ l- HIV u jżommu f’ livell baxx.
It also increases CD4 cell counts.
Iżid ukoll l- ammont ta ’ ċelloli CD4.
These CD4 cells play an important role in maintaining a healthy immune system to help fight infection.
Dawn iċ- ċelloli CD4 li għandhom rwol importanti biex iżommu is- sistema immunitarja b’ saħħitha u kapaċi tikkombatti l- infezzjonijiet.
Response to treatment with Zerit varies between patients.
Mhux il- pazjenti kollha jirrispondu għat- trattament b’ Zerit bl- istess mod.
Your doctor will therefore be monitoring the effectiveness of your treatment.
Għalhekk it- tabib tiegħek għandu jsegwi mill- qrib l- effikaċja tal- kura tiegħek.
Zerit may improve your condition, but it is not a cure for your HIV infection.
Zerit jista ’ jagħmlek aħjar, iżda mhuwiex ta ’ fejqan għall- infezzjoni b’ HIV.
Treatment with Zerit has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b’ Zerit ma ntweriex li jnaqqas ir- riskju li tinxtered l- infezzjoni b’ HIV li xi ħadd ieħor b’ kuntatt sesswali jew mid - demm.
Therefore, you must continue to take appropriate precautions to avoid giving the virus to others.
Għalhekk, għandek tkompli tieħu prekawzjonijiet apposta biex ma tagħtix il- virus lil xi ħadd ieħor.
During your treatment, other infections linked to your weakened immunity (opportunistic infections) may arise.
Waqt il- kura, jista ’ jkollok infezzjonijiet oħra li jiġu minħabba li s- sistema immunitarja tiegħek hija dgħajfa (infezzjonijiet opportunistiċi).
These will require specific and sometimes preventive treatment.
Dawn għandhom bżonn kura apposta u xi kultant kura preventiva minn qabel.
BEFORE YOU TAKE Zerit
QABEL MA TIEĦU Zerit
If you are allergic (hypersensitive) to stavudine or any of the other ingredients of Zerit.
Tiħux Zerit Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal aprepitant jew għal sustanzi oħra ta 'Zerit.
Contact your doctor or pharmacist for advice.
Fittex il- parir tat- tabib jew l- ispiżjar tiegħek.
Take special care with Zerit:
Oqgħod attent ħafna bi Zerit:
Before treatment with Zerit, you should have told your doctor: if you suffer from kidney disease or liver disease (such as hepatitis), if you have had peripheral neuropathy (persistent numbness, tingling, or pain in the feet and/ or hands), or if you have suffered from pancreatitis (inflammation of the pancreas).
Qabel ma tieħu l- mediċina, għandek tkun għidt lit- tabib: jekk int tbati minn mard tal- kliewi jew tal- fwied (bħall- epatite) jekk qatt kellek newropatija periferali (tnemnim, nuqqas ta ’ sensazzjoni jew uġigħ fis- saqajn u/ jew l- idejn, persistenti), jew jekk qatt batejt minn pankreatite (infjammazzjoni fil- frixa).
The class of medicines to which Zerit belongs (NRTIs) can cause a sometimes fatal condition called lactic acidosis, together with an enlarged liver.
89 Il- grupp ta ’ mediċini li jagħmel parti minnu Zerit (NRTIs) xi kultant jista ’ jikkawża marda li tista ’ twassal għall- mewt li jisimha aċidożi lattika flimkien ma ’ tkabbir tal- fwied.
This condition usually does not occur until a few
Din il- marda s- soltu ma toħroġx qabel xi ftit xhur wara li nbdiet il- kura.
This rare, but very serious side effect occurs more often in women, particularly if very overweight.
Dan l- effett mhux mixtieq li huwa rari, imma gravi ħafna, iktar joħroġ fin- nisa, speċjalment jekk huma ħoxnin ħafna.
In addition, rare cases of liver failure/ renal failure or fatal hepatitis have been reported.
Ukoll, ġew irrappurtati xi każi rari ta ’ falliment tal- fwied/ tal- kliewi jew epatite li tista ’ twassal għall- mewt.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
Pazjenti b’ epatite B jew C kronika u li qegħdin jieħdu l- mediċini antiretrovirali għandhom riskju akbar li jkollom effetti avversi fil- fwied severi li jistgħu iwasslu għall- mewt, u għadhom mnejn ikollhom bżonn testijiet tad- demm biex il- funzjoni tal- fwied tagħhom tiġi kkontrollata.
If you develop one of the following, contact your doctor: persistent numbness, tingling or pain in feet and/ or hands (this may indicate the beginning of peripheral neuropathy, an adverse effect on the nerves), muscular weakness or abdominal pain, nausea or vomiting, or rapid deep breathing, drowsiness (which may indicate pancreatitis, liver disturbance such as hepatitis, or lactic acidosis).
Jekk tiżviluppa waħda minn dawn li ġejjin, jekk jogħġbok ikkuntattja lit- tabib tiegħek: tnemnim, nuqqas ta ’ sensazzjoni jew uġigħ ta ’ l- idejn u/ jew saqajn, persistenti (dan jista ’ juri l - bidu tan- newropatija periferali, li huwa effett avvers fuq in- nervituri), muskoli dgħajfa jew uġigħ ta ’ żaqq, dardir jew remettar, jew nifs fil- fond mgħaġġel ħafna, ngħas (li jistgħu jindikaw infjammazzjoni tal- frixa, problema fil - fwied bħal epatite, jew aċidożi lattika)
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F' xi pazjenti b' infezzjoni tal- HIV avvanzata (AIDS) u bi storja ta 'infezzjoni opportunistika, sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet preċdenti, jistgħu jseħħu wara li tinbeda kura kontra l - HIV.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa mifhum li dawn is- sintomi huma dovuti għal titjib fir- rispons immuni tal- ġisem, li jippermetti lill- ġisem jġġieled infezzjonijiet li setgħu kienu preżenti mingħajr sintomi ovvji.
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tinnota xi sintomi ta 'infezzjoni, jekk jogħġbok informa lit- tatbib tiegħek minnufih.
Redistribution, accumulation, or loss of body fat may occur in patients receiving antiretroviral therapy.
Jista ’ jkun hemm tqassim mibdul, żieda, jew telfa ta ’ xaħam tal- ġisem f’ pazjenti li qegħdin fuq mediċina antiretrovirali.
Some NRTIs, such as stavudine, have been associated with a loss of body fat (lipoatrophy).
Xi NRTIs, bħal stavudine, kienu assoċjati ma 'telf fix- xaħam tal- ġisem (lipoatrofija).
Contact your doctor if you notice changes in body fat.
Kellem lit- tabib tiegħek jekk tara xi tibdil fil- pożizzjoni tax- xaħam fil- ġisem tiegħek.
Bone problems: some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Problemi fl- għadam: xi pazjenti li jkunu qegħdin jieħdu kura antiretrovirali f' kombinazzjoni jistgħu jiżviluppaw marda fl- għadam imsejħa osteonekrożi (mewt tat- tessut ta 'l- għadam ikkawżata minn telf fil- provvista tad- demm lejn l- għadma).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul tat- terpija antiretrovirali f' kombinazzjoni, l- użu kortikosterojde, il- konsum ta 'l- alkoħol, immunosuppressjoni severa, indiċi għoli tal- massa korporali, fost oħrajn, jistgħu jkunu wħud mill- bosta fatturi ta' riskju għall- iżvilupp ta 'din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta 'osteonekrożi huma ebusija fil- ġogi, uġigħ (b' mod speċjali fil- ġenbejn, irkoppa u spalla) u diffikultà fil - movimenti.
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi sintomi minn dawn, jekk jogħġbok informa lit- tabib tiegħek.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Except for zidovudine, which interferes with the activity of stavudine, Zerit may be taken with many of the other medicines commonly used in patients with HIV infection.
Barra zidovudine, li jfixkel l- attività ta ’ stavudine, Zerit jista ’ jittieħed ma ’ ħafna mill- mediċini l- oħra li s- soltu jintużaw f ’ pazjenti b’ infezzjoni bl- HIV.
These include the protease inhibitors (such as nelfinavir) and NRTIs.
Dawn jinkludu l- inibituri tal- protejażi (bħal nelfinavir) u NRTIs.
Please tell your doctor if you are taking doxorubicin or ribavirin as undesirable interactions may occur.
Jekk jogħġbok għid lit- tabib jekk qed tieħu doxorubicin jew ribavirin minħabba li jistgħu jseħħu interazzjonijiet mhux mixtieqa.
Taking Zerit with food and drink:
Meta tieħu Zerit ma ’ l- ikel u max- xorb:
For maximum effect, Zerit should be taken on an empty stomach, and preferably at least one hour before a meal.
Għall- aħjar effett, Zerit għandu jittieħed fuq stonku vojt u preferibilment mill- anqas siegħa qabel l - ikel.
If this is not possible, the capsules may also be taken with a light meal.
Jekk dan mhux possibbli, il- kapsuli jistgħu ukoll jittieħdu ma ’ ikel ħafif.
Pregnancy If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
Tqala Jekk toħroġ tqila jew qed tippjana biex toħroġ tqila, għandek tkellem lit- tabib tiegħek biex tiddiskuti l - effetti avversi potenzjali li jista ’ jkollok u l- benefiċċji u r- riskji tat- terapija antiretrivirali fuqek u fuq it - tarbija.
Lactic acidosis (sometimes fatal) has been reported in pregnant women who received stavudine in combination with other antiretroviral treatment.
Aċidożi lattika (xi drabi fatali) ġiet irrapurtata f’ nisa tqal li irċevew stavudine flimkien ma ’ terapija antiretrovirali oħra.
If you have taken Zerit during your pregnancy, your doctor may request regular visits to monitor the development of your child.
Jekk ħadt Zerit waqt it- tqala, it- tabib jista ’ jordnalek visti regolari biex jiċċekja l- iżvilupp tat- tarbija.
Such visits may include blood tests and other diagnostic tests.
Dawn il- visti jistgħu jinkludu testijiet tad- demm u testijiet dijagnostiċi oħra.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
90 Fit- tfal fejn l- omm ħadet analogi tan- nukleosidi u tan- nukleotidi waqt it- tqala, il- benefiċċju tar- riskju inqas ta ’ infezzjoni bl’ HIV huwa ikbar mir- riskju ta ’ l- effetti mhux mixtieqa.
85 Breast-feeding Inform your doctor if you are breast-feeding.
Treddigħ Avża lit- tabib tiegħek jekk inti qegħda tredda ’.
It is recommended that HIV-infected women should not breast-feed under any circumstances in order to avoid transmission of HIV to the baby.
Huwa rrikmandat li nisa li huma nfettati bl- HIV ma għandhom qatt ireddgħu u taħt l- ebda ċirkostanza, biex ma jgħaddux il- virus ta ’ l- HIV lit- tarbija.
No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta 'magni Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni
These capsules contain lactose.
Tagħrif importanti fuq xi wħud mis- sustanzi ta 'Zerit Dawn il- kapsuli fihom il- lattosju.
HOW TO TAKE Zerit
KIF GĦANDEK TIEĦU Zerit
Always take Zerit exactly as your doctor has told you.
Dejjem għandek tuża Zerit skond il- parir tat- tabib.
You should check with your doctor if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma 'l - ispiżjar tiegħek jekk ikollok xi dubju.
Your doctor has defined your daily dose based on your weight and individual characteristics.
It- tabib għażel id- doża tiegħek ta ’ kuljum skond il- piz u l - karatteristiċi individwali tiegħek.
Please follow these recommendations closely as they will give you the best chance to delay development of a resistance to the medicinal product.
Jekk jogħġbok segwi dawn ir- rakkomandazzjonijiet mill- qrib għax b’ hekk ikollok l- aħjar ċans li ma tiżvilluppax reżistenza għall- mediċina.
Do not change the dose on your own.
Tbiddilx id- doża minn rajk.
Continue to take this medicine until your doctor tells you otherwise.
Ibqa ’ ħu din il- mediċina sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
For adults and children whose body weight is 30 kg or more, the usual starting dose is 30 or 40 mg given twice daily (with approximately 12 hours between each dose).
Għall- adulti u tfal li l- piz tal- ġisem tagħhom huwa ta ’ 30 kg jew iktar, d- doża tal- bidu is- soltu tkun ta ’ 30 jew 40 mg darbtejn kuljum (bejn wieħed u ieħor 12- il siegħa bejn kull doża).
Children older than 3 months, whose body weight is less than 30 kg, should receive 1 mg/ kg twice daily.
Tfal akbar minn 3 xhur, li l- piż tagħhom huwa inqas minn 30 kg, għandhom jirċievu 1 mg/ kg darbtejn kuljum.
To obtain optimal absorption, the capsules should be swallowed with a glass of water, preferentially at least one hour before a meal and on an empty stomach.
Biex il- mediċina tiġi assorbita sew, il- kapsuli għandhom jinbelgħu ma ’ tazza ilma, l- aħjar jekk dan iseħħ mill- anqas siegħa qabel l- ikel u fuq stonku vojt.
If this is not possible, Zerit may also be taken with a light meal.
Jekk dan ma ’ jistax isir, Zerit jista ’ wkoll jittieħed ma ’ ikla ħafifa.
If you have problems swallowing capsules you should ask your doctor about the possibility of changing to the solution form of this medicine or you could carefully open the capsule and mix its contents with some food.
Jekk tbati biex tibla ’ l- kapsuli għandek tistaqsi lit- tabib tiegħek dwar il- possibilta` li tibdel il- mediċina għall- mistura jew inkella tista ’ tiftaħ il- kapsula bil- galbu u tħawwad il- kontenut ma ’ xi ftit ikel.
If you take more Zerit than you should:
Jekk tieħu Zerit aktar milli suppost għandek:
If you have taken too many capsules or if someone accidentally swallows some, there is no immediate danger.
Jekk ħadt wisq kapsuli jew xi ħadd jibla ’ xi kapsuli bi żball, m’ hemm l- ebda periklu immedjat.
However, you should contact your doctor or the nearest hospital for advice.
Madanakollu, għandek tfittex il- parir tat- tabib tiegħek jew ta ’ l- eqreb sptar.
If you forget to take Zerit:
Jekk tinsa tieħu Zerit:
If you accidentally miss a dose, then simply take your normal dose when the next one is due.
Jekk bi żball ma tiħux doża, ħu d- doża normali meta jkun jerġa ’ jmissek.
If you stop taking Zerit:
Jekk tieqaf tieħu Zerit:
The decision to stop using Zerit should be discussed with your doctor.
Id- deċiżjoni jekk għandekx twaqqaf Zerit għandha tiġi diskussa mat- tabib tiegħek.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI OĦRA
Like all medicines, Zerit can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Zerit jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection, it is not always possible to differentiate between unwanted effects caused by Zerit, or those caused by any other medicines you may be taking at the same time, or by the complications of the infection.
Waqt il- kura ta ’ l- infezzjoni HIV, m’ huwiex dejjem possibbli li wieħed jagħraf l- effetti mhux mixtieqa ikkawżati b ’ - Zerit jew minn dawk ikkawżati minn xi mediċini oħra li tista ’ tkun qed tieħu fl- istess żmien, jew mill- kumplikazzjonijiet ta ’ l- infezzjoni.
For this reason, it is important that you inform your doctor of any change in your health.
Għal din ir- raġuni huwa importanti li tgħarraf lit - tabib tiegħek jekk tara xi tibdil f’ saħħtek.
The most frequently reported side effects in adults taking Zerit in combination with other HIV medicinal products (lamivudine and efavirenz) were skin rash, headache, dizziness and peripheral
91 L- effetti mhux mixtieqa l- iktar komuni f’ adulti li ħadu Zerit ma ’ mediċini oħrajn kontra l- HIV (lamivudine u efavirenz) kienu raxx, uġigħ ta ’ ras, sturdament u newropatija ta ’ l- idejn u s- saqajn.
Serious but uncommon side effects are pancreatitis, liver disturbance or lactic acidosis.
Effetti mhux mixtieqa gravi iżda mhux komuni huma infjammazzjoni tal- frixa, taħwid fil- funzjoni tal - fwied jew aċidożi lattika.
Other side effects have been reported: fatigue, nausea/ vomiting, diarrhoea, indigestion, abdominal pain, fat redistribution (including breast enlargement in women), breast enlargement in men, numbness or weakness of arms and legs, muscle aching.
Effetti oħrajn mhux mixtieqa: għejja, dardir/ remettar, diarreja, ħruq ta ’ stonku, uġigħ ta ’ żaqq, tibdil fix- xaħam tal- ġisem (fin- nisa jista ’ jikber is- sider), tkabbir tas- sider fl - irġiel, tnemnim jew debolezza ta ’ l- idejn u s- saqajn, u wġigħ fil- muskoli.
Some patients in studies of adults taking Zerit in combination with other HIV drugs (lamivudine and efavirenz) experienced changes in mood or ability to think clearly.
Fi studji ta ’ adulti li ħadu Zerit ma ’ mediċini oħra kontra l- HIV (lamivudine u efavirenz) xi pazjenti ħassew tibdil fil- burdata jew ma ħassewhomx jistgħu jaħsbu sew.
These symptoms include anxiety, sleeping problems, depression, abnormal thinking, abnormal dreams.
Dawn is- sintomi jinkludu ansjetà, tbatija biex torqod, dwejjaq, ħsieb mhux normali, ħolm mhux normali.
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
It- terapija ta ’ kombinazzjoni antiretrovirali tista ’ twassal għal tibdil fil- forma tal- ġisem minħabba tibdil fil- mod kif inhu mqassam ix- xaħam.
These may include loss of fat from legs, arms and face, increased fat in the abdomen ("belly") and other internal organs, breast enlargement and fatty lumps on the back of the neck ("buffalo hump").
Dan jista ’ jinkludi telf ta ’ xaħam mis- saqajn, dirgħajn u l - wiċċ, żieda ta’ xaħam fl- addome (‘ żaqq ’) u madwar l- organi ta ’ ġol- ġisem, tkabbir tas- sider u ħotba ta ’ xaħam fuq wara ta ’ l- għonq (‘ buffalo hump ’).
The cause and long-term health effects of these conditions are not known at this time.
Għadna ma nafux x’ inhi l- kawża u x’ inhu l- effett fit- tul ta ’ dawn il- kundizzjonijiet.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
It- terapija ta ’ kombinazzjoni antiretrovirali tista ’ wkoll twassal għal livell għoli ta ’ aċidu lattiku u zokkor fid- demm, iperlipimja (livell għoli ta ’ xaħam fid- demm) u reżistenza għall- insulina.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you 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 TO STORE Zerit
KIF TAĦŻEN Zerit
Do not use Zerit after the expiry date which is stated on the carton, the bottle label and/ or the blister after EXP.
Tużax Zerit wara d- data ta 'skadenza li tidher fuq il- kaxxa, it- tikketta tal- flixkun u/ jew il- folja wara JIS.
What Zerit contains
X' fih Zerit
The active substance is stavudine The other ingredients of the powder contained in the hard capsule are: lactose (120 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Is- sustanza attiva hija stavudine Sustanzi oħra tat- trab li hemm fil- kapsula iebsa jinkludu: lactose (120 mg), magnesium stearate, microcrystalline cellulose u sodium starch glycolate.
The ingredients of the capsule shell are gelatine, iron oxide colorant (E172), silicon dioxide, sodium laurilsulphate and titanium dioxide colorant (E171).
Il- parti ta ’ barra tal- kapsula fiha ġelatina, kulur iron oxide (E172), silicon dioxide, sodium laurilsulphate u kulur titanium dioxide (E171).
The capsule shells are marked using edible black printing ink containing shellac, propylene glycol, purified water, potassium hydroxide and iron oxide (E172).
Il- qxur tal- kapsuli huma mmarkati permezz ta 'linka sewda li tista' tittiekel li fiha shellac, propylene glycol, ilma ppurifikat, potassium hydroxide u iron oxide (E172).
What Zerit looks like and content of the pack
Id- dehra ta 'Zerit u l- kontenut tal- pakkett
Zerit 15 mg hard capsules are red and yellow and marked with “ BMS 1964” on one side and “ 15” on the other side.
Zerit 15 mg kapsuli iebsin aħmar u isfar u mmarkati b ’ “ BMS 1964 ” fuq naħa waħda u “ 15 ” fuq in - naħa l- oħra.
Zerit 15 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Zerit 15 mg kapsuli iebsin jiġu f’ pakketti tal- folji b’ 56 kapsula iebsin jew fliexken b’ 60 kapsuli iebsin.
To help protect the capsules from excessive moisture, the bottle includes a desiccant canister.
Biex jilqa ’ l- kapsuli minn umdità eċċessiva, il- flixkun fih ċilindru li jnixxef (dessicant).
Marketing Authorisation Holder and Manufacturer
92 Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
87 BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Ir- Renju Unit
BRISTOL-MYERS SQUIBB Champ “ Lachaud”, La Goualle F-19250 Meymac - France
BRISTOL- MYERS SQUIBB Champ “ Lachaud ”, La Goualle F- 19250 Meymac – Franza
Contrada Fontana del Ceraso 03012 Anagni (FR) - Italy
Contrada Fontana del Ceraso 03012 Anagni (FR) – L- Italja
88 France BRISTOL-MYERS SQUIBB SARL Tél: + 33 (0)810 410 500
93 France BRISTOL- MYERS SQUIBB SARL Tél: + 33 (0) 810 410 500
This leaflet was last approved in {month year}.
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
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 Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
89 PACKAGE LEAFLET:
94 FULJETT TA 'TAGĦRIF:
The class of medicines to which Zerit belongs (NRTIs) can cause a sometimes fatal condition called lactic acidosis, together with an enlarged liver.
95 Il- grupp ta ’ mediċini li jagħmel parti minnu Zerit (NRTIs) xi kultant jista ’ jikkawża marda li tista ’ twassal għall- mewt li jisimha aċidożi lattika flimkien ma ’ tkabbir tal- fwied.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
96 Fit- tfal fejn l- omm ħadet analogi tan- nukleosidi u tan- nukleotidi waqt it- tqala, il- benefiċċju tar- riskju inqas ta ’ infezzjoni bl’ HIV huwa ikbar mir- riskju ta ’ l- effetti mhux mixtieqa.
91 Breast-feeding Inform your doctor if you are breast-feeding.
Treddigħ Avża lit- tabib tiegħek jekk inti qegħda tredda ’.
The most frequently reported side effects in adults taking Zerit in combination with other HIV medicinal products (lamivudine and efavirenz) were skin rash, headache, dizziness and peripheral
97 L- effetti mhux mixtieqa l- iktar komuni f’ adulti li ħadu Zerit ma ’ mediċini oħrajn kontra l- HIV (lamivudine u efavirenz) kienu raxx, uġigħ ta ’ ras, sturdament u newropatija ta ’ l- idejn u s- saqajn.
The active substance is stavudine The other ingredients of the powder contained in the hard capsule are: lactose (180 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Is- sustanza attiva hija stavudine Sustanzi oħra tat- trab li hemm fil- kapsula iebsa jinkludu: lactose (180 mg), magnesium stearate, microcrystalline cellulose u sodium starch glycolate.
Zerit 20 mg hard capsules are brown and marked with “ BMS 1965” on one side and “ 20” on the other side.
Zerit 20 mg kapsuli iebsin kannella u mmarkati b ’ “ BMS 1965 ” fuq naħa waħda u “ 20 ” fuq in- naħa l - oħra.
Zerit 20 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Zerit 20 mg kapsuli iebsin jiġu f’ pakketti tal- folji b’ 56 kapsula iebsin jew fliexken b’ 60 kapsuli iebsin.
Marketing Authorisation Holder and Manufacturer
98 Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
93 BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Ir- Renju Unit
94 France BRISTOL-MYERS SQUIBB SARL Tél: + 33 (0)810 410 500
99 France BRISTOL- MYERS SQUIBB SARL Tél: + 33 (0) 810 410 500
95 PACKAGE LEAFLET:
100 FULJETT TA 'TAGĦRIF:
The class of medicines to which Zerit belongs (NRTIs) can cause a sometimes fatal condition called lactic acidosis, together with an enlarged liver.
101 Il- grupp ta ’ mediċini li jagħmel parti minnu Zerit (NRTIs) xi kultant jista ’ jikkawża marda li tista ’ twassal għall- mewt li jisimha aċidożi lattika flimkien ma ’ tkabbir tal- fwied.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
102 Fit- tfal fejn l- omm ħadet analogi tan- nukleosidi u tan- nukleotidi waqt it- tqala, il- benefiċċju tar- riskju inqas ta ’ infezzjoni bl’ HIV huwa ikbar mir- riskju ta ’ l- effetti mhux mixtieqa.
97 Breast-feeding Inform your doctor if you are breast-feeding.
Treddigħ Avża lit- tabib tiegħek jekk inti qegħda tredda ’.
The most frequently reported side effects in adults taking Zerit in combination with other HIV medicinal products (lamivudine and efavirenz) were skin rash, headache, dizziness and peripheral
103 L- effetti mhux mixtieqa l- iktar komuni f’ adulti li ħadu Zerit ma ’ mediċini oħrajn kontra l- HIV (lamivudine u efavirenz) kienu raxx, uġigħ ta ’ ras, sturdament u newropatija ta ’ l- idejn u s- saqajn.
Zerit 30 mg hard capsules are light and dark orange and marked with “ BMS 1966” on one side and “ 30” on the other side.
Zerit 30 mg kapsuli iebsin oranġjo ċar u skur u mmarkati b ’ “ BMS 1966 ” fuq naħa waħda u “ 30 ” fuq in- naħa l- oħra.
Zerit 30 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Zerit 30 mg kapsuli iebsin jiġu f’ pakketti tal- folji b’ 56 kapsula iebsin jew fliexken b’ 60 kapsuli iebsin.
Marketing Authorisation Holder and Manufacturer
104 Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
99 BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Ir- Renju Unit
100 France BRISTOL-MYERS SQUIBB SARL Tél: + 33 (0)810 410 500
105 France BRISTOL- MYERS SQUIBB SARL Tél: + 33 (0) 810 410 500
101 PACKAGE LEAFLET:
106 FULJETT TA 'TAGĦRIF:
The class of medicines to which Zerit belongs (NRTIs) can cause a sometimes fatal condition called lactic acidosis, together with an enlarged liver.
107 Il- grupp ta ’ mediċini li jagħmel parti minnu Zerit (NRTIs) xi kultant jista ’ jikkawża marda li tista ’ twassal għall- mewt li jisimha aċidożi lattika flimkien ma ’ tkabbir tal- fwied.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
108 Fit- tfal fejn l- omm ħadet analogi tan- nukleosidi u tan- nukleotidi waqt it- tqala, il- benefiċċju tar- riskju inqas ta ’ infezzjoni bl’ HIV huwa ikbar mir- riskju ta ’ l- effetti mhux mixtieqa.
103 Breast-feeding Inform your doctor if you are breast-feeding.
Treddigħ Avża lit- tabib tiegħek jekk inti qegħda tredda ’.
The most frequently reported side effects in adults taking Zerit in combination with other HIV medicinal products (lamivudine and efavirenz) were skin rash, headache, dizziness and peripheral
109 L- effetti mhux mixtieqa l- iktar komuni f’ adulti li ħadu Zerit ma ’ mediċini oħrajn kontra l- HIV (lamivudine u efavirenz) kienu raxx, uġigħ ta ’ ras, sturdament u newropatija ta ’ l- idejn u s- saqajn.
The active substance is stavudine The other ingredients of the powder contained in the hard capsule are: lactose (240 mg), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Is- sustanza attiva hija stavudine Sustanzi oħra tat- trab li hemm fil- kapsula iebsa jinkludu: lactose (240 mg), magnesium stearate, microcrystalline cellulose u sodium starch glycolate.
Zerit 40 mg hard capsules are dark orange and marked with “ BMS 1967” on one side and “ 40” on the other side.
Zerit 40 mg kapsuli iebsin oranġjo skur u mmarkati b ’ “ BMS 1967 ” fuq naħa waħda u “ 40 ” fuq in - naħa l- oħra.
Zerit 40 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Zerit 40 mg kapsuli iebsin jiġu f’ pakketti tal- folji b’ 56 kapsula iebsin jew fliexken b’ 60 kapsuli iebsin.
Marketing Authorisation Holder and Manufacturer
110 Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
105 BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Ir- Renju Unit
106 France BRISTOL-MYERS SQUIBB SARL Tél: + 33 (0)810 410 500
111 France BRISTOL- MYERS SQUIBB SARL Tél: + 33 (0) 810 410 500
107 PACKAGE LEAFLET:
112 FULJETT TA 'TAGĦRIF:
Zerit 200 mg powder for oral solution Stavudine
Zerit 200 mg trab li jinħall f’ likwidu u jittieħed mill- ħalq Stavudine
Zerit belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs).
Zerit jagħmel parti minn grupp ta ’ mediċini antivirali, magħrufa wkoll bħala antiretrovirali, msemmijin nukleosidi inibituri tat- traskrittażi nversi (NRTIs).
During your treatment, other infections, linked to your weakened immunity (opportunistic infections) may arise.
Waqt il- kura, jista ’ jkollok infezzjonijiet oħra li jiġu minħabba li s- sistema immunitarja tiegħek hija dgħajfa (infezzjonijiet opportunistiċi).
The class of medicines to which Zerit belongs (NRTIs) can cause a sometimes fatal condition called lactic acidosis, together with an enlarged liver.
113 Il- grupp ta ’ mediċini li jagħmel parti minnu Zerit (NRTIs) xi kultant jista ’ jikkawża marda li tista ’ twassal għall- mewt li jisimha aċidożi lattika flimkien ma ’ tkabbir tal- fwied.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
114 Fit- tfal fejn l- omm ħadet analogi tan- nukleosidi u tan- nukleotidi waqt it- tqala, il- benefiċċju tar- riskju inqas ta ’ infezzjoni bl’ HIV huwa ikbar mir- riskju ta ’ l- effetti mhux mixtieqa.
109 Breast-feeding Inform your doctor if you are breast-feeding.
Treddigħ Avża lit- tabib tiegħek jekk inti qegħda tredda ’.
After reconstitution with water, the solution contains 50 mg of sucrose per ml of solution.
Tagħrif importanti fuq xi wħud mis- sustanzi ta 'Zerit Wara rikostituzzjoni bl- ilma, is- soluzzjoni ikun fiha 50 mg ta ’ sucrose kull ml ta' soluzzjoni.
This should be taken into account in patients with diabetes mellitus.
Dan għandu jitqies f' pazjenti b' diabetes mellitus.
May be harmful to the teeth.
Jista 'jagħmel ħsara lis- snien.
This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
Dan il- prodott fih methylhydroxybenzoate (E218) u propylhydroxybenzoate (E216) li jista 'jikkawża reazzjonijiet allerġiċi (jista' jkun imdewwma).
Please follow these recommendations closely as they will give you the best chance to delay development of a resistance to the medicinal product.
Jekk jogħġbok segwi dawn ir- rakkomandazzjonijiet mill- qrib għax b’ hekk ikollok l- aħjar ċans li ma tiżviluppax reżistenza għall- mediċina.
Babies from birth to 13 days old should receive 0.5 mg/ kg twice daily.
Trabi mit- twelid sa 13- il ġurnata għandhom jieħdu 0. 5 mg/ kg darbtejn kuljum.
Babies from at least 14 days old and children whose body weight is less than 30 kg, should receive 1 mg/ kg twice daily.
Trabi li għandhom mill- inqas 14- il ġurnata u tfal li l- piż tagħhom huwa inqas minn 30 kg, għandhom jieħdu 1 mg/ kg darbtejn kuljum.
To obtain optimal absorption, Zerit should be taken at least one hour before a meal and on an empty stomach.
Biex il- mediċina tiġi assorbita sew, Zerit għandu jittieħed mill- anqas siegħa qabel l- ikel u fuq stonku vojt.
Prepare the ready-to-use solution by mixing the powder with 202 ml of water or by slowly adding water up to the fill mark on the bottle.
Lesti t- taħlita billi tħallat it- trab ma ’ 202 ml ilma jew inkella billi timla l- flixkun bl- ilma bil- mod sakemm jimtela ’ sal- marka li hemm fuq il- flixkun.
Then screw the cap on tightly and shake the bottle well until the powder dissolves completely, and take or dispense the solution with the measuring cup provided.
Għalaq il- flixkun sew bl- għatu tal- kamin u ċaqlaq il- flixkun sew sakemm it- trab jinħall għal kollox, imbagħad ħu jew agħti t- taħlita billi tuża t- tazza biex tkejjel li hemm mal- flixkun.
For infants who require a dose less than 10 ml, ask your pharmacist for a syringe to use to accurately measure the oral dose.
Fit- trabi li għandhom bżonn doża ta ’ inqas minn 10 ml, itlob lill- ispiżjar tiegħek biex jagħtik siringa li tista ’ tuża biex tkejjel id- doża sew.
Do not worry if the solution remains slightly hazy after mixing with water; this is normal.
Tinkwetax jekk it- taħlita tibqa ’ daqsxejn imċajpra wara li tħallatha ma ’ l- ilma; dan hu normali.
If needed, consult your pharmacist for help with this procedure.
Jekk hemm bżonn, staqsi lill- ispiżjar biex jgħinek.
If you have taken too much of the solution, or if someone accidentally swallows some, there is no immediate danger.
Jekk ħadt mit- taħlita jew xi ħadd jibla ’ xi ftit, m’ hemm l- ebda periklu immedjat.
If you have any further questions on the use of this product, ask you doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta 'dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
110 When treating HIV infection it is not always possible to differentiate between unwanted effects caused by Zerit or those caused by any other medicines you may be taking at the same time, or by the complications of the infection.
Waqt il- kura ta ’ l- infezzjoni HIV, m’ huwiex dejjem possibbli li wieħed jagħraf l- effetti mhux mixtieqa ikkawżati b '- Zerit jew minn dawk ikkawżati minn xi mediċini oħra li tista ’ tkun qed tieħu fl- istess żmien jew mill- kumplikazzjonijiet ta ’ l- infezzjoni.
The most frequently reported side effects in adults taking Zerit in combination with other HIV medicinal products (lamivudine and efavirenz) were skin rash, headache, dizziness and peripheral neuropathy.
L- effetti mhux mixtieqa l- iktar komuni f’ adulti li ħadu Zerit ma ’ mediċini oħrajn kontra l- HIV (lamivudine u efavirenz) kienu raxx, uġigħ ta ’ ras, sturdament u newropatija ta ’ l- idejn u s- saqajn.
The prepared oral solution is stable for 30 days in a refrigerator (2°C -8°C).
Is- soluzzjoni orali mħejjija hija stabbli għal 30 jum fi friġġ (2°C - 8°C).
Do not use Zerit after the expiry date which is stated on the bottle and on the carton after EXP.
Tużax Zerit wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kartuna u fuq il- folja wara JIS.
- The active substance is stavudine
- Is- sustanza attiva hija stavudine
- The other ingredients of the powder are: cherry flavour, methylhydroxybenzoate (E218),
- Is- sustanzi l- oħra tat- trab huma: benna taċ- ċirasa, methylhydroxybenzoate (E218),
propylhydroxybenzoate (E216), silicon dioxide, simethicone, sodium carmellose, sorbic acid, stearate emulsifiers and sucrose.
propylhydroxybenzoate (E216), silicon dioxide, simethicone, sodium carmellose, sorbic acid, stearate emulsifiers u sucrose.
What Zerit looks like and content of the pack
Id- dehra ta 'Zerit u d- daqs tal- pakkett
The powder contains 200 mg stavudine.
It- trab fih 200 mg stavudine.
The reconstituted solution contains 1 mg of stavudine per ml.
Is- soluzzjoni rikostitwita fiha 1 mg stavudine kull ml.
Before reconstitution the Zerit powder appears as off-white to pale-pink, gritty powder.
116 Qabel rikostituzzjoni, it- trab Zerit jidher bħala trab offwajt għal roża ċar, ramli.
When reconstituted with 202 ml of water, produces 210 ml of a colorless to slightly pink, hazy solution.
Meta rikostitwit b' 202 ml t' ilma, jipproduċi 210 ml ta 'soluzzjoni bla kulur għal kemmxejn roża, mdardra.
Zerit 200 mg powder for oral solution is supplied in a bottle containing 200 ml solution.
Zerit 200 mg trab għal soluzzjoni orali jiġi fi flixkun li fih soluzzjoni ta ’ 200 ml.
111 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
España BRISTOL-MYERS SQUIBB, S. A.
117 España BRISTOL- MYERS SQUIBB, S. A.
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 jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina..
What is Zevalin?
X’ inhu Zevalin?
Zevalin is a kit for the preparation of a ‘ radiolabelled’ infusion (drip into a vein) of the active substance ibritumomab tiuxetan.
Zevalin huwa kit għall- preparazzjoni għall- infużjoni (dripp fil- vina) ‘ radjommarkata ’ (radiolabelled) tas- sustanza attiva ibritumomab tiuxetan.
What is Zevalin used for?
Għal xiex jintuża Zevalin?
Zevalin is not used directly, but it must be radiolabelled before use.
Zevalin ma jintużax direttament, iżda għandu jiġi radjommarkat qabel l- użu.
Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Ir- radjomarkatura (radiolabelling) hija teknika li permezz tagħha sustanża tiġi mmarkata b’ kompost radjoattiv.
Zevalin is radiolabelled by mixing it with a solution of radioactive yttrium (90Y) chloride.
Zevalin jiġi radjommarkat billi jitħallat ma ’ soluzzjoni ta ’ ittrju (90Y) klorur radjoattiv.
The radiolabelled medicine is used to treat adult patients with follicular B-cell non-Hodgkin’ s lymphoma.
Il- mediċina radjommarkata tintuża għat- trattament ta ’ pazjenti adulti b’ linfoma mhux ta ’ Hodgkin follikulari b’ ċelluli B (follicular B- cell non- Hodgkin’ s lymphoma).
This is a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-lymphocytes, or B-cells.
Dan huwa tip ta ’ kanċer tat- tessut linfatiku (parti mis- sistema immunitarja) li jolqot tip ta ’ ċelluli tad- demm bojod imsejħa "linfoċiti B" jew "ċelluli B".
Zevalin is used in the following groups of patients: • patients who have gone into remission (reduction in the number of cancerous cells) after their first ‘ induction treatment’ (initial chemotherapy treatment) for lymphoma.
Zevalin jintuża fil- gruppi ta ’ pazjenti li ġejjin: • pazjenti li esperjenzaw remissjoni (tnaqqis tal- għadd ta ’ ċelluli tal- kanċer) wara l- ewwel ‘ trattament ta ’ induzzjoni ’ tagħhom (trattament kemjoterapewtiku inizjali) għal- linfoma.
Zevalin is given as ‘ consolidation therapy’ to improve the remission; • patients in whom rituximab (another treatment for non-Hodgkin ’ s lymphoma) is no longer effective or whose disease has come back after rituximab treatment.
Zevalin jingħata bħala ‘ terapija ta ’ konsolidament ’ biex itejjeb ir- remissjoni; • il- pazjenti li għalihom rituximab (trattament ieħor għal- linfoma mhux ta ’ Hodgkin) ma għadux effikaċi jew li rkadew wara trattament b’ rituximab.
How is Zevalin used?
Kif jintuża Zevalin?
Radiolabelled Zevalin treatment should only be handled and given by someone who is authorised to use radioactive medicines.
It- trattament b’ Zevalin radjommarkat għandu jiġi mmaniġġjat u mogħti biss minn persuna awtorizzata biex tuża mediċini radjoattivi.
Before treatment with radiolabelled Zevalin, the patients must first receive an infusion of rituximab (at a dose lower than would be used for treatment) to clear B-cells from their circulation, leaving the cancerous B-cells in the lymph tissue.
Qabel it- trattament b’ Zevalin radjommarkat, l- ewwel il- pazjenti għandhom jingħataw infużjoni ta ’ rituximab (f’ doża anqas minn dik użata għat- trattament) biex jitneħħew iċ- ċelluli B miċ- ċirkolazzjoni u b’ hekk jitħallew iċ- ċelluli B tal- kanċer fit- tessut linfatiku.
This enables Zevalin to deliver radiation more specifically to the cancerous B– cells.
Dan jippermetti lil Zevalin iwassal ir - radjazzjoni b’ mod iktar immirat lejn iċ- ċelluli B tal- kanċer.
This is followed, seven to nine days later, by a second infusion of rituximab and an injection of radiolabelled Zevalin.
Sussegwentement, wara sebat ijiem sa disgħa, tingħata t- tieni infużjoni ta ’ rituximab u l- injezzjoni ta ’ Zevalin radjommarkat.
Zevalin must be given as a slow infusion lasting 10 minutes.
Zevalin għandu jingħata permezz ta ’ infużjoni bil- mod li ddum 10 minuti.
The dose of Zevalin is calculated to give the appropriate amount of radioactivity for the patient’ s condition, based on the blood cell count.
Id- doża ta ’ Zevalin hija kkalkulata b’ tali mod li tingħata kwantità adegwata ta ’ radjoattività għall- kundizzjoni tal- pazjent, skont l- għadd taċ - ċelluli tad- demm.
Reproduction is authorised provided the source is acknowledged. an antigen) that is found in certain cells in the body.
Is- sustanza attiva f’ Zevalin, ibritumomab, hija antikorp monoklonali.
Ibritumomab has been designed to target an antigen, CD20, which is present on the surface of all B-lymphocytes.
Ibritumomab inħoloq biex jintrabat ma ’ antiġene, CD20, preżenti fuq wiċċ il- linfoċiti B kollha.
When Zevalin is radiolabelled, the radioactive element yttrium-90 (90Y) is attached to ibritumomab.
Meta Zevalin ikun radjommarkat, l- element radjoattiv ittrju- 90 (90Y) intrabat ma ’ ibritumomab.
When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target CD20 antigen on the B-cells.
Meta l- mediċina radjommarkata tiġi injettata lill- pazjent, l- antikorp monoklonali jgħaddi r- radjoattività lill - antiġene fil- mira CD20 fuq iċ- ċelluli B.
Once the antibody has bound to the antigen, the radiation can act locally and destroy the lymphoma B-cells.
Ladarba l- antikorp ikun intrabat mal- antiġene, ir- radjazzjoni tista ’ taġixxi lokalment u teqred il- linfoma b’ ċelluli B.
How has Zevalin been studied?
Kif ġie studjat Zevalin?
For consolidation therapy, Zevalin has been studied in one main study involving 414 patients who had achieved a partial or complete remission during induction treatment for non-Hodgkin’ s lymphoma.
Għat- terapija ta ’ konsolidament, Zevalin ġie eżaminat fi studju ewlieni wieħed li involva 414- il pazjent li kisbu remissjoni parzjali jew totali matul it- trattament ta ’ induzzjoni għal- linfoma mhux ta ’ Hodgkin.
The study compared patients who received Zevalin and patients who received no additional treatment.
L- istudju qabbel il- pazjenti ttrattati b’ Zevalin ma ’ dawk ittrattati bl- ebda trattament addizzjonali.
The main measure of effectiveness was the length of time the patients survived without their disease getting worse.
Il- kejl ewlieni tal- effikaċja kien it- tul ta ’ żmien li għexu l- pazjenti mingħajr ma l- marda tagħhom aggravat.
Zevalin has also been studied in a total of 306 patients with non-Hodgkin’ s lymphoma who were not responding to other treatments or whose disease had come back after previous treatment.
Zevalin ġie studjat ukoll fuq total ta ’ 306 pazjenti bil- linfoma mhux ta ’ Hodgkin li ma kinux qegħdin jirrispondu għal trattamenti oħrajn jew irkadew wara t- trattament preċedenti.
The main study compared the effectiveness of Zevalin with that of rituximab in 143 patients.
L- istudju ewlieni qabbel l- effikaċja ta ’ Zevalin ma ’ dik ta ’ rituximab f’ 143 pazjent.
In an additional study, 57 patients with follicular lymphoma who had been previously treated and were not responding to rituximab received Zevalin.
Fi studju addizzjonali, 57 pazjent li jbatu minn linfoma follikulari li ġew ittrattati qabel u ma kinux qegħdin jirrispondu għal rituximab, irċevew Zevalin.