qanastek/EMEA-V3 huggingface dataset:
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq jimpenja ruħu li jwettaq studji addizzjonali u attivitajiet ta' farmakoviġilanza addizzjonali dettaljati fil- Pjan ta 'Farmakoviġilanza.
Tygacil 50 mg powder for solution for infusion Tigecycline
Tygacil 50 mg trab għal soluzzjoni għall- infużjoni Tigecycline
Each vial contains 50 mg tigecycline.
Kull kunjett fih 50 mg ta 'eculizumab.
Each vial contains 100 mg of lactose monohydrate.
Kull kunjett fih 100 mg ta ’ lactose monohydrate.
The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide.
Il- pH jista ’ jiġi aġġustat b’ hydrochloric acid, u jekk meħtieġ b’ sodium hydroxide
Read the package leaflet before use for directions on reconstitution and dilution.
Aqra l- fuljett tat- tagħrif qabel tuża għall- istruzzjonijiet dwar ir- rikostituzzjoni u d- dilwazzjoni.
For intravenous use after reconstitution and dilution.
Għal użu ġol- vina wara r- rikostituzzjoni u d- dilwazzjoni.
Justification for not including Braille accepted
Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata.
Tygacil 50 mg powder for infusion Tigecycline For IV use only
Tygacil 50mg trab għall- infużjoni Tigecycline Għal użu IV biss
21 PACKAGE LEAFLET INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Tygacil 50 mg powder for solution for infusion tigecycline
Tygacil 50mg trab għal soluzzjoni għall- infużjoni tigecycline
Read all of this leaflet carefully before you are given this medicine.
Aqra dan il- fuljett kollu qabel tibda tirċievi din il- mediċina.
- If you have any further questions, ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek
It may harm
Tista 'tagħmlilhom il -
them, even if their symptoms are the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li
this leaflet, please tell your doctor or pharmacist.
m' humiex imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What Tygacil is and what it is used for 2.
X' inhu Tygacil u għalxiex jintuża 2.
Before you receive Tygacil 3.
Qabel ma tieħu Tygacil 3.
How Tygacil is given 4.
Kif jingħata Tygacil 4.
Possible Side Effects 5.
Effetti sekondarji li jista 'jkollu 5.
How to Store Tygacil 6.
Kif taħżen Tygacil 6.
WHAT TYGACIL IS AND WHAT IT IS USED FOR
X' INHU TYGACIL U GĦALXIEX JINTUŻA
Tygacil is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.
Tygacil huwa antibijotiku tal- grupp glycylcycline li jaħdem billi jwaqqaf l- iżvilupp ta 'batterji li jikkaġunaw infezzjonijiet.
Your doctor prescribed Tygacil because you have one of the following types of serious infections:
It- tabib tiegħek ippreskriva Tygacil minħabba li għandek wieħed mit- tipi differenti ta 'infezzjonijiet serji:
• Complicated infection of the skin and soft tissues • Complicated infection in the abdomen
• Infezzjoni ikkomplikata tal- ġilda u tat- tessuti rotob • Infezzjoni ikkumplikata fl- addome
BEFORE YOU RECEIVE TYGACIL
QABEL MA TIEĦU TYGACIL
Do not use Tygacil • If you are allergic (hypersensitive) to tigecycline, the active substance of Tygacil.
Tieħux Tygacil • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal tigecycline, is- sustanza attiva ta ’ Tygacil.
If you are allergic to tetracycline class antibiotics (e. g., minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Jekk inti allerġiku għal antibijotiċi tal- kategorija ta 'tetraċiklini (eż., minocycline, doxycycline, eċċ.), tista' tkun allerġiku għal tigecycline.
Take special care with Tygacil • Tell your doctor immediately if you develop symptoms of an allergic reaction. • Tell your doctor immediately if you develop severe abdominal pain, nausea, and vomiting.
Oqgħod attent ħafna b' Tygacil • Għid lit- tabib tiegħek minnufih jekk tiżviluppa sintomi ta ’ reazzjoni allerġika. • Għid lit- tabib tiegħek minnufih jekk tiżviluppa uġigħ addominali sever, nawsea u remettar.
These may be symptoms of acute pancreatitis. • Tell your doctor if you are suffering from diarrhoea before you are given Tygacil.
Dawn jistgħu jkunu sinjali ta ’ pankreatite akuta. • Għid lit- tabib tiegħek jekk qed tbati minn dijarea qabel ma tingħata Tygacil.
If you develop diarrhoea during or after your treatment, tell your doctor at once.
Jekk tiżviluppa dijarea waqt jew wara t- trattament tiegħek, għid lit- tabib tiegħek minnufih.
Do not take any diarrhoea medicine without first checking with your doctor. • Tell your doctor if you have or previously had any side effects due to antibiotics belonging to the tetracycline class (e. g., skin sensitization to sun light, staining on developing teeth, pancreas inflammation, and alteration of certain laboratory values aimed at measuring how well your blood clots).
Tieħux mediċina għad- dijarea mingħajr ma 'l- ewwel tivverifika mat- tabib tiegħek.
22 • In certain serious infections, your doctor may consider to use Tygacil in combination with other antibiotics. • Tell your doctor if you are taking certain medicines (named anticoagulants) aimed at avoiding an excess of blood clotting (see also Using other medicines in this leaflet). • Tell your doctor if you are taking the contraceptive pill as you may need an additional method of contraception while receiving Tygacil (see also Using other medicines in this leaflet). • Tell your doctor if you have, or previously had liver problems.
22 • Għid lit- tabib tiegħek jekk qabel kellek xi effetti sekondarji minħabba antibijotiċi li jappartjenu għal kategorija ta 'tetraċiklini (eż., sensitizzazzjoni għal- ġilda minħabba d- dawl tax- xemx, titbigħ ta' snien li qed jiżviluppa, infjammazzjoni tal- frixa u bidla f' ċertu riżultati tal- laboratorju li jkejlu kif demmek jgħaqqad). • F' ċertu infezzjonijiet serji, it- tabib tiegħek jista 'jikkonsidra li juża Tygacil f' kombinazzjoni ma' antibijotiċi oħra. • Għid lit- tabib tiegħek jekk qed tieħu ċertu mediċini (antikoagulanti msemmija) li l- għan tagħhom hu li jevitaw it- taqgħid tad- demm (ara wkoll Meta tieħu mediċini oħra f' dan il- fuljett). • Għid lit- tabib tiegħek jekk qed tieħu l- pillola kontraċettiva billi għandu mnejn ikollok bżonn tuża metodu ieħor ta 'kontraċezzjoni waqt li qed tieħu Tygacil (ara wkoll Meta tieħu mediċini oħra f' dan il - fuljett). • Għid lit- tabib tiegħek jekk għandek, jew kellek problemi tal- fwied.
Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects. • While antibiotics including Tygacil fight certain bacteria, other bacteria and fungi may continue to grow.
Skond il- kundizzjoni tal- fwied tiegħek, it- tabib tiegħek jista 'jnaqqas id- doża sabiex jevita effetti sekondarji potenzjali. • Filwaqt li antibijotiċi bħal Tygacil jissiltu ma ċertu batterji, batterji oħrajn u fungi jistgħu jibqgħu jaħdmu.
This is called overgrowth.
Dan jissejjaħ overgrowth.
Your doctor will monitor you for any potential infections and treat you if necessary. • Tygacil is not to be used in children or adolescents (under 18 years of age).
It- tabib tiegħek ser jissorveljak għal infezzjonijiet potenzjali u jekk hemm bżonn jikkurak. • Tygacil m' għandux jintuża fi tfal u adoloxxenti (taħt it- 18- il sena ta 'età).
In children less than 8 years, tigecycline may induce permanent dental defects such as staining on the developing teeth.
Fi tfal li għandhom anqas minn 8 snin, tigecycline jista 'jinduċi difetti dentali permanenti bħal titbigħ fi snien li qed jiżviluppa.
Using other medicines Always tell your doctor if you are taking or have recently taken any other medicines, including medicines you buy without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Tygacil may prolong certain tests that measure how well your blood is clotting.
Tygacil għandu mnejn iddewwem ċertu testijiet li jkejlu kemm idum biex jgħaqqad id- demm.
It is important that you tell your doctor if you are taking medicines to avoid an excess of blood clotting.
Huwa importanti li tgħid it- tabib tiegħek jekk intix tieħu mediċini li jimpedixxu d- demm milli jgħaqqad b' mod eċċessiv.
If this were the case, your doctor will monitor you closely.
Jekk dan kien il- każ, it- tabib tiegħek ser jissorveljak mill- qrib.
Tygacil may interfere with the contraceptive pill (birth control pill).
Tygacil jista 'jinterferixxi mal- pillola kontraċettiva (pillola li tikkontrolla t- twelidijiet).
Talk to your doctor about the need for an additional method of contraception while receiving Tygacil.
Kellem lit- tabib tiegħek dwar il- bżonn ta 'metodu addizzjonali ta' kontraċezzjoni meta tirċievi Tygacil.
Pregnancy and breast-feeding Tygacil may cause foetal harm.
Tqala u treddigħ Tygacil jista 'jikkaġuna ħsara fetali.
If you are pregnant, or are planning to become pregnant, talk to your doctor before receiving Tygacil.
Jekk inti tqila jew qed tippjana li tinqabad tqila, kellem lit- tabib tiegħek qabel ma tirċievi Tygacil.
It is not known if Tygacil passes into breast milk in humans.
Mhux magħruf jekk Tygacil jgħaddiex fil- ħalib tas- sider tal- bniedem.
Ask your doctor for advice before breast-feeding your baby.
Staqsi lit- tabib tiegħek għal pariri qabel ma tredda 'lit- tarbija tiegħek.
Driving and using machines Tygacil may cause side effects such as dizziness.
Sewqan u tħaddim ta 'magni Tygacil jista' jikkawża effetti sekondarji bħal sturdamenti.
This may impair your ability to drive or operate machinery.
Dan jista 'jtellef il- ħila tiegħek li ssuq jew tħaddem inġenji.
HOW TYGACIL IS GIVEN
KIF JINGĦATA TYGACIL
Tygacil will be given to you by a doctor or a nurse.
Tygacil ser jingħatlek minn tabib jew infermiera.
The recommended dose is 100 mg given initially, followed by 50 mg every 12 hours.
Id- doża rakkomandata hi ta '100 mg li tingħata fil- bidu, segwita b' 50 mg kull 12- il siegħa.
This dose is given intravenously (directly into your blood stream) over a period of 30 to 60 minutes.
Din id- doża tingħata ġol- vina (direttament f' demmek) fuq perijodu ta '30 sa 60 minuta.
A course of treatment usually lasts for 5 to 14 days.
Kors ta 'trattament ġeneralment idum sejjer għal 5 sa 14- il jum.
Your doctor will decide how long you should be treated.
It- tabib tiegħek ser jiddeċiedi għalkemm għandek tiġi trattat.
23 If you receive more Tygacil than you should If you are concerned that you may have been given too much Tygacil, talk to your doctor or nurse immediately.
23 Jekk tieħu Tygacil aktar milli suppost Jekk inti mħasseb li stajt ingħatajt aktar Tygacil milli suppost, kellem lit- tabib jew 'l- infermiera minnufih.
If you miss a dose of Tygacil If you are concerned that you may have missed a dose, talk to your doctor or nurse immediately.
Jekk tinsa tieħu doża ta 'Tygacil Jekk inti mħasseb li qbiżt xi doża, kellem lit- tabib jew' l- infermiera tiegħek minnufih.
Like all medicines, Tygacil may have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Tygacil jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common side effects reported in at least 1 in 10 patients receiving Tygacil are: • Nausea, vomiting, diarrhoea.
L- aktar effetti sekondarji komuni rapportati f 'ta ’ lanqas pazjent 1 f' 10 li kienu qed jirċievu Tygacil huma: • Nawsja, rimettar, dijarea
Common side effects reported in at least 1 in 100 patients but in less than 1 in 10 patients receiving Tygacil are: • Abscess (collection of pus), infections • Laboratory measurements of decreased ability to form blood clots • Dizziness • Vein irritations from the injection, including pain, inflammation, swelling and clotting • Abdominal pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite) • Increases in liver enzymes, hyperbilirubinaemia (excess of bile pigment in the blood) • Pruritus (itching), rash • Headache • Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
Effetti sekondarji komuni rrapportati f 'ta ’ lanqas pazjent 1 f' 100 imma f' inqas minn 1 minn kull 10 li jirċievu Tygacil huma: • Axxessi (ġbir ta ’ materja), infezzjonijiet • Kejl tal- laboratorju tal- ħila mnaqqsa li jgħaqqad id- demm fit- testijiet. • Sturdament • Irritazzjonijiet fil- vini mill- injezzjoni li jinkludu uġigħ, infjammazzjoni, tinfiħ u d- demm jgħaqqad. • Uġigħ addominali, dispepsja (uġigħ fl- istonku u indiġestjoni), anoreksja (imur l- aptit) • Żieda fl- enzimi tal- fwied, iperbilirubinemija (eċċess tal- pigment tal- bila fid- demm) • Pririte (ħakk), raxx • Uġigħ ta' ras • Żieda fl- amylase, li hu enzim li jinsab fil- glandoli tas- saliva u l- frixa, żieda fl- urea nitrogen fid- dem (BUN).
Uncommon side effects reported in at least 1 in 1,000 patients but less than 1 in 100 patients receiving Tygacil are: • Sepsis (severe infection in the body and blood stream)/ septic shock (serious medical condition which can lead to multiple organ failure and death as a result of sepsis) • Low protein levels in the blood • Acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting) • Jaundice • Injection site reaction (pain, redness, inflammation). • Inflammation of the liver
Effetti sekondarji mhux komuni rapportati f' aktar minn 1 f' kull 1, 000 pazjent imma f' inqas minn 1 minn kull 100 li jirċievu Tygacil huma: • Sepsis (infezzjoni severa fil- ġisem u fiċ- ċirkolazzjoni tad- demm) / xokk settiku (kundizzjoni medika serja li tista ’ twassal għal falliment multiplu ta ’ organi u l- mewt bħala riżultat ta ’ sepsis) • Livelli baxxi ta 'proteini fid- demm • Pankreatite akuta (frixa infjammata li tista ’ tikkaġuna uġigħ addominali qawwi, dardir u remettar) • Suffejra, infjammazzjoni tal- fwied • Reazzjoni fil- lok ta' l- injezzjoni (uġigħ, ħmura, infjammazzjoni).
Other side effects reported (frequency not known) in patients receiving Tygacil are: • Anaphylaxis/ anaphylactoid reactions (that may range from mild to severe, including a sudden, generalised allergic reaction that may lead to a life-threatening shock [e. g. difficulty in breathing, drop of blood pressure, fast pulse]). • Low platelet levels in the blood (which may lead to an increased bleeding tendency and bruising/ haematoma)
Effetti sekondarji oħra rapportati (frekwenza mhix magħrufa) f’ pazjenti li qed jirċievu Tygacil huma: • Anafilassi/ reazzjonijiet anafilattojdi (li jistgħu jvarjaw minn ħfief sa severi, li jinkludi reazzjoni allerġika ġeneralizzata li tista ’ twassal għal xokk li jkun ta ’ periklu għal ħajja [e. g. diffikultà biex tieħu n- nifs, il - pressjoni tad- demm taqa ’, polz mgħaġġel]). • Livell baxx ta ’ pjastrini fid- demm (li jista ’ jwassal għal żieda fl- emorraġiji u tbenġil/ ematomi)
Pseudomembranous colitis may occur with most antibiotics including Tygacil.
Kolite psewdomembranuża tista ’ sseħħ b’ ħafna antibijotiċi li jinkludu Tygacil.
This consists of severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation, which may occur during or after your treatment.
Din tikkonsisti minn dijarea qawwija, persistenti u bid- demm u hija assoċjata ma ’ uġigħ addominali jew deni, li jistgħu jkunu sinjali ta ’ infjammazzjoni serja ta ’ l- imsaren, u li tista ’ sseħħ waqt jew wara l- kura.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE TYGACIL
KIF TAĦŻEN TYGACIL
Tygacil should be stored at or below 25°C.
Tygacil għandu jinżamm f’ temperatura ta ’ 25oC jew inqas.
Do not use Tygacil after the expiry date which is stated on the vial.
M' għandekx tuża Tygacil wara d- data li jiskadi li tidher fuq il- kunjett.
Storage after preparation Once the powder has been made into a solution and diluted ready for use, it should be given to you almost immediately.
Ħażna wara l- preparazzjoni Ġaladarba t- trab ikun sar f' soluzzjoni u dilwit lest biex jintuża, il- mediċina għandha tingħatalek minnufih.
What Tygacil contains The active substance is tigecycline.
X' fih Tygacil Is- sustanza attiva hija tigecycline.
Each vial contains 50 mg of tigecycline.
Kull kunjett fih 50 mg ta 'tigecycline.
The other ingredients are lactose monohydrate, hydrochloric acid, and sodium hydroxide.
Is- sustanzi l- oħra huma lactose monohydrate, hydrochloric acid, u sodium hydroxide
What Tygacil looks like and contents of the pack Tygacil is supplied in a vial and looks like an orange powder or cake before it is diluted.
Id- dehra ta 'Tygacil u l- kontenuti tal- pakkett Tygacil jiġi f' kunjett u jidher bħala trab jew kejk oranġjo qabel ma jiġi dilwit.
These vials are distributed to the hospital in a ten tray pack.
Dawn il- kunjetti huma distribwiti lill- isptar f' pakkett fi trej ta 'għaxar kunjetti.
The powder should be mixed in the vial with a small amount of solution.
It- trab għandu jiġi mħallat fil- kunjett b' ammont żgħir ta 'soluzzjoni.
The vial should be gently swirled until the medicine is dissolved.
Il- kunjett għandu jiġi ġentilment imdawwar sakemm il- mediċina tinħall.
Thereafter, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag or other suitable infusion container in the hospital.
Minn hemm 'il quddiem, is- soluzzjoni rikostitwita għandha titneħħa minnufih minn ġol- kunjett u għandha tiġi miżjuda ma borża jew reċipjent ieħor adattat għal infużjoni ta' 100 ml fl- isptar.
The Tygacil solution should be yellow to orange in colour after dissolving; if it is not, the solution should be discarded.
Is- soluzzjoni Tygacil għandha tkun ta ’ kulur isfar sa oranġjo wara li tiddisolvi; jekk le, is- soluzzjoni għandha tiġi mormija.
Marketing Authorisation Holder:
Id- Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom
New Lane Huntercombe Lane South Havant Taplow, Maidenhead Hampshire, PO9 2NG Berkshire SL6 0PH Ir- Renju Unit Ir- Renju Unit
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE Tηλ: +357 22 817690 Φαξ: +357 22 751855
Kύπρος Wyeth Hellas (Cyprus Branch) AEBE Τ: +357 22 817690 Φαξ: +357 22 751855
Salomone Pharma Ltd.
Salamone Pharma Ltd.
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f '[data]
26 Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/
26 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA): http: // www. emea. europa. eu /
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam tal- kura medika:
Instructions for use and handling (see also 3.
Struzzjonijiet għal użu u maniġġjar (ara wkoll 3.
HOW TYGACIL IS GIVEN in this leaflet)
KIF JINGĦATA TYGACIL f' dan il- fuljett)
The lyophilised powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection or dextrose 50 mg/ ml (5%) solution for injection to achieve a concentration of 10 mg/ ml of tigecycline.
It- trab lajofilizzat għandu jiġi rikostitwit b’ 5. 3 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew soluzzjoni għall- injezzjoni ta’ dextrose 50 mg/ ml (5%) biex tinkiseb konċentrazzjoni ta ’ 10 mg/ ml ta ’ tigecycline.
The vial should be gently swirled until the active substance is dissolved.
Il- kunjett għandu jiġi ġentilment imdawwar sakemm il- prodott mediċinali jinħall.
Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e. g. glass bottle).
Minn hemm 'il quddiem, 5 ml ta ’ soluzzjoni rikostitwita għandha tiġi immedjatament miġbuda mill- kunjett u miżjuda ma ’ borża għal infużjoni intravenuża ta ’ 100 ml jew reċipjent ieħor adattat għall - infużjoni (eż. flixkun tal- ħġieġ).
For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag for infusion or other suitable infusion container (e. g. glass bottle).
Għal doża ta ’ 100 mg, irrikostitwixxi billi tuża żewġ kunjetti f’ borża intravenuża ta ’ 100 ml jew xi reċipjent ieħor adattat għall- infużjoni (eż. flixkun tal- ħġieġ).
The vial contains a 6% overage.
Il- kunjett fih 6% overage.
Parenteral products should be inspected visually for particulate matter and discolouration (e. g. green or black) prior to administration.
Prodotti parenterali għandhom jiġu spezzjonati viżwalment għal frak u tindis fil- kulur (eż. aħdar jew iswed) qabel ma jingħataw.
If the same intravenous line is used for sequential infusion of several active substances, the line should be flushed before and after infusion of Tygacil with either sodium chloride 9 mg/ ml (0.9%) solution for injection or dextrose 50 mg/ ml (5%) solution for injection.
Jekk l- istess pajp intravenuż huwa użat għall- infuzjoni sekwenzjali ta ’ bosta sustanzi attivi, il- pajp għandu jiġi maħsul qabel jew wara l- infuzzjoni ta ’ Tygacil jew b’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew dextrose 50 mg/ ml (5%) għall- injezzjoni.
Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line.
Għandha ssir injezzjoni b’ infużjoni kompatibbli ma ’ tigecycline u xi prodott( i) mediċinali ieħor( oħrajn) permezz ta ’ dan il- pajp komuni (ara sezzjoni 6. 2).
Compatible intravenous solutions include: sodium chloride 9 mg/ ml (0.9%) solution for injection and dextrose 50 mg/ ml (5%) solution for injection.
Soluzzjonijiet intravenużi kompatibbli jinkludu: soluzzjoni għall- injezzjoni ta 'sodium chloride 9 mg/ ml (0. 9%) u soluzzjoni għall- injezzjoni dextrose 50 mg/ ml (5%).
When administered through a Y-site, compatibility of Tygacil diluted in sodium chloride 0.9% for injection is demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer’ s, lidocaine HCl, morphine, norepinephrine, piperacillin/ tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.
Meta jkun mogħti minn ġo sit- Y, il- kompatibbilità ta ’ Tygacil dilwit f’ sodium chloride 0. 9% għall - injezzjoni tintwera bil- prodotti mediċinali jew dilwenti li ġejjin: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer’ s, lidocaine HCl, morphine, norepinephrine, piperacillin/ tazobactam (formulazzjoni EDTA), potassium chloride, propofol, ranitidine HCl, theophylline u tobrramycin
Once reconstituted and diluted in the bag or other suitable infusion container (e. g. glass bottle) tigecycline should be used immediately.
Ġaladarba ikun rikostitwit u dilwit fil- borża jew reċipjent ta 'l- infużjoni ieħor adattat (eż. flixkun tal - ħġieġ), tigecycline għandu jintuża minnufih.
For single use only, any unused solution should be discarded.
Biex jintuża darba biss, b' kull soluzzjoni mhix użata għandha tiġi mormija.
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 g all- Prodotti Medi inali g all- U u mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex jasal g ar- rakkomandazzjonijiet tieg u dwar kif tintu a l- medi ina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk te tie aktar informazzjoni dwar il- kundizzjoni medika tieg ek jew it- trattament tieg ek, aqra l- Fuljett ta ’ Tag rif (parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispi jar tieg ek.
What is Tysabri?
X’ inhu Tysabri?
Tysabri is a concentrate that is made up into a solution for infusion (drip into a vein).
Tysabri huwa kon entrat li jit allat f’ soluzzjoni g all- infu joni (drip ol- vina).
It contains the active substance natalizumab.
Fih is- sustanza attiva natalizumab.
What is Tysabri used for?
G al xiex jintu a Tysabri?
Tysabri is used to treat adults with multiple sclerosis (MS).
Tysabri jintu a fit- trattament ta ’ adulti li jbatu mill- isklero i multipla (MS).
It is used in the type of MS known as ‘ relapsing-remitting’, when the patient has attacks (relapses) followed by periods with no symptoms (remissions).
Jintu a fit- tip ta ’ MS mag rufa b ala ‘ re idiva- remittenti ’ (relapsing- remitting), meta l- pazjent ikollu attakki (re idivi) segwiti minn perjodi bla sintomi (remissjonijiet).
It is used when the disease is: • highly active despite treatment with a beta-interferon (another type of medicine used in MS), or; • severe and getting worse rapidly.
Jintu a meta l- marda hija: • attiva afna minkejja trattament b’ beta- interferon (tip ta ’ medi ina o ra u ata f’ MS), jew; • gravi u li qieg da tiggrava rapidament.
The medicine can only be obtained with a prescription.
Il- medi ina tista ’ tinkiseb biss b’ ri etta tat- tabib.
How is Tysabri used?
Kif jintu a Tysabri?
Treatment with Tysabri should be started and supervised by a doctor who is experienced in treating diseases of the nervous system, and who has access to a type of scanning machine called a magnetic resonance imaging (MRI) machine.
It- trattament b’ Tysabri g andu jinbeda u jkun sorveljat minn tabib b’ esperjenza fit- trattament ta ’ mard tas- sistema nervu a, u li g andu a ess g al tip ta ’ magna tal- iskenjar imsej a magna tal- imma ini tar- re onanza manjetika (magnetic resonance imaging (MRI)).
This machine will enable the doctor to check for changes in the brain linked to MS or the rare brain infection called progressive multifocal leukoencephalopathy (PML).
lewkoen efalopatija multifokali progressiva (PML).
Tysabri is given as one infusion lasting one hour every four weeks.
Tysabri jing ata kull erba ’ img at b ala infu joni wa da li ddum sieg a.
Because the infusion can trigger an allergic reaction, the patient must be monitored during and for one hour after the infusion.
Min abba li l- infu joni tista ’ tqanqal reazzjoni aller ika, il- pazjent je tie li jkun sorveljat waqt u g al sieg a wara l - infu joni.
If there is no clear benefit for the patient after six months, the doctor will have to re-assess the treatment.
Jekk ma hemm l- ebda benefi ju ar g all- pazjent wara sitt xhur, it- tabib ikollu jivvaluta mill - did it- trattament.
Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine.
Je tie li l- pazjenti ttrattati b’ Tysabri jing ataw skeda ta ’ twissija spe jali li tag ti fil- qosor l - informazzjoni ta ’ sigurtà ewlenija dwar il- medi ina.
Patients should show this card to their partner or carer, as well as to other doctors treating them, because they may notice symptoms of PML that the patient is not aware of, such as changes in mood, behaviour or speech.
Il- pazjenti g andhom juru din l- iskeda lis- sie eb tag hom jew lill- persuna li tkun qieg da tie u siebhom, kif ukoll lil tobba o rajn li jkunu qeg din jittrattawhom, min abba li jistg u jinnotaw sintomi ta ’ PML li l- pazjent ma jkunx konxju tag hom, b alma huma bidliet fil- burdata, im iba jew diskors.
MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells.
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li ie ddisinjat biex jag raf u je el ma ’ struttura spe ifika (imsej a anti ene) li tinsab fuq erti elloli fil - isem.
By blocking the integrin, natalizumab stops the leucocytes from going from the blood into the brain.
Natalizumab ie ddisinjat biex je el ma ’ parti spe ifika ta ’ ‘ integrina ’ imsej a ‘ 4 1 integrina ’.
This reduces inflammation, and the nerve damage caused by MS.
Dan inaqqas l- infjammazzjoni, u l - sara lin- nervituri kka unati mill- MS.
How has Tysabri been studied?
Kif ie studjat Tysabri?
Two studies, both lasting two years, have looked at Tysabri in MS.
L- effetti ta ’ Tysabri g all- ewwel ew ittestjati fuq mudelli sperimentali qabel ma ew studjati fuq il - bniedem. ew studji, it- tnejn li huma damu sentejn, studjaw Tysabri fl- MS.
One study compared Tysabri on its own (monotherapy) with placebo (a dummy treatment) in 942 patients.
Studju wie ed qabbel Tysabri wa du (monoterapija) ma ’ pla ebo (trattament finta) f’ 942 pazjent.
The second study looked at the effect of adding Tysabri to interferon beta-1a (another medicine used in MS) in 1,171 patients.
It- tieni studju e amina l - effett ta - ieda ta ’ Tysabri ma ’ interferon beta- 1a (medi ina o ra u ata fl- MS) f’ 1, 171 pazjent.
The main measures of effectiveness were the number of relapses, and the changes in the patients’ level of disability, measured using a standard scale (the Expanded Disability Status Scale).
Il- kejl ewlieni tal- effika ja kienet in- numru ta ’ rikaduti, u l- bidliet fil- livell tad- di abilità tal- pazjent, imkejla permezz tal- u u ta ’ skala standard (Expanded Disability Status Scale).
What benefit has Tysabri shown during the studies?
Liema benefi ju wera Tysabri waqt l- istudji mwettqa?
In the monotherapy study, Tysabri was more effective than placebo in reducing the number of relapses.
Fl- istudju tal- monoterapija, Tysabri rri ulta iktar effika i mill- pla ebo biex inaqqas in- numru ta ’ rikaduti.
After one year, there was a decrease of about two-thirds in the number of MS attacks in Tysabri-treated patients, in comparison with the patients who received placebo.
Wara sena, kien hemm tnaqqis ta ’ madwar ew terzi fin- numru ta ’ attakki ta ’ MS f’ pazjenti ttrattati b’ Tysabri, meta mqabbla ma ’ pazjenti ttrattati bil- pla ebo.
Tysabri was also more effective than placebo on the disabling effects of MS: over two years, the risk of disability getting worse was reduced by 42% in comparison with placebo.
Tysabri kien ukoll iktar effika i mill- pla ebo fuq l- effetti tal- MS li jikka unaw di abilità: fuq perjodu ta ’ sentejn, ir- riskju li d - di abilità tiggrava tnaqqas bi 42% meta mqabbel mal- pla ebo.
In the add-on study with interferon beta-1a, the risk of disability getting worse and the number of relapses were reduced.
Fl- istudju komplimentari b’ interferon beta- 1a, tnaqqas ir- riskju li d- di abilità tiggrava kif ukoll in - numru ta ’ rikaduti.
However, the way the study was designed did not allow the clear identification of whether these results were due to Tysabri only, or to the combination.
Madankollu, il- mod kif l- istudju kien imfassal ma alliex l- identifikazzjoni ara ta ’ jekk dawn ir- ri ultati se ewx min abba Tysabri biss, jew g all- kombinazzjoni.
What is the risk associated with Tysabri?
X’ inhu r- riskju asso jat ma ’ Tysabri?
Patients, carers and doctors need to be aware that Tysabri can be associated with infections, including PML.
Je tie li l- pazjenti, dawk li jie du sieb il- pazjenti u t- tobba jkunu konxji li Tysabri jista ’ jkun asso jat ma ’ infezzjonijiet, inklu i PML.
PML has symptoms that are similar to those of an MS attack, and usually leads to severe disability or death.
PML g andha sintomi analogi g al dawk ta ’ attakk ta ’ MS, u eneralment twassal g al di abilità gravi jew mewt.
If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.
Jekk ikun hemm suspett ta ’ PML, it- tabib g andu jwaqqaf it- trattament sakemm ikun ert li l- pazjent ma jkollux l- infezzjoni.
In the studies, the most common side effects with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infections of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (rash), headache, dizziness, vomiting, nausea (feeling sick), arthralgia (joint pain), rigors (shaking chills), pyrexia (fever) and fatigue (tiredness).
Fl- istudji, l- iktar effetti sekondarji komuni b’ Tysabri (li dehru f’ bejn pazjent 1 u 10 minn 100) kienu infezzjonijiet tal- passa i urinarji (infezzjonijiet tal- istrutturi li j orru l- awrina), na ofarin ite (infjammazzjoni tal- imnie er u l- ger uma), urtikarja (raxx), u ig ta ’ ras, sturdament, remettar, naw ea (dardir), artral ija (u ig fil - ogi), tertir (tkexkix ta ’ bard), piressija (deni) u g eja.
For the full list of all side effects reported with Tysabri, see the Package Leaflet.
G al- lista s i a ta ’ effetti sekondarji kollha rrappurtati ma ’ Tysabri, ara l- Fuljett ta ’ Tag rif.
About 6% of the patients in the studies developed long-lasting antibodies against natalizumab.
Madwar 6% tal- pazjenti fl- istudji viluppaw antikorpi kontra natalizumab li jservu fit- tul.
This led to a decrease in the effectiveness of the medicine.
Dan wassal g al tnaqqis fl- effika ja tal- medi ina.
Tysabri should not be used in people who may be hypersensitive (allergic) to natalizumab or any of the other ingredients.
Tysabri m’ g andux jintu a f’ persuni li jistg u jkunu ipersensittivi (aller i i) g al natalizumab jew g al xi sustanza o ra tieg u.
It must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune systems are weakened because of disease or other medicines they are receiving or may have received before.
M’ g andux jing ata lil pazjenti li g andhom PML jew li huma f’ riskju li jie du infezzjoni, inklu i pazjenti li s- sistemi immunitarji tag hom huma mdg ajfin min abba mard jew medi ini o ra li qed jir ievu jew li setg u r evew qabel.
Tysabri must not be given with beta-interferon or glatiramer acetate (other long-term medicines for MS).
Tysabri m’ g andux jing ata ma ’ beta- interferon jew glatiramer a etat (jew medi ini fuq tul ta ’ mien g all- MS o rajn).
It also must not be given to patients who have cancer (unless it is a type of skin cancer called basal cell carcinoma) or to people under 18 years of age.
M’ g andux jing ata wkoll lil pazjenti li g andhom kan er (sakemm mhuwiex tip ta ’ kan er imsejja kar inoma b ’ elloli ba ali) jew lil nies ta t l- età tat- 18- il sena.
For the full list of restrictions, see the Package Leaflet.
G al- lista s i a ta' restrizzjonijiet, ara l- Fuljett ta ’ Tag rif.
Why has Tysabri been approved?
G aliex ie approvat Tysabri?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of Tysabri in MS, on both relapses and disability, had been clearly shown.
Il- Kumitat g all- Prodotti Medi inali g all- U u mill- Bniedem (CHMP) ikkonkluda li l- effika ja ta ’ Tysabri fl- MS, kemm fuq ir- rikaduti kif ukoll fuq id- di abilità, intweriet b’ mod ar.
However, because of its safety profile, the medicine should only be used in patients who have a real need for the medicine.
Madankollu, min abba l- profil ta ’ sigurtà tag ha, il- medi ina g andha tintu a biss f’ pazjenti li g andhom b onn reali tal- medi ina.
The Committee decided that Tysabri’ s benefits are greater than its risks as single disease modifying therapy in highly active relapsing remitting MS for patients with high disease activity despite treatment with a beta-interferon, or with rapidly evolving severe relapsing remitting MS.
Il- Kumitat idde ieda li l- benefi ji ta ’ Tysabri huma og la mir- riskji tieg u b ala terapija singola li timmodifika l- marda fl- MS re idiva- remittenti attiva afna g all- pazjenti b’ attività tal- marda g olja minkejja t- trattament b’ beta- interferon, jew bi MS re idiva- remittenti gravi li qieg da tevolvi rapidament.
The Committee recommended that Tysabri be given marketing authorisation.
Il- Kumitat irrakkomanda li Tysabri jing ata awtorizzazzjoni g at- tqeg id fis- suq.
2/ 3 Other information about Tysabri:
2/ 3 Liema mi uri qed jittie du sabiex ji i assigurat u u sigur g al Tysabri?
The European Commission granted a marketing authorisation valid throughout the European Union for Tysabri to Elan Pharma International Ltd on 27 June 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni g at- tqeg id fis- suq fl- Unjoni Ewropea kollha g al Tysabri lil Elan Pharma International Ltd fis- 27 ta ’ unju 2006.
The full EPAR for Tysabri can be found here.
L- EPAR s i g al Tysabri jista ’ ji i kkonsultat hawn.
This summary was last updated in 11-2008.
Dan is- sommarju ie a ornat l- a
Pharmaceutical Form
farmaċewtika Konċentrat għal
Content (concentration)
(konċentrazzjoni)
Concentrate for solution for infusion
soluzzjoni għall - infużjoni
TYSABRI 300 mg concentrate for solution for infusion.
TYSABRI 300 mg konċentrat għal soluzzjoni għall- infużjoni.
Each ml of concentrate contains 20 mg of natalizumab.
Kull ml ta ’ konċentrat fih 20 mg ta ’ natalizumab.
Natalizumab is a recombinant humanised anti-α 4-integrin antibody produced in a murine cell line by recombinant DNA technology.
Natalizumab huwa antikorp rikombinat umanizzat anti- α4- integrin prodott minn razza ta ’ ċelluli tal - ġrieden permezz ta ’ teknoloġija tat- tfassil tad- DNA.
When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ ml of natalizumab.
Meta jiġi dilwit (ara sezzjoni 6. 6), is- soluzzjoni għall- infużjoni fiha madwar 2. 6 mg/ ml ta ’ natalizumab.
TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:
TYSABRI huwa indikat bħala monoterapija li timmodifika l- marda fi sklerożi multipla attiva ħafna li tirkada u tbatti għall- ġruppi ta ’ pazjenti li ġejjin:
• Patients with high disease activity despite treatment with a beta-interferon (see section 5.1);
• Pazjenti li għandhom attività għolja tal- marda għalkemm ikkurati b’ interferon- beta (ara sezzjoni 5. 1);
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis (see section 5.1).
• Pazjenti bi sklerozi multipla severa li tirkada u tbatti u li qed tiżviluppa malajr (ara sezzjoni 5. 1).
TYSABRI therapy is to be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Terapija b’ TYSABRI għandha tinbeda u tiġi sorveljata minn tobba speċjalizzati b’ esperjenza fid - dijanjosi u l- kura ta ’ kundizzjonijiet newroloġiċi, f’ ċentri b’ aċċess f’ waqtu ta ’ MRI.
Patients treated with TYSABRI must be given the patient alert card.
Pazjenti kkurati b’ TYSABRI għandhom jingħataw kartuna ta ’ allarm tal- pazjenti.
Resources for the management of hypersensitivity reactions and access to MRI should be available.
Għandhom ikunu disponibbli riżorsi għall- immaniġġjar ta ’ reazzjonijiet ta ’ sensitività eċċessiva u aċċess għall- MRI.
After dilution (see section 6.6), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions.
Wara d- dilwizzjoni (ara sezzjoni 6. 6), l- infużjoni għandha tingħata fuq madwar siegħa u l- pazjenti għandhom jiġu sorveljati waqt l- infużjoni u għal siegħa wara li tintem l- infużjoni għal sinjali u sintomi ta ’ reazzjonijiet ta ’ sensitività eċċessiva.
TYSABRI must not be administered as a bolus injection.
TYSABRI m’ għandux jingħata bħala injezzjoni bolus.
If there are signs of
Il- pazjenti jistgħu jaqilbu direttament minn beta interferon jew glatiramer acetate għal natalizumab dejjem jekk m’ hemm l- ebda sinjali ta ’ anormalitajiet rilevanti relatati mal- kura e. ż. newtropenija.
2 treatment-related abnormalities these must return to normal before treatment with natalizumab is started.
Jekk 2 hemm sinjali ta ’ anormalitajiet relatati mal- kura dawn għandhom jerġgħu għan- normal qabel ma ’ tinbeda kura b’ natalizumab.
Some patients may have been exposed to immunosuppressive medications (e. g. mitoxantrone, cyclophosphamide, azathioprine).
Xi pazjenti setgħu kienu esposti għall- medikazzjoni immunosoppressiva (e. ż. mitoxantrone, cyclophosphamide, azathioprine).
These drugs have the potential to cause prolonged immunosuppression, even after dosing is discontinued.
Dawn il- mediċini għandhom il- potenzjal li jikkawżaw immunosoppressjoni mtawwla, anki wara li jitwaqqaf id- dożaġġ.
Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI.
Għalhekk, it- tabib għandu jikkonferma li dawn il- pazjenti m’ għandhomx immunità mdgħajjfa qabel ma tinbeda kura b’ TYSABRI.
Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months.
Kontinwazzjoni tat- terapija għandha tiġi kkunsidrat mill- ġdid b’ attenzjoni f’ pazjenti li ma wrew l - ebda evidenza ta ’ benefiċċju terapewtiku wara 6 xhur.
Data on the safety and efficacy of natalizumab beyond 2 years are not available.
Mhux disponibbli tagħrif dwar is- sigurtà u l- effikaċja ta ’ natalizumab wara sentejn.
Continued therapy beyond this time should be considered only following a reassessment of the potential for benefit and risk.
Kontinwazzjoni ta ’ terapija wara dan it- tul ta ’ żmien għandha tiġi kkunsidrata biss wara studju mill- ġdid tal- potenzjali għall- benefiċċju u riskju.
TYSABRI 300 mg is administered by intravenous infusion once every 4 weeks.
TYSABRI 300 mg jingħata permezz ta ’ infużjoni ġol- vini darba kull 4 ġimgħat.
TYSABRI is not recommended for use in patients aged over 65 due to a lack of data in this population.
L- użu ta ’ TYSABRI f’ pazjenti b’ eta ’ ta ’ aktar minn 65 mhux irrakkomandat minħabba n- nuqqas ta ’ tagħrif f’ din il- popolazzjoni.
TYSABRI is contraindicated in children and adolescents (see section 4.3).
TYSABRI huwa kontra- indikat fit- tfal u adoloxxenti (ara sezzjoni 4. 3).
Renal and hepatic impairment
Indeboliment tal- kliewi u tal- fwied
Studies have not been conducted to examine the effects of renal or hepatic impairment.
Ma sarux studji biex jiġu eżaminati l- effetti ta ’ indeboliment tal- kliewi u tal- fwied.
The mechanism for elimination and results from population pharmacokinetics suggest that dose adjustment would not be necessary in patients with renal or hepatic impairment.
Il- mekkaniżmu għall- eliminazzjoni u r- riżultati minn farmakokinetika tal- popolazzjoni jissuġġerixxu li mhux neċessarju aġġustament fid- doża f’ pazjenti f’ indeboliment tal- kliewi u tal- fwied.
Readministration
Għotja mill- ġdid
The efficacy of re-administration has not been established, for safety see section 4.4.
Miħabba sigurtà, l- effikaċja ta ’ l- għotja mill- ġdid ma ġewx stabbiliti, ara sezzjoni 4. 4
Hypersensitivity to natalizumab or to any of the excipients.
Sensittività eċċessiva għal natalizumab jew għal xi sustanzi mhux attivi.
Progressive multifocal leukoencephalopathy (PML).
Lewkoenċefalopatija multifokali progressiva (PML).
Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e. g. mitoxantrone or cyclophosphamide, see also sections 4.4 and 4.8).
Pazjenti b’ riskju akbar għall- infezzjonijiet opportunistiċi, fosthom pazjenti b’ immunità mdgħajjfa (inkuż dawk li bħalissa qed jieħdu terapiji immunosoppressivi jew dawk b’ immunità mdgħajjfa minħabba terapija preċedenti, e. ż. mitoxantrone jew cyclophosphamide, ara wkoll sezzjonijiet 4. 4 u 4. 8).
Combination with beta-interferons or glatiramer acetate.
Użu flimkien ma ’ beta- interferons jew glatiramer acetate.
Known active malignancies, except for patients with cutaneous basal cell carcinoma.
Tumuri malinn magħrufa, minbarra pazjenti b’ karċinoma kutanja taċ- ċellula bażika.
Children and adolescents.
Tfal u adoloxxenti.
Progressive Multifocal Leukoencephalopathy (PML)
Lewkoenċefalopatija Multifokali Progressiva (PML)
Use of TYSABRI has been associated with an increased risk of PML.
L- użu ta ’ TYSABRI kien assoċjat ma ’ żjieda fir- riskju ta ’ PML.
Before initiation of treatment with TYSABRI, a recent (usually within 3 months) Magnetic Resonance Image should be available.
Qabel ma tinbeda l- kura b’ TYSABRI, għandu jkun disponibbli Magnetic Resonance Image riċenti (ġeneralment sa 3 xhur).
Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML.
Il- pazjenti għandhom jiġu sorveljati f’ intervalli regolari għal sintomi newroloġiċi ġodda jew li marru għal agħar jew għal sinjali li jissuġġerixxu PML.
If PML is suspected, further dosing must be suspended until PML has been excluded.
Jekk ikun hemm suspett ta ’ PML, aktar dożaġġ għandu jiġi sospiż sakemm tiġi eskluża PML.
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are typical of MS or possibly suggestive of PML.
It- tabib għandu jeżamina l- pazjent biex jiddetermina jekk is- sintomi humiex indikattivi ta ’ disfunzjoni newroloġika, u jekk dan hu l- każ, jekk dawn is- sintomi humiex tipiċi ta ’ MS jew li possibilment jissuġġerixxu PML.
If any doubt exists, further evaluation, including MRI scan preferably with contrast (compared with pre- treatment MRI), CSF testing for JC Viral DNA and repeat neurological assessments, should be considered as described in the Physician Information and Management Guidelines (see educational guidance).
Jekk ikun hemm xi dubji, għandu jiġi kkunsidrat li jsiru aktar eżamijiet, inluż scan ta ’ l- MRI preferibbilment b’ kuntrast (imqabbel ma ’ MRI ta ’ qabel il- kura), l- eżaminazzjoni tas- CSF għal DNA Virali JC u ripetizzjoni ta ’ valutazzjonijiet newroloġiċi kif deskritt fl- Informazzjoni għat - Tabib u Linji Gwida għall- Immaniġġjar (ara gwida ta ’ edukazzjoni).
Once the clinician has excluded PML (if necessary, by repeating clinical, imaging and/ or laboratory investigations if clinical suspicion remains), dosing of natalizumab may resume.
Ladarba it- tabib jeskludi PML, (jekk hemm bżonn billi jiġu ripetuti immaġini kliniċi u/ jew investigazzjonijiet tal- laboratorju jekk jibqa ’ suspett kliniku), l- għotja ta ’ natalizumab tista ’ titkompla.
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e. g. cognitive or psychiatric symptoms).
It- tabib għandu joqod attent ħafna għal sintomi li jissuġġerixxu PML li l- pazjent jista ma jindunax bihom (e. ż. sintomi konoxxittivi jew psikjatriċi).
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Il- pazjenti għandhom jiġu rrakkomandati wkoll sabiex jinfurmaw lis- sieħeb tagħhom jew dawk li qed jieħdu ħsiebhom dwar il- kura tagħhom, minħabba li huma jistgħu jinnutaw sintomi li l- pazjent ma jindunax bihom.
If a patient develops PML the dosing of TYSABRI must be permanently discontinued.
Jekk pazjent jiżviluppa PML l- għotja ta ’ TYSABRI għandha tiġi mwaqqfa għal kollox.
Following reconstitution of the immune system in immunocompromised patients with PML, stabilisation or improved outcome has been seen (see section 5.2).
Wara rikostituzzjoni tas- sistema mmunitarja f’ pazjenti b’ PML b’ immunità mdgħajjfa, kien hemm stabilizzazzjoni u titjib fir- riżultat (ara sezzjoni 5. 2).
It remains unknown if early detection of PML and suspension of TYSABRI therapy may lead to similar stabilisation or improved outcome.
Għad mhux magħruf jekk is- sejba bikrija ta ’ PML u t- twaqqif ta ’ terapija b’ TYSABRI jistgħux iwasslu għal stabilizzazzjoni jew titjib fir- riżultat simili.
Other Opportunistic Infections
Infezzjonijiet Opportunistiċi Oħra