qanastek/EMEA-V3 huggingface dataset:
Simulect powder Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 10 mg basiliximab as powder for solution for injection or infusion.
Trab Simulect Kunjett tal- ħġieġ tip I bla kulur tapp tal- lastku butyl miksi b’ fluor- resin griż, miżmum f’ postu bi strippa ta ’ aluminium fil- ġenb, tapp ċelesti ta ’ polypropylene li tiftħu b’ subgħajk, li jkun fih 10 mg basiliximab bħala trab għal soluzzjoni għall- injezzjoni jew infużjoni.
Simulect is also available in vials with 20 mg basiliximab.
Simulect jista ’ jinstab ukoll f’ kunjetti b’ 20 mg basiliximab.
Reconstitution To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml of water for injections aseptically to the vial containing the Simulect powder.
Rikostituzzjoni Biex tipprepara s- soluzzjoni għall- infużjoni jew għall- injezzjoni, ħu 2. 5 ml ilma għall- injezzjonijiet b’ mod asettiku mill- ampulla ta ’ 5 ml li tiġi magħha u żid dawn iż- 2. 5 ml, ilma għall- injezzjonijiet b’ mod asettiku ġol- kunjett li fih it- trab ta ’ Simulect.
Shake the vial gently to dissolve the powder, avoiding foaming.
Ħawwad il- kunjett bil- mod biex jinħall it- trab, tevita r- rawgħa.
From a microbiological point of view, the product should be used immediately.
Mil - lat mikrobijoloġiku, il - prodott għandu jintuża mill- ewwel.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Jekk ma jintużax mill- ewwel, il- ħinijiet tal- ħażna u l - kondizzjonijiet ta ’ qabel l- użu huma r- responsabbiltà ta ’ min qed jużah.
The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ ml (5%) for infusion.
16 Is- soluzzjoni rikostitwita hija iżotonika u tista ’ tingħata bħala injezzjoni bolus jew miżjuda b’ salina normali jew b’ dextrose 50 mg/ ml (5%) għall- infużjoni sa 25 ml jew aktar.
Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line.
Peress li m’ hemm l- ebda informazzjoni jekk Simulect jistax jitħallat ma ’ prodotti mediċinali oħrajn li jingħataw minn ġol- vina, għaldaqstant Simulect m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn u dejjem għandu jingħata permezz ta ’ pajp ta ’ l- infużjoni separat.
Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland
Novartis Pharma AG Lichtstrasse 35 CH- 4056 Basel L- Iżvizzera
The Marketing Authorisation Holder should submit annual PSURs.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jissottometti PSURs kull sena.
FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK
KAXXA LI TINTLEWA GĦAL KUNJETT 1 U AMPULLA 1 BĦALA PAKKETT B’ WIEĦED
Simulect 20 mg powder and solvent for solution for injection or infusion basiliximab
Simulect 20 mg trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni basiliximab
One vial contains 20 mg of basiliximab.
Kunjett wieħed li fih 20 mg ta ’ basiliximab.
It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine.
Fih ukoll potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine.
The solvent ampoule contains 5 ml water for injections.
L- ampulla tas- solvent fiha 5 ml ilma għall- injezzjonijiet.
One vial with 20 mg powder for solution for injection/ infusion One ampoule of 5 ml solvent
Ampulla waħda ta ’ 5 ml solvent.
EXP Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours).
EXP Uża immedjatament wara li tħallat (stabbli b’ mod kimiku u fiżiku f’ temperatura ta ’ 2°C - 8°C għal 24 siegħa jew fit- temperatura ambjentali għal 4 sigħat).
Please open here.
Jekk jogħġbok iftaħ hawn.
Simulect 20 mg powder for solution for injection/ infusion basiliximab Intravenous use
Simulect 20 mg trab għal soluzzjoni għall- injezzjoni/ infużjoni basiliximab Użu għal ġol- vini
AMPOULE LABEL
TIKKETTA TA ’ L- AMPULLA
Solvent for Simulect Water for injections
Solvent għal Simulect Ilma għall- injezzjonijiet
See package leaflet
Ara l- fuljett ta ’ tagħrif.
Simulect 10 mg powder and solvent for solution for injection or infusion basiliximab
Simulect 10 mg trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni basiliximab
One vial contains 10 mg of basiliximab.
Kunjett wieħed li fih 10 mg ta ’ basiliximab.
One vial with 10 mg powder for solution for injection/ infusion One ampoule of 5 ml solvent
Kunjett wieħed b’ 10 mg trab għal soluzzjoni għall- injezzjoni/ infużjoni.
EXP Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours).
JIS Uża immedjatament wara li tħallat (stabbli b’ mod kimiku u fiżiku f’ temperatura ta ’ 2°C - 8°C għal 24 siegħa jew fit- temperatura ambjentali għal 4 sigħat).
Simulect 10 mg powder for solution for injection/ infusion basiliximab Intravenous use
Simulect 10 mg trab għal soluzzjoni għall- injezzjoni/ infużjoni basiliximab Użu għal ġol- vini
28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Simulect 20 mg powder and solvent for solution for injection or infusion Basiliximab
Simulect 20 mg trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni Basiliximab
Read all of this leaflet carefully before you are given this medicine.
Aqra sew dan il- fuljett kollu qabel ma tingħata din il- mediċina. − Żomm dan il- fuljett.
- If you have any further questions, ask your doctor, nurse or pharmacist.
Jista ’ jkollok bżonn terġa taqrah. − Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib, lill- infermier jew lill- ispiżjar tiegħek. − 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, lill- infermier jew lill- ispiżjar tiegħek.
What Simulect is and what it is used for 2.
X’ inhu Simulect u għalxiex jintuża 2.
Before you are given Simulect 3.
Qabel ma tingħata Simulect 3.
How Simulect is given to you 4.
Kif jingħatalek Simulect 4.
How to store Simulect 6.
Kif taħżen Simulect 6.
WHAT SIMULECT IS AND WHAT IT IS USED FOR
X’ INHU SIMULECT U GĦALXIEX JINTUŻA
Simulect belongs to a group of medicines called immunosuppressants.
Simulect jifforma parti minn grupp ta ’ mediċini li jissejħu immunosoppressiva.
It is given in hospital to adults, adolescents and children who are having a kidney transplant.
Jingħata fl- isptar lill - adulti, adolexxenti u lit- tfal li qed jirċievu trapjant tal- kliewi.
Immunosuppressants reduce the body’ s response to anything that it sees as “ foreign” – which includes transplanted organs.
L- immunosoppressiva jnaqqsu r - reazzjoni tal- ġisem għal kull ħaġa li l- ġisem jara bħala ħaġa barranija – inklużi organi trapjantati.
The body’ s immune system thinks a transplanted organ is a foreign body and will try to reject it.
Is - sistema immuni tal- ġisem taħseb li organu trapjantat huwa oġġett barrani, u tipprova tirriġettah.
Simulect works by stopping the immune cells that attack transplanted organs.
Simulect jaħdem billi jwaqqaf ċelloli immuni li jattakaw organi trapjantati.
You will only be given two doses of Simulect.
Inti tingħata biss żewġ dożi ta ’ Simulect.
These will be given in hospital, around the time of your transplant operation.
Dawn ser jingħataw, fl- isptar, matul iż- żmien ta ’ l - operazzjoni tat- trapjant tiegħek.
Simulect is given to stop your body from rejecting the new organ during the first 4 to 6 weeks after the transplant operation, when rejection is most likely.
Simulect jingħata biex iwaqqaf lill- ġismek milli jirriġetta l- organu l - ġdid waqt l- ewwel 4 sa 6 ġimgħat wara l- operazzjoni tat- trapjant meta r- riġett huwa l- aktar probabbli.
You will be given other medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids and after you leave hospital.
Inti tingħata mediċini oħrajn li jgħinuk tipproteġi l- kilwa l- ġdida tiegħek f’ dan iż- żmien bħal ciclosporin u kortikosterojdi u wara li toħroġ mill- isptar.
BEFORE YOU ARE GIVEN SIMULECT
QABEL MA TINGĦATA SIMULECT
Follow your doctor’ s instructions carefully.
Segwi l- istruzzjonijiet tat- tabib tiegħek sewwa.
If you are unsure about anything, ask your doctor, nurse or pharmacist.
Jekk m’ intix ċert fuq xi ħaġa, staqsi lit- tabib, lill - infermier jew lill- ispiżjar tiegħek.
You must not be given Simulect
M’ għandekx tingħata Simulect
- if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect
- jekk inti allerġiku (tbati minn sensittività eċċessiva) għal basiliximab jew sustanzi oħra ta ’
listed in section 6 under “ What Simulect contains”.
Simulect li huma elenkati f’ sezzjoni 6 taħt “ X’ fih Simulect ”..
Tell your doctor if you suspect you may have had an allergic reaction to any of these ingredients in the past.
Għid lit- tabib tiegħek jekk tissusspetta li seta kellek reazzjoni allerġika għal kwalunkwe minn dawn l- ingredjenti fil- passat.
- if you are pregnant or breast-feeding.
- jekk ħriġt tqila jew qed tredda ’.
Take special care with Simulect
Oqgħod attent ħafna b’ Simulect
- if you have previously received a transplant that failed after only a short time or,
- jekk kont irċevejt qabel trapjant li ma rnexxiex wara biss żmien qasir jew,
- if you have previously been in the operating theatre for a transplantation that in the end was not
- jekk dħalt għal operazzjoni ta ’ trapjant qabel li mbagħad ma saritx.
In this situation, you may have received Simulect.
F’ każ bħal dan jista ’ jkun li diġà ngħatajt Simulect.
Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.
It- tabib tiegħek ser jivverifika dan għalik u jiddiskuti miegħek il- possibilità li terġa ’ tingħata kura b’ Simulect.
31 Using other medicines Please tell your doctor, nurse or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
31 aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Older patients (aged 65 years and over) Simulect can be given to older patients, but the information available is limited.
Pazjenti akbar fl- età (li għandhom 65 sena u aktar) Simulect jista ’ jingħata lill- anzjani izda t- tagħrif li hemm huwa limitat.
Your doctor may discuss this with you before you are given Simulect.
It- tabib tiegħek jista ’ jiddiskuti miegħek fuq dan il- fatt qabel ma jingħatalek Simulect.
Children and adolescents (aged 1 to 17 years) Simulect can be given to children and adolescents.
Tfal u f’ adolexxenti (li għandhom minn sena sa 17- il sena) Simulect jista ’ jingħata lit- tfal u lill- adolexxenti.
The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.
Id- doża għat- tfal li jiżnu anqas minn 35 kg tkun inqas mid- doża li s- soltu tingħata lill- adulti.
Pregnancy and breast-feeding It is very important to tell your doctor before your transplant if you are pregnant or you think that you may be pregnant.
Tqala u treddigħ Huwa importanti ħafna li tgħid lit- tabib tiegħek jekk ħriġt tqila, jew taħseb li tista ’ tkun ħriġt tqila.
You must not be given Simulect if you are pregnant.
M’ għandekx tingħata Simulect jekk ħriġt tqila.
You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect.
Għandek tuża kontraċezzjoni xierqa sabiex tevita t - tqala waqt il- kura u sa 4 xhur wara li tkun irċevejt l- aħħar doża ta ’ Simulect.
If you become pregnant during this time, despite the use of contraceptive measures, you should tell your doctor immediately.
Jekk toħroġ tqila f’ dan iż - żmien, minkejja l- użu ta ’ miżuri ta ’ kontraċezzjoni, għandek tgħid lit- tabib tiegħek mill- ewwel.
You should also tell your doctor if you are breast-feeding.
Għandek ukoll tgħid lit- tabib tiegħek jekk qed tredda ’.
Simulect may harm your baby.
Simulect jista ’ jgħamel ħsara lit- tarbija tiegħek.
You must not breast-feed after being given Simulect or up to 4 months after the second dose.
M’ għandekx tredda ’ wara li tkun ingħatajt Simulect u sa 4 xhur wara t- tieni doża.
Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.
Staqsi lit- tabib, lill- infermier jew lill- ispiżjar tiegħek għal parir qabel ma tieħu kwalunkwe mediċina waqt it- tqala jew waqt li qed tredda ’.
Driving and using machines There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines.
Sewqan u tħaddim ta ’ magni M’ hemm l- ebda evidenza li tindika li Simulect għandu effett fuq il- ħila tiegħek biex issuq karozza jew li tuża l- magni.
HOW SIMULECT IS GIVEN TO YOU
KIF JINGĦATALEK SIMULECT
You will only be given Simulect if you are receiving a new kidney.
Simulect għandu jingħatalek biss jekk qed tirċievi kilwa ġdida.
Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20– 30 minutes or as an intravenous injection using a syringe.
Simulect jingħata darbtejn, fl- isptar, jew bil- mod permezz ta ’ labra ġol- vina bħala infużjoni fuq medda ta ’ 20– 30 minuta jew bħala injezzjoni għal ġol- vina permezz ta ’ siringa.
If you have experienced a severe allergic reaction to Simulect or if you had complications after your surgery such as graft loss, the second dose of Simulect should not be given to you.
Jekk kellek esperjenza b’ reazzjoni allerġika severa għal Simulect jew jekk kellek komplikazzjonijiet wara l- operazzjoni tiegħek bħal telf ta ’ trapjant, it- tieni doża ta ’ Simulect m’ għandhiex tingħatalek.
The first dose is given just before the transplant operation, and the second dose 4 days after the operation.
L- ewwel doża tingħatalek eżatt qabel l- operazzjoni ta ’ trapjant, u t- tieni doża 4 ijiem wara l - operazzjoni.
Usual dose for adults The usual dose for adults is 20 mg in each infusion or injection.
Id- doża li ssoltu tingħata għall- adulti Id- doża li ssoltu tingħata għall- adulti hija 20 mg f’ kull infużjoni jew injezzjoni.
Usual dose for children and adolescents (aged 1 to 17 years)
Id- doża li ssoltu tingħata għat- tfal u l- adolexxenti (li għandhom minn sena sa 17- il sena)
- For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each
- Għal tfal u adolexxenti li jiżnu 35 kg jew aktar, id- doża ta ’ Simulect mogħtija f’ kull infużjoni
infusion or injection is 20 mg.
jew injezzjoni hija ta ’ 20 mg.
- For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each
- Għal tfal u adolexxenti li jiżnu anqas minn 35 kg, id- doża ta ’ Simulect mogħtija f’ kull infużjoni
infusion or injection is 10 mg.
jew injezzjoni hija ta ’ 10 mg.
If you are given too much Simulect An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer.
Jekk tingħata aktar Simulect milli suppost Doża eċċessiva ta ’ Simulect x’ aktarx li ma tikkawżalekx effetti oħra mill- ewwel iżda, tista ’ iddgħajjiflek is- sistema immuni għal żmien itwal.
Your doctor will watch out for any effects on your immune system and treat them if necessary.
It- tabib tiegħek ser joqgħod attent għal xi effetti fuq is- sistema immuni tiegħek, u jikkurak fejn ikun hemm bżonn.
Like all medicines, Simulect can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Simulect jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related to the medicine.
Għid lit- tabib jew lill- infermier tiegħek kemm jista ’ jkun malajr jekk ikollok xi sintomi mhux mistennija waqt li tkun qed tieħu Simulect, jew waqt it- 8 ġimgħat ta ’ wara, anki jekk taħseb li dawn mhux relatati mal- mediċina.
Sudden severe allergic reactions have been reported in patients treated with Simulect.
Reazzjonijiet allerġiċi f’ salt u severi kienu rrappurtati f’ pazjenti kkurati b’ Simulect.
If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, wheezing or trouble breathing or flu-like symptoms, tell your doctor or nurse immediately.
Jekk tinnota xi sinjali ta ’ allerġija f’ salt bħal raxx, ħakk jew ħorriqija fuq il- ġilda, nefħa tal- wiċċ, xofftejn, ilsien jew partijiet oħra tal- ġisem, qalb tħabbat bl- għaġġla, sturdament, ras ħafifa, qtugħ ta ’ nifs, tħarħir jew tbatija biex tieħu n- nifs jew sintomi li jixbħu l- influwenza, għid lit- tabib jew lill- infermier tiegħek mill- ewwel.
In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e. g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.
Fl- adulti, l- effetti mhux mixtieqa l- aktar kommuni li dehru kienu stitikezza, dardir, dijarea, żieda fil - piż, uġigħ ta ’ ras, uġigħ, nefħa fl- idejn, fl- għekiesi jew fir- riġlejn, pressjoni għolja, anemija, tibdil fil - kimika tad- demm (eż. potassium, kolesterol, phosphate u krejatenina), kumplikazzjonijiet tal- ġerħa ta ’ l- operazzjoni u tipi differenti. ta ’ infezzjonijiet.
In children, the most commonly reported side effects were constipation, excessive growth of normal hair, runny or blocked nose, fever, high blood pressure, and various kinds of infections.
Fit- tfal, effetti oħra l- aktar kommuni li dehru kienu stitikezza, ix- xagħar normali jikber b’ mod eċċessiv, imnieħer imblukkat, deni, pressjoni għolja u tipi ta ’ infezzjonijiet differenti.
HOW TO STORE SIMULECT
KIF TAĦŻEN SIMULECT
What Simulect contains
X’ fih Simulect
- The active substance is basiliximab.
- Is- sustanza attiva hija basiliximab.
Each vial contains 20 mg of basiliximab.
Kull kunjett fih 20 mg basiliximab.
- The other ingredients are: potassium dihydrogen phosphate; disodium phosphate, anhydrous;
- Is- sustanzi l- oħra huma: potassium dihydrogen phosphate; disodium phosphate, anhydrous;
sodium chloride; sucrose; mannitol (E421); glycine.
sodium chloride; sucrose; mannitol (E421); glycine.
What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 20 mg of basiliximab.
Id- Dehra ta ’ Simulect u l- kontenuti tal- pakkett Simulect jiġi bħala trab abjad f’ kunjett tal- ħġieġ mingħajr kulur li jkun fih 20 mg ta ’ basiliximab.
It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections.
Jiġi f’ pakkett b’ ampulla tal- ħġieġ mingħajr kulur li jkun fiha 5 ml ilma sterili għall- injezzjonijiet.
This solvent is used to dissolve the powder before it is given to you.
Dan is - solvent jintuża biex jinħall it- trab qabel ma jingħatalek.
Simulect is also available in vials with 10 mg basiliximab.
Simulect jiġi ukoll f’ kunjetti b’ 10 mg basiliximab.
33 Manufacturer Novartis Pharma S. A. S.
33 Manifattur Novartis Pharma S. A. S.
35 INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION
35 ISTRUZZJONIJIET GHAL RIKONSTITUZZJONI U KIF GĦANDU JINGĦATA
Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Simulect m’ għandux jingħata sakemm ma jkunx ġie aċċertat b’ mod assolut li l- pazjent ikun ser jirċievi t- trapjant u l- immunosuppressjoni li tingħata miegħu.
To prepare the solution for infusion or injection, add 5 ml water for injections from the accompanying ampoule to the vial containing the Simulect powder, using aseptic technique.
Biex tipprepara s- soluzzjoni għall- infużjoni jew injezzjoni, żid 5 ml ilma għall- injezzjonijiet mill - ampulla li tiġi ma ’ dan il- prodott għal ġol- kunjett li fih t- trab ta ’ Simulect, permezz ta ’ teknika asettika.
Shake the vial gently to dissolve the powder, avoiding foaming.
Ħawwad il- kunjett bil- mod biex jinħall it- trab, fil- waqt li tevita r- rawgħa.
It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately.
Huwa rakkomandat li wara li titħallat is- soluzzjoni mingħajr kulur, ċara, tgħati fl- abjad għandha tintuża mill- ewwel.
Reconstituted products should be inspected visually for particulate matter prior to administration.
Prodotti rikostitwiti għandhom jiġu miflija għal xi frak qabel ma jingħataw.
Do not use if foreign particles are present.
Tużax jekk ikun fih xi biċċiet li mhux ġejjin minnu.
After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature.
Wara li jitħallat, l- istabilità kimika u fiżika intweriet għal 24 siegħa f’ temperatura ta ’ bejn 2°C - 8°C jew għal 4 sigħat f’ temperatura ambjentali.
Discard the reconstituted solution if not used within that time.
Jekk is- soluzzjoni rikostitwita ma tintużax f’ dan il- perijodu, din għandha tintrema.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Jekk ma jintużax mill- ewwel, il- ħinijiet tal- ħażna waqt l- użu u l - kondizzjonijiet tal- ħażna qabel l- użu huma r- responsabbiltà ta’ min qed jużah.
Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus injection.
Simulect rikostitwit għandu jingħata bħala infużjoni ġol- vina fuq medda ta ’ 20 u 30 minuta, jew inkella bħala injezzjoni bolus.
The reconstituted solution is isotonic.
It- taħlita rikostitwita hija iżotonika.
For infusion, the reconstituted solution should be diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ ml (5%).
Għall- infużjoni, it- taħlita rikostitwita għandha tiġi dilwita għal volum ta ’ 50 ml jew aktar b’ salina normali jew b’ dextrose 50 mg/ ml (5%).
The first dose should be given within 2 hours before transplantation surgery, and the second dose 4 days after transplantation.
L- ewwel doża għandha tingħata fi żmien sagħtejn qabel il- kirurġija tat- trapjant, u t - tieni doża erbat ijiem wara t- trapjant.
The second dose should not be given if severe hypersensitivity reactions to Simulect or graft loss occur.
It- tieni doża m’ għandhiex tingħata jekk ikun hemm reazzjonijiet qawwija ta ’ sensittività eċċessiva għal Simulect jew inkella jkun intilef it- trapjant.
Since no data are available on the compatibility of Simulect with other intravenous substances, Simulect should not be mixed with other medications/ substances and should always be given through a separate infusion line.
Peress li m’ hemm l- ebda tagħrif dwar il- kompatibilità ta ’ Simulect ma ’ sustanzi oħrajn li jistgħu jingħataw ġol- vina, Simulect m’ għandux jitħallat ma ’ mediċini/ sustanzi oħrajn, u għandu jingħata dejjem minn sett ta ’ infuzjoni separata.
Compatibility with the following infusion sets has been verified:
Ġie verifikat li huwa kompatibbli ma ’ dawn is- settijiet ta ’ infużjoni:
Infusion bag
Borża ta ’ l- infużjoni
- Baxter minibag NaCl 0.9%
- Baxter minibag NaCl 0. 9%
Infusion sets
Sett ta ’ l- infużjoni
Do not use after the expiry date stated on the pack.
M’ għandekx tuża wara d- data li jiskadi fiha li tidher fuq il- pakkett.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kwalunkwe fdalijiet tal- prodott mhux użati jew għar- rimi għandhom jintremew skond il- liġijiet lokali.
Simulect 10 mg powder and solvent for solution for injection or infusion Basiliximab
Simulect 10 mg trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni Basiliximab
37 Using other medicines Please tell your doctor, nurse or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
37 aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20– 30 minutes or as an intravenous injection using a syringe.
Simulect jingħata darbtejn, fl- isptar, jew bil- mod permezz ta ’ labra ġol- vina bħala infużjoni fuq medda ta ’ 20– 30 minuta, jew bħala injezzjoni għal ġol- vina permezz ta ’ siringa.
If you are given too much Simulect An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer.
Jekk tingħata aktar Simulect milli suppost Doża eċċessiva ta ’ Simulect x’ aktarx li ma tikkawżalekx effetti oħra mill- ewwel iżda.
Your doctor will watch out for any effects on your immune system and treat them if necessary.
Biss, tista ’ iddgħajjiflek is- sistema immuni għal żmien itwal.
If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, wheezing or trouble breathing or flu-like symptoms, tell your doctor or nurse immediately.
Jekk tinnota xi sinjali ta ’ allerġija f’ salt bħal raxx, ħakk jew ħorriqija fuq il- ġilda, nefħa tal- wiċċ, xofftejn, ilsien jew partijiet oħra tal- ġisem, qalb tħabbat bl- għaġġla, sturdament, ras ħafifa, qtugħ ta ’ nifs, tħarħir jew tbatija biex tieħu n- nifs, jew sintomi li jixbħu l- influwenza, għid lit- tabib jew lill- infermier tiegħek mill- ewwel.
In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e. g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.
Fl- adulti, l- effetti mhux mixtieqa l- aktar kommuni li dehru kienu stitikezza, dardir, dijarea, żieda fil - piż, uġigħ ta ’ ras, uġigħ, nefħa fl- idejn, fl- għekiesi jew fir- riġlejn, pressjoni għolja, anemija, tibdil fil - kimika tad- demm (eż. potassium, kolesterol, phosphate u krejatenina), kumplikazzjonijiet tal- ġerħa ta ’ l- operazzjoni u tipi differenti ta ’ infezzjonijiet.
Each vial contains 10 mg of basiliximab.
Kull kunjett fih 10 mg basiliximab.
What Simulect looks like and contents of the pack Simulect comes as a white powder in a colourless glass vial containing 10 mg of basiliximab.
Id- Dehra ta ’ Simulect u l- kontenuti tal- pakkett Simulect jiġi bħala trab abjad f’ kunjett tal- ħġieġ mingħajr kulur li jkun fih 10 mg ta ’ basiliximab.
It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections.
Jiġi f’ pakkett b’ ampulla tal- ħġieġ mingħajr kulur li jkun fiha 5 ml ilma sterili għall- injezzjoni.
2.5 ml of the sterile water is used to dissolve the powder before it is given to you.
2. 5 ml ta ’ ilma sterili jintuża sabiex jinħall it- trab qabel ma jingħatalek.
Simulect is also available in vials with 20 mg basiliximab.
Simulect jiġi wkoll f’ kunjetti b’ 20 mg basiliximab.
39 Manufacturer Novartis Pharma S. A. S.
39 Manifattur Novartis Pharma S. A. S.
41 INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION
41 ISTRUZZJONIJIET GHAL RIKONSTITUZZJONI U KIF GĦANDU JINGĦATA
Simulect 10 mg must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.
Simulect 10 mg m’ għandux jingħata sakemm ma jkunx ġie aċċertat b’ mod assolut li l- pazjent ikun ser jirċievi t- trapjant u l- immunosuppressjoni li tingħata miegħu.
To prepare the solution for infusion or injection, take 2.5 ml water for injections out of the accompanying 5 ml ampoule aseptically and add this 2.5 ml water for injections to the vial containing the Simulect powder, using aseptic technique.
Biex tipprepara s- soluzzjoni għall- infużjoni jew injezzjoni, hu 2. 5 ml ilma għall- injezzjonijiet b’ mod asettiku mill- ampulla ta ’ 5 ml li tiġi magħha u żid dawn iż- 2. 5 ml ilma għall- injezzjonijiet b’ mod asettiku ġol- kunjett li fih it- trab ta ’ Simulect, permezz ta ’ teknika asettika.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Jekk ma jintużax mill- ewwel, il- ħinijiet tal- ħażna waqt l- użu u l- kondizzjonijiet tal- ħażna qabel l- użu huma r - responsabbiltà ta’ min qed jużah.
Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus injection.
Simulect rikostitwit għandu jingħata bħala infużjoni fil- vina fuq medda ta ’ 20 u 30 minuta, jew inkella bħala injezzjoni bolus.
For infusion, the reconstituted solution should be diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ ml (5%).
Għall- infużjoni, it- taħlita rikostitwita għandha tiġi dilwita għal volum ta ’ 25 ml jew aktar b’ salina normali jew b’ dextrose 50 mg/ ml (5%).
The first dose should be given within 2 hours before transplantation surgery, and the second dose 4 days after transplantation.
L- ewwel doża għandha tingħata fi żmien sagħtejn qabel il- kirurġija tat- trapjant, u t- tieni doża erbat ijiem wara t- trapjant.
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTTI MEDIĊINALI LI JRIDU JIĠU INDIRIZZATI LILL- ISTATI MEMBRI
The EU Member States shall ensure that:
L- Istati Membri ta ’ l- UE għandhom jiżguraw li:
The MAH shall agree the details of a distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Il- MAH għandu jiftiehem id- dettalji ta ’ sistema ta ’ distribuzzjoni ma ’ l- Awtoritajiet Nazzjonali Kompetenti u jrid jimplimenta tali programm fil- pajjiżi konċernati sabiex jiżgura li.
• drug distribution will only be possible after checking that the patient has effectively received a meningococcal vaccination with a written confirmation • prior to distribution, all health care professionals are provided with information on the following key safety concerns: o Headache o Infusion reaction o Neisseria and general infection o Risk of serious haemolysis following eculizumab discontinuation and proposed management o Pregnancy and need of adequate contraception in women of childbearing potential o Immunogenicity o Renal and hepatic impairment.
Uġigħ ta ’ ras o Ir- reazzjoni għall- infużjoni o Neisseria u infezzjoni ġenerali o Ir- riskju ta ’ emolisi serja wara t- twaqqif ta ’ eculizumab u l- ġestjoni proposta o It- tqala u l- bżonn ta ’ kontraċezzjoni adegwata f’ nisa li jistgħu jinqabdu tqal o L- immunoġeniċità o L- indeboliment renali u tal- fwied. o
Prior to launch, the MAH shall agree on the implementation of a patient card system in each Member Sate.
Qabel ma jintroduċih, il- MAH għandu jiftiehem fuq l- implimentazzjoni ta ’ sistema ta ’ kard għall- pazjent f’ kull Stat Membru.
This patient card will provide details of the signs and symptoms of infection as well as instruction for the patient to immediately seek medical care.
Din il- card għall- pazjent għandha tipprovdi dettalji dwar is- sinjali u s- sintomi ta ’ l- infezzjoni kif ukoll struzzjoni għall- pazjent biex ifittex kura medika minnufih.
The card will also provide information to health care professionals that the patient is receiving Soliris treatment.
Il- kard se tipprovdi wkoll informazzjoni għall- professjonisti tal- kura tas - saħħa li l- pazjent qiegħed jirċievi kura b’ Soliris.
The MAH shall propose a detailed methodology for the Health Care Professionals and Patient survey.
Il- MAH għandu jipproponi metodoloġija dettaljata għall- istħarriġ tal- Professjonisti tal- Kura tas - Saħħa u l- Pazjent.
In addition to the assessment of the satisfaction of eculizumab information provided, the proposed questionnaire will investigate other methods for assessing the effectiveness of the risk minimisation program (e. g. surveys to follow compliance to vaccination).
Minbarra l- evalwazzjoni tas- sodisfazzjon bl- informazzjoni pprovduta dwar eculizumab, il- kwestjonarju propost se jinvestiga metodi oħra sabiex tiġi evalwata l- effikaċja tal - programm għat- tnaqqis tar- riskju (p. e. stħarriġ sabiex isegwi l- osservanza tat- tilqim).
The evaluation of the goals for distribution of educational materials should also be considered.
L - evalwazzjoni tal- miri għat- tqassim ta ’ materjali edukattivi għandha tiġi wkoll ikkunsidrata.
What is Soliris?
X' inhu Soliris?
Soliris is a concentrate that is made up into a solution for infusion.
Soliris huwa konċentrat li jitħallat biex tiġi ffurmata soluzzjoni għall- infużjoni.
It contains the active substance eculizumab.
Fih is- sustanza attiva eculizumab.
What is Soliris used for?
Għalxiex jintuża Soliris?
Soliris is used to treat patients with paroxysmal nocturnal haemoglobinuria (PNH), a rare, life- threatening genetic disease that causes the red blood cells to be broken down too quickly.
Soliris jintuża fit- trattament ta 'pazjenti b' paroxysmal nocturnal haemoglobinuria (PNH), marda ġenetika rari li tista' tqiegħed ħajjet il- pazjent fil- periklu billi tikkaġuna t- tkissir taċ- celloli l- ħomor b' rata mgħaġġla wisq.
This results in anaemia (low red blood cell counts), thrombosis (formation of blood clots in the blood vessels) and dark urine.
Dan iwassal għal anemija (tnaqqis fil- għadd ta 'ċelloli ħomor fid- demm, trombożi (il- formazzjoni ta' għoqod tad- demm fl- arterji u l- vini) u awrina skura.
The medicine can only be obtained with a prescription.
Billi l- għadd ta 'pazjenti li għandhom PNH huwa wieħed baxx, il- marda hi meqjusa' rari 'u Soliris ġie propost bħala' mediċina orfni '(mediċina użata fil- mardiet rari) fis- 17 ta' Ottubru 2003 Il- mediċina tista 'tinkiseb biss b' riċetta ta' tabib.
How is Soliris used?
Kif jintuża Soliris?
Soliris should be given by a healthcare professional, such as a doctor or nurse, under the supervision of a doctor who has experience in the management of patients with blood disorders.
Soliris għandu jingħata minn professjonisti tal- ħarsien tas- saħħa bħal tabib jew infermier, b' superviżjoni minn tabib b’ esperjenza fil- ġestjoni ta 'pazjenti b' diżordnijiet fid- demm.
Treatment with Soliris consists of an intravenous infusion (drip into a vein) of 600 mg over 25 to 45 minutes once a week, followed by 900 mg in the fifth week.
Soliris jingħata b’ infużjoni intravenuża (drip fil- vina) ta '600 mg li ddum għaddejja bejn 25 u 45 minuta darba fil - ġimgħa, segwita minn 900 mg fil- ħames gimgħa.
Thereafter, the dose should be maintained at 900 mg, given approximately every two weeks.
Wara dan, id- doża għandha titkompla b' rata ta '900 mg, mogħtija bejn wieħed u ieħor kull ġimagħtejn.
At least two weeks before starting Soliris treatment, patients must be vaccinated against meningitis caused by the bacterium Neisseria meningitidis and revaccinated according to current guidelines.
Ta 'l- inqas ġimagħtejn qabel il- bidu tat - trattament b' Soliris, il- pazjenti jridu jitlaqqmu kontra l- meninġite kkawżata bil- batterju Neisseria meningitidis u mlaqqma mill- ġdid skond il- linji gwida attwali.
Soliris has not been studied in children or in patients who have problems with their kidneys or liver.
Soliris ma ġiex studjat fit- tfal jew f' pazjenti li jkollhom problemi fil- kliewi jew fil- fwied.
Patients who receive Soliris must be given a special card that explains the symptoms of certain types of infection, instructing them to seek medical care immediately if they experience them.
Il- pazjenti li jkunu qed jieħdu Soliris għandhom jingħataw kartuna speċjali li tfisser is- sintomi ta 'ċerti tipi ta' infezzjoni, u tagħtihom istruzzjoni biex immedjatament jitolbu għajnuna medika jekk jesperjenzawhom.
How does Soliris work?
Kif jaħdem Soliris?
The active substance in Soliris, eculizumab, is a monoclonal antibody.
Is- sustanza attiva f’ Soliris, eculizumab, hi antikorp monoklonali.
Eculizumab has been designed to bind to the C5 complement protein, which is part of the body’ s defence system called ‘ complement’.
Eculizumab ġie mfassal biex jeħel mal- proteina komplimentari C5, li tifforma parti mis- sistema ta 'difiża tal- ġisem magħrufa bħala' complement ''.
In PNH, patients have a defect in a protein (called CD59) on the surface of their red blood cells that normally stops complement from attacking the cells.
Fil- PNH, il- pazjenti jkollhom difett f' proteina (magħrufa bħala CD59) fuq is- superfiċje taċ- ċelloli tad - demm ħomor li normalment ma tħallix il- complement jattakka ċ- ċelloli.
This defect results in complement destroying the
Dan id- difett iwassal biex il - complement jeqred iċ- ċelloli tad- demm ħomor.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Bl- imblukkar tas- C5 complement protein, eculizumab 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
By blocking the C5 complement protein, eculizumab prevents complement from attacking the cells, reducing their destruction and improving the symptoms of the disease.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ma jħallix il- complement jattakka ċ- ċelloli, u jnaqqas il- qerda tagħhom u b' hekk itejjeb is- sintomi tal - marda.
How has Soliris been studied?
Kif ġie studjat Soliris?
The effects of Soliris were first tested in experimental models before being studied in humans.
L- effetti ta 'Soliris għall- ewwel ġew ittestjati f' mudelli esperimentali qabel ma' ġew studjati fuq il - bnedmin.
Soliris has been studied in one main study involving 88 adult patients with PNH who had had at least four blood transfusions for anaemia in the previous year.
Soliris ġie studjat fi studju wieħed ewlieni li fih ħadu sehem 88 pazjent adult b' PNH li kienu ħadu ta 'l- anqas erba' trasfużjonijiet tad- demm għall- anemija fis- sena ta 'qabel.
The effects of Soliris were compared with those of placebo (a dummy treatment).
L- effetti ta 'Soliris ġew mqabbla ma dawk ta' plaċebo (trattament finta).
The main measures of effectiveness were the proportion of patients whose levels of haemoglobin (a protein found in red blood cells) remained above their individual target level, and the number of red blood cell transfusions that the patients needed during the first 26 weeks of treatment.
Il- mezzi ewlenin ta 'l- effettività kienu l- proporzjoni ta' pazjenti li l- livell ta 'emoglobina (proteina li tinstab fiċ- ċelloli l- ħomor) tagħhom baqgħet' il fuq mil- livell individwali mixtieq, u n- numru ta 'trasfużjonijiet taċ- ċelloli ħomor tad- demm meħtieġa matul l- ewwel 26 ġimgħa ta' trattament.
What benefit has Soliris shown during the studies?
X' benefiċċji ta 'Soliris intwerew f' dawn l- istudji?
Soliris was more effective than placebo in improving the symptoms of PNH.
Soliris kien iktar effettiv mill- plaċebo fit- titjib tas- sintomi tal- PNH.
In the main study, 21 (49%) of the 43 patients receiving Soliris had stable haemoglobin levels, and, on average, they did not need any transfusions of red blood cells.
Fl- istudju ewlieni, 21 (49%) mit - 43 pazjent li kienu qed jingħataw Soliris kellhom livelli ta 'l- emoglobina stabbli, u, bħala medja, ma kellhomx bżonn trasfużjonijiet taċ- ċelloli tad- demm ħomor.
In comparison, none of the 44 patients receiving placebo had stable haemoglobin levels, and they needed an average of 10 transfusions.
Min- naħa l- oħra, ħadd mill- 44 pazjent li kienu qed jingħataw il- plaċebo ma 'kellu livelli ta' l- emoglobina stabbli, u dawn kellhom bżonn medja ta '10 trasfużjonijiet.
What is the risk associated with Soliris?
X' riskji huma assoċjati ma 'Soliris?
The most common side effects with Soliris (seen in more than 1 patient in 10) are urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (colds), dizziness, headache, diarrhoea, nausea (feeling sick), back pain, arthralgia (joint pain), pyrexia (fever) and contusion (bruising).
L- iktar effetti sekondarji komuni rrappurtati ma 'Soliris (li dehru f' iktar minn pazjent wieħed minn kull10) kienu infezzjonijiet fis- sistema ta' l- awrina (infezzjonijiet fl- istrutturi li jġorru l- awrina), nażofarinġite (infjammazzjoni fl- imnieħer u fil- gerżuma), infezzjonijiet fil- parti ta 'fuq tal- pajp tan - nifs (irjiħat), sturdament, uġigħ ta' ras, dijareja, dardir, uġigħ fid- dar, uġigħ fil- ġogi, deni u tbenġil.
For the full list of all side effects reported with Soliris, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati ma' Soliris, ara l- Fuljett ta 'Tagħrif.
Because of an increased risk of meningitis, Soliris should not be given to people who are infected with Neisseria meningitidis, or who have not been vaccinated against this bacterium.
Minħabba żieda fir- riskju tal- meninġite, Soliris m' għandux jingħata lil persuni infettati b' Neisseria meningitidis, jew li ma kinux tlaqqmu kontra dan il- batterju.
It should not be used in people who may be hypersensitive (allergic) to eculizumab, mouse proteins or any of the other ingredients, or who have, or are thought to have, inherited deficiencies in complement.
M' għandux jingħata lil persuni allerġiċi għal eculizumab, għall- proteini tal- ġrieden jew għal xi sustanza oħra tiegħu, jew li jkunu wirtu, jew li jkun maħsub li setgħu wirtu, xi defiċjenzi fil- complement.
Why has Soliris been approved?
Għaliex ġie approvat Soliris?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Soliris are greater than its risks for the treatment of patients with PNH, but noted that evidence of the benefit of Soliris is limited to patients who have had blood transfusions in the past.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Soliris fit- trattament ta' pazjenti b 'PNH huma ikbar mir- riskji, iżda nnota li l- evidenza dwar il - benefiċċju ta' Soliris hi limitata għal pazjenti li jkunu ħadu trasfużjonijiet tad- demm fl- imgħoddi.
The Committee recommended that Soliris be given marketing authorisation.
Il - Kumitat irrakkomanda li Soliris jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Soliris?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Soliris?
The company that makes Soliris will agree the details of a system in each Member State that will ensure that distribution of the medicine only occurs after checking that the patient has been vaccinated appropriately.
Il- Kumpanija li tagħmel Soliris se tiftiehem dwar id- dettalji ta 'sistema f' kull Stat Membru li tiżgura li d- distribuzzjoni tal- mediċina ssir biss wara li jkun verifikat li l- pazjent tlaqqam kif suppost.
It will also provide prescribers with information on the safety of the medicine.
Se tipprovdi wkoll tagħrif dwar is- sigurtà tal- mediċina.
Other information about Soliris:
Tagħrif ieħor dwar Soliris:
The European Commission granted a marketing authorisation valid throughout the European Union for Soliris to Alexion Europe SAS on 20 June 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Soliris valida fl- Unjoni Ewropea kollha lil Alexion Europe SAS fil - 20 ta ’ Ġunju 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Soliris is available here.
Is- sommarju ta 'l- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni dwar Soliris jista' jinstab hawn.
The full EPAR for Soliris can be found here.
L- EPAR sħiħ għal Soliris jista 'jinstab minn hawn.
This summary was last updated in 05-2007.
Dan is- sommarju ġie aġġornat l- aħħar f' Mejju ta 'l- 2007.
EU Number
EU/ 1/ 07/ 393/ 001
Concentrate for solution for infusion
Konċentrat għal soluzzjoni għall- infużjoni Użu għal ġol- vini
30 ml (10 mg/ ml)
Kunjett (ħġieġ) 30ml (10mg/ ml)
Soliris 300 mg concentrate for solution for infusion
Soliris 300mg konċentrat għal soluzzjoni għall- infużjoni
Each vial of 30 ml contains 300 mg of eculizumab (10 mg/ ml).
Kull kunjett ta ’ 30 ml fih 300mg ta 'eculizumab (10 mg/ ml).
Eculizumab is a humanised monoclonal IgG2/ 4κ antibody produced in NS0 cell line by recombinant DNA technology.
Eculizumab huwa antikorp IgG2/ 4κ monoklonali umanizzat prodott f' linja ta ’ ċelloli NS0 b' teknoloġija tad- DNA rikombinanti.
After dilution, the final concentration of the solution to be infused is 5mg/ ml.
Wara d- dilwizzjoni, il- konċentrazzjoni finali tas- soluzzjoni għal infużjoni hi 5mg/ ml.
Sodium (5.00 mmol per dose (1 vial))
Sodium (5. 00 mmol kull doża (kunjett))
Concentrate for Solution for Infusion.
Konċentrat għal Soluzzjoni għal Infużjoni.
Clear, colorless, pH 7.0 solution.
Soluzzjoni ċara u bla kulur b’ pH ta ’ 7. 0.
Soliris (eculizumab) is indicated for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH).
Soliris (eculizumab) huwa indikat għat- trattament ta 'pazjenti b' emoglobinurja notturnali parossimali (PNH).
Evidence of clinical benefit of Soliris in the treatment of patients with PNH is limited to patients with history of transfusions.
L- evidenza ta ’ benefiċċju kliniku ta ’ Soliris fit- trattament ta ’ pazjenti b’ PNH hija limitata għal pazjenti bi storja ta ’ trasfużjonijiet.
To reduce the risk of meningococcal infection (Neisseria meningitidis), all patients must be vaccinated at least 2 weeks prior to receiving Soliris and must be re-vaccinated according to current medical guidelines for vaccination use (see section 4.4).
Biex jitnaqqas ir- riskju ta ’ infezzjoni meningokokkali (Neisseria meningitidis), il- pazjenti kollha jridu jiġu mlaqqma mill- anqas ġimagħtejn qabel ma jirċievu Soliris u jridu jerġgħu jitlaqqmu skond linji gwida mediċi kurrenti dwar l- użu tat- tilqim (ara sezzjoni 4. 4).
Soliris should be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological disorders.
Soliris għandu jingħata minn professjonist tal- kura tas- saħħa u taħt is- superviżjoni ta ’ tabib b’ esperjenza fil- ġestjoni ta ’ pazjenti b’ disturbi ematoloġiċi.
The dosing regimen consists of a 5-week initial phase followed by a maintenance phase:
Ir- reġimen ta ’ dożaġġ jikkonsisti minn fażi inizjali ta ’ 5 ġimgħat segwita minn fażi ta ’ manteniment: • Fażi inizjali:
600 mg of eculizumab via a 25 - 45 minute intravenous infusion every week for the first 4 weeks, followed by 900 mg of eculizumab for the fifth week of the initial phase.
600 mg ta ’ eculizumab permezz ta ’ infużjoni fil- vini ta ’ 25 – 45 minuta kull ġimgħa għall- ewwel 4 ġimgħat, segwiti minn 900 mg ta ’ eculizumab għall- ħames ġimgħa tal - fażi inizjali. • Fażi ta ’ manteniment:
900 mg of Soliris administered via a 25 - 45 minute intravenous infusion every 14 ± 2 days (see Section 5.1).
900 mg ta ’ Soliris mogħtija permezz ta ’ infużjoni fil- vini ta ’ 25 – 45 minuta kull 14- il jum (jumejn aktar jew jumejn inqas) (ara Sezzjoni 5. 1).
Instructions for preparation of the diluted solutions are described in section 6.6.
L- istruzzjonijiet għat- tħejjija tas- soluzzjonijiet dilwiti huma deskritti f' sezzjoni 6. 6.
2 Do not administer as an intravenous push or bolus injection.
2 Tagħtix bħala intravenous push jew injezzjoni bolus.
Soliris should only be administered via intravenous infusion as described below.
Soliris għandu jingħata biss permezz ta ’ infużjoni fil- vini kif deskritt hawn isfel.
The diluted solution of Soliris should be administered by intravenous infusion over 25 – 45 minutes via gravity feed, a syringe-type pump, or an infusion pump.
Is- soluzzjoni dilwita ta 'Soliris għandha tingħata b' infużjoni fil- vini fuq 25 - 45 minuta permezz ta' gravity feed, pompa t- tip ta 'siringa, jew pompa ta' l- infużjoni.
It is not necessary to protect the diluted solution of Soliris from light during administration to the patient.
Mhux meħtieġ li s- soluzzjoni dilwita ta 'Soliris tkun protetta mid- dawl waqt li tingħata lill- pazjent.
Patients should be monitored for one hour following infusion.
Il- pazjenti għandhom jiġu mmonitorjati għal siegħa wara l- infużjoni.