qanastek/EMEA-V3 huggingface dataset:
When diluted in glucose 50 mg/ ml (5%) solution for infusion, Tevagrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Meta jiġi dilwit ġo soluzzjoni għal infużjoni ta’ glucose 50 mg/ ml (5%), Tevagrastim huwa kompatibbli mal- ħġieġ u varji tipi ta ’ plastik, fosthom il- PVC, polyolefin (co- polymer ta ’ polypropylene u polyethylene) u polypropylene.
Tevagrastim does not contain any preservative.
Tevagrastim ma fih l- ebda preservattiv.
In view of the possible risk of microbial contamination, Tevagrastim syringes are for single use only.
Minħabba r- riskju potenzjali ta ’ kontaminazzjoni b’ mikrobi, is- siringi ta ’ Tevagrastim iridu jintużaw darba biss.
16 Accidental exposure to freezing temperatures does not adversely affect the stability of Tevagrastim.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Tevagrastim.
10 D-79199 Kirchzarten Germany
10 D- 79199 Kirchzarten Il- Ġermanja
Tevagrastim 48 MIU/ 0.8 ml solution for injection or infusion
Tevagrastim 48 MIU/ 0. 8ml soluzzjoni għall- injezzjoni jew infużjoni
31 Tevagrastim should not be diluted with sodium chloride solution.
Tevagrastim m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
32 Accidental exposure to freezing temperatures does not adversely affect the stability of Tevagrastim.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Tevagrastim.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Pjan tal- Farmakoviġilanza L- MAH irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 2. 1 ippreżentata f' Modulu 1. 8. 1. ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel ma l- prodott jibda jinbiegħ.
EXPIRY DATE 38 EXP
DATA TA ’ META JISKADI
After dilution use within 24 hours.
38 Wara li jiġi dilwit użah fiż- żmien 24 siegħa.
Tevagrastim 30 MIU/ 0.5 ml
Tevagrastim 30 MIU/ 0. 5ml
EXPIRY DATE 40 EXP
DATA TA ’ META JISKADI
After dilution use within 24 hours.
40 Wara li jiġi dilwit użah fiż żmien 24 siegħa.
Tevagrastim 48 MIU/ 0.8 ml
Tevagrastim 48 MIU/ 0. 8ml
EXP 42 After dilution use within 24 hours.
42 Wara li jiġi dilwit użah fiż żmien 24 siegħa.
EXP 44 After dilution use within 24 hours.
44 Wara li jiġi dilwit użah fiż żmien 24 siegħa.
EXP 46 After dilution use within 24 hours.
46 Wara li jiġi dilwit użah fiż- żmien 24 siegħa.
Tevagrastim 30 MIU/ 0.5 ml
Tevagrastim 30 MIU/ 0. 5 ml
EXP 48 After dilution use within 24 hours.
48 Wara li jiġi dilwit użah fiż- żmien 24 siegħa.
Tevagrastim 48 MIU/ 0.8 ml
Tevagrastim 48 MIU/ 0. 8 ml
Tevagrastim 30 MIU/ 0.5 ml solution for injection or infusion Tevagrastim 48 MIU/ 0.8 ml solution for injection or infusion
Tevagrastim 30 MIU/ 0. 5ml soluzzjoni għall- injezzjoni jew infużjoni Tevagrastim 48 MIU/ 0. 8ml soluzzjoni għall- injezzjoni jew infużjoni
What Tevagrastim is and what it is used for 2.
X’ inhu Tevagrastim u għalxiex jintuża 2.
Before you use Tevagrastim 3.
Qabel ma tuża Tevagrastim 3.
How to use Tevagrastim 4.
Kif għandek tuża Tevagrastim 4.
How to store Tevagrastim 6.
Kif taħżen Tevagrastim 6.
WHAT Tevagrastim IS AND WHAT IT IS USED FOR
X’ INHU Tevagrastim U GĦALXIEX JINTUŻA
What Tevagrastim is Tevagrastim contains the active substance filgrastim.
X’ inhu Tevagrastim Tevagrastim fih is- sostanza attiva filgrastim.
What Tevagrastim is used for Your doctor has prescribed Tevagrastim for you to help your body make more white blood cells.
Għalxiex jintuża Tevagrastim It- tabib tiegħek tak Tevagrastim biex jgħin il- ġismek jipproduċi aktar ċelluli bojod.
Your doctor will tell you why you are being treated with Tevagrastim.
It- tabib tiegħek ser jgħidlek il- għaliex qed tingħata kura b’ Tevagrastim.
Tevagrastim is useful in several different conditions which are:
Tevagrastim huwa ta ’ benefiċju f’ ħafna kundizzjonijiet differenti li huma:
BEFORE YOU USE Tevagrastim
QABEL MA TUŻA Tevagrastim
Do not use Tevagrastim
Tużax Tevagrastim
Take special care with Tevagrastim
Oqgħod attent ħafna b’ Tevagrastim
You will need to have regular blood tests whilst being treated with Tevagrastim to count the number of neutrophils and other white blood cells in your blood.
Ikollok bżonn tagħmel analiżi tad- demm regolari waqt il- kura b’ Tevagrastim biex isir magħruf l- għadd ta ’ newtrofili u l- għadd ta ’ celluli bojod oħra ġo demmek.
Tevagrastim has not been tested in pregnant women.
Tevagrastim ma ġiex ittestjat f’ nisa tqal.
Important information about some of the ingredients of Tevagrastim This medicine contains sorbitol (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Tevagrastim Din il- mediċina fiha sorbitol (tip ta ’ zokkor).
HOW TO USE Tevagrastim
KIF GĦANDEK TUŻA Tevagrastim
Always use Tevagrastim exactly as your doctor has told you.
Dejjem għandek tuża Tevagrastim skond il- parir tat- tabib.
The amount of Tevagrastim you need will depend on the condition you are taking Tevagrastim for and on your bodyweight.
Id- doża li ssoltu tingħata hija … L- ammont ta ’ Tevagrastim li għandek bżonn ser jiddependi fuq il- kundizzjoni tiegħek, ir- raġuni għaliex trid tieħu Tevagrastim, u fuq il- piz ta’ ġismek.
Your doctor will tell you when to stop using Tevagrastim.
It- tabib tiegħek jgħidlek meta għandek tieqaf tieħu Tevagrastim.
It is quite normal to have a number of courses of Tevagrastim treatment.
Hija ħaġa normali li jkollok bżonn numru ta ’ korsijiet ta ’ kura b’ Tevagrastim
Tevagrastim and chemotherapy The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day.
Tevagrastim u kimoterapija Id- doża li tintuża normali hija 0. 5 miljun international units (MIU) għal kull kilogramm ta ’ piż tal - ġisem, kuljum.
Tevagrastim and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Tevagrastim u trapjant tal- mudullun Id- doża tal- bidu li tintuża normali hija 1 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
You will normally receive your first dose of Tevagrastim at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Normalment, tirċievi l- ewwel doża tiegħek ta ’ Tevagrastim mill- inqas 24 siegħa wara l- kimoterapija imma qabel 24 hours li tirċievi t- trasfużjoni tal- mudullun.
Tevagrastim and severe chronic neutropenia The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
54 Id- doża tal- bidu li tintuża normali hija bejn 0. 5 miljun u 1. 2 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum, mogħtija bħala doża waħda jew ħafna.
Long-term treatment with Tevagrastim is required for neutropenia.
Għat- trattament ta ’ newtropenja, ikun hemm bżonn ta ’ kura b’ Tevagrastim fit- tul.
54 Tevagrastim and neutropenia in patients with HIV infection The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day.
Tevagrastim u newtropenja f’ pazjenti bl- infezzjoni ta ’ HIV Id- doża tal- bidu li tintuża normali hija bejn 0. 1 u 0. 4 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
Long term treatment with Tevagrastim may be required to maintain a normal number of white cells in your blood.
Jista ’ jkun hemm bżonn ta ’ kura b’ Tevagrastim fit- tul sabiex jinżammu livelli normali ta ’ l- għadd ta ’ ċelluli bojod f’ demmek.
Tevagrastim and peripheral blood stem cell mobilisation If you are donating stem cells for yourself, the usual dose is 0.5 million to 1 million international units (MIU) per kilogram bodyweight each day.
Tevagrastim u mobilizzazzjoni ta ’ ċelluli proġenitriċi tad- demm periferali Jekk inti donatur ta ’ PBPC għalik innifsek, id- doża li tintuża komunement hija 0. 5 miljun sa 1 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
Tevagrastim treatment will last for up to 2 weeks and in exceptional cases longer.
Kura b’ Tevagrastim ser idum sa ġimgħatejn jew, f’ każijiet eċċezzjonali, anki iktar.
Tevagrastim treatment will last for 4 to 5 days.
Kura b’ Tevagrastim ser jieħu minn 4 sa 5 ijiem.
If you use more Tevagrastim than you should If you use more Tevagrastim than you should, contact your doctor or pharmacist as soon as possible.
Jekk tuża Tevagrastim aktar milli suppost Jekk tuża Tevagrastim aktar milli suppost, għandek tgħarraf lit- tabib jew l- ispiżjar tiegħek mill- iktar fis possibbli.
If you forget to use Tevagrastim Do not use a double dose to make up for a forgotten injection.
Jekk tinsa tuża Tevagrastim M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using Tevagrastim Before you stop using Tevagrastim, talk to your doctor.
Jekk tieqaf tuża Tevagrastim Qabel ma tieqaf tuża Tevagrastim, tkellem mat- tabib tiegħek.
Like all medicines, Tevagrastim can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Tevagrastim jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
more than 1 user in 10 1 to 10 users in 100 1 to 10 users in 1,000 1 to 10 users in 10,000 less than 1 user in 10,000 frequency cannot be estimated from the available data.
talanqas 1 minn kull 10 pazjent f’ 1000 talanqas 1 minn kull 10 pazjent f’ 10, 000 anqas minn 1 minn kull 10, 000 pazjent ma tistax tittieħed stima mid- data disponibbli
If you think you are having this type of reaction, stop your Tevagrastim injection and get medical help immediately.
Jekk taħseb li qed ikollok xi reazzjoni minn dawn, waqqaf l- injezzjoni ta ’ Tevagrastim u fittex għajnuna medika immedjatament.
If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Tevagrastim.
Jekk tbati mill- marda ta ’ Sickle Cell, kun żgur li tgħarraf it- tabib tiegħek qabel ma tibda kura b’ Tevagrastim.
HOW TO STORE Tevagrastim
KIF TAĦŻEN Tevagrastim
Do not use Tevagrastim after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Tużax Tevagrastim wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq is- siringa mimlija għal- lest wara “ JIS ”.
Do not use Tevagrastim if you notice it is cloudy or there are particles in it.
Tużax Tevagrastim jekk tinnota li s- soluzzjoni mhix ċara jew jekk hemm xi frak fiha.
What Tevagrastim contains
X’ fih Tevagrastim:
Tevagrastim 30 MIU/ 0.5 ml:
Tevagrastim 30 MIU/ 0. 5ml:
Tevagrastim 48 MIU/ 0.8 ml:
Tevagrastim 48 MIU:
You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “ Important information about some of the ingredients of Tevagrastim”.
Tista ’ ssib informazzjoni dettaljata dwar l- ingredjent sorbitol (tip ta ’ zokkor) f’ sezzjoni 2 taħt it - titlu “ Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Tevagrastim ”.
What Tevagrastim looks like and contents of the pack Tevagrastim is a solution for injection or infusion in a pre-filled syringe.
Tevagrastim huwa soluzzjoni għall- injezzjoni jew infużjoni ġo siringa mimlija għal- lest.
Tevagrastim is a clear and colourless solution.
Tevagrastim huwa soluzzjoni ċar u mingħajr kulur.
Tevagrastim are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Tevagrastim jiġi f’ pakketti ta ’ 1, 5 jew 10 siringi mimlijin għal- lest jew f’ pakkett multiplu ta’ 10 (2 pakketti ta ’ 5).
Marketing Authorisation Holder Teva Generics GmbH Kandelstr.
Teva Generics GmbH Kandelstr.
Manufacturer Teva Pharma B. V.
Teva Pharma B. V.
58 INFORMATION FOR INJECTING YOURSELF
58 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
This section contains information on how to give yourself an injection of Tevagrastim.
Din il- parti tal- fuljett fiha tagħrif dwar kif tagħti injezzjoni ta ’ Tevagrastim lilek innifsek.
How do I inject Tevagrastim myself?
Kif ninjetta Tevagrastim lili innifsi?
- a pre-filled syringe of Tevagrastim,
- siringa mimlija għal- lest b’ Tevagrastim;
What should I do before I give myself a subcutaneous injection of Tevagrastim?
X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b’ Tevagrastim?
Take your Tevagrastim pre-filled syringe out of the refrigerator.
Oħroġ s- siringa mimlija għal- lest b’ Tevagrastim mill- friġġ.
Check the appearance of Tevagrastim.
Iċċekkja d- dehra ta ’ Tevagrastim.
Do not warm Tevagrastim in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Tevagrastim bl’ ebda mod ieħor (eżempju: issaħħanx fil- forn majkrowejv jew f’ ilma jaħraq).
Find a comfortable, well-lit place and put everything you need where you can reach them (the Tevagrastim pre-filled syringe, alcohol wipes and the puncture-proof container).
(is- siringa mimlija għal- lest b’ Tevagrastim, msielaħ ta ’ l- alkoħol u r- reċipjent li ma jitaqqabx).
How do I prepare my Tevagrastim injection?
Kif nipprepara l- injezzjoni ta ’ Tevagrastim?
Before you inject Tevagrastim you must do the following:
Qabel ma tinjetta ratiogratim trid tagħmel dan li ġej:
59 2 2.
59 2
Push the plunger up to the number (ml) on the syringe that matches the dose of Tevagrastim that your doctor prescribed.
Imbotta l- planġer san- numru (ml) fuq it- tubu tas- siringa li jikkorispondi mad- doża ta ’ Tevagrastim preskritta mit- tabib tiegħek.
Check again to make sure the correct dose of Tevagrastim is in the syringe.
Erġa iċċekkja li hemm id- doża preskritta ta’ Tevagrastim fis- siringa.
Do not use any Tevagrastim that is left in the syringe.
M’ għandekx tuża xi Tevagrastim li jkun baqa ’ fis- siringa.
Tevagrastim does not contain any preservative.
Tevagrastim ma fihx l- ebda preservattiv.
In view of the possible risk of microbial contamination, Tevagrastim syringes are for single use only.
Minħabba r- riskju potenzjali ta ’ kontaminazzjoni bil- mikrobi, is- siringi ta ’ Tevagrastim iridu jintużaw darba biss.
Accidental exposure to freezing temperatures does not adversely affect the stability of Tevagrastim.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Tevagrastim.
Tevagrastim should not be diluted with sodium chloride solution.
Tevagrastim m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
If required, Tevagrastim may be diluted in glucose 50 mg/ ml (5%) solution for infusion.
Jekk ikun hemm bżonn, Tevagrastim jista ’ jiġi dilwit f’ soluzzjoni għal infużjoni ta ’ glucose 50 mg/ ml (5%).
When diluted in glucose 50 mg/ ml (5%) solution for
Meta l- volum finali ta ’
61 infusion, Tevagrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Meta jiġi dilwit ġo soluzzjoni għal infużjoni ta’ glucose 50 mg/ ml (5%), Tevagrastim huwa kompatibbli mal- ħġieġ u varji tipi ta ’ plastik, fosthom il- PVC, polyolefin (co- polymer ta ’ polypropylene u polyethylene) u polypropylene.
CONDITIONS OR RESTRICTION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONI DWAR L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM IKUNU IMPLIMENTATI MILL- ISTATI MEMBRI
1 The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
1 L- Istati Membri jridu jiżguraw li l- kundizzjonijiet jew ir- restrizzjonijiet kollha dwar l- użu bla periklu u effettiv tal- prodott mediċinali deskritti hawn taħt ikunu implimentati:
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below. o Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional’ s Kit containing the following:
L- Istati Membri għandhom jaqblu fuq id- dettalji tas- sistema tad- distribuzzjoni kkontrollata ma ’ l- MAH skond ir- regolamenti nazzjonali u s- sistemi tal- kura tas- saħħa u jridu jimplimentaw tali programm fuq livell nazzjonali biex jiżguraw li: o Qabel it- tnedija, it- tobba u l- ispiżjara kollha li biħsiebhom jagħtu bir- riċetta tat- tabib jew jiddistribwixxu Thalidomide Celgene jirċievu ittra magħrufa bħala Għażiż Professjonist tal- Kura tas- Saħħa kif deskritta hawn taħt. o Qabel l- għoti bir- riċetta tat- tabib, il- professjonisti kollha tal- kura tas- saħħa li biħsiebhom jagħtu bir- riċetta (u bi qbil ma ’ l- Awtorità Nazzjonali Kompetenti, jiddistribwixxu) Thalidomide Celgene ser jingħataw Kitt Edukattiv tal- Professjonist fil- Qasam tal- Kura tas- Saħħa li fih dan li ġej:
Healthcare professional booklet Patient booklets Patient cards Summary of Product Characteristics, Package Leaflet and Labelling
Fuljett tal- professjonisti tal- kura tas- saħħa Fuljetti edukattivi tal- pazjent Kards tal- pazjenti Sommarju tal- Karatteristiċi tal- Prodott, Fuljett ta ’ Tagħrif u Tikketta
The Member States shall put into place measures to ensure that: o The maximum treatment duration for one prescription shall be 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Prescriptions can only be dispensed within 7 days of the date of the prescription
L- Istati Membri ser jistabbilixxu miżuri biex jiżguraw li; o Il- perijodu massimu tat- trattament għal riċetta waħda għandu jkun 4 ġimgħat għal nisa li jistgħu joħorġu tqal 12- il ġimgħa għal irġiel u nisa li ma jistgħux joħorġu tqal o Ir- riċetti tal- mediċina jistgħu jingħataw biss fi żmien 7 t’ ijiem mid- data ta ’ l- għoti tar- riċetta tal- mediċina.
The Member States shall ensure that the MAH implements a pregnancy prevention programme (PPP) within their territory.
L- Istati Membri għandhom jiżguraw li l- MAH jimplimenta l- programm tal- prevenzjoni tat- tqala (PPP) fi ħdan it- territorju tagħhom.
Details of how the PPP will be implemented should be agreed with the Marketing Authorisation Holder and put in place prior to the marketing of the product.
Dettalji dwar kif il- PPP ser ikun implimentat għandhom ikunu miftehma mad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u jkunu stabbiliti qabel mal- prodott jitqiegħed fis- suq.
The Member States should agree the local implementation of the patient card system
L- Istati Membri għandhom jaqblu fuq l- implimentazzjoni lokali tas- sistema tal- kard tal- pazjent.
The Member States should ensure that the MAH provides the educational materials to the national patients’ organisations for review or if such an organisation does not exist or can not be involved, to a relevant patients group.
L- Istati Membri għandhom jiżguraw li l- MAH jagħti l- materjal edukattiv lill- organizzazzjonijiet nazzjonali tal- pazjenti għar- reviżjoni jew jekk tali organizzazzjoni ma teżistix jew ma tistax tkun involuta, lill- grupp relevanti tal- pazjenti.
Patients involved should be preferably naïve to the history of thalidomide.
Il- pazjenti involuti, preferibbilment m' għandhom qatt ma kienu ħadu thalidomide qabel.
Results of the user testing will have to be provided to the national competent authority and final materials validated at a national level.
Ir- riżultati tat- testijiet ta ’ l - utent għandhom jingħataw lill- awtorità nazzjonali kompetenti u l- materjal finali għandu jkun validat fil- livell nazzjonali.
The Member State should agree with the Marketing Authorisation Holder prior to the launch of the product: o The most appropriate strategies to monitor the off label use within national territory o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP.
L- Istati Membri għandhom jaqblu mad- Detentur ta 'l - Awtorizzazzjoni għat- Tqegħid fis- Suq qabel il- varar tal- prodott fuq: o L- istrateġiji l- aktar adekawati biex jimmonitorjaw l- użu ta ’ l- off label fi ħdan it- territorju nazzjonali o Il- ġbir ta ’ dejta dettaljata li għandu jinkludu ta ’ l- anqas id- demografiċi u l- indikazzjoni tal- pazjent biex isir monitoraġġ mill- qrib ta ’ l- użu off- label fi ħdan it- territorju nazzjonali o It- twaqqif ta ’ miżuri nazzjonali biex jassessjaw l- effettività u l- konformità mal- PPP.
The Member States shall report to the EMEA the following information at 6 monthly intervals following the Commission Decision: o The status of implementation of the PPP within their MS o Estimates of usage in their MS
L- Istati Membri għandhom jirrapportaw lill- EMEA it- tagħrif li ġej kull sitt xhur wara d- Deċiżjoni tal- Kummissjoni: o L- istatus ta ’ l- implimentazzjoni tal- PPP fi ħdan il- MS tagħhom o L- istimi ta ’ l- użu fil- MS tagħhom
The Member States shall ensure that the following key elements are included in the appropriate material:
L- Istati Membri għandhom jiżguraw li l- elementi prinċipali li ġejjin huma nklużi fil- materjal li hu adattat:
2 Dear Healthcare Professional letter The Dear Healthcare Professional letter will consist of two parts: • Core text as agreed by the CHMP • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed
2 L- ittra magħrufa bħala Għażiż Professjonist tal- Kura tas- Saħħa L- ittra magħrufa bħala Għażiż Professjonist tal- Kura tas- Saħħa għandha tikkonsisti f’ żewġ partijiet: • Test prinċipali hekk kif ikun sar qbil fuqu mis- CHMP • Kundizzjonijiet speċifiċi nazzjonali li jkun sar qbil fuqhom ma ’ l- Awtorità Nazzjonali Kompetenti dwar: o id- distribuzzjoni tal- prodott o il- proċeduri biex jiżguraw li jkunu ttieħdu l- miżuri kollha adattati qabel ma thalidomide jiġi iddistribut
Educational healthcare professional’ s kit The Educational healthcare professional’ s kit shall contain the following elements: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority using the forms provided in the “ Educational Healthcare Professional’ s Kit” (if applicable to a Member State)
Kitt edukattiv tal- professjonisti tal- kura tas- saħħa Il- Kitt tal- professjonisti tal- kura tas- saħħa ser ikun fih l- elementi li ġejjin: • Fuljett tal- professjonisti tal- kura tas- saħħa o Storja ta ’ thalidomide, sfond dwar Thalidomide Celgene u l - indikazzjoni liċenzjata tagħha o Posoloġija o Perijodu massimu ta ’ kemm iddum ir- riċetta 4 ġimgħat għal nisa li jistgħu joħorġu tqal 12- il ġimgħa għall- irġiel u għal nisa li ma jistgħux joħorġu tqal o Teratoġeniċità u l- ħtieġa li jiġi evitat l- esponiment tal- fetu o Obbligazzjonijiet tal- professjonisti tal- kura tas- saħħa li biħsiebhom jagħtu bir- riċetta tat- tabib jew jiddistribwixxu Thalidomide Celgene inklużi:
Safety Advice relevant to all patients Description and management of thromboembolic and cardiovascular events, and peripheral neuropathy Disposal of unwanted medicine Not to donate blood during treatment and for one week after treatment ends
Il- ħtieġa li jipprovdu parir u servizz ta ’ parir li huma komprensivi lill- pazjenti Li l- pazjenti għandhom ikunu kapaċi jikkonformaw mal- kundizzjonijiet ta 'l- użu sigur ta ’ thalidomide Il- bżonn li l- pazjenti jingħataw materjal edukattiv adattat tal- pazjent Jirrapportaw kwalunkwe tqala, newropatija jew kwalunkwe episodju avvers lil Celgene u lill- awtorità lokali tas- saħħa billi jużaw il- formoli pprovduti fil - “ Kitt Edukattiv tal- Professjonisti fil- Qasam tal- Kura tas- Saħħa ” (jekk dan ikun jgħodd għal Stat Membru)
Algorithm for Pregnancy Prevention Plan implementation This shall assist with patient categorisation, and determination of required pregnancy prevention and testing measures.
Avviż dwar is- Sigurtà li jgħodd għall- pazjenti kollha o Deskrizzjoni u ġestjoni ta ’ l- episodji tromboemboliċi u kardjovaskulari u newropatija periferali Rimi ta ’ mediċina li mhix aktar meħtieġa M’ għandekx tagħti demm matul it- trattament u għal ġimgħa wara t - tmiem tat- trattament
Pregnancy Prevention Programme information Definition of women with childbearing potential (WCBP) and actions the prescriber should take if childbearing status is unclear Information on what is effective contraception Safety advice for WCBP • Need to avoid foetal exposure • Pregnancy prevention requirement, definition and need for adequate contraceptive methods • That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception • Pregnancy testing requirements o Advice on suitable tests
Algoritma ta ’ l- implimentazzjoni tal- Pjan tal- Prevenzjoni tat- Tqala o Dan ser jgħin fil- kategorizzazzjoni tal- pazjenti, u d- determinazzjoni tal- miżuri meħtieġa għall- prevenzjoni u għat- testijiet tat- tqala.
3 o Frequency (before commencing, monthly during treatment and after finishing treatment) • Need to stop Thalidomide Celgene immediately upon suspicion of pregnancy • Need to tell treating doctor immediately upon suspicion of pregnancy Safety advice for men • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not using effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom during intercourse • That he should not donate semen during therapy and for one week following discontinuation of thalidomide
Tagħrif dwar il- Programm tal- Prevenzjoni tat- Tqala o Id- definizzjoni ta ’ mara li tista ’ toħroġ tqila (WCBP) u miżuri li min jikteb ir- riċetta medika għandu jieħu jekk l- istatus ta ’ jekk tistax toħroġ tqila mhux ċar Tagħrif dwar x’ inhu kontraċettiv effettiv Parir dwar is- sigurtà għal WCBP • Il- bżonn li jkun evitat l- esponiment tal- fetu • Ħtieġa ta ’ prevenzjoni tat- tqala, definizzjoni u l- bżonn ta ’ metodi kontraċettivi adegwati • Jekk għandha bżonn tibdel jew ma tużax aktar il- metodu tagħha ta 'kontraċettiv hi għandha tgħarraf:
o
- lit- tabib, li qed jiktbilha r- riċetta medika tal- kontraċettivi tagħha,
Pregnancy reporting requirements Stop Thalidomide Celgene immediately upon suspicion of pregnancy Refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation Complete pregnancy reporting form as provided in the “ Educational Healthcare Professional’ s Kit” Local contact details for reporting of any suspected pregnancy
li qed tieħu t- thalidomide
• Pregnancy initial and outcome reporting forms • Post-marketing and compliance assessment (as applicable to a Member State) • Neuropathy and adverse reaction reporting forms
- lit- tabib li qed jagħtiha bir– riċetta medika thalidomide li hi
Female patient of childbearing potential Female patient of non-childbearing potential Male patient
• Il- ħtieġa li Thalidomide Celgene jitwaqqaf minnufih hekk kif ikun hemm suspett ta ’ tqala • Il- ħtieġa li t- tabib li jkun qiegħed jikkurah jiġi infurmat minnufih hekk kif ikun hemm suspett ta ’ tqala.
o
• Formoli tar- rapport inizjali u tar- riżultat tat- tqala • Assessjar ta ’ wara t- tqegħid fis- suq u l- konformità (hekk kif japplikaw għal Stat Membru) • Formoli dwar rapport ta ’ newropatija u episodju avvers
All treatment initiation forms should contain the following elements:
• Formoli tal- bidu tat- trattament o Għandu jkun hemm 3 tipi ta ’ formoli tal- bidu tat- trattament:
Teratogenicity warning Date of counselling Affirmation of patient understanding regarding the risk of thalidomide and the PPP measures.
Pazjenta mara li tista ’ toħroġ tqila Pazjenta mara li ma tistax toħroġ tqila Pazjent raġel o Il- formoli kollha tal- bidu tat- trattament għandu jkollhom dawn l- elementi li ġejjin:
Patient details, signature and date Prescriber name, signature and date Aim of this document i. e. as stated in the PPP: “ The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide.
Twissija dwar it- teratoġeniċità Data tas- servizz tal- pariri Affermazzjoni li l- pazjent fehem ir- riskju ta ’ thalidomide u l- miżuri PPP Dettalji tal- pazjent, firma u data L- isem ta ’ min ta r- riċetta tal- mediċina, firma u data L- għan ta ’ dan id- dokument i. e. hekk kif inhu miktub fil- PPP “ L- għan tal- formola tal- bidu tat- trattament hu li jipproteġi l- pazjenti u kwalunkwe fetu li jista ’ jkun hemm billi jiżgura li l- pazjenti jkunu informati kompletament dwar u jifhmu r- riskju tat- teratoġeniċità u reazzjonijiet avversi oħra marbuta ma 'l- użu ta ’ thalidomide.
It is not a contract and does not absolve anybody from his/ her responsibilities with regard to the safe use of the product and prevention of foetal exposure .”
Mhux kuntratt u ma jassolva lil ħadd mir- responsabbilitajiet tiegħu/ tagħha dwar l- użu sigur tal- prodott u l- prevenzjoni ta ’ l- esponiment tal- fetu. ”
Treatment initiation forms for female patients with childbearing potential should also include:
Il- Formoli tal- bidu tat- trattament għal pazjenti nisa li jistgħu joħorġu tqal għandhom o jinkludu wkoll:
Confirmation that the physician has discussed the following: • The need to avoid foetal exposure • That if she is pregnant or plans to be, she must not take Thalidomide Celgene • The need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment
Konfirma li t- tabib iddiskuta dan li ġej: • Il- bżonn li jiġi evitat esponiment għall- fetu
That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception
Li jekk ikollha bżonn tibdel jew twaqqaf il- metodu tagħha ta ’ kontraċettiv hi għandha tavża lit -: - tabib, li qed jagħtiha bir- riċetta medika l- kontraċettiv tagħha, li qed tieħu thalidomide - tabib li qed jagħtiha bir- riċetta medika thalidomide li hi waqfet jew biddlet il- metodu tagħha ta ’ kontraċettiv
The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment
Il- bżonn ta 'testijiet tat- tqala i. e qabel it- trattament, kull 4 ġimgħat matul it- trattament u wara t- trattament
The need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
Il- bżonn li tieqaf minnufih milli tieħu Thalidomide Celgene hekk kif ikun hemm suspett ta ’ tqala
The need to contact their doctor immediately upon suspicion of pregnancy
Il- bżonn li jikkuntattjaw lit- tabib tagħhom minnufih hekk kif ikun hemm suspett ta ’ tqala
That she sh ould not share the treatment with any other person That she should not donate blood during therapy and for one week following discontinuation of thalidomide
Li hi m’ għandha taqsam it- trattament ma ’ ħadd Li hi m’ għandhiex tagħti demm matul it- terapija u għal ġimgħa wara t- twaqqif ta ’ thalidomide
That she should return the capsules to the pharmacist at the end of treatment
Li hi għandha tagħti lura l- kapsuli lill- ispiżjar fit- tmiem tat- trattament
Treatment initiation forms for female patients with no childbearing potential should also include:
Formoli tal- bidu tat- trattament għall- pazjenti nisa li ma jistgħux joħorġu tqal o għandhom jinkludu:
Confirmation that the physician has discussed the following: • That she should not share the treatment with any other person • That she should not donate blood during therapy and for one week following discontinuation of thalidomide • That she should return the capsules to the pharmacist at the end of treatment
Konferma li t- tabib kien iddiskuta dan li ġej: • Li hi m’ għandha taqsam it- trattament ma ’ ħadd • Li m’ għandhiex tagħti d- demm matul it- terapija u għal ġimgħa wara t- twaqqif ta ’ thalidomide • Li hi għandha tagħti lura l- kapsuli lill- ispiżjar fit- tmiem it- trattament
C onfirmation that the physician has discussed the following: • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not on effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom • That he should not donate blood or semen during therapy and for one week following discontinuation of thalidomide • That he should not share the treatment with any other person • That he should return the capsules to the pharmacist at the end of treatment
Li hu m’ għandu jaqsam it- trattament ma ’ ħadd • Li hu għandu jagħti lura l- kapsuli lill- ispiżjar fit- tmiem tat - trattament
• Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing status potential o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if female with childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if female with childbearing potential) o pregnancy test dates and results
• Kards tal- Pazjent u jew strumenti ekwivalenti: o verifika li ngħata servizz konsultattiv adattat o dokumentazzjoni ta ’ l- istatus tal- fatt jekk il- pazjenta tistax toħroġ tqila o kaxxa (jew simili) li t- tabib jittikkja biex jikkonfirma li l- pazjent qed juża kontraċettiv effettiv (jekk hi mara li tista ’ toħroġ tqila) o verifika ta ’ test inizjali negattiv tat- tqala qabel il- bidu tat- trattament (jekk hi mara li tista ’ toħroġ tqila) o dati u riżultati tat- test tat- tqala
• Education booklets for patients: o The booklets can be of 3 types or a single patient booklet that combines the information for each patient category:
5 o Il- fuljetti jistgħu jkunu ta ’ 3 tipi, jew fuljett ta ’ pazjent wieħed li jgħaqqad l- informazzjoni għal kull kategorija ta ’ pazjenti:
Booklet for women of childbearing potential and their partners Booklet for women patients who are not of childbearing potential
Fuljett għal nisa li jistgħu joħorġu tqal u l- partner tagħhom Fuljett għal pazjenti nisa li ma jistax ikollhom it- tfal Fuljett għall- pazjenti rġiel
o All booklets should contain the following information That Thalidomide Celgene is teratogenic That Thalidomide Celgene may cause thromboembolism, cardiovascular events and neuropathy Description of the patient card and its use in the individual Member State National or other applicable specific arrangements for a prescription for thalidomide to be dispensed That Thalidomide Celgene must not be given to any other person That the patient should not donate blood during therapy and for one week following discontinuation of thalidomide That the patient should tell their doctor about any adverse events That any unused capsules should be returned to the pharmacist at the end of the treatment
Il- fuljetti kollha għandu jkun fihom dawn l- elementi li ġejjin: o Thalidomide Celgene huwa teratoġeniku Thalidomide Celgene għandu mnejn jikkawża tromboemboliżmu, episodji kardjovaskulari u newropatija Deskrizzjoni tal- kard tal- pazjent u l- użu tagħha fl- Istat Membru Individwali Arranġamenti nazzjonali jew oħrajn applikabbli speċifiċi sabiex ikun jista ’ jingħata thalidomide b’ riċetta M’ għandekx tagħti Thalidomide Celgene lil ħaddieħor Il- pazjent m’ għandux jagħti d- demm matul it- terapija u għal ġimgħa wara t- twaqqif ta ’ thalidomide Il- pazjent għandu javża lit- tabib tiegħu b’ kull effett avvers li jkollu Li kwalunkwe kapsuli mhux użati għandhom jingħataw lura lill- ispiżjar fit- tmiem tal- kura.
o The following information should also be provided in the appropriate booklet Female patient of childbearing potential • The need to avoid foetal exposure • The need for effective contraception • That if she needs to change or stop using her method of contraception she should inform:
Pazjenti nisa li jistgħu joħorġu tqal
- the physician prescribing her contraception that she is on
- lit- tabib, li qed jiktbilha ir- riċetta medika tal- kontraċettiv tagħha,
thalidomide
li hi qed tieħu t- thalidomide
- the physician prescribing thalidomide that she has stopped or
- lit- tabib li qed jagħtiha bir- riċetta medika thalidomide li ma
The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment
għadhiex tieħu jew biddlet il- metodu tagħha ta 'kontraċettiv • Il- ħtieġa għal testijiet tat- tqala; i. e. qabel it- trattament kull 4 ġimgħat matul it- trattament u wara t- trattament • Il- ħtieġa li Thalidomide Celgene jitwaqqaf minnufih ma ’ l- inqas suspett ta ’ tqala • Il- ħtieġa li t- tabib jiġi nnotifikat minnufih malli jkun hemm suspett ta ’ tqala
Male patients • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not on effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom • That he should not donate semen during therapy and for one week following discontinuation of thalidomide.
Pazjenti rġiel • Il- ħtieġa li tiġi evitata espożizzjoni lill- fetu • Li thalidomide jinsab fis- semen u l- ħtieġa li jintużaw kondoms jekk is- sieħba sesswali tkun tqila jew hi mara li tista ’ toħroġ tqila li mhux qed tuża kontraċettiv effettiv • Jekk is- sieħba tiegħu toħroġ tqila, huwa għandu jinforma minnufih lit- tabib li jkun qiegħed jikkurah u dejjem għandu juża kondom. • M’ għandux jagħti semen matul it- terapija u għal ġimgħa wara t- twaqqif ta ’ thalidomide
What is Thalidomide Celgene?
X' inhu Thalidomide Celgene?
Thalidomide Celgene is a medicine containing the active substance thalidomide.
Thalidomide Celgene huwa mediċina li fiha s- sustanza attiva thalidomide.
It is available as capsules (50 mg).
Huwa disponibbli f' kapsuli (tal- 50 mg).
What is Thalidomide Celgene used for?
Għal xiex jintuża Thalidomide Celgene?
Thalidomide Celgene is used to treat multiple myeloma (a cancer of the bone marrow) in combination with melphalan and prednisone (anticancer medicines) in patients who have not been treated for multiple myeloma before.
Thalidomide Celgene jintuża fit- trattament tal- mjeloma multipla (kanċer tal- mudullun tal- għadam) flimkien ma 'melphalan u prednisone (mediċini ta' kontra l- kanċer) f' pazjenti li ma jkunux ġew trattati għall- mjeloma multipla qabel.
It is used in patients aged over 65 years, and in younger patients if they cannot be treated with high-dose chemotherapy (anticancer treatments).
Jintuża fuq pazjenti 'l fuq minn 65 sena, u f' pazjenti iżgħar jekk ma jkunux jistgħu jiġu ttrattati b' doża qawwija ta' kemjoterapija (mediċini ta 'kontra l- kanċer).
Thalidomide Celgene must be prescribed and dispensed according to a special programme put in place to prevent the exposure of unborn children to the medicine.
Thalidomide Celgene għandu jiġi preskritt u mogħti skont programm speċjali implimentat biex jipprevjeni l- esponiment għall- mediċina tal- fetu.
Because the number of patients with multiple myeloma is low, the disease is considered ‘ rare’, and Thalidomide Celgene was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 20 November 2001.
Billi l- għadd ta 'pazjenti bil- mjeloma multipla huwa wieħed żgħir, il- marda hija kkunsidrata' rari ', u Thalidomide Celgene ġie klassifikat bħala' mediċina orfni '(mediċina użata f' mard rari) fl- 20 ta' Novembru 2001.
How is Thalidomide Celgene used?
Kif jintuża Thalidomide Celgene?
Treatment with Thalidomide Celgene must be started and monitored under the supervision of a doctor who is skilled in using medicines that modulate the immune system or anticancer medicines.
It- trattament b' Thalidomide Celgene għandu jinbeda u jiġi sorveljat minn tabib imħarreġ fl- użu ta 'mediċini li jimmodulaw is- sistema immunitarja jew fl- użu ta' mediċini ta 'kontra l- kanċer.
The doctor must also understand the risks of thalidomide and the ways in which the use of the medicine must be monitored.
It- tabib għandu jifhem ukoll ir- riskji ta 'thalidomide u l- modi li bihom għandu jiġi sorveljat l- użu tal- mediċina.
The recommended dose of Thalidomide Celgene is four capsules a day, taken at the same time, preferably at bedtime.
Id- doża rakkomandata ta 'Thalidomide Celgene hija ta' erba 'kapsuli kuljum, meħudin fl- istess ħin tal - jum, preferibbilment f' ħin l- irqad.
The capsules can be taken with or without food.
Il- kapsuli jistgħu jittieħdu mal- ikel jew weħidhom.
Thalidomide Celgene can be used for a maximum of 12 treatment cycles, with each cycle lasting six weeks.
Thalidomide Celgene jista 'jintuża għal massimu ta' 12- il ċiklu ta 'trattament, b' kull ċiklu jdum sitt ġimgħat.
The doctor may delay, reduce or stop doses if the patient experiences certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.
It- tabib jista 'jdewwem, inaqqas jew iwaqqaf id- dożi jekk il- pazjent jesperjenza ċerti effetti sekondarji, fosthom għoqiedi tad- demm, ħsara fin- nervituri, raxx, tnaqqis tal- frekwenza kardijaka, sturdament jew ngħas.
Each patient should also receive an anticoagulant (a medicine to prevent the formation of blood clots) for at least the first five months of treatment, after careful assessment of the patient ’ s individual risk.
Kull pazjent għandu jingħata wkoll antikoagulant (mediċina għall- prevenzjoni tal- formazzjoni ta 'għoqiedi tad- demm) għal tal- anqas l- ewwel ħames xhur trattament, wara valutazzjoni bir- reqqa tar - riskju individwali tal- pazjent.
Patients who have severe problems with their kidneys or liver should be carefully monitored for side effects.
Il- pazjenti li jkollhom problemi gravi fil- kliewi jew fil- fwied għandhom jiġu sorveljati bir- reqqa għal xi effetti sekondarji.
Thalidomide Celgene is not recommended for use in patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Thalidomide Celgene mhuwiex rakkomandat għall- użu f’ pazjenti ta 'taħt it- 18- il sena minħabba nuqqas ta' tagħrif dwar is- sigurtà u l- effikaċja f' dan il- grupp ta ’ età.
How does Thalidomide Celgene work?
Kif jaħdem Thalidomide Celgene?
The active substance in Thalidomide Celgene, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating some of the specialised cells of the immune system (the body’ s defence mechanism) to attack the cancer cells.
Huwa maħsub li s- sustanza attiva f' Thalidomide Celgene, thalidomide, taħdem billi timblokka l - iżvilupp ta 'ċelluli tal- kanċer, u billi tistimula wħud miċ- ċelluli tas- sistema immunitarja (il - mekkaniżmu ta' difiża tal- ġisem) biex tattakka ċelluli tal- kanċer.
This can help to slow down the progression of multiple myeloma.
Dan jista 'jgħin biex inaqqas ir- rata tal- progressjoni tal- mjeloma multipla.
How has Thalidomide Celgene been studied?
Kif ġie studjat Thalidomide Celgene?
The effects of Thalidomide Celgene were first tested in experimental models before being studied in humans.
Għall- ewwel, l- effetti ta 'Thalidomide Celgene ġew ittestjati f' mudelli sperimentali qabel ma ġew studjati fuq il- bnedmin.
The effectiveness of Thalidomide Celgene was studied in one main study involving 447 patients with multiple myeloma.
L- effikaċja ta 'Thalidomide Celgene ġiet studjata fi studju wieħed ewlieni li fih ħadu sehem 447 pazjent bil- mjeloma multipla.
The study included patients over 65 years of age, as well as younger patients who could not be treated with high-dose chemotherapy.
Fl- istudju ħadu sehem pazjenti li għandhom 'il fuq minn 65 sena, kif ukoll pazjenti iżgħar li ma setgħux jiġu ttrattati b' kemjoterapija b' doża għolja.
The study compared the effect of melphalan and prednisone, with or without Thalidomide Celgene, on survival times.
L- istudju qabbel l- effett ta 'melphalan u prednisone, ma' jew mingħajr Thalidomide Celgene, fuq iż- żmien ta 'sopravivenza.
The company also presented the results of a study looking at the combination of Thalidomide Celgene and dexamethasone as ‘ induction’ treatment for multiple myeloma for use before high-dose chemotherapy.
Il- kumpanija ppreżentat ukoll ir- riżultati ta 'studju li eżamina wkoll il- kombinazzjoni ta' Thalidomide Celgene ma 'dexamethasone bħala trattament ta' 'induzzjoni' għall- mjeloma multipla għall- użu qabel kemjoterapija b' doża għolja.
However, it withdrew this application during the assessment of the medicine.
Madankollu, il- kumpanija rtirat l- applikazzjoni waqt il- valutazzjoni tal - mediċina.
What benefit has Thalidomide Celgene shown during the studies?
Liema benefiċċju wera Thalidomide Celgene waqt l- istudji mwettqa?
Survival times were longer in the patients receiving Thalidomide Celgene in addition to melphalan and prednisone.
Il- pazjenti li ħadu Thalidomide Celgene flimkien ma 'melphalan u prednisone kellhom żmien ta' sopravivenza itwal.
Patients receiving melphalan and prednisone survived for an average of 33.2 months from the start of the study, compared with 51.6 months when the treatment also included Thalidomide Celgene.
Il- pazjenti li ngħataw melphalan u prednisone għexu medja ta '33. 2 xahar mill - bidu tal- istudju, meta mqabbla ma' 51. 6 xahar meta t- trattament kien fih ukoll Thalidomide Celgene.
What is the risk associated with Thalidomide Celgene?
X' inhu r- riskju assoċjat ma 'Thalidomide Celgene?
Most patients taking thalidomide experience side effects.
Ħafna mill- pazjenti li jieħdu thalidomide jesperjenzaw effetti sekondarji.
The most common side effects (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet), tremor (shaking), dizziness, paraesthesia (unusual sensations like pins and needles), dysaesthesia (reduced sense of touch), somnolence (sleepiness), constipation and peripheral oedema (swelling, usually in the legs).
Ħafna mill- effetti sekondarji (li dehru f' iktar minn pazjent wieħed minn kull 10) huma n- newtropenija (livelli baxxi ta 'newtrofili, tip ta' ċelluli tad- demm bojod), lewkopenija (għadd baxx ta 'ċelluli tad- demm bojod), anemija (għadd baxx ta' ċelluli tad- demm ħomor), linfopenija (livelli baxxi ta 'linfoċiti, tip ieħor ta' ċelluli tad- demm bojod), tromboċitopenija (livelli baxxi ta ’ platelets fid- demm), newropatija periferika (ħsara fin - nervituri, li tikkawża tnemnim, uġigħ fl- idejn u fis- saqajn li kif ukoll jinħassu mtarrxin), rogħda, sturdament, parestesija (sensazzjoni mhux tas- soltu bħal tniggiż), disestesija (tnaqqis fis- sens tal - mess), ħedla tan- ngħas, stitikezza u edema periferika (nefħa ġeneralment fir- riġlejn).