qanastek/EMEA-V3 huggingface dataset:
CONDITIONS OF THE MARKETING AUTHORISATION
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
10 A.
10 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Name and address of the manufacturers of the biological active substance
Isem u indirizz tal- manifatturi tas- sustanza bijoloġika attiva
Jevany Bohumil 138 CZ-281 63 Kostelec nad Cernymi lesy Czech Republic
Jevany Bohumil 138 CZ- 281 63 Kostelec nad Cernymi lesy Ir- Repubblika Ċeka
Baxter AG Uferstrasse 15 2304 Orth/ Donau Austria
Baxter AG Uferstrasse 15 2304 Orth/ Donau L- Awstrija
Celvapan can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Celvapan takes due account of the officially declared pandemic strain.
Celvapan jista ’ jitqiegħed fis- suq biss meta jkun hemm dikjarazzjoni uffiċjali tal- WHO/ UE dwar l - influwenza pandemika, bil- kundizzjoni li d- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq għal Celvapan jieħu in konsiderazzjoni r- razza pandemika dikjarata uffiċjalment.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version V01 (dated June 2006) 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.
Sistema ta ’ farmakoviġilanza Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li l- farmakoviġilanza, kif deskritta f’ verżjoni V01 (datata Ġunju 2006) ippreżentata fil- modulu 1. 8. 1 tal- Applikazzjoni tal - Awtorizzazzjoni għat- Tqegħid fis- Suq qegħda f’ postha u bdiet taħdem minn qabel u taħdem waqt li l - prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMP V 2.0 (dated 14 Aug 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq studju ta ’ reġistru u attivitajiet ta ’ farmakoviġilanza, kif miftehem fil- verżjoni RMP V 2. 0 (datat 14 t’ Awwissu 2008) tal- Pjan ta ’ Ġestjoni tar- Riskju (RMP) preżentata f’ Modulu 1. 8. 2 tal- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
12 Skont il- Linja Gwida ta ’ CHMP dwar Sistemi ta ’ Ġestjoni dwar ir- Riskju għal prodotti mediċinali li jintużaw mill- bniedem, RMP aġġornat għandu jiġi sottomess fl- istess ħin tar- Rapport ta ’ Aġġornament Perijodiku dwar is- Sigurtà (PSUR).
11 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, RMP aġġornat għandu jiġi sottomess • Meta jasal tagħrif ġdid li jista ’ jkollu impatt fuq l- Ispeċifikazzjoni dwar is- Sigurtà attwali, il - Pjan ta ’ Farmakoviġilanza u attivitajiet li jnaqqsu r- riskju • Fi żmien 60 jum li jintlaħaq tragward importanti (farmakoviġilanza dwar minimizzazzjoni ta ’ riskju) • Fuq talba tal- EMEA
PSURs PSUR submission during the influenza pandemic:
PSURs Is- sottomissjoni ta ’ PSUR waqt l- influwenza pandemika:
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/ 2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Waqt sitwazzjoni pandemika, il- frekwenza ta ’ rapporti ta ’ aġġornament perijodiċi dwar ir- riskju speċifikati f’ Artikolu 24 tar- Regolament (KE) Nru 726/ 2004 mhux ser ikunu biżżejjed għal monitoraġġ b’ mod sikur ta ’ vaċċin pandemiku li għalih livelli għoljin ta ’ espożizzjoni huma mistennija f’ perijodu qasir ta ’ żmien.
Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Sitwazzjoni bħal din tkun teħtieġ avviżi ta ’ malajr dwar tagħrif fuq is- sigurtà li jista ’ jkollha l- ikbar implikazzjonijiet fuq il- bilanċ dwar is- siwi - benefiċċju f’ pandemija.
Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Analiżi fil- pront ta ’ informazzjoni kumulattiva dwar is- sigurtà, fid- dawl tal- firxa tal- espożizzjoni, tkun kruċjali għal deċiżjonijiet regolatorji u l- protezzjoni tal - popolazzjoni li trid tiġi vaċċinata.
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Barra minn hekk, waqt pandemija, riżorsi meħtieġa għal evalwazzjoni fil- fond tar- Rapporti ta ’ Aġġornament Perijodiku dwar is- Sigurtà fil- format kif speċifikat f’ Volum 9a tar- Regoli li Jigvernaw Prodott Mediċinali fl- Unjoni Ewropea jistgħu ma jkunux adegwati għal identifikazzjoni ta ’ malajr għal tagħrif ġdid ta ’ sigurtà.
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Bħala konsegwenza, hekk kif il- pandemija hija dikjarata (Fażi 6 tal- Pjan Globali ta ’ dwar it - tħejjija fuq l- Influwenza ta ’ WHO) u l- vaċċin pandemiku jintuża, id- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- Suq għandu jissottometti rapporti ta ’ aġġornament perijodiku bil- perijodiċità u l- format mfissra kif ġej:
Frequency of submission
Frekwenza ta ’ sottomissjoni
- The clock will start from the first Monday after shipment of the first batch of vaccine.
- L- arloġġ jitlaq fl- ewwel Tnejn wara li jintbagħat l- ewwel lott tal- vaċċin.
- First data-lock point is 14 days later.
- L- ewwel data lock point hu 14- il jum wara.
- Report submission is no later than day 22 (i. e. the following Monday).
- Is- sottomissjoni tar- rapport irid isir mhux inqas minn jum 22 (i. e.
- Reporting to be fortnightly for the first 3 months of the pandemic.
- Ir- rapporti jridu jsiru kull ħmistax fl- ewwel tliet xhur tal- pandemija.
- Periodicity will be reviewed by the MAH and the (Co-) Rapporteur at 3 monthly
(Ko) Reġistratur f’ intervalli ta ’ 3 xhur
Format The report shall include the following Tables of aggregate data using the agreed templates:
Format Ir- rapport għandu jinkludi t- Tabelli li ġejjin ta ’ tagħrif aggregat bl- użu tal- galvijiet miftehma:
Fatal and/ or life-threatening reactions – for each Preferred Term (PT), including the proportion of fatal reports 2.
Reazzjonijiet fatali u/ jew ta ’ theddida għal ħajja - għal kull terminu preferut (PT), li jinkludi l- proporzjon ta ’ rapporti fatali 2.
Adverse Events of Special Interest (PTs) 3.
Każijiet Avversi ta ’ Interess Speċjali (PTs) 3.
Serious unexpected reactions (PTs) 4.
Reazzjonijiet mhux mistennija serji (PTs) 4.
All events occurring in the following age groups:
Kull każ li jseħħ fil- gruppi ta ’ etajiet li ġejjin:
6-23 months, 2-8 years, 8-17 years, 18-60 years, > 60 years All events occurring in pregnant women 5.
6- 23 xahar, 2- 8 snin, 8- 17- il sena, 18 - 60 sena, > 60 sena Kull każ li jseħħ f’ nisa tqal 5.
All events reported by patients that have been entered into the database by data-lock point 6.
Kull każ rapportat minn pazjenti li ġew imdaħħla fid- database bid- data- lock point 6.
A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Ġabra fil- qosor kumulattiva tal- każijiet kollha rapportati matul il- perijodu, imqassma skont it- tip ta ’ reporter (pazjent jew professjonist tal- kura tas- saħħa), serjetà, stennija u jekk kinetx spontanea jew soliċitata.
Presentation of data will take into consideration the following recommendations:
Il- preżentazzjoni tat- tagħrif għandu jqis ir- rakkomandazzjonijiet li ġejjin:
- Serious expected reactions will be reviewed by the MAH as part of their signal detection
- Reazzjonijiet mistennija serji ser jiġu riveduti mid- Detentur tal- Awtorizzazzjoni għat -
procedures and will only form part of the report if an issue of concern arises.
Tqegħid fis- Suq bħala parti mill- proċeduri senjalitiċi tagħhom u jagħmlu parti mir - rapport jekk ikun hemm kwistjoni ta ’ tħassib.
- All tables will be based on number of events (presented on PT level, sorted by System
- Kull tabella ser tkun ibbażata fuq għadd ta ’ każijiet (ippreżentati f’ livell PT, irranġati
Organ Class [SOC]) and not number of cases.
skont il- Kategorija tal- Organi fis- Sistema [SOC]) u mhux fuq l- għadd ta ’ każijiet.
- Tables 1 to 4 will be based on events reported from healthcare professionals only.
- It- Tabelli 1 sa 4 ser ikunu bbażati fuq każijiet rapportati minn professjonisti tal- kura tas -
- In Tables 1 to 5, numbers will be provided for events received during the reporting period
- F’ Tabelli 1 sa 5, numri ser jiġu provduti għal każijiet li waslu waqt il- perijodu ta ’
and cumulatively.
rapportaġġ u b’ mod kumulattiv.
12
It -
Product-specific data can be evaluated during signal work-up.
tagħrif speċifiku fuq il- prodott jista ’ jiġi evalwat waqt it- tħaddim tas- sinjali.
-
- Ebda listi fuq il- linja m’ huma meħtieġa - dawn jistgħu jiġu provduti minn rapporti ta ’
No line listings are required – these can be provided in signal evaluation reports as necessary.
evalwazzjoni tas- sinjali, kif meħtieġ.
A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
Ġabra fil- qosor għandha tiġi provduta wkoll mar- rapporti ta ’ aġġornament perijodiku dwar is - sigurtà, fejn kull settur ta ’ tħassib għandu jiġi enfasizzat, ix- xogħol bis- sinjali jingħata prijorità( fil- każ ta ’ sinjali multipli) u żminijiet xierqa għal sottomissjoni ta ’ evalwazzjoni dwar senjalitika sħiħa provduti.
All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
Kull rapport ta ’ evalwazzjoni tas- sinjali għandu jiġi provdut, inkluż dawk li sussegwentement ma ġewx identifikati bħala li kienu sinjali.
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in: i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world
Sommarju tad- distribuzzjoni tal- vaċċin għandu jiġi inkluż u għandu jagħti stampa dettaljata tal- għadd ta ’ dożi ta ’ vaċċin fornut fi:
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Rilaxx tal- lott uffiċjali: b’ mod konformi mal- Artikolu 114 Direttiva 2001/ 83/ KE kif emendata, ir- rilaxx tal- lott uffiċjali għandu jsir minn laboratorju tal- Istat jew kull laboratorju ieħor maħtur għal dan l- iskop.
C.
Ċ.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI TAD- DETENTUR TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile in case the Pandemic will be declared.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jtemm il- programmi ta ’ studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta ’ dawn l- istudji għandhom iservu ta ’ bażi għall- istima tal- profil bejn is- siwi/ riskju li ssir kull sena, wara li l- Pandemija tiġi dikjarata.
Area Clinical
Aspett Kliniku
Description During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Deskrizzjoni Waqt il- pandemija l- applikant għandu jiġbor it- tagħrif ta ’ sigurtà klinika u effettività tal- vaċċin pandemiku u jagħti din l - informazzjoni lil CHMP għal evalwazzjoni.
Due date Depending on and after implementation of vaccine when first pandemic will take place.
Skont fi u wara
Pharmacovigilance
Farmakoviġilanza
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Matul il- pandemija, l- applikant ser imexxi studju prospettiv ta ’ koorti kif identifikat fil- pjan ta ’ farmakoviġilanza.
Depending on and after implementation of vaccine when first pandemic will take place.
l- implimentazzjoni tal- vaċċin meta l- ewwel pandemija ser isseħ
14 A.
14 ANNESS III
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
CELVAPAN suspension for injection Pandemic influenza vaccine (whole virion, Vero cell derived, inactivated)
CELVAPAN suspensjoni għall- injezzjoni Vaċċin kontra l- influwenza pandemika (virion sħiħ, derivat minn ċelluli Vero, inattivat)
Whole virus influenza vaccine, inactivated containing antigen of pandemic strain*:
Vaċċin kontra l- influwenza b’ virus sħiħ, inattivat, li fih antiġen ta’ razza pandemika *:
A/ Vietnam/ 1203/ 2004 (H5N1)
A/ Vjetnam/ 1203/ 2004 (H5N1)
7.5 microgram**
7. 5 mikrogrammi **
per 0.5 ml dose
għal kull doża ta ’ 0. 5 ml
* propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin
* propagati f’ ċelluli Vero (razza ta ’ ċelluli kontinwi ta ’ oriġini mammifera) ** espressi f’ mikrogrammi emaglutinin
Trometamol, sodium chloride, water for injections, polysorbate 80
Trometamol Sodium chloride Ilma għall- injezzjonijiet Polysorbate 80
Suspension for injection.
Suspensjoni għal injezzjoni.
20 multidose vials (10 doses per vial – 0.5 ml per dose)
20 kunjetti b’ ħafna dożi (10 dożi f’ kull kunjett – 0. 5 ml għal kull doża)
Intramuscular use.
Użu għal ġol- muskoli.
After first opening, the vial is to be used within a maximum of 3 hours.
Wara li jinfetaħ għall- ewwel darba, il- kunjett għandu jintuża f’ ħin massimu ta ’ 3 sigħat.
Do not inject intravascularly.
Tinjettax ġol- vini
Store in refrigerator.
Aħżen fi friġġ.
Dispose of in accordance with local requirements.
Armi skont il- liġijiet lokali.
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL FOR 10-DOSE VIAL
TIKKETTA GĦAL KUNJETT TA ’ 10 DOŻI
CELVAPAN suspension for injection (whole virion, Vero cell derived, inactivated) Pandemic influenza vaccine I. M.
CELVAPAN suspensjoni għall- injezzjoni Vaċċin kontra l- influwenza pandemika (virus sħiħ, derivat minn ċelluli Vero, inattivat) Użu għal ġol- muskoli
Shake before use
Ħawwad qabel l- użu
Multidose vial (10 doses of 0.5 ml pervial)
Kunjett b’ ħafna dożi (10 dożi ta ’ 0. 5 ml kull kunjett)
BAXTER AG A-1221 Vienna Austria
BAXTER AG A- 1221 Vienna L- Awstrija
CELVAPAN suspension for injection Pandemic influenza vaccine (whole virion, Vero cell derived, inactivated)
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
Read all of this leaflet carefully before you start receiving this vaccine.
Vaċċin kontra l- influwenza pandemika (virion sħiħ, derivat minn ċelluli Vero, inattivat)
- Keep this leaflet.
Żomm dan il- fuljett.
- If you have any further questions, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
- This vaccine has been prescribed for you.
Dan il- vaċċin ġie mogħti lilek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
In this leaflet 1.
F’ dan il- fuljett 1.
What CELVAPAN is and what it is used for 2.
X’ inhu CELVAPAN u għalxiex jintuża 2.
Before you receive CELVAPAN 3.
Qabel ma tieħu CELVAPAN 3.
How CELVAPAN is given 4.
Kif għandek tieħu CELVAPAN 4.
How to store CELVAPAN 6.
Kif taħżen CELVAPAN 6.
WHAT CELVAPAN IS AND WHAT IT IS USED FOR
X’ INHU CELVAPAN U GĦALXIEX JINTUŻA
CELVAPAN is a vaccine used in adults of 18 years of age and older.
CELVAPAN huwa vaċċin użat f’ persuni adulti ta ’ 18- il sena u aktar.
It is used to prevent influenza (flu) in an officially declared pandemic.
Jintuża biex jipprevjeni l- influwenza f’ pandemija li tkun ġiet iddikjarata uffiċjalment.
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world.
L- influwenza pandemika hi tip ta ’ influwenza li sseħħ kull ftit għexieren ta ’ snin u li tinfirex malajr u taffettwa l- biċċa l- kbira tal- pajjiżi u reġjuni madwar id- dinja.
The symptoms (signs) of pandemic flu are similar to those of an “ ordinary” flu but are usually more severe.
Is- sintomi (sinjali) tal- influwenza pandemika huma bħal dawk ta ’ influwenza “ ordinarja ” iżda normalment ikunu iktar severi.
The vaccine works by helping the body to produce its own protection (antibodies) against the disease.
Il- vaċċin jaħdem billi jgħin lill- ġisem jipproduċi l- protezzjoni (antikorpi) tiegħu stess kontra l- marda.
BEFORE YOU RECEIVE CELVAPAN
QABEL MA TIEĦU CELVAPAN
Do not use CELVAPAN:
Tużax CELVAPAN:
• if you previously had a serious allergic reaction (i. e. life-threatening) to CELVAPAN. • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.
• jekk qabel kellek reazzjoni allerġika serja (jiġifieri ta ’ theddida għall- ħajja) għal CELVAPAN. • jekk int allerġiku/ a għal xi sustanzi jew residwi ta ’ traċċa kontenuti (formaldehyde, benzonase, sucrose) kontenuti fil- vaċċin.
The active substance and other ingredients in CELVAPAN are listed in Section 6 at the end of the leaflet.
Is- sustanza attiva u s- sustanzi l- oħra f’ CELVAPAN huma elenkati f’ Sezzjoni 6 fl- aħħar tal- fuljett.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Sinjali ta ’ reazzjoni allerġika jistgħu jinkludu raxx tal- ġilda bil- ħakk, qtugħ ta ’ nifs u nefħa fil- wiċċ jew fl- ilsien.
However, in a pandemic situation, your doctor may recommend to give the vaccine.
Madankollu, f’ sitwazzjoni pandemika, it- tabib tiegħek jista ’ jirrakkomanda li jingħata l- vaċċin.
Take special care with CELVAPAN:
Oqgħod attent ħafna b’ CELVAPAN:
You should tell your doctor before vaccination • if you have a severe infection with a high temperature (over 38°C).
Għandek tgħid lit- tabib tiegħek qabel it- tilqima • jekk għandek infezzjoni severa b’ deni qawwi (fuq 38°C).
If this applies to you then your vaccination will usually be postponed until you are feeling better.
Jekk dan japplika għalik, allura t- tilqima tiegħek normalment ser tiġi posposta sakemm tħossok aħjar.
A minor infection such as a cold should not be problem, but your doctor should advise whether you could still be vaccinated with CELVAPAN. • if you have a poor immune response (as for example because of immunosuppressive therapy, e. g. corticosteroid treatments or chemotherapy for cancer);
Infezzjoni żgħira bħal riħ, m’ għandhiex tkun problema, iżda t- tabib tiegħek għandu jagħtik parir jekk tistax tingħata tilqima b’ CELVAPAN. • jekk għandek rispons immunitarju dgħajjef (bħal, per eżempju, minħabba terapija immunosuppressiva, eż. trattamenti kortikosterojdi jew kimoterapija għall- kanċer); • jekk tkun ser tagħmel xi test tad- demm biex tara hemmx evidenza ta ’ infezzjoni b’ ċerti viruses.
In the first few weeks after vaccination with CELVAPAN the results of these tests may not be correct.
Fl- ewwel ftit ġimgħat wara t- tilqima b’ CELVAPAN, ir- riżultati ta ’ dawn it- testijiet jistgħu ma jkunux korretti.
Tell the doctor requesting these tests that you have recently received CELVAPAN; • If you have a bleeding problem or bruise easily.
Għid lit- tabib li jitlob dawn it- testijiet li inti dan l- aħħar irċivejt CELVAPAN; 21 • jekk għandek problema ta ’ ħruġ ta ’ demm jew titbenġel faċilment.
There is no information on the use of CELVAPAN below 18 years of age.
M’ hemm l- ebda informazzjoni dwar l- użu ta ’ CELVAPAN f’ persuni li għandhom inqas minn 18- il sena.
In case of pandemic national recommendations will be followed.
F’ każ ta ’ pandemija, ir- rakkomandazzjonijiet nazzjonali ser jiġu segwiti.
Taking other medicines: • Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine. • CELVAPAN should not be given at the same time as other vaccines.
Meta tieħu mediċini oħra: • Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta jew jekk dan l- aħħar tkun ħadt xi tilqima oħra. • CELVAPAN ma għandux jingħata fl- istess ħin ma ’ tilqim ieħor.
However, if this cannot be avoided, the other vaccine should be injected into the other limb.
Madankollu, jekk dan ma jkunx jista ’ jiġi evitat, it- tilqima l- oħra għandha tiġi injettata fir- riġel/ driegħ l- ieħor.
You should be aware that the side effects may be intensified. • If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, CELVAPAN can still be given but your response to the vaccine may be poor. • CELVAPAN should not be given at the same time as immunoglobulins.
Għandek tkun konxju li l- effetti sekondarji jistgħu jiħraxu. • Jekk tieħu kwalunkwe mediċini li jnaqqsu l- immunità għall- infezzjonijiet, jew jekk qed tieħu kwalunkwe tip ieħor ta ’ kura (bħal radjuterapija) li taffettwa lis- sistema immuni, CELVAPAN xorta jista ’ jingħata, iżda r- rispons tiegħek għat- tilqima jista ’ jkun batut. • CELVAPAN m’ għandux jingħata fl- istess ħin ma ’ immunoglobulini.
However, if this cannot be avoided, the immunoglobulins should be injected into the other limb.
Madankollu, jekk dan ma jkunx jista ’ jiġi evitat, l- immunoglobulini għandhom jiġu injettati fir- riġel/ driegħ l- ieħor.
Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant, or are breast-feeding.
Għid lit- tabib tiegħek jekk inti tqila, jekk taħseb li tista ’ tkun tqila, qed tippjana li toħroġ tqila jew jekk qiegħda tredda ’.
Your doctor will decide if you should receive CELVAPAN.
It- tabib tiegħek jiddeċiedi jekk għandekx tieħu CELVAPAN.
CELVAPAN may make you feel dizzy or sick which may affect your ability to drive or use machines.
CELVAPAN jista ’ jikkawża li tħossok stordut/ a jew imdardar/ imdardra u dan jista ’ jaffettwa l- ħila tiegħek li ssuq jew li tuża l- magni.
HOW CELVAPAN IS GIVEN
KIF GĦANDEK TIEĦU CELVAPAN
Adults from the age of 18 years and older will receive two injections of CELVAPAN.
Adulti minn 18- il sena 'l fuq jingħataw żewġ injezzjonijiet ta ’ CELVAPAN.
The time period between the first and the second injection must be at least three weeks.
Il- perjodu ta ’ żmien bejn l- ewwel u t- tieni injezzjoni għandu jkun ta ’ mill- inqas tliet ġimgħat.
CELVAPAN is given as an injection into the muscle (usually in the upper arm).
CELVAPAN jingħata bħala injezzjoni fil- muskolu (normalment fil- parti ta ’ fuq ta ’ driegħ).
The vaccine should never be given into a vein.
Il- vaċċin qatt ma għandu jingħata f’ vina.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk ikollok xi mistoqsijiet oħra dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, CELVAPAN can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, CELVAPAN jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In the clinical studies with CELVAPAN, most side effects were mild in nature and short term.
Fl- istudji kliniċi b’ CELVAPAN, ħafna mill- effetti sekondarji kienu ta ’ natura ħafifa u ma damux.
The side-effects are generally similar to those related to the influenza vaccine.
L- effetti sekondarji huma ġeneralment simili għal dawk relatati mal- vaċċin tal- influwenza.
There were fewer side effects after the second vaccination compared with the first.
Kien hemm inqas effetti sekondarji wara t- tieni tilqima meta mqabbla mal- ewwel waħda.
The most frequently occurring side effect was injection site pain, which was usually mild.
L- aktar effett sekondarju frekwenti kien uġigħ fis- sit tal- injezzjoni, li normalment kien wieħed ħafif.
The following side effects have been reported in clinical studies.
22 Ġew irrappurtati dawn l- effetti sekondarji fl- istudji kliniċi
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) 21 uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Il- frekwenza tal- effetti sekondarji possibbli elenkata hawn taħt hi definita bl- użu tal- konvenzjoni li ġejja: komuni ħafna (jaffettwaw iżjed minn utent 1 f’ kull 10) komuni (jaffettwaw minn 1 sa 10 utenti f’ kull 100) mhux komuni (jaffettwaw minn 1 sa 10 utenti f’ kull 1, 000) rari (jaffettwaw minn 1 sa 10 utenti f’ kull 10, 000) rari ħafna (jaffettwaw inqas minn utent 1 minn kull 10, 000) mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Very common: • pain at the injection site
Komuni ħafna: • uġigħ fis- sit tal- injezzjoni
Common: • runny nose and sore throat, • headache, dizziness, vertigo (motion sickness) • sweating more than usual, • joint or muscle pain, • chills, fatigue (feeling tired), malaise (generally feeling unwell), fever, • tissue hardening, redness, swelling or bruising at the injection site
Komuni: • imnieħer inixxi u uġigħ fil- griżmejn, • uġigħ ta ’ ras, sturdament, vertiġini (mard tal- moviment), • ħruġ aktar min- normal ta ’ għaraq, • uġigħ fil- ġogi jew fil- muskoli, • rogħda, għeja (tħossok għajjien), telqa (tħossok ma tiflaħx b’ mod ġenerali), deni, • twebbis tat- tessut, ħmura, nefħa jew tbenġil fis- sit tal- injezzjoni.
Uncommon: • swollen glands, • insomnia (difficulty sleeping), restlessness, • impaired perception of touch, pain, heat and cold, sleepiness, • conjunctivitis (an inflammation of the eye), • sudden hearing loss, • reduced blood pressure, • shortness of breath, cough, congestion of the nose, • nausea, vomiting, diarrhoea, stomach pain, • rash, itching, • irritation at the injection site
Mhux komuni: • glandoli minfuħin, • insomnija (diffikultà biex torqod), irrekwitezza, • indeboliment fil- perċezzjoni tal- mess, tal- uġigħ, tas- sħana u l- kesħa, ngħas, • konġuntivite (infjammazzjoni tal- għajn), • telf ta ’ smigħ f’ daqqa, • tnaqqis fil- pressjoni tad- demm, • qtugħ ta ’ nifs, sogħla, konġestjoni tal- imnieħer, • dardir, rimettar, dijarea, uġigħ fl- istonku, • raxx, ħakk, • irritazzjoni fis- sit tal- injezzjoni.
Other side effects which have occurred in the days or weeks after vaccination with flu vaccines include:
Effetti sekondarji oħrajn li jkunu seħħew fil- jiem jew ġimgħat wara t- tilqima b’ tilqim kontra l- influwenza jinkludu:
Uncommon: • Generalized skin reactions such as itching, hives or rash
Mhux komuni: • Reazzjonijiet ġeneralizzati tal- ġilda bħal ħakk, ħorriqija jew raxx
Rare: • Nerve pain (neuralgia) • Tingling and numbness • Fits • Transient low blood platelet count • Allergic reactions, in rare cases leading to shock (a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death)
Rari • Uġigħ fin- nervaturi (newralaġja) • Tagħrix u nuqqas ta ’ sensazzjoni • Attakk ta ’ isteriżmu • Għadd baxx ta ’ plejtlits tad- demm temporanju • Reazzjonijiet allerġiċi, li f’ każijiet rari jwasslu għal xokk (tnaqqis perikoluż fil- pressjoni tad- demm, li, jekk ma jiġix trattat, jista ’ jwassal għal kollass, koma u mewt)
Very rare: • Inflammation of blood vessels (vasculitis) with s transient kidney problems • Inflammation of the brain and spinal chord (encephalomyelitis) • Temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face
Rari ħafna: • Infjammazzjoni tal- vini u tal- arterji (vaskulite) bi problemi temporanji fil- kliewi • Infjammazzjoni tal- moħħ u tal- korda spinali (enċefalomajelite) • Infjammazzjoni temporanja tan- nervituri, li tikkawża uġigħ, dgħufija u paraliżi fl- estremitajiet u spiss twassal għas- sider u l- wiċċ
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmija f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE CELVAPAN
KIF TAĦŻEN CELVAPAN
Do not use CELVAPAN after the expiry date which is stated on the carton.
Tużax CELVAPAN wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°C- 8°C).
After first opening the vial is to be used within a maximum of 3 hours.
Wara li jinfetaħ għall- ewwel darba, il- kunjett għandu jintuża f’ ħin massimu ta ’ 3 sigħat.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew mal- ilma tad- dranaġġ jew mal- iskart domestiku.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall- protezzjoni tal- ambjent.
What CELVAPAN contains
X’ fih CELVAPAN
Active substance:
Sustanza attiva:
Whole virion influenza vaccine, inactivated, containing antigen of pandemic strain*:
Vaċċin ta ’ kontra l- influwenza ta ’ virjon sħiħ, inattivat, li fih antiġen tar- razza pandemika *:
* propagated in Vero cells (continuous cell line of mammalian origin) ** haemagglutinin
* propagati f’ ċelluli Vero (razza ta ’ ċelluli kontinwi ta ’ oriġini mammifera) ** emaglutinin
The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.
Is- sustanzi l- oħrajn huma: trometamol, sodium chloride, ilma għall- injezzjonijiet, polysorbate 80.
What CELVAPAN looks like and contents of the pack
Id- dehra ta ’ CELVAPAN u l- kontenuti tal- pakkett
CELVAPAN is an off-white, opalescent, translucent liquid.
CELVAPAN huwa likwidu ofwajt, opalexxenti u transluċidu.
1 pack of CELVAPAN contains 20 multidose vials of 5 ml suspension for injection for 10 doses.
1 pakkett ta ’ CELVAPAN fih 20 kunjetti b’ ħafna dożi ta ’ 5 ml ta ’ suspensjoni għall- injezzjoni għal 10 dożi.
Marketing Authorization Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Baxter AG Industriestrasse 67 A-1221 Vienna, Austria
Baxter AG Industriestrasse 67 A- 1221 Vienna, L- Awstrija
Baxter AG Uferstrasse 15 A-2304 Orth/ Donau Austria
Baxter AG Uferstrasse 15 A- 2304 Orth/ Donau L- Awstrija
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder given below:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
23 België/ Belgique/ Belgien Baxter Belgium SPRL Bd. de la Plaine/ Pleinlaan 5 B-1050 Brussel/ Bruxelles/ Brüssel Tél/ Tel: + 32 2 650 1711
24 Luxembourg/ Luxemburg België/ Belgique/ Belgien Baxter Belgium SPRL Baxter Belgium SPRL Bd. de la Plaine/ Pleinlaan 5 Bd. de la Plaine/ Pleinlaan 5 B- 1050 Bruxelles/ Brüssel B- 1050 Brussel/ Bruxelles/ Brüssel Tél/ Tel: + 32 2 650 1711 Tél/ Tel: + 32 2 650 1711
Ελλάδα Baxter Hellas ΕΠΕ Εθνάρχου Μακαρίου 34 Ηλιούπολη GR-163 41 Αθήνα Τηλ.: +30-210-99 87 000
Polska Ελλάδα Baxter Polaka Sp. z o. o.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/ H
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA):
---------------------------------------------------------------------------------------------------------------------------
Hhttp: // www. emea. europa. eu /
The following information is intended for medical or health care professionals only:
26 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Prior to administration, the vaccine should be allowed to reach room temperature and the vial should be shaken well.
Qabel l- għoti, it- tilqima għandha titħalla tilħaq it- temperatura tal- kamra u l- kunjett għandu jitħawwad tajjeb.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Kull doża ta ’ tilqima ta ’ 0. 5 ml tinġibed ġo siringa għall- injezzjoni.
25 The vaccine should not be administered intravascularly.
It- tilqima m’ għandhiex tingħata ġol- vini/ arterji.
Any unused vaccine or waste material should be disposed of in accordance with local requirements .”
Kull tilqima jew fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
EPAR summary for the public This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex jasal għar- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Ceplene?
X’ inhu Ceplene?
Ceplene is a solution for injection that contains the active substance histamine dihydrochloride (0.5 mg/ 0.5 ml).
Ceplene huwa soluzzjoni għall- injezzjoni li fiha s- sustanza attiva dikloridrat tal- istamina (0. 5 mg/ 0. 5 ml).
What is Ceplene used for?
Għalxiex jintuża Ceplene?
Ceplene is used in combination with interleukin-2 (an anticancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Ceplene jintuża f’ kumbinazzjoni ma ’ interleukin- 2 (mediċina kontra l- kanċer) bħala kura ta ’ manteniment f’ adulti b’ lewkimja majelojde akuta (AML), tip ta ’ kanċer li jaffettwa ċ- ċelloli bojod tad- demm.
It is used during the patients’ first ‘ remission’ (a period without symptoms of the disease after the first course of treatment).
Huwa jintuża waqt l- ewwel ‘ remissjoni ’ tal- pazjenti (perijodu mingħajr sintomi tal- marda wara l- ewwel kors ta ’ kura).
The effectiveness of Ceplene has not been fully demonstrated in patients older than 60 years of age.
L- effikaċja ta ’ Ceplene ma nwerietx bis- sħiħ f’ pazjenti ta ’ età ikbar minn 60 sena.
Because the number of people with AML is low, the disease is rare, and Ceplene was designated as an ‘ orphan medicine’ (a medicine used in rare disease) on 11 April 2005.
Minħabba li n- numru ta ’ pazjenti li għandhom AML huwa wieħed baxx, hija ġiet ikkunsidrata bħala ‘ rari ’, u fil- 11 ta ’ April 2005, Ceplene ġie ikklassifikat bħala ‘ mediċina orfni ’ (mediċina li tintuża f’ mard rari).
How is Ceplene used?
Kif jintuża Ceplene?
Ceplene should be given under the supervision of a doctor who has experience in the treatment of AML.
Ceplene għandu jingħata taħt is- sorveljanza ta ’ tabib li għandu esperjenza fil- kura ta ’ AML.
The recommended dose of Ceplene is a 0.5-mg injection under the skin, twice a day, one to three minutes after an interleukin-2 injection.
Id- doża rrakkomandata ta ’ Ceplene hija injezzjoni ta ’ 0. 5 mg taħt il- ġilda, darbtejn kuljum, minuta sa tliet minuti wara injezzjoni ta ’ interleukin- 2.
Ceplene and interleukin-2 are given for 10 cycles.
Ceplene u interleukin- 2 jingħataw għal 10 ċikli.
The first three cycles consist of three weeks of treatment, followed by a three-week rest period.
L- ewwel tliet ċikli jikkonsistu fi tliet ġimgħat ta ’ kura, segwiti minn perijodu ta ’ mistrieħ ta ’ tliet ġimgħat.
The following seven cycles consist of three weeks of treatment, followed by a six-week rest period.
Is- seba ’ ċikli ta ’ wara jikkonsistu minn tliet ġimgħat ta ’ kura, segwiti minn perijodu ta ’ mistrieħ ta ’ sitt ġimgħat.
When Ceplene is first given, the patient ’ s blood pressure, heart rate and lung function must be monitored.
Meta Ceplene jingħata l- ewwel darba, il- pressjoni tad- demm, ir- rata tat- taħbita tal- qalb u l- funzjoni tal- pulmun tal- pazjent jeħtieġ li jkunu sorveljati.
Depending on the patient ’ s response to treatment and side effects, the treatment may be suspended or the dose adjusted.
Il- kura tista ’ tkun sospiża jew id- doża aġġustata, jiddependi fuq ir- reazzjoni għall- kura tal- pazjent u l- effetti sekondarji.
Each Ceplene injection must be given slowly over five to 15 minutes, in a different site from the interleukin-2 injection, and preferably in the thigh or abdomen (tummy).
Kull injezzjoni ta ’ Ceplene jeħtieġ li tingħata bil- mod fuq ħames sa 15- il minuta, f’ sit differenti mill - injezzjoni ta ’ interleukin- 2, u preferibbilment fil- koxxa jew fl- addome (żaqq).
Patients can inject themselves once they have been trained appropriately.
Il- pazjenti jistgħu jinjettaw lilhom infushom ġa la darba jkunu ġew imħarrġin b’ mod addattat.
Ceplene should be used with caution in patients who have severe problems with their kidneys or moderate to severe problems with their liver.
Ceplene għandu jintuża bil- kawtela f’ pazjenti li għandhom problemi severi bil- kliewi tagħhom jew problemi moderati għal severi bil- fwied tagħhom.
Ceplene 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.
Ceplene mhuwiex rakkomandat għall- użu f’ pazjenti taħt l- età ta ’ 18- il sena minħabba nuqqas ta ’ informazzjoni fuq is- sigurtà u l- effikaċja f’ dan il- grupp ta ’ età.
Reproduction is authorised provided the source is acknowledged. is given with interleukin-2, it helps the immune system to kill the leukaemia cells that may remain in the body during remission.
Is- sustanza attiva f’ Ceplene, istamina dijdrokloridu (histamine dihydrochloride), hija modulator immuni.
This can increase the length of time until AML comes back.
Dan jista ’ jtawwal iż- żmien sakemm tirritorna AML.
How has Ceplene been studied?
Kif ġie studjat Ceplene?
The effects of Ceplene were first tested in experimental models before being studied in humans.
L- effetti ta ’ Ceplene għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Because histamine is a known substance, the company also presented data from the published literature.
Peress li l- istamina hija sustanza magħrufa, il- kumpanija ppreżentat ukoll dejta mill - letteratura ppubblikata.
The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
L- effikaċja ta ’ Ceplene ġiet studjata fi studju wieħed ewlieni li involva 320 adult b’ AML li kienu f ’ remissjoni wara kura għal- lewkimja.
Ceplene was given in combination with interleukin-2 and compared with no treatment.
Ceplene ingħata f’ kumbinazzjoni ma ’ interleukin- 2 u ma tqabbel ma ’ l- ebda kura.
The main measure of effectiveness was the length of time until the disease came back or the patient died.
Il- miżura ewlenija tal- effikaċja kienet it- tul ta ’ żmien sakemm irritornat il- marda jew il- pazjent miet.
What benefit has Ceplene shown during the studies?
Liema benefiċċju wera Ceplene waqt l- istudji mwettqa?
The combination of Ceplene and interleukin-2 was more effective than no treatment in increasing the time until AML came back or the patient died: in the patients in their first complete remission, the average time without disease increased from 291 days with no treatment to 450 days after treatment with Ceplene and interleukin-2.
Il- kombinazzjoni ta ’ Ceplene u interleukin- 2 kienet iktar effettiva milli l- ebda kura fiż- żieda taż- żmien sakemm irritornat AML jew il- pazjent miet: f’ pazjenti fl- ewwel remissjoni kompluta tagħhom, iż - żmien medju mingħajr mard żdied minn 291- il jum mingħajr kura għal 450 jum wara kura b’ Ceplene u interleukin- 2.
No effect of Ceplene and interleukin-2 was seen in patients in second or later remission.
Ma deher l- ebda effett ta ’ Ceplene u interleukin- 2 fit- tieni remissjoni jew iktar.
What is the risk associated with Ceplene?
X’ inhu r- riskju assoċjat ma ’ Ceplene?
The most common side effects with Ceplene (seen in more than 1 patient in 10) are eosinophilia (an increase in eosinophil levels, a type of white blood cell), thrombocytopenia (low blood platelet counts), headache, dizziness, dysgeusia (a bitter or unusual taste in the mouth), tachycardia (rapid heart beat), flushing (reddening), hypotension (low blood pressure), cough, dyspnoea (shortness of breath), nausea (feeling sick), dyspepsia (indigestion), diarrhoea, rash, arthralgia (pain in the joints), myalgia (muscle pain), pyrexia (fever), rigors (shaking chills), fatigue (tiredness), flu-like symptoms, feeling hot and injection site reaction (redness, bruising, pain and inflammation).
L- iktar effetti sekondarji komuni b’ Ceplene (li dehru f' iktar minn pazjent 1 minn kull 10) huma eosinofilija (żieda fil- livelli ta ’ eosinofili, tip ta ’ ċellola bajda tad- demm), tromboċitopenija (għedud baxxi ta ’ pjastrini fid- demm), uġigħ ta ’ ras, sturdament, disgewsija (togħma morra jew mhux tas- soltu fil- ħalq), takikardija (taħbit tal- qalb mgħaġġel), fwawar (ħmura), ipotensjoni (pressjoni tad- demm baxxa), sogħla, dispnea (qtugħ ta ’ nifs), nawżja (dardir), dispepsija (indiġestjoni), dijarea, raxx, artralġija (uġigħ fil- ġoġi), mijalġija (uġigħ fil- muskoli), deni, rogħda bil- bard, għeja kbira, sintomi bħal tal- influwenza, tħossok taħraq u reazzjoni fis- sit tal- injezzjoni (ħmura, tbenġil, uġigħ u infjammazzjoni).
For the full list of all side effects reported with Ceplene, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ Ceplene, ara l- Fuljett ta ’ Tagħrif.
Ceplene should not be used in people who may be hypersensitive (allergic) to histamine dihydrochloride or any of the other ingredients.
Ceplene m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għall- istamina dijdrokloridu (histamine dihydrochloride) jew għal xi sustanza oħra tiegħu.
It must not be used in patients who have severe heart problems or in women who are pregnant or breast-feeding.
Huwa m’ għandux jintuża f’ pazjenti li għandhom problemi severi tal- qalb jew f’ nisa li huma tqal jew li qegħdin ireddgħu.
It must also not be used in patients who have received a bone marrow transplant from a donor, or who are taking steroids (used to reduce or prevent inflammation), clonidine (used to reduce high blood pressure) or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn).
Huwa m’ għandux jintuża wkoll f’ pazjenti li rċievew trapjant tal- mudullun mingħand donatur, jew li qegħdin jieħdu l - isterojdi (użati biex inaqqsu jew jimpedixxu l- infjammazzjoni), clonidine (użat biex inaqqas il - pressjoni għolja tad- demm) jew imblokkaturi tal- istamina H2 (użati biex jikkuraw ulċeri fl- istonku, indiġestjoni jew ħruq ta ’ stonku).
Why has Ceplene been approved?
Għaliex ġie approvat Ceplene?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ceplene’ s benefits are greater than its risks as maintenance treatment in adults with AML when used in combination with interleukin-2.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Ceplene huma ikbar mir- riskji tiegħu għal kura ta ’ manteniment f’ adulti b’ AML meta wżat f’ kombinazzjoni ma ’ interleukin- 2.
The Committee recommended that Ceplene be given marketing authorisation.
Il- Kumitat irrakkomanda li Ceplene jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Ceplene has been authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
Ceplene ġie awtorizzat taħt ‘ Ċirkostanzi Eċċezzjonali ’, peress, li minħabba li l- marda hija rari, ma kienx possibbli li jinġabar it- tagħrif kollu dwar il- mediċina.
Every year, the EMEA will review any new data that may become available and this summary will be updated as necessary.
Kull sena, l- EMEA tirrevedi kwalunkwe tagħrif ġdid li jista 'jinkiseb u dan is- sommarju se jiġi aġġornat kif meħtieġ.
What information is still awaited for Ceplene?
Liema informazzjoni għadha mistennija għal Ceplene?
The company will carry out further studies to look in more detail at the effectiveness of the combination of Ceplene and interleukin-2 and at how the combination works.
Il- kumpanija se tagħmel iktar studji biex tħares iktar fid- dettall lejn l- effikaċja tal- kumbinazzjoni ta ’ Ceplene u interleukin- 2 u lejn kif taħdem il- kombinazzjoni.
Other information about Ceplene:
2/ 3 Informazzjoni oħra dwar Ceplene:
The European Commission granted a marketing authorisation valid throughout the European Union for Ceplene to EpiCept GmbH on 7 October 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Ceplene lil EpiCept GmbH fis- 7 ta ’ Ottubru 2008.
The summary of opinion of the Committee for Orphan Medicinal Products for Ceplene is available here.
Is- sommarju tal- opinjoni tal- Kumitat għal Prodotti Mediċinali Orfni għal Ceplene huwa disponibbli hawn.
The full EPAR for Ceplene can be found here.
L- EPAR sħiħ għal Ceplene jista ’ jinstab hawn.
This summary was last updated in 08-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi 08- 2008.
EU number
Numru ta ’ Proċedura ta ’ l - EU
Strength
Dożaġġ
Packaging
Pakkett
Content (concentration)
Kontenut (konċentrazzjoni)
Solution for injection
Użu għal taħt il - ġilda
Subcutaneous use Vial (glass)
Kunjett (tal - ħġieġ)
14 Vials
14 Kunjetti
Ceplene 0.5 mg/ 0.5 ml solution for injection
Ceplene 0. 5 mg/ 0. 5 ml soluzzjoni għall- injezzjoni
QUALITATIVE AND QUANTITATIVE COMPOSITION
KOMPOŻIZZJONI KWALITATTIVA U KWANTITATTIVA
One vial of 0.5 ml of solution contains 0.5 mg of histamine dihydrochloride.
Kunjett ta ’ 0. 5 ml tas- soluzzjoni fiha 0. 5 mg istamina dikloridrat [dihydrochloride]).
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta 'sustanzi mhux attivi, ara sezzjoni 6. 1.
Solution for injection.
Soluzzjoni għall- injezzjoni.
Clear, colourless aqueous solution.
Soluzzjoni ċara, bla kulur u akkwea.
Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2).
Ceplene huwa indikat bħala terapija ta 'manteniment għall- pazjenti adulti li jbatu minn lewċemija mjelojde akuta fl- ewwel remissjoni ttrattata fl- istess ħin b' interleukin- 2 (IL- 2).
The efficacy of Ceplene has not been fully demonstrated in patients older than age 60.
L- effikaċja ta 'Ceplene ma ntwerietx bis- sħiħ f' pazjenti ta' età ikbar minn 60 sena.
4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta 'kif għandu jingħata