qanastek/EMEA-V3 huggingface dataset:
The needle of the syringe containing the 4 ml of water for injections should be inserted through the rubber top of the azacitidine vial followed by injection of the water for injections into the vial.
Il- labra tas- siringa li jkun fiha l- 4 ml ta ’ ilma għall- injezzjonijiet għandha tiddaħħal minn ġol - għatu tal- lastku tal- kunjett ta ’ azacitidine segwita mill- injezzjoni tal- ilma għall- injezzjonijiet ġol- kunjett.
Following removal of the syringe and needle, the vial should be vigorously shaken until a uniform cloudy suspension is achieved.
Wara li jitneħħew is- siringa u l- labra, il- kunjett għandu jiċċaqlaq bis- saħħa sakemm tikseb suspensjoni uniformi u mċajpra.
After reconstitution each ml of suspension will contain 25 mg of azacitidine (100 mg/4 ml).
Wara r- rikostituzzjoni kull millilitru ta ’ suspensjoni ser ikun fih 25 mg ta ’ azacitidine (100 mg/ 4 ml).
The reconstituted product is a homogeneous, cloudy suspension, free of agglomerates.
Il- prodott rikostitwit hu suspensjoni omoġenja u mċajpra, mingħajr agglomerati.
The product should be discarded if it contains large particles or agglomerates.
Is- suspensjoni għandha tintrema jekk ikun fiha frak kbir jew agglomerati.
The rubber top should be cleaned and a new syringe with needle inserted.
It- tapp tal- lastku għandu jitnaddaf u tiddaħħal siringa ġdida bil- labra.
The vial should then be turned upside down, making sure the needle tip is below the level of the liquid.
Imbagħad il- kunjett għandu jinqaleb ta ’ taħt fuq, u jiġi aċċertat li t- tarf tal- labra jkun taħt il- livell tal- likwidu.
The plunger should then be pulled back to withdraw the amount of medicinal product required for the proper dose, making sure to purge any air trapped within the syringe.
Imbagħad il- planġer għandu jinġibed lura biex jiġbed l- ammont tal- prodott mediċinali meħtieġ għad- doża adattata, u jiġi aċċertat li titneħħa xi arja li tkun inqabdet ġos- siringa.
The syringe with needle should then be removed from the vial and the needle disposed of.
Is- siringa bil - labra għandha mbagħad titneħħa mill- kunjett, u l- labra tintrema.
A fresh subcutaneous needle (recommended 25-gauge) should then be firmly attached to the syringe.
Labra ġdida għall- injezzjonijiet taħt il- ġilda (daqs ta ’ 25- gauge hu rakkomandat) għandha mbagħad titwaħħal b’ mod sod mas- siringa.
The needle should not be purged prior to injection, in order to reduce the incidence of local injection site reactions.
Il- labra m’ għandhiex tkun purged qabel l- injezzjoni biex titnaqqas l- inċidenza ta ’ reazzjonijiet lokali fis- sit ta ’ l- injezzjoni.
If needed (doses over 100 mg) all the above steps for preparation of the suspension should be repeated.
Jekk ikun hemm bżonn (dożi ta ’ iktar minn 100 mg) il- passi kollha t’ hawn fuq għall - preparazzjoni tas- suspensjoni għandhom jiġu ripetuti.
For doses greater than 100 mg (4 ml), the dose should be equally divided into 2 syringes (e.g, dose 150 mg = 6 ml, 2 syringes with 3 ml in each syringe).
Doża 150 mg = 6 ml, 2 siringi bi 3 ml f’ kull siringa).
The contents of the dosing syringe must be re-suspended immediately prior to administration.
Il- kontenut tas- siringa tad- dożaġġ għandu jerġa ’ jsir f’ suspensjoni mill- ġdid immedjatament qabel l- għoti.
The temperature of the suspension at the time of injection should be approximately 20ºC-25ºC.
It- temperatura tas- suspensjoni fil- ħin tal- injezzjoni għandha tkun ta ’ madwar 20°C- 25°C.
To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.
Biex tagħmel suspensjoni mill- ġdid, irrombla bis- saħħa s- siringa bejn il- kefef ta ’ idejk sakemm tikseb suspensjoni uniformi u mċajpra.
The Vidaza suspension should be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes.
Is- suspensjoni ta ’ Vidaza għandha tkun ippreparata immedjatament qabel l- użu u s- suspensjoni rikostitwita għandha tingħata fi żmien 45 minuta.
If elapsed time is greater than 45 minutes, the reconstituted suspension should be discarded appropriately and a new dose prepared.
Jekk jgħaddu iktar minn 45 minuta, is- suspensjoni rikostitwita għandha tintrema kif suppost u doża ġdida tkun ippreparata.
Alternatively, if the product needs to be reconstituted in advance of the administration, it must be placed in a refrigerator (2°C to 12 8°C) immediately after reconstitution, and kept in the refrigerator for a maximum of 8 hours.
Alternattivament, jekk il - prodott ikollu bżonn jiġi rikostitwit qabel l- għoti, għandu jitpoġġa ġo friġġ (2°C sa 8°C) immedjatament wara r- rikostituzzjoni, u jinżamm fil- friġġ għal massimu ta ’ 8 sigħat.
If the elapsed time in the refrigerator is greater than 8 hours, the suspension should be discarded appropriately and a new dose prepared.
Jekk il- ħin fil - friġġ ikun ta ’ iktar minn 8 sigħat, is- suspensjoni għandha tintrema kif suppost u doża ġdida tkun ippreparata.
The syringe filled with reconstituted suspension should be allowed up to 30 minutes prior to administration to reach a temperature of approximately 20°C-25°C.
Is- siringa mimlija bis- suspensjoni rikostitwita għandha titħalla sa 30 minuta qabel l- għoti biex tilħaq temperatura ta ’ madwar 20°C- 25°C.
If the elapsed time is longer than 30 minutes, the suspension should be discarded appropriately and a new dose prepared.
Jekk jgħaddu iktar minn 30 minuta, is- suspensjoni għandha tintrema kif suppost u doża ġdida tkun ippreparata.
Calculation of an individual dose The total dose, according to the body surface area (BSA) can be calculated as follows:
Kalkulazzjoni ta ’ doża individwali Id- doża totali skond l- erja tas- superfiċje tal- ġisem (BSA) tista ’ tkun ikkalkulata kif ġej:
Total dose (mg) = Dose (mg/m2) x BSA (m2)
Doża totali (mg) = Doża (mg/ m2) x BSA (m2)
The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m2.
It- tabella li ġejja hi pprovduta biss bħala eżempju ta ’ kif tikkalkula dożi individwali ta ’ azacitidine li huma bbażati fuq valur medju tal- BSA ta ’ 1. 8 m2.
Dose mg/m2 (% of recommended starting dose)
Doża mg/ m2 (% tad- doża tal- bidu
Total dose based on BSA value of 1.8 m2
Doża totali bbażata fuq il- valur BSA ta ’ 1. 8 m2
Number of vials required
Numru ta ’ kunjetti meħtieġa
Total volume of reconstituted suspension required
Volum totali tas - suspensjoni rikostitwita
75 mg/m2 (100%)
rakkomandata)
37.5 mg/m2 (50%)
meħtieġa
25 mg/m2 (33%)
75 mg/ m2 (100%) 37. 5 mg/ m2 (50%) 25 mg/ m2 (33%)
45 mg
135 mg 67. 5 mg 45 mg
1 vial
2 kunjetti kunjett 1 kunjett 1
1.8 ml
5. 4 ml 2. 7 ml 1. 8 ml
Reconstituted Vidaza should be injected subcutaneously (insert the needle at a 45-90o angle) using a 25-gauge needle into the upper arm, thigh or abdomen.
Vidaza rikostitwit għandu jkun injettat taħt il- ġilda (daħħal il- labra f’ angolu ta ’ 45- 90°) billi tuża labra 25- gauge fil- parti ta ’ fuq tad- driegħ, koxxa jew addome.
Doses greater than 4 ml should be injected into two separate sites.
Dożi ikbar minn 4 ml għandhom ikunu injettati f’ żewġ postijiet separati.
Injection sites should be rotated.
Ibdel il- postijiet fejn tingħata l- injezzjoni.
New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
Injezzjonijiet ġodda għandhom jingħataw mill- inqas 2. 5 ċm mill- post ta ’ qabel u qatt f’ żoni fejn il- ġilda tkun ratba, imbenġla, ħamra, jew iebsa.
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom Tel: +44 1753 240600 Fax: +44 1753 240656
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA Ir- Renju Unit Tel: +44 1753 240600 Fax: +44 1753 240656
13 ANNEX II
14 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT B.
Sedge Close Headway, Great Oakley Corby, Northhants NN18 8HS United Kingdom
Sedge Close Headway, Great Oakley Corby, Northhants NN18 8HS Ir- Renju Unit
Baxter Oncology GmbH Kantstrasse 2 33790 Halle/Westfalen Germany
Baxter Oncology GmbH Kantstrasse 2 33790 Halle/ Westfalen Il- Ġermanja
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (ara Anness I:
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 5.1 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 ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 5. 1 ippreżentata fil- modulu 1. 8. 1 tal- Applikazzjoni ta ’ l- Awtorizzazzjoni għat - tqegħid fis- suq, tkun implimentata u tkun taħdem qabel ma l- prodott jibda jinbiegħ u waqt li l- prodott jitqiegħed 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 3.0 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.
Pjan dwar l- Immaniġġjar tar- Riskju Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq iwiegħed li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- pjan tal- Farmakoviġilanza kif miftehma f’ verżjoni 3. 0 tal- Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat fil- modulu 1. 8. 2 tal- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- tqegħid fis- suq u kwalunkwe aġġornamenti sussegwenti tal- RMP mifthema mill- 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).
Skond il- Linja Gwida CHMP dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (PSUR) li jmiss.
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
Barra minn hekk, għandu jkun sottomess RMP aġġornat • meta wieħed jircievi informazzjoni ġdida li tista ’ teffetwa l- ispeċifikazzjoni tas- Sigurta` kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskji
15 • At the request of the EMEA
16 • fi żmien 60 jum minn meta jintlaħaq punt importanti (ta ’ Farmakoviġilanza jew li jnaqqsu r - riskji) • fuq talba tal- EMEA.
Vidaza 25 mg/ml powder for suspension for injection Azacitidine
Vidaza 25 mg/ ml trab għal suspensjoni għall- injezzjoni Azacitidine
After reconstitution, each ml suspension contains 25 mg azacitidine.
Wara r- rikostituzzjoni, kull ml ta 'suspensjoni jkun fih 25 mg azacitidine.
Also contains Mannitol.
Fih ukoll Mannitol.
1 vial – 100 mg
Trab għal suspensjoni għall- injezzjoni. kunjett 1 – 100 mg
Shake the suspension vigorously before administration.
Ċaqlaq is- suspensjoni bis- saħħa qabel l- għoti.
The suspension may be stored at 25°C for 45 minutes or at 2°C to 8°C for 8 hours.
Is- suspensjoni rikostitwita tista ’ tinħażen f’ temperatura ta ’ 25°C għal 45 minuta jew f’ temperatura ta ’ 2°C sa 8°C għal 8 sigħat.
Any unused product or waste material should be discarded according to the local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA Ir- Renju Unit
Vial Label
Tikketta tal- kunjett
Vidaza 25 mg/ml powder for suspension for injection Azacitidine Subcutaneous use
Vidaza 25 mg/ ml trab għal suspensjoni għall- injezzjoni Azacitidine Użu għal taħt il- ġilda
please tell your doctor or nurse.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- infirmiera tiegħek.
What Vidaza is and what it is used for 2.
X’ inhu Vidaza u għalxiex jintuża 2.
Before you use Vidaza 3.
Qabel ma tuża Vidaza 3.
How to use Vidaza 4.
Kif għandek tuża Vidaza 4.
Possible side effects 5 How to store Vidaza 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen Vidaza 6.
WHAT VIDAZA IS AND WHAT IT IS USED FOR
X’ INHU VIDAZA U GĦALXIEX JINTUŻA
Vidaza contains the active substance azacitidine.
Vidaza fih is- sustanza attiva msejħa azacitidine.
It works by preventing the growth of cancer cells.
Din taħdem billi timpedixxi t- tkabbir ta ’ ċelluli tal - kanċer.
Vidaza is used in adults who are not eligible for stem cell transplantation to treat:
Vidaza jintuża fl- adulti li mhumiex eliġibbli għal trapjant b ’ ċelluli staminali biex jikkura:
• higher-risk myelodysplastic syndromes (MDS) a group of illnesses of the bone marrow resulting in the production of too few blood cells. • chronic myelomonocytic leukaemia (CMML). • acute myeloid leukaemia (AML).
• sindromi majelodisplastiċi (MDS) ta ’ riskju ogħla, grupp ta ’ mard tal- mudullun li jirriżulta fil - produzzjoni ta ’ ftit wisq ċelluli tad- demm. • lewkimja majelomonoċitika kronika (CMML). • lewkimja majelojde akuta (AML).
Talk to your doctor if you have any questions about how Vidaza works or why this medicine has been prescribed for you.
Kellem lit- tabib tiegħek jekk għandek xi mistoqsijiet dwar kif Vidaza jaħdem jew għaliex qed tingħata riċetta għal din il- mediċina.
BEFORE YOU USE VIDAZA
QABEL MA TUŻA VIDAZA
Do not use Vidaza • if you are allergic (hypersensitive) to azacitidine or to any of the other ingredients of Vidaza (see section 6). • if you have advanced liver cancer. • if you are breast-feeding.
Tużax Vidaza • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal azacitidine jew għal sustanzi oħra ta ’ Vidaza (ara sezzjoni 6). • jekk għandek kanċer avvanzat tal- fwied. • jekk qed tredda ’.
Take special care with Vidaza Check with your doctor or nurse before using this medicine if you have: • decreased counts of platelets, red or white blood cells. • kidney disease. • liver disease.
Oqgħod attent ħafna b’ Vidaza Iċċekkja mat- tabib jew infermiera tiegħek qabel ma tuża din il- mediċina jekk għandek: • tnaqqis fl- għadd ta ’ plejtlits, ċelluli ħomor jew bojod tad- demm. • mard tal- kliewi. • mard tal- fwied.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before having Vidaza.
Jekk m’ intix ċert/ a jekk xi waħda minn dawn t’ hawn fuq tapplika għalik, kellem lit- tabib jew infermiera tiegħek qabel ma tuża Vidaza.
Vidaza is not recommended for use in children and adolescents below the age of 18.
Vidaza mhuwiex rakkomandat għall- użu fit- tfal jew fl- adolexxenti taħt it- 18- il sena.
23 You will have blood tests before you begin treatment with Vidaza and at the start of each period of treatment (called a ‘cycle’).
24 Ser isirulek testijiet tad- demm qabel ma tibda l- kura b’ Vidaza u fil- bidu ta ’ kull perjodu ta ’ kura (imsejjaħ ‘ ċiklu ’).
This is to check that you have enough blood cells and that your liver and kidneys are working properly.
Dan isir biex jiċċekkja li għandek biżżejjed ċelluli tad- demm u li l- fwied u l- kliewi qed jaħdmu kif suppost.
For men having Vidaza, please see the section “Pregnancy and breast feeding” below.
Għall- irġiel li qed jieħdu Vidaza, jekk jogħġbok ara s- sezzjoni “ Tqala u treddigħ ” hawn taħt.
Taking other medicines Please tell your doctor or nurse if you are using or have recently used any other medicines including medicines obtained without a prescription and herbal preparations.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- infermiera tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra li jinkludu dawk miksuba mingħajr riċetta u preparazzjonijiet mediċinali li ġejjin mill - ħxejjex.
This is because Vidaza may affect the way some other medicines work.
Dan għaliex Vidaza jista ’ jaffettwa l- mod kif jaħdmu xi mediċini oħra.
Also, some other medicines may affect the way Vidaza works.
Flimkien ma ’ dan, xi mediċini oħra jistgħu jaffettwaw il- mod kif jaħdem Vidaza.
Pregnancy and breast-feeding You should not use Vidaza during pregnancy as it may be harmful to the baby.
Tqala u treddigħ M’ għandekx tuża Vidaza matul it- tqala għax jista ’ jkun ta ’ ħsara għat- tarbija.
Use an effective method of contraception during and up to 3 months after treatment with Vidaza.
Uża metodu effettiv ta ’ kontraċezzjoni matul u sa 3 xhur wara l- kura b’ Vidaza.
Tell your doctor straight away if you become pregnant during treatment with Vidaza.
Għid lit- tabib tiegħek immedjatament jekk tinqabad tqila matul il- kura b’ Vidaza.
You must not use Vidaza if you are breast-feeding.
M’ għandekx tuża Vidaza jekk qed tredda ’.
It is not known if Vidaza passes into the mother’s milk and therefore you must not breast-feed your baby during treatment.
Mhux magħruf jekk Vidaza jgħaddix fil- ħalib tal- omm u għalhekk m’ għandekx tredda ’ lit- tarbija tiegħek matul il- kura.
Men should not father a child while receiving treatment with Vidaza.
L- irġiel m’ għandhomx inisslu trabi meta jkunu qed jirċievu kura b’ Vidaza.
Talk to your doctor if you wish to conserve your sperm before starting this treatment.
Kellem lit- tabib tiegħek jekk tixtieq tikkonserva l- isperma tiegħek qabel tibda din il- kura.
Driving and using machines No studies of the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Some people may feel tired after being given Vidaza.
Xi nies jistgħu jħossuhom għajjenin wara li jingħataw Vidaza.
If this happens to you, do not drive or use any tools or machines.
Jekk dan jiġri lilek, issuqx u tħaddimx għodda jew makkinarju.
HOW TO USE VIDAZA
KIF GĦANDEK TUŻA VIDAZA
Your doctor will give you another medicine to prevent nausea and vomiting at the start of each treatment cycle, before giving you Vidaza.
It- tabib tiegħek ser jagħtik mediċina oħra biex ma jkollokx nawseja u rimettar fil- bidu ta ’ kull ċiklu tal- kura, qabel ma jagħtik Vidaza.
• The usual dose is 75 mg per m2 body surface area.
Id- doża li ssoltu tingħata hija 75 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem.
Your doctor will chose your dose of Vidaza, depending on your general condition, height and weight.
It- tabib tiegħek ser • jagħżel id- doża tiegħek ta ’ Vidaza, skond il- kundizzjoni ġenerali, it- tul u l- piż tiegħek.
Your doctor will check your progress and may change your dose if necessary. • Vidaza is given every day for one week, followed by a rest period of 3 weeks.
It- tabib tiegħek ser jiċċekkja l- progress tiegħek u jista ’ jibdel id- doża tiegħek jekk ikun hemm bżonn. • Vidaza jingħata kuljum għal ġimgħa, segwit minn perjodu ta ’ serħan ta ’ 3 ġimgħat.
This “treatment cycle” will be repeated every 4 weeks.
Dan iċ - “ ċiklu tal- kura ” ser jiġi ripetut kull 4 ġimgħat.
You will usually receive at least 6 treatment cycles.
Normalment inti ser tirċievi mill- inqas 6 ċikli tal - kura.
Vidaza will be given to you as an injection under the skin (subcutaneously) by a doctor or nurse.
Vidaza ser jingħatalek bħala injezzjoni taħt il- ġilda minn tabib jew infermiera.
It may be given under the skin on your thigh, tummy or upper arm.
Jista ’ jingħatalek taħt il- ġilda fil- koxxa, żaqqek jew fin- naħa ta ’ fuq tad- driegħ.
If you have any further questions on the use of this product, ask your doctor or nurse.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- infermiera tiegħek.
Like all medicines, Vidaza can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Vidaza jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor straight away if you notice any of the following side effects:
25 Għid lit- tabib tiegħek immedjatament jekk tinnota kwalunkwe minn dawn l- effetti sekondarji li ġejjin:
• A fever.
• Deni.
This may be due to an infection as a result of having low levels of white blood cells. • Chest pain or shortness of breath which may be accompanied with a fever.
Dan jista ’ jseħħ minħabba infezzjoni bħala riżultat li jkollok livelli baxxi ta ’ ċelluli bojod tad- demm. • Uġigħ fis- sider jew qtugħ ta ’ nifs li jista ’ jkun akkompanjat minn deni.
Such as blood in the stools due to bleeding in the stomach or gut.
Dan jista ’ jseħħ minħabba infezzjoni fil- pulmun imsejħa “ pnewmonja ”. • Ħruġ ta ’ demm.
24 • Difficulty breathing, swelling of the lips, itching or rash.
Bħal demm fl- ippurgar minħabba ħruġ ta ’ demm fl- istonku jew fl- imsaren. • Diffikultà biex tieħu n- nifs, nefha fix- xufftejn, ħakk jew raxx.
This may be due to an allergic (hypersensitivity) reaction.
Dan jista ’ jiġri minħabba reazzjoni allerġika (sensittività eċċessiva).
Side effects may occur with certain frequencies, which are defined as follows:
L- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data
jaffettwaw iktar minn utent 1 minn kull 10 jaffettwaw minn 1 sa 10 utenti minn kull 100 jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 jaffettwaw inqas minn utent 1 minn kull 10, 000 ma tistax tittieħed stima mid- data disponibbli
Very common side effects • Reduced red blood count (anaemia).
Effetti sekondarji komuni ħafna • Tnaqqis fl- għadd ta ’ ċelluli ħomor tad- demm (anemija).
You may feel tired and pale. • Reduced white blood cell count.
Tista ’ tħossok għajjien/ a u tkun musfar/ a. • Tnaqqis fl- għadd ta ’ ċelluli bojod tad- demm.
This may be accompanied by a fever.
Dan jista ’ jkun akkompanjat minn deni.
You are also more likely to get infections. • A low blood platelet count (thrombocytopenia).
Ikun mistenni wkoll li jkollok infezzjonijiet. • Għadd baxx ta ’ plejtlits fid- demm (tromboċitopenja).
You are more prone to bleeding and bruising. • Constipation, diarrhoea, nausea, vomiting. • Pneumonia. • Chest pain, being short of breath. • Tiredness (fatigue). • Injection site reaction including redness, pain or a skin reaction. • Loss of appetite. • Joint aches. • Bruising. • Rash. • Red or purple spots under your skin. • Pain in your belly (abdominal pain). • Itching. • Fever. • Sore nose and throat. • Dizziness. • Headache.
Tkun iktar suxxettibbli għal ħruġ ta ’ demm u tbenġil. • Stitikezza dijarea, nawseja, rimettar. • Pnewmonja. • Uġigħ fis- sider, qtugħ ta ’ nifs. • Għeja kbira. • Reazzjoni fejn tkun ingħatat l- injezzjoni li tinkludi ħmura, uġigħ jew reazzjoni fil- ġilda. • Nuqqas fl- aptit. • Uġigħ fil- ġogi. • Tbenġil. • Raxx. • Tikek ħomor jew vjola taħt il- ġilda. • Uġigħ ta ’ żaqq (uġigħ addominali). • Ħakk. • Deni. • Uġigħ fl- imnieħer u fil- gerżuma. • Sturdament. • Uġigħ ta ’ ras.
Common side effects • Bleeding inside your head. • An infection of the blood caused by bacteria (sepsis).
Effetti sekondarji komuni • Ħruġ ta ’ demm ġo rasek. • Infezzjoni tad- demm ikkawżata mill- batterji (sepsis).
This may be due to low levels of white cells in your blood. • Bone marrow failure.
Din tista ’ sseħħ minħabba livelli baxxi ta ’ ċelluli bojod fid- demm tiegħek. • Insuffiċjenza tal- mudullun.
This can cause low levels of red and white blood cells and platelets. • A type of anaemia where your red and white blood cells and platelets are reduced. • An infection in your urine. • A viral infection causing cold sores (herpes). • Bleeding gums, bleeding in the stomach or gut, bleeding from around your back passage due to piles (haemorrhoidal haemorrhage), bleeding in your eye, bleeding under your skin, or into your skin (haematoma). • Blood in your urine. • Ulcers of your mouth or tongue. • Changes to your skin at the injection site.
Din tista ’ tikkawża livelli baxxi ta ’ ċelluli tad- demm ħomor u bojod u plejtlits. • Tip ta ’ anemija fejn iċ- ċelluli tad- demm ħomor u bojod u l- plejtlits jonqsu. • Infezzjoni fl- awrina tiegħek. • Infezzjoni virali li tikkawża nfafet fil- ġilda (herpes).
These include swelling, a hard lump, bruising, bleeding into your skin (haematoma), rash, itching and changes in the skin colour. • Redness of your skin. • An infection of the nose and throat, or sore throat. • Sore or runny nose or sinuses (sinusitis). • Low levels of potassium in your blood. • High or low blood pressure (hypertension or hypotension).
26 • Ħruġ ta ’ demm mill- ħanek, ħruġ ta ’ demm fl- istonku jew fl- imsaren, ħruġ ta ’ demm minn fejn tipporga minħabba l- murliti (emorraġija tal- murliti), ħruġ ta ’ demm f’ għajnejk, ħruġ ta ’ demm taħt il- ġilda, jew ġol- ġilda (ematoma). • Demm fl- awrina tiegħek. • Ulċeri f’ ħalqek jew f’ ilsienek. • Tibdil fil- ġilda tiegħek fis- sit ta ’ l- injezzjoni.
25 • Being short of breath when you move. • Pain in your throat and voicebox. • Indigestion. • Weight loss. • Lethargy. • Feeling generally unwell. • Muscle aches. • Anxiety or having trouble sleeping (insomnia). • Being confused. • Hair loss.
Dan jinkludi nefħa, għoqda iebsa, tbenġil, ħruġ ta ’ demm ġol- ġilda tiegħek (ematoma), raxx, ħakk u tibdil fil- kulur tal- ġilda. • Ħmura fil- ġilda tiegħek. • Infezzjoni fl- imnieħer u l- gerżuma, jew uġigħ fil- gerżuma. • Uġigħ fl- imnieħer jew imnieħer inixxi jew fis- sinus (sinusite). • Livelli baxxi ta ’ potassium fid- demm tiegħek. • Pressjoni tad- demm għolja jew baxxa (ipertensjoni jew ipotensjoni). • Taqta ’ n- nifs meta tiċċaqlaq. • Uġigħ fil- gerżuma u fil- larinġi tiegħek. • Indiġestjoni. • Telf ta ’ piż. • Letarġija. • Sensazzjoni ġenerali li ma tħossokx tajjeb. • Uġigħ fil- muskoli. • Ansjetà jew ikollok problemi biex torqod (insomnja). • Tħossok konfuż. • Telf ta ’ xagħar.
Uncommon side effects • Allergic (hypersensitivity) reaction.
Effetti sekondarji mhux komuni • Reazzjoni allerġika (sensittività eċċessiva).
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 nurse.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- infermiera tiegħek.
HOW TO STORE VIDAZA
KIF TAĦŻEN VIDAZA
Do not use Vidaza after the expiry date which is stated on the vial label and the carton.
Tużax Vidaza wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kunjett u fuq il- kaxxa tal- kartun.
The reconstituted suspension may be stored at 25°C for 45 minutes or at 2°C to 8°C for 8 hours.
Is- suspensjoni rikostitwita tista ’ tinħażen f’ temperatura ta ’ 25°C għal 45 minuta jew f’ temperatura ta ’ 2°C sa 8°C għal 8 sigħat.
Your doctor or pharmacist are responsible for storing Vidaza.
It- tabib jew l- ispiżjar tiegħek huma responsabbli biex jaħżnu Vidaza.
They are also responsible for disposing of any unused Vidaza correctly.
Huma wkoll responsabbli biex jarmu kwalunkwe Vidaza mhux użat b’ mod korrett.
What Vidaza contains • The active substance is azacitidine.
X’ fih Vidaza • Is- sustanza attiva hi azacitidine.
1 vial contains 100 mg azacitidine.
Kunjett 1 fih 100 mg azacitidine.
After reconstitution with 4 ml of water for injections, the reconstituted suspension contains 25 mg/ml azacitidine. • The other ingredient is mannitol (E421).
Wara r- rikostituzzjoni b’ 4 ml ta ’ ilma għall- injezzjonijiet, is- suspensjoni rikostitwita jkun fiha 25 mg/ ml azacitidine. • Is- sustanza l- oħra hi mannitol (E421).
What Vidaza looks like and contents of the pack Vidaza is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine.
Id- Dehra ta ’ Vidaza u l- kontenuti tal- pakkett Vidaza hu trab għal suspensjoni għall- injezzjoni abjad u hu fornut f’ kunjett tal- ħġieġ li fih 100 mg ta ’ azacitidine.
Marketing Authorisation Holder Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom
27 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA Ir- Renju Unit
Manufacturer Baxter Oncology GmbH Kantstrasse 2 33790 Halle/Westfalen Germany
Manifattur Baxter Oncology GmbH Kantstrasse 2 33790 Halle/ Westfalen Il- Ġermanja JEW Catalent UK Packaging Limited Sedge Close Headway Great Oakley Corby Northamptonshire NN18 8HS Ir- Renju Unit
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
< -------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
< ------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
If reconst ituted azacitidine comes into contact with the skin, immediately and thoroughly wash with soap and water.
Jekk azacitidine rikostitwit imiss mal- ġilda, aħsel immedjatament u bir- reqqa bis- sapun u bl- ilma.
Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned below “ Reconstitution Procedure”.
Inkompatibilitajiet Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija hawn taħt “ Proċedura tar- Rikostituzzjoni ”.
Alternatively, if the product needs to be reconstituted in advance of the administration, it must be placed in a refrigerator (2°C to 8°C) immediately after reconstitution, and kept in the refrigerator for a maximum of 8 hours.
Alternattivament, jekk il - prodott ikollu bżonn jiġi rikostitwit qabel l- għoti, għandu jitpoġġa ġo friġġ (2°C sa 8°C) immedjatament wara r- rikostituzzjoni, u jinżamm fil- friġġ għal massimu ta ’ 8 sigħat.
The syringe filled with reconstituted suspension should be allowed up to 30 minutes prior to administration to reach a temperature of approximately 20ºC-25ºC.
Is- siringa mimlija bis- suspensjoni rikostitwita għandha titħalla sa 30 minuta qabel l- għoti biex tilħaq temperatura ta ’ madwar 20°C- 25°C.
Total dose (mg) = Dose (mg/ m2) x BSA (m2)
Doża totali (mg) = Doża (mg/ m2) x BSA (m2)
75 mg/m 2 (100%)
rakkomandata)
Any unused product or waste material should be disposed of in accordance with local requirements.
29 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
What is Vimpat?
X’ inhu Vimpat?
Vimpat is a medicine containing the active substance lacosamide.
Vimpat huwa prodott mediċinali li fih is- sustanza attiva lacosamide.
It is available as oval tablets (pink:
Jiġi bħala pilloli ovali (roża:
50 mg; yellow:
50 mg; sofor:
100 mg; salmon:
100 mg; kulur is- salamun:
200 mg), as a syrup (15 mg/ ml) and as a solution for infusion (drip into a vein, 10 mg/ ml).
200 mg), bħala mistura (15 mg/ ml) u bħala soluzzjoni għall- infużjoni (drip ġol- vina, 10 mg/ ml).
What is Vimpat used for?
Għalxiex jintuża Vimpat?
Vimpat is used to treat partial-onset seizures (epileptic fits starting from one specific part of the brain) as an add-on to other antiepileptic medicines in patients with epilepsy aged 16 years and older.
Vimpat jintuża biex jikkura aċċessjonijiet ta ’ bidu parzjali (aċċessjonijiet epilettiċi li jibdew minn parti speċifika tal- moħħ) bħala mediċina miżjuda ma ’ mediċini antiepilettiċi oħrajn f’ pazjenti ta ’ 16- il sena jew ikbar bl- epilessija.
It can be used in patients with partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to the whole brain).
Jista ’ jintuża f’ pazjenti b’ aċċessjonijiet ta ’ bidu parzjali bi jew mingħajr ġeneralizzazzjoni (fejn sussegwentament, l- aċċessjoni tinfirex mal- moħħ kollu).
How is Vimpat used?
Kif jintuża Vimpat?
Vimpat is taken twice a day, with or without food.
Vimpat jittieħed darbtejn kuljum, mal- ikel jew fuq stonku vojt.
The recommended starting dose is 50 mg twice a day.
Id- doża tal- bidu rrakkomandata hija 50 mg darbtejn kujum.
After one week, the dose should be increased to 100 mg twice a day and then, depending on the patient’ s response, it may be further increased every week by 50 mg twice a day to the maximum dose of 200 mg twice a day.
Wara ġimgħa d- doża għandha tiżdied għal 100 mg darbtejn kuljum u mbagħad, jiddependi fuq ir- reazzjoni tal- pazjent, tista ’ tiżdied iktar kull ġimgħa b’ 50 mg darbtejn kuljum sad - doża massima ta ’ 200 mg darbtejn kuljum.
A special pack with tablets of all four strengths is available to help when initiating treatment.
Pakkett speċjali bil- pilloli tal- erba ’ qawwiet huwa disponibbli biex jgħin meta tkun sejra tinbeda l- kura.
Lower doses may be used in patients who have problems with their kidneys.
Dożi iktar baxxi jistgħu jintużaw f’ pazjenti li għandhom problemi bil- kliewi tagħhom.
If the patient is temporarily unable to take the tablets or syrup, Vimpat can be given at the same dose as an infusion lasting 15 minutes to one hour.
Jekk temporanjament, il- pazjent ma jkunx jista ’ jieħu l- pilloli jew il- mistura, Vimpat jista ’ jingħata fl- istess doża bħala infużjoni li ddum minn 15- il minuta sa siegħa.
This should only be used for a few days.
Din għandha tintuża għal ftit jiem biss.
How does Vimpat work?
Kif jaħdem Vimpat?
The active substance in Vimpat, lacosamide, is an anti-epileptic medicine.
Is- sustanza attiva f’ Vimpat, lacosamide, hija mediċina antiepilettika.
Epilepsy is caused by excessive electrical activity in the brain.
L- epilessija hija kkaġunata minn attività elettrika eċċessiva fil- moħħ.
The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Għadu mhuwiex ċar il- mod eżatt kif jaħdem lacosamide iżda jidher li dan inaqqas l- attività tal- kanali tas- sodju (pori fil- wiċċ taċ- ċelloli tan- nervituri) li jippermettu li ssir it- trażmissjoni ta ’ impulsi elettriċi bejn iċ- ċelloli tan- nervituri.
Lacosamide is also thought to be involved in the development of nerve cells that have been damaged.
Lacosamide huwa maħsub ukoll li huwa involut fl- iżvilupp ta ’ ċelloli tan- nervituri li tkun saritilhom il- ħsara.
Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit happening.
Flimkien, dawn l - azzjonijiet jistgħu jimpedixxu milli l- attività elettrika tinfirex mal- moħħ, u jnaqqsu ċ- ċans li sseħħ aċċessjoni epilettika.
How has Vimpat been studied?
Kif ġie studjat Vimpat?
The effectiveness of Vimpat taken by mouth has been compared with that of placebo (a dummy treatment) in three main studies involving a total of 1,308 patients.
L- effikaċja ta ’ Vimpat meta meħud mill- ħalq tqabblet ma ’ dik ta ’ plaċebo (kura finta) fi tliet studji ewlenin li b’ kollox involvew 1, 308 pazjenti.
Patients added Vimpat at a dose of 200 mg, 400 mg or 600 mg a day, or placebo to their existing treatment of up to three other anti-epileptic medicines.
Il- pazjenti żiedu Vimpat f’ doża ta ’ 200 mg, 400 mg jew 600 mg kuljum, jew plaċebo mal- kura eżistenti tagħhom magħmula minn mhux aktar minn tliet mediċini antiepilettiċi oħrajn.
The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of treatment with a stable dose.
Il- miżura ewlenija tal- effikaċja kienet in- numru ta ’ pazjenti li l- għadd ta ’ aċċessjonijiet tagħhom tnaqqas għallinqas bin- nofs wara 12- il ġimgħa ta ’ kura b’ doża stabbli.
Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.
Żewġ studji addizjonali ħarsu lejn it- tul ta ’ żmien xieraq tal- infużjoni għas- soluzzjoni Vimpat u qabblu s- sikurezza tiegħu ma ’ dik ta ’ infużjonijiet bi plaċebo f’ total ta ’ 199 pazjent.
What benefit has Vimpat shown during the studies?
Liema benefiċċju wera Vimpat waqt l- istudji mwettqa?
Vimpat, at doses of 200 or 400 mg a day, was more effective than placebo in reducing the number of seizures.
Vimpat, f’ dożi ta ’ 200 jew 400 mg kuljum, kien iktar effettiv minn plaċebo fit- tnaqqis tan- numru ta ’ aċċessjonijiet.
Looking at the results of the three main studies taken together, 34% of the patients adding Vimpat 200 mg/ day and 40% of the patients adding Vimpat 400 mg/ day to their existing treatment achieved at least a 50% reduction in the number of seizures.
Meta wieħed iħares lejn ir- riżultati tat- tliet studji ewlenin meħudin flimkien, 34% tal - pazjenti li żiedu Vimpat 200 mg/ kuljum u 40% tal- pazjenti li żiedu Vimpat 400 mg/ kuljum mal- kura eżistenti tagħhom kisbu tnaqqis ta ’ mill- inqas 50% fin- numru ta ’ aċċessjonijiet.
This was compared with 23% of the patients adding placebo.
Dan tqabbel ma ’ 23% tal- pazjenti li żiedu plaċebo.
The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.
Id- doża ta ’ 600 mg kienet effettiva daqs id- doża ta ’ 400 mg, iżda kellha iktar effetti sekondarji.
What is the risk associated with Vimpat?
X’ inhu r- riskju assoċjat ma ’ Vimpat?
The most common side effects with Vimpat (seen in more than 1 patient in 10) are dizziness, headache, diplopia (double vision) and nausea (feeling sick).
L- iktar effetti sekondarji komuni b’ Vimpat (li dehru f’ iktar minn pazjent 1 minn kull 10) huma sturdament, uġigħ ta ’ ras, diplopja (viżta doppja) u nawżeja (dardir).
For the full list of all side effects reported with Vimpat, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ Vimpat, ara l- Fuljett ta ’ Tagħrif.
Vimpat should not be used in people who may be hypersensitive (allergic) to lacosamide or any of the other ingredients, or who have second or third degree AV block (a type of heart rhythm disorder).
Vimpat m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal lacosamide jew għal xi sustanza oħra tiegħu, jew li għandhom imblokk AV tat- tieni jew tat- tielet grad (tip ta ’ disturb tar- ritmu tal- qalb).
Vimpat tablets must not be used in people who are hypersensitive to peanut or soya.
Il- pilloli Vimpat m’ għandhomx jintużaw minn persuni li huma ipersensittivi għall- karawett jew soja.
Why has Vimpat been approved?
Għaliex ġie approvat Vimpat?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vimpat’ s benefits are greater than its risks when used as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Vimpat huma ikbar mir- riskji tiegħu meta jintuża bħala terapija miżjuda fil- kura ta ’ aċċessjonijiet ta ’ bidu parzjali bi jew mingħajr ġeneralizzazzjoni f’ pazjenti bl- epilessija ta ’ età ta ’ 16- il sena jew ikbar.
The Committee recommended that Vimpat be given marketing authorisation.
Il- Kumitat irrakkomanda li Vimpat jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Vimpat:
Informazzjoni oħra dwar Vimpat:
The European Commission granted a marketing authorisation valid throughout the European Union for Vimpat to UCB Pharma S. A. on 29 August 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Vimpat lil UCB Pharma S. A. fid- 29 ta ’ Awwissu 2008.
The full EPAR for Vimpat can be found here.
L- EPAR sħiħ għal Vimpat jista ’ jinstab hawnhekk.
Invented
Isem
Content
Għamla
name
Il- pakkett
Pharmaceutical Form
Daqs tal- Pakkett
administration
ta ’ l- EU
Packaging
Ivvintat
(concentration)
Farmaċewtika
Package size
(Konċentrazzjoni)
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq Użu mill- ħalq
Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu)
Folja (PVC/ PVDC/ alu) Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu Folja (PVC/ PVDC/ alu
14 tablets 56 tablets 168 tablets 14 tablets 56 tablets 168 tablets 14 tablets 56 tablets 168 tablets 14 tablets 56 tablets 168 tablets Treatment initiation pack:
14 pilloli 56 pilloli 168 pilloli 14 pilloli 56 pilloli 168 pilloli 14 pilloli 56 pilloli 168 pilloli 14 pilloli 56 pilloli 168 pilloli Pakkett tal- bidu tat - trattament:
14 tablets + 14 tablets + 14 tablets + 14 tablets
14- il pillola + 14- il pillola + 14- il pillola + 14- il pillola
Syrup Syrup Solution for infusion
Mistura Mistura Soluzzjoni għall - infużjoni
Oral use Oral use Intravenous use
Użu mill- ħalq Użu mill- ħalq Użu minn ġol - vina
Bottle (glass or PET) Bottle (glass or PET) Vial (glass)
Flixkun (ħġieġ jew PET) Flixkun (ħġieġ jew PET) Fjala (ħġieġ)
1 bottle 1 bottle 1 vial
flixkun wieħed flixkun wieħed fjala waħda
Vimpat 50 mg film-coated tablets
Vimpat 50 mg pilloli miksija b’ rita
Each film-coated tablet contains 50 mg lacosamide.
Kull pillola miksija b’ rita fiha 50 mg lacosamide.
Each film-coated tablet contains 0.17 mg soya-lecithin.
Kull pillola miksija b’ rita fiha 0. 17 mg soya- lecithin.
Film-coated tablet Pinkish, oval film-coated tablet debossed with ‘ SP’ on one side and ‘ 50’ on the other side.
Pillola miksija b’ rita ovali, tagħti fir- roża, b ’ ‘ SP ’ imnaqqxa fuq naħa waħda u ‘ 50 ’ fuq in- naħa l- oħra.
Vimpat is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
Vimpat huwa indikat bħala terapija miżjuda fit- trattament ta ’ aċċessjonijiet tat- tip ‘ partial- onset ’ kemm b’ ġeneralizzazzjoni sekondarja kif ukoll mingħajr, f’ pazjenti bl’ epilessija ta ’ 16 il- sena ‘ l fuq.
Vimpat must be taken twice a day.
Vimpat għandu jittieħed darbtejn kuljum.
The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.
Id- doża rrikkmandata tal- bidu hija ta ’ 50 mg/ darbtejn kuljum, li għandha tiżdied għal doża terapewtika inizjali ta ’ 100 mg darbtejn kuljum wara ġimgħa.
Depending on response and tolerability, the maintenance dose can be further increased by 50 mg twice a day every week, to a maximum recommended daily dose of 400 mg (200 mg twice a day).
Id - doża ta ’ manteniment tista ’ tiġi miżjuda aktar, skond ir- rispons u t- tolerabbilta`, b ’ 50 mg darbtejn kuljum kull ġimgħa, għal doża massima ta ’ kuljum irrikkmandata ta ’ 400 mg (200 mg darbtejn kuljum).
Vimpat may be taken with or without food.
Vimpat jista ’ jittieħed kemm ma ’ l- ikel kif ukoll mhux ma ’ l- ikel.
In accordance with current clinical practice, if Vimpat has to be discontinued, it is recommended this be done gradually (e. g. taper the daily dose by 200 mg/ week).
Jekk Vimpat ikollu jitwaqqaf, huwa rrikkmandat li dan isir gradwalment (eż. id- doża ta ’ kuljum titnaqqas b ’ 200 mg/ ġimgħa), skond il- prattika klinika kurrenti.
Use in patients with renal impairment No dose adjustment is necessary in mildly and moderately renally impaired patients (CLCR > 30 ml/ min).
Użu f’ pazjenti b’ indeboliment renali M’ hemmx bżonn aġġustament f’ pazjenti b’ indeboliment ħafif jew moderat tal- kliewi (CLCR > 30 ml/ min).
A maximum dose of 250 mg/ day is recommended for patients with severe renal impairment (CLCR ≤ 30 ml/ min) and in patients with endstage renal disease.
Doża massima ta ’ 250 mg/ ġurnata hija rrikkmandata għal pazjenti b’ indeboliment sever tal- kliewi (CLCR ≤30 ml/ min) u f ’ pazjenti b’ mard tal- kliewi fl’ aħħar fażi.
Treatment of patients with end-stage renal disease should be made with caution as there is little clinical experience and accumulation of a metabolite (with no known pharmacological activity).
Għal pazjenti li jkollhom bżonn id- dijaliżi tad- demm, huwa rrikkmandat suppliment ta ’ sa 50% tad- doża tal- ġurnata maqsuma eżatt wara d- dijaliżi tad- demm. It- trattament tal- pazjenti bil- mard tal- kliewi fl- aħħar stadju għandu jsir b’ kawtela għaliex hemm biss ftit esperjenza klinika u hemm akkumulazzjoni ta ’ prodott tal - metaboliżmu (li m’ għandux attivita` farmakoloġika magħrufa).
In all patients with renal impairment, the dose titration should be performed with caution (see section 5.2).
F’ kull pazjent b’ indeboliment tal - kliewi, it- titrazzjoni tad- doża għandha issir b’ kawtela (ara sezzjoni 5. 2).
Use in patients with hepatic impairment No dose adjustment is needed for patients with mild to moderate hepatic impairment.
Użu f’ pazjenti b’ indeboliment tal- fwied M’ hemmx bżonn aġġustament f’ pazjenti b’ indeboliment ħafif jew moderat tal- fwied.
The dose titration in these patients should be performed with caution considering co-existing renal impairment.
It- titrazzjoni tad- doża f’ dawn il- pazjenti għandha issir b’ kawtela, wara li jitqies ukoll xi indeboliment renali li jista ’ jkun hemm.
The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2).
Il- farmakokinetika ta ’ lacosamide ma ġietx studjata f’ pazjenti b’ indeboliment sever tal- fwied (ara sezzjoni 5. 2).
Use in elderly (over 65 years of age) No dose reduction is necessary in elderly patients.
2 Użu fl- anzjani (‘ l fuq minn 65 sena) M’ hemmx bżonn tnaqqis fid- doża f’ pazjenti anzjani.
The experience with lacosamide in elderly patients with epilepsy is limited.
L- esperjenza b’ lacosamide f’ pazjenti anzjani bl- epilessija hija limitata.
2 should be considered in elderly patients (see ‘ Use in patients with renal impairment’ above and section 5.2).
F’ pazjenti anzjani, għandu jitqies it- tnaqqis fil- clearance tal- kliewi b’ żieda fil- livelli AUC assocjat ma ’ l- eta` (ara ‘ Użu f’ pazjenti b’ indeboliment renali ’ hawn fuq u sezzjoni 5. 2).
Paediatric patients Vimpat is not recommended for use in children and adolescents below the age of 16 as there is no data on safety and efficacy in these age groups.
Pazjenti pedjatriċi Vimpat mhux irrikkmandat għall- użu fit- tfal u l- addoloxxenti taħt is - 16 – il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u jew l- effikaċja f’ dawn il- grupp ta’ dawn l- etajjiet.
Hypersensitivity to the active substance or to peanuts or soya or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew għal- karawett, jew soya jew għal xi sustanzi mhux attivi.
Known second- or third-degree atrioventricular (AV) block.
Blokk atrijoventrikulari (AV) magħruf tat- tieni jew tielet grad.
Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls.
It- trattament b’ lacosamide huwa assoċjat ma ’ sturdament li tista ’ tiżdied l- inċidenza ta ’ korriment aċċidentali jew waqgħat.