qanastek/EMEA-V3 huggingface dataset:
As a result of a preplanned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered VELCADE, regardless of disease status.
Minħabba analiżi ad interim maħsuba minn qabel, il- parti b’ dexamethasone twaqqfet wara rakkomandazzjoni tal- kumitat li kien qed jimmonitorja t- tagħrif, u l- pazjenti kollha li kienu qed jieħdu dexamethasone b’ mod random ġew offruti VELCADE, irrisprettivament mill- istat tal- marda.
Summary of Disease Outcomes from the Phase III and Phase II studies
Sommarju ta ’ l- effetti tal- marda wara l- istudji ta ’ Fażi II u Fażi III
Phase III Phase III
Fażi III
Phase III > 1 Prior line of
Fażi III Linja waħda ta ’
≥ 2
Fażi III > Linja waħda ta ’
Phase II prior
Fażi II ≥2 linji minn
1 Prior line of therapy
terapija minn qabel terapija minn qabel
Dex Vc Dex Vc Dex
żmien
=336a 106b
TTP, jiem
[53,71]
n=315c
response (%) CR
rispons (%)
Dex n =312c 2 (< 1) b
2
CR
(4) **
57 (45) d
57 (45) d 29 (26) d
29 (26) d
b
Days (months)
Jiem (xhur)
242 (8.0)
242 (8. 0)
169 (5.6)
169 (5. 6)
246 (8.1)
246 (8. 1) 189 (6. 2)
189 (6.2)
(7. 8)
238 (7.8)
126 (4. 1)
126 (4.1)
385 *
385*
Żmien għal
Time to response CR + PR (days) a
rispons
Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001 c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study drug. d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history *CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA = not applicable, NE = not estimated
37 d valur- p mit- test chi- square Cochran- Mantel- Haenszel aġġustata għal fatturi stratifikati; analiżi skond il- linja tat- terapija teskludi stratifikazzjoni għall- istorja terapewtika * CR+PR+MR ** CR=CR, (IF -); nCR=CR (IF+) MA = Mhux Applikabbli, MS = Ma saritx stima
The fraction of bortezomib bound to plasma proteins was not concentration-dependent.
Il- porzjon ta 'bortezomib li ntrabat mal- proteini tal- plażma ma kienx jiddependi mill- konċentrazzjoni.
Metabolism In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolized via cytochrome P450 enzymes, 3A4,
Metaboliżmu Studji in vitro bi kromożomi ta ’ fwied uman u isożimi P450 ċitokromiċi espressi mid- DNA uman jindikaw li bortezomib huwa primarjament metabolizzat bl- ossiġnu permezz ta ’ isożimi P450 ċitokromiċi, 3A4, 2ċ19, u 1A2.
Elimination The mean elimination half-life of bortezomib upon multiple dosing ranged from 40-193 hours.
Eliminazzjoni Il- half- life medja ta ’ eliminazzjoni (t1/ 2) ta ’ bortezomib wara li ngħataw ħafna dożi kienet fuq medda minn 40- 193 siegħa.
Special populations Hepatic impairment Formal studies in patients with severely impaired hepatic function have not been conducted to date (see section 4.4).
Popolazzjonijiet speċjali Indeboliment tal- fwied Sa llum ma sarux studji formali f' pazjenti b’ indeboliment qawwi tal- funzjoni tal- fwied. (ara sezzjoni 4. 4).
In the absence of data VELCADE is contraindicated in patients with severe liver impairment (see section 4.3).
(ara sezzjoni 4. 3).
Renal impairment A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups:
Indeboliment tal- kliewi Studju farmakokinetiku sar f’ pazjenti bi gradi varji ta ’ indeboliment tal- kliewi li kienu kklassifikati skond il- valuri tat- tneħħija tal- kreatinina (CrCL) tagħhom fil- gruppi li ġejjin:
5.3 Preclinical safety data
38 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary cells (CHO) at concentrations as low as 3.125 μ g/ ml, which was the lowest concentration evaluated.
Bortezomib kellu attività klastoġenika (aberrazzjonijiet fl- istruttura tal- kromożomi) f' eżami in vitro għal aberrazzjonijiet kromosomali b' ċelluli ta 'l- ovarji tal- ħamster Ċiniż (CHO) anke b' konċentrazzjonijiet ta' 3. 125 μg/ ml, li kienet l- iċken konċentrazzjoni li kienet evalwata.
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/ or diarrhoea, haematopoietic and lymphatic tissues resulting in peripheral blood cytopenias, lymphoid tissue atrophy and hematopoietic bone marrow hypocellularity: peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Fi studji ta 'tossiċità ġenerali ta' iktar minn ċiklu wieħed, li saru fuq il- firien u x- xadini, l- organi li ntlaqtu prinċipalment kienu l- passaġġ gastro- intestinali, li wassal għal rimettar u/ jew dijarrea: tessuti ħematopojetiċi u limfatiċi, li wassal għal ċitopenji fid- demm periferali, atrofija tat- tessuti limfojdi u ipoċellularità ħematopojetika tal- mudullun; newropatija periferali (osservat f' xadini, ġrieden u klieb) li tinkludi l- axons tan- nervituri sensorjali; u bidliet ħfief fil- kliewi.
6.3 Incompatibilities
6. 2 Inkompatibilitajiet
The reconstituted solution should be used immediately after preparation.
Is- soluzzjoni rikostitwita għandha tintuża malli tiġi ppreparata.
Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap.
Ħġieg tat- tip 1, fjala ta ’ 10 ml, b' tapp griż tal- bromobutyl u siġill ta 'l- aluminju b’ għatu blu jgħajjat.
The vial is contained in a transparent blister pack consisting of a tray with a lid.
Il- fjala qegħda ġo pakkett trasparenti li jikkonsisti fi trej b’ għatu Pakkett li fih fjala waħda li tintuża darba biss.
Instructions for reconstitution Each 10 ml vial must be reconstituted with 3.5 ml of sodium chloride 9 mg/ ml (0.9%) for injection.
Istruzzjonijiet għar- rikostituzzjoni Kull fjala ta '10 ml trid tkun rikostitwita b' 3. 5 ml ta' sodium chloride 9 mg/ ml (0. 9%) għall- injezzjoni.
After reconstitution, each ml solution contains 1 mg bortezomib.
Wara r- rikostituzzjoni, kull ml ta ’ soluzzjoni jkun fih 1mg bortezomib.
39 Disposal For single use only.
Rimi Għal użu darba biss.
JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg, 30 B-2340 Beerse Belgium
JANSSEN- CILAG INTERNATIONAL NV Turnhoutseweg 30 B- 2340 Beerse Il- Belġju
40 ANNEX II
40 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA RESPONSABBLI GĦALL - HRUĠ TAL- LOTT
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 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.
L- MAH jimpenja ruħu li jagħmel studji u attivitajiet oħra ta ’ farmakoviġilanza li huma dettaljati fil - Pjan ta ’ Farmakoviġilanza, hekk kif ġew miftehma f’ verżjoni 2. 0 tal- Pjan ta 'l- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modul 1. 8. 2 ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornamenti sussegwenti ta ’ l- RMP hekk kif inhu 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).
Skond il- Linja Gwida tas- CHMP dwar is- Sistemi ta ’ Immaniġġjar tar- Riskju għall- prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jiġi sottomess fl- istess ħin tar- Rapport Perjodiku ta '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 • At the request of the EMEA
Barra minn dan, RMP aġġornat għandu jkun sottomess: • Meta jasal tagħrif ġdid li għandu mnejn jolqot l- Ispeċifikazzjoni kurrenti tas- Sigurtà, il- Pjan tal- Farmakoviġilanza jew attivitajiet tat- tnaqqis tar- riskju • Fi żmien 60 ġurnata minn meta tintlaħaq data importanti (farmakoviġilanza jew tnaqqis tar- riskju) • Fuq talba ta ’ l- EMEA
PSURs The MAH will submit 6-monthly PSURs, unless otherwise specified by the CHMP.
PSURs Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq (MAH) se jissottometti PSURs kull 6 xhur, sakemm ma jiġix speċifikat mod ieħor mis- CHMP.
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.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena.
42 Area Clinical
42 Arja Klinika
Description As an adjunct to the population pharmacokinetics (PK) study nested in the ongoing Phase III trial, the applicant will conduct a clinical PK study in 24 patients with multiple myeloma receiving bortezomib at the doses of 1.0 and 1.3 mg/ m2, twice a week for two weeks followed by a rest period.
Deskrizzjoni Bħala żieda ma ’ l- istudju farmakokinetika (PK) tal - popolazzjoni fi ħdan il- prova ta ’ Fażi III li għaddej, l - applikant jagħmel studju kliniku PK f’ 24 pazjent b’ majloma multipla li qed jieħdu bortezomib bid- dożi ta ’ 1. 0 u 1. 3 mg/ m2, darbtejn fil- ġimgħa għal ġimgħatejn li warajhom ikun hemm perjodu ta ’ mistrieħ.
The aim of this study is to investigate: bortezomib PK after single and multiple dose treatment; the mechanisms behind the observed changes in the PK parameters after repeated dosing; any clinically plausible intrinsic factors that may explain and reduce variability; the relationship between body weight/ body surface area/ lean body weight) and PK parameters since dosing regimen is based on BSA; the concentration-proteasome inhibition relationship using PK/ PD-modelling;
L- għan ta ’ dan l- istudju huwa li jinvestiga: bortezomib PK wara kura b’ doża waħda u doża multipla; il- mekkaniżmi wara l- bidliet osservati fil- parametri PK wara dożaġġ repetut; xi fattur intrinsiku klinikament plawżibbli li jista ’ jispjega jew inaqqas il- varjabilità; ir- relazzjoni bejn it- toqol tal- ġisem/ is- superfiċje tal - ġisem/ it- toqol tal- ġisem bla xaħam) u parameteri PK billi l- metodu ta ’ dożaġġ huwa bbażat fuq BSA; ir- relazzjoni bejn il- konċentrazzjoni u l- inibizzjoni tal - proteasome bl- użu ta ’ mmudellar PK/ PD;
Date due To be reviewed annually Summary of final results of PK studies below by 31 December 2010 Liver impairment study Final study report expected by 31 December 2010
Sommarju tar - riżultati finali ta ’ l - istudji PK li ġejjin sal- 31 ta ’ Diċembru 2010 Studju dwar l - indeboliment tal - fwied.
The applicant will present the results from the planned Phase I/ II clinical trial (protocol under review at NCI) aimed at ruling out the possibility that secondary to proteasome inhibition bortezomib treatment may increase the risk of amyloidosis and/ or may have an adverse impact on its progression and organ manifestations.
L- applikant irid jippreżenta r- riżultati ta ’ prova klinika ta ’ Fażi I/ II ippjanata (il- protokol qed jiġi rivedut f’ NCI) biex ikun jista ’ jeskludi l- possibilità li l- kura b’ bortezomib li hija sekondarja għall- inibizzjoni ta ’ proteasome tista ’ tnaqqas ir- riskju ta ’ amilojdosi u/ jew jista ’ jkollhom impatt mhux mixtieq fuq il- progressjoni tagħhom u l- manifestazzjonijiet tagħhom fl- organi.
If this trial will not start or otherwise fail to address the relevant issues, the applicant commits to re-discuss and agree with CHMP the possibility to conduct a randomised controlled trial (or agreed alternative design) in patients with amyloidosis.
Jekk il- prova ma tibdiex jew għal xi raġuni oħra tonqos milli tindirizza l- kwistjonijiet relevanti, l- applikant jikkommetti ruħu li jerġa ’ jiddiskuti u jaqbel mal - CHMP dwar il- possibilità li jagħmel prova kkontrollata random (jew forma oħra maqbula) f’ pazjenti b’ amilojdosi.
To be reviewed annually Final study report expected by 4Q 2008
Rivedut kull sena Rapport final dwar l - istudju mistenni sa 4Q 2008
OUTER CARTON, VELCADE 1 mg
KARTUNA TA 'BARRA, VELCADE 1 mg
VELCADE 1 mg powder for solution for injection bortezomib
VELCADE 1 mg trab għal soluzzjoni għall- injezzjoni bortezomib
After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
Wara r- rikostituzzjoni, 1 ml ta 'soluzzjoni għall- injezzjoni fiha 1 mg bortezomib
Mannitol (E421), nitrogen
Mannitol (E 421), nitroġenu
Powder for solution for injection 1 vial
Trab għal soluzzjoni għall- injezzjoni Fjala waħda
Read the package leaflet before use.
Aqra l- fuljett tal- prodott qabel l- użu.
CYTOTOXIC.
ĊITOTOSSIKU.
Special handling instructions For single use only.
Istruzzjonijiet speċjali dwar immaniġġar Għal użu darba biss.
SPECIAL STORAGE CONDITIONS
46 Żomm il- fjala fil- kaxxa ta 'barra sabiex tilqa ’ mid- dawl..
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull prodott mhux użat jew skart għandu jitrema skond il- liġijiet lokali.
JANSSEN-CILAG INTERNATIONAL NV Turnhoutseweg, 30 B-2340 Beerse Belgium
JANSSEN- CILAG INTERNATIONAL NV Turnhoutseweg, 30 B- 2340 Beerse Il- Belġju
47 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
47 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
GLASS VIAL (5 ml) VELCADE 1 mg
FJALA TAL- ĦĠIEĠ (5 ml) VELCADE 1 mg
VELCADE 1 mg powder for injection bortezomib IV use.
VELCADE 1 mg trab għall- injezzjoni bortezomib Użu għal ġol- vini.
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
48 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON, VELCADE 3.5 mg
KARTUNA TA 'BARRA, VELCADE 3. 5 mg
VELCADE 3.5 mg powder for solution for injection bortezomib
VELCADE 3. 5 mg trab għal soluzzjoni għall- injezzjoni bortezomib
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Kull fjala fiha 3. 5 mg bortezomib (bħala mannitol boronic ester).
SPECIAL STORAGE CONDITIONS
49 Żomm il- fjala fil- kaxxa ta 'barra sabiex tilqa ’ mid- dawl..
GLASS VIAL (10 ml) VELCADE 3.5 mg
FJALA TAL- ĦĠIEĠ (10 ml) VELCADE 3. 5 mg
VELCADE 3.5 mg powder for solution for injection bortezomib Intravenous use.
VELCADE 3. 5 mg trab għal soluzzjoni għall- injezzjoni bortezomib Użu għal ġol- vini.
VELCADE 1 mg powder for solution for injection VELCADE 3.5 mg powder for solution for injection Bortezomib
VELCADE 1 mg trab għal soluzzjoni għall- injezzjoni VELCADE 3. 5 mg trab għal soluzzjoni għall- injezzjoni Bortezomib
What VELCADE is and what it is used for 2.
X’ inhu VELCADE u għalxiex jintuża 2.
Before you use VELCADE 3.
Qabel ma tuża VELCADE 3.
How to use VELCADE 4.
Kif għandek tuża VELCADE 4.
How to store VELCADE 6.
Kif taħżen VELCADE 6.
WHAT VELCADE IS AND WHAT IT IS USED FOR
X’ INHU VELCADE U GĦALXIEX JINTUŻA
VELCADE contains the active substance bortezomib, a so-called ‘ proteasome inhibitor’.
VELCADE fih is- sustanza attiva bortezomib, hekk imsejjaħ ‘ impeditur ta ’ proteasome ’.
Proteasomes play an important role in controlling cell function and growth.
Il - proteasomes għandhom rwol important fil- kontroll tal- funzjoni u t- tkabbir taċ- ċellula.
By interfering with their function, bortezomib can kill cancer cells.
Billi jinterferixxi mal- funzjoni tagħhom bortezomib jista ’ joqtol iċ- ċelluli tal- kanċer.
VELCADE is used for the treatment multiple myeloma (a cancer of the bone marrow) in adults:
VELCADE jintuża għall- kura ta 'majloma multipla (kanċer tal- mudullun) fl- adulti:
- in combination with other medicines containing melphalan and prednisone, for patients who
- flimkien ma ’ mediċini oħra li fihom melphalan u prednisone, għall- pazjenti li qatt ma kienu
have not been previously treated for multiple myeloma and are unsuitable for high-dose chemotherapy with bone marrow transplant.
kkurati għall- majloma multipla qabel u li m’ humiex eliġibbli għal doża għolja ta ’ kimoterapija ma ’ trapjant tal- mudullun.
- alone (monotherapy) for patients whose disease is worsening (progressive) after receiving at
- waħdu għall- pazjenti li l- marda tagħhom qed tiħrax (progressiva) wara li jkunu rċievew mill -
least one prior treatment and for whom. bone marrow transplantation was not successful or is unsuitable.
anqas kura oħra qabel u li trapjant tal- mudullun ma kienx irnexxa fihom jew mhuwiex tajjeb għalihom.
BEFORE YOU USE VELCADE
QABEL MA TUŻA VELCADE
Do not use VELCADE
Tużax VELCADE
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of
- jekk int allerġiku (tbati minn sensittività eċċessiva) għas- sustanza attiva jew sustanzi oħra ta ’
- if you have severe liver problems
- jekk int għandek problemi serji fil- fwied
- if you have certain severe pulmonary or heart problems.
- jekk inti għandek ċerti problemi serji pulmonari jew tal- qalb
Take special care with VELCADE You should tell your doctor if you have any of the following: • low numbers of red or white blood cells • bleeding problems and/ or low number of platelets in your blood • diarrhoea, constipation, nausea or vomiting • fainting, dizziness or light-headedness in the past. • kidney problems • liver problems. • numbness, tingling, or pain in the hands or feet (neuropathy) in the past.
Oqogħod attent ħafna b’ VELCADE Inti għandek tgħid lit- tabib tiegħek jekk għandek xi waħda minn dawn li ġejjin: • numru baxx ta 'ċelluli ħomor jew bojod fid- demm, • problemi bi fsada u/ jew numru baxx ta ’ plejtlits fid- demm tiegħek • dijarea, stitikezza, nawsja jew rimettar • ġieli ntlift minn sensik jew kellek sturdamenti fil- passat • problemi fil- kliewi • problemi, fil- fwied • kellek titrix, tnemnim jew uġigħ f' idejk jew saqajk (newropatija) fil- passat • problemi b' qalbek jew bil- pressjoni • kondizzjoni li tissejjaħ amyloidosis
53 • a condition called amyloidosis. • shortness of breath or cough
53 • qtugħ ta ’ nifs jew sogħla
You will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Inti se jkollok tieħu testijiet regolari tad- demm qabel u waqt il- kura tiegħek b’ VELCADE, biex tiċċekkja b’ mod regolari l- għadd ta ’ ċelluli fid- demm tiegħek
VELCADE should not be used in children and adolescents, due to limited experience.
VELCADE m’ għandux jintuża fit- tfal u fl- adoloxxenti, minħabba esperjenza limitata..
Using other medicines Please tell your doctor, or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
In particular, tell you doctor if you are using medicines containing any of the following active substances:
B’ mod partikolari, għid lit- tabib tiegħek jekk qed tuża mediċini li fihom xi wieħed minn dawn is - sustanzi attivi li ġejjin:
- ketoconazole, used to treat fungal infections
- ketoconazole, użat għall- kura ta ’ infezzjonijiet
- fluoxetine, used to treat depression
- fluoxetine, użat għall- kura ta ’ dipressjoni
- rifampicin, and antibiotic used to treat bacterial infections
- rifampicin, antibijotiku użat biex jikkura infezzjonijiet tal- batterji
- oral antidiabetics
- antidijabetiċi li jittieħdu mill- ħalq
Pregnancy and breast-feeding You should not use VELCADE if you are pregnant, unless clearly necessary.
Tqala u treddigħ M’ għandekx tuża VELCADE jekk inti tqila, jekk mhux meħtieġ b’ mod ċar.
Both men and women receiving VELCADE must use effective contraception during and for up to 3 months after treatment.
Kemm l- irġiel kif ukoll in- nisa li qed jirċievu VELCADE għandhom jużaw kontraċezzjoni effettiva waqt u sa ’ 3 xhur wara l- kura.
If, despite these measures, pregnancy occurs, tell your doctor immediately.
Jekk, minkejja dawn il- miżuri, xorta tinqabad tqila, għid lit- tabib tiegħek immedjatament..
You should not breast-feed while using VELCADE.
Inti m ’ għandekx tredda ’ waqt li tkun qed tuża VELCADE.
Discuss with your doctorwhen it is safe to restart breast-feeding after finishing your treatment.
Iiddiskuti mat- tabib tiegħek, dwar meta ma jibqax ta ’ periklu li terġa ’ tibda tredda ’ wara li tispiċċa l- kura tiegħek.
Driving and using machines VELCADE might cause tiredness, dizziness, fainting, or blurred vision.
Sewqan u tħaddim ta ’ magni VELCADE jista 'jikkawża għeja, sturdament, ħass ħażin, jew vista mċajpra.
Do not drive or operate any dangerous tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Jekk tħoss effetti sekondarji bħal dawn m’ għandekx issuq jew tagħmel użu minn għodda perikoluża jew tħaddem magni; anke jekk ma tħosshomx, inti xorta trid toqgħod attent.
HOW TO USE VELCADE
KIF GĦANDEK TUŻA VELCADE
Your doctor will work out your dose of VELCADE according to your height and weight (body surface area).
It- tabib tiegħek se jaħdem id- doża tieghek ta ’ VELCADE skont kemm int twil/ a u kemm tiżen (erja tas- superfiċje tal- ġisem).
The usual starting dose is 1.3 mg/ m2 body surface area.
Id- doża tal- bidu s- soltu hi 1. 3 mg/ m2 tal- erja tas- superfiċje tal- ġisem.
Your doctor may change the dose and total number of cycles, depending on your response to the treatment and on the occurrence of certain side effects.
It- tabib tiegħek jista ’ jibdel id- doża u n- numru totali ta ’ ċikli, skont ir- rispons tiegħek għall- kura u skont kif jseħħu ċerti effetti sekondarji.
Monotherapy When VELCADE is given alone, one cycle of treatment with VELCADE consists of a total of 4 doses.
Monoterapija Meta VELCADE jingħata waħdu, ċiklu wieħed ta 'trattament b' VELCADE jikkonsisti f' total ta' 4 dożi.
Doses are given on days 1, 4, 8 and 11, followed by a 10-day ‘ rest period ’ without treatment.
Id- dożi jingħataw fil- jiem 1, 4, 8 u 11, segwiti minn10 ijiem ta ’ ‘ perjodu ta ’ mistrieħ ’ mingħajr kura.
Therefore, the duration of a treatment cycle is 21 days (3 weeks).
Għalhekk, iż- żmien kemm idum ċiklu ta ’ kura huwa 21 jum (3 ġimgħat).
Combination therapy If you have not been treated before for multiple myeloma, you will receive VELCADE together with two other medicines containing melphalan and prednisone.
Kura kkombinata Jekk inti qatt ma ġejt ikkurat/ a għal majloma multipla qabel, inti tirċievi VELCADE flimkien ma ’ żewġ mediċini oħra li fihom melphalan u prednisone.
In this case, the duration of a cycle is 6 weeks.
F’ dan il- każ iż- żmien kemm iddum il- kura huwa ta ’ 6 ġimgħat.
The treatment consists of a total of 9 cycles (54 weeks).
Il- kura tikkonsisti f’ total ta ’ 9 ċikli (54 ġimgħa).
In Cycles 1-4, VELCADE is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32).
Fiċ- ċikli minn 1- 4, VELCADE jingħata darbtejn fil- ġimgħa (jiem 1, 4, 8, 11, 22, 25, 29 u 32).
In Cycles 5-9, VELCADE is administered once weekly (days 1, 8, 22 and 29).
Fiċ- ċikli minn 5- 9, VELCADE jingħata darba fil- ġimgħa (jiem 1, 8, 22 u 29).
Melphalan and prednisone are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
54 Melphalan u prednisone jingħataw it- tnejn li huma mill- ħalq fil- jiem 1, 2, 3 u 4 ta ’ l- ewwel ġimgħa, ta ’ kull ċiklu.
How VELCADE is given You will receive VELCADE in a specialised medical unit, under the supervision of a health care professional experienced in the use of cytotoxic medicinal products.
Kif jingħata VELCADE Inti se tirċievi VELCADE f’ post mediku speċjalizzat taħt is- superviżjoni ta ’ professjonist fil- qasam tas- saħħa li għandu esperjenza fl- użu ta ’ prodotti mediċinali ċitotossiċi.
VELCADE powder has to be dissolved before administration.
It- trab VELCADE għandu jinħall qabel ma jingħata.
This will be done by a healthcare professional.
Dan se jsir mill- professjonist fil- qasam tas- saħħa.
The resulting solution is then injected into a vein rapidly, over 3 to 5 seconds.
Is- soluzzjoni li tinkiseb imbagħad tiġi injettata ġo vina malajr, fuq perjodu ta ’ 3- 5 sekondi.
Like all medicines, VELCADE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, VELCADE jista ’ jkollu effetti sekondarji għalkemm ma jidhrux fuq kulħadd.
Some of these effects may be serious.
Xi wħud minn dawn l- effetti jistgħu jkunu serji.
Treatment with VELCADE can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Il- kura b’ VELCADE tista ’ b’ mod komuni ħafna tikkawża tnaqqis fin- numru ta ’ ċelluli ħomor u bojod tad- demm u plejtlits fid- demm tiegħek.
Therefore, you will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Għalhekk, inti se jkollok tieħu testijiet tad- demm regolari qabel u waqt il- kura tiegħek b’ VELCADE, biex tiċċekkja b’ mod regolari l- għadd ta ’ ċelluli fid- demm tiegħek.
You may experience a reduction in the number of
Inti jista ’ jkollok tnaqqis fl- għadd ta ’
- platelets, which may make you be more prone to bruising, or to bleeding without obvious injury
- plejtlits li jġgħaluk tkun aktar suxxettibbli għal tbenġil, jew għal fsada mingħajr ma jkun ovvju
(e. g. bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver).
li weġġajt (eż. fsada mill- imsaren, mill- istonku, mill- ħalq u mill- ħanek jew fsada fil- moħħ jew fsada mill- fwied).
- red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness
- ċelluli ħomor li jistgħu jikkawżaw anemija, b’ sintomi bħal għeja u ġilda pallida
- white blood cells may make you more prone to infections or flu-like symptoms.
- ċelluli bojod li jistgħu jagħmluk aktar suxxettibbli għal infezzjonijiet u sintomi bħal tal -
Side effects may occur with certain frequencies, which are defined as follows:
Dawn l- effetti sekondarji jistgħu jiġru b’ ċerti frekwenzi, li huma iddefiniti kif ġej:
- very common: affects more than 1 user in 10
- komuni ħafna: jolqtu iktar minn persuna 1 minn kull 10 li jużawh
- common: affects 1 to 10 users in 100
- komuni: jolqtu minn persuna 1 sa 10 persuni minn kull 100 li jużawh
- uncommon: affects 1 to 10 users in 1,000
- mhux komuni: jolqtu minn persuna 1 sa 10 persuni minn kull 1, 000 li jużawh
- rare: affects 1 to 10 users in 10,000
- rari: jolqtu minn persuna 1 sa 10 persuni minn kull 10, 000 li jużawh
- very rare: affects less than 1 user in 10,000
- rari ħafna: jolqtu inqas minn persuna 1 minn kull 10, 000 jużawh
- not known: frequency cannot be estimated from the available data
- mhux magħruf: ma tistax tittieħed stima mid- data disponibbli
Very common side effects • Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage. • Reduction in the number of red blood cells and or white blood cells (see above) • Fever, shivering fits • Shortness of breath without exercise • Feeling sick (nausea) or vomiting, loss of appetite • Constipation with or without bloating (can be severe), • Diarrhoea: if this happens, it is important that you drink more water than usual.
Effetti sekondarji komuni ħafna • Sensittività, xi parti minn ġismek imtarrxa, tnemnim jew sensazzjoni ta 'ħruq fil- ġilda, jew uġigħ fl- idejn jew fis- saqajn, minħabba ħsara fin- nervituri. • Tnaqqis fl- għadd ta' ċelluli ħomor jew ċelluli bojod (ara hawn fuq) • Deni, attakki ta 'tertir • Diffikultà biex tieħu n- nifs mingħajr eżerċizzju • Tħossok imdardar (nawsja) jew tirremetti, nuqqas ta ’ aptit • Stitikezza b’ nefħa jew mingħajrha (tista ’ tkun qawwija) • Dijarea; jekk jiġri hekk, importanti li tixrob iktar ilma mis- soltu.
Your doctor may give you another medicine to control diarrhoea. • Muscle pain • Tiredness • Headache • Herpes zoster infection (including disseminated)
It- tabib tiegħek jista 'jagħtik mediċina oħra biex tikkontrolla d- dijarea. • Uġigħ fil- muskoli • Għeja • Uġigħ ta ’ ras • Infezzjoni b’ herpes zoster (inkluż infezzjoni mifruxa)
Common side effects • Sudden fall of blood pressure on standing which may lead to fainting • Depression which may be severe, confusion • Swelling around the eyes or face (which may rarely be due to a serious allergic reaction), or swelling in the ankles, wrists, arms or legs.
Effetti sekondarji komuni • Il- pressjoni tad- demm taqa 'f' daqqa meta tkun bil- wieqfa, li jista' jwassal biex tintilef minn sensik. • Dipressjoni li tista 'tkun qawwija, konfużjoni • Nefħa madwar l- għajnejn jew wiċċ (li rarament ikun ġej minn reazzjoni allerġika serja) jew nefħa fl- għarqub, il- polz, id- dirgħajn jew ir- riġlejn.
55 • Blurred vision • Nose bleeds • Difficulty in sleeping, sweating, anxiety • Overtiredness (fatigue)
55 • Sensazzjoni ġenerali ta 'mard, sturdament, tħoss kollox idur bik, tħossok batut. • Bidliet fil- potassju fid- demm, wisq zokkor fid- demm • Uġigħ fis- sider u tqaħqiħ bil- bili, qtugħ ta ’ nifs jew ġilda xotta • Tipi differenti ta ’ raxx u/ jew ħakk, boċċi fil- ġilda jew ġilda xotta • Ħmura tal- ġilda jew ħmura u uġigħ fis- sit ta ’ l- injezzjoni • Diżidratazzjoni • Aċtu fl- istonku, tintefaħ bil- gass, tfewwieq, gass jew uġigħ fl- istonku • Ħalq jew xufftejn misluħin, ħalq xott, ulċeri fil- ħalq jew uġigħ fil- gerżuma. • Telf tal- piż, nuqqas ta ’ aptit • Bugħawwieġ, uġigħ fl- għadam, uġigħ fid- dirgħajn jew ir- riġlejn, jew id- dahar • Vista mċajpra • Fsada minn imnieħrek. • Diffikultà biex torqod, għaraq, ansjetà • Għejja żejda (għeja kbira)
Uncommon side effects • Palpitations (sensation of rapid or irregular heart beat), changes in heart beat, heart failure, heart attack, chest pain, chest discomfort or decreased ability of the heart to work • Bleeding from your bowels or stomach, bloody stools, bleeding in the brain, bleeding from the liver or bleeding from mucosal membranes e. g. mouth • Paralysis, seizures • Breathing becomes shallow, difficult or stops, wheezing, difficulty in breathing, cough that produces frothy sputum that may be tinged with blood or coughing blood • Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/ proteins in the urine • Yellow discolouration of eyes and skin (jaundice) • Loss of attention, restlessness or agitation, changes in your mental status, mood swings • Facial blushing or tiny broken capillaries • Hearing loss, deafness or ringing in the ears • Changes in calcium, sodium, magnesium, and phosphates in your blood, too little sugar in your blood • Hormone abnormality affecting salt and water absorption • Irritated eyes, excessively wet or dry eyes, discharge from the eyes, abnormal vision, eye infections (including herpes zoster), bleeding of the eye or sensitivity to light • Swelling of your lymph nodes • Joint or muscle stiffness, muscle spasms or twitching, pain in your bottom • Hair loss • Allergic reactions • Mouth pain, retching • Abdominal pain • Weight increase
Effetti sekondarji mhux komuni • Palpitazzjonijiet (sensazzjoni ta 'taħbit mgħaġġel jew irregolari tal- qalb), bidla fit- taħbit tal - qalb, waqfien tal- qalb, attakk ta' qalb, uġigħ fis- sider, skumdità fis- sider jew tnaqqis fil- ħila tal - qalb li taħdem • Fsada fl- imsaren jew l- istonku, ippurgar imdemmi, fsada fil- moħħ, fsada mill- fwied jew fsada tal- membrani mukużi bħall- ħalq • Paraliżi, puplesija • In- nifs jonqos, isir diffiċli jew jieqaf, tħarħir jew diffikultà biex jieħu nifs, sogħla li tipproduċi bżieq mirgħi li jista ’ jkun fih xi ftit demm jew tisgħol id- demm. • Żieda jew tnaqqis fl- ammont tal- awrina (minħabba ħsara fil- kliewi), tweġġa 'biex tagħmel l - awrina jew fsada/ proteina fl- awrina • Sfura ta' l- għajnejn u l- ġilda (suffejra) • Titlef l- attenzjoni, tkun bla kwiet jew aġitat/ a, bidla fl- istat mentali tiegħek, bidliet fil- burdati • Ħmura fil- wiċċ jew kapillari żgħar ħafna maqsuma • Telf tas- smiegħ, nuqqas tas- smigħ jew ċempil fil- widnejn • Bidliet f’ calcium, sodium, magnesium, u phosphates fid- demm tiegħek, ftit wisq zokkor fid - demm • Anormalitajiet ormonali li jaffettwaw l- assorbiment tal- melħ u l- ilma • Għajnejn irritati, għajnejn imdemmgħin jew xotti wisq, ħmieġ mill- għajnejn, vista mhux normali, infezzjonijiet fl- għajnejn (inkluż herpes zoster), fsada fil- għajn jew sensittività lejn id - dawl. • In- noduli tal- limfi jintefħu • Ebusija fil- ġogi jew il- muskoli, spażmi fil- muskoli, uġigħ fil- warrani tiegħek • Telf ta 'xagħar • Reazzjonijiet allerġiċi • Uġigħ fil- ħalq, rimettar • Uġigħ fiż- żaqq • Żieda fil- piz
Not known • Inflammation of the lining around your heart
Mhux magħruf • Infjammazzjoni tar- rita ta ’ madwar il- qalb.
HOW TO STORE VELCADE
KIF TAĦŻEN VELCADE
Do not store above 30°C.
56 Taħżinx f' temperatura iktar minn 30°C.
Do not use after the expiry date stated on the vial and the carton after EXP.
Tużax wara d- data ta ’ skadenza li tidher fuq il- fjala u l- kartuna wara JIS.
If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Jekk is- soluzzjoni ma tintużax minnufih, iż- żmien u l- kondizzjonijiet waqt il- ħażna qabel l- użu huma r- responsabbilta` ta 'min jagħmel użu minnha.
However, the reconstituted solution is stable for 8 hours at 25 °C in the original vial and/ or a syringe prior to administration, with a maximum of 8 hours in the syringe.
Madankollu, is- soluzzjoni rrikostitwita hija stabbli għal 8 sigħat f' temperatura ta '25 °C fil- fjala oriġinali u/ jew ġo siringa qabel ma tingħata, b' massimu ta' 8 sigħat ġos- siringa.
What VELCADE contains
X ’ fih VELCADE
- The active substance is bortezomib.
- Is- sustanza attiva hi bortezomib.
Each vial contains 1 mg or 3.5 mg of bortezomib (as a
Wara li
After reconstitution, 1 ml of solution for injection contains 1 mg bortezomib.
jkun rikostitwit, 1 ml tas- soluzzjoni għall- injezzjoni jkun fiha 1 mg ta 'bortezomib.
- The other ingredients are mannitol (E421) and nitrogen.
- Is- sustanzi l- oħra huma mannitol (E 421) u nitroġenu.
What VELCADE looks like and contents of the pack VELCADE powder for solution for injection is a white to off-white cake or powder.
Id- Dehra ta ’ VELCADE u l- kontenuti tal- pakkett VELCADE trab għal soluzzjoni għall- injezzjoni huwa kappa jew trab minn abjad sa offwajt.
Each carton of VELCADE 1 mg powder for solution for injection contains a glass vial with a green cap, in a transparent blister pack.
Kull kartuna ta ’ VELCADE 1mg trab għal soluzzjoni għall- injezzjoni fih fjala tal- ħġieġ b’ tapp aħdar, f’ pakkett b’ folja trasparenti.
Each carton of VELCADE 3.5 mg powder for solution for injection contains a glass vial with a royal blue cap, in a transparent blister pack.
Kull kartuna ta ’ VELCADE 3. 5 mg trab għal soluzzjoni għall- injezzjoni fih fjala tal- ħġieġ b’ tapp blu jgħajjat f’ pakkett b’ folja trasparenti.
Turnhoutseweg, 30 B-2340 Beerse Belgium
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq JANSSEN- CILAG INTERNATIONAL NV Turnhoutseweg 30 B- 2340 Beerse Il- Belġju
Turnhoutseweg 30 B-2340 Beerse Belgium
Il- Manifattur Janssen Pharmaceutica N. V., Turnhoutseweg 30 B- 2340 Beerse Il- Belġju
57 For any information about this product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
België/ Belgique/ Belgien JANSSEN-CILAG N. V. / S. A.
57 België/ Belgique/ Belgien JANSSEN- CILAG N. V. / S. A.
Z O. O., WIŚ NIOWY BUSINESS PARK BUILDING "F" UL.
Z O. O., Wiśniowy Business Park Building "F" ul.
58 España JANSSEN-CILAG, S. A.
58 España JANSSEN- CILAG, S. A.
59 This leaflet was last approved in
59 Din il- mediċina kienet awtorizzata taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’.
This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product.
Dan ifisser li għal raġunijiet xjentifiċi kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) se tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u dan il- fuljett ser jiġi aġġornat skond il- bżonn.
INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:
60 INFORMAZZJONI GĦAL PROFESSJONISTI MEDIĊI U TAS- SAĦĦA BISS:
RECONSTITUTION
RIKOSTITUZZJONI
VELCADE is a cytotoxic agent.
VELCADE huwa sustanza ċitotossika.
Therefore, caution should be used during handling and preparation.
Għalhekk, trid issir attenzjoni waqt l- immanipular u l - preparazzjoni.
Use of gloves and other protective clothing to prevent skin contact is recommended.
Huwa rakkomandat l- użu ta 'ngwanti u ħwejjeġ protettivi.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF VELCADE SINCE NO PRESERVATIVE IS PRESENT.
IT- TEKNIKA ASETTIKA GĦANDHA TIĠI OSSERVATA B' MOD STRETT WAQT L - IMANIĠĠJAR TA 'VELCADE BILLI MA FIHX PRESERVANTI.
1.1. a) Preparation of the 1 mg vial: add 1.0 ml of sterile, 9 mg/ ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder.
1. 1. a) Preparazzjoni tal- fjala ta ’ 1 mg: żid 1. 0 ml ta '9 mg/ ml (0. 9%) ta' soluzzjoni sterili ta 'sodium chloride għall- injezzjoni fil- fjala li fiha t- trab VELCADE.
b) Preparation of the 3.5 mg vial: add 3.5 ml of sterile, 9 mg/ ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder.
b) Preparazzjoni tal- fjala ta ’ 3. 5 mg: żid 3. 5 ml ta '9 mg/ ml (0. 9%) ta' soluzzjoni sterili ta 'sodium chloride għall- injezzjoni fil- fjala li fiha t- trab VELCADE.
The concentration of the resulting solution will be 1 mg/ ml.
Il- konċentrazzjoni tas- soluzzjoni li tinkiseb tkun ta '1 mg/ ml.
The solution will be clear and colourless, with a final pH of 4 to 7.
Is- soluzzjoni tkun ċara u bla kulur, b' pH finali ta 'bejn 4 u 7.
You do not need to check the pH of the solution.
M' għandekx għalfejn tiċċekkja l- pH tas- soluzzjoni.
Before administration, visually inspect the solution for particulate matter and discolouration.
Qabel l- amministrazzjoni, ifli s- soluzzjoni għal xi frak jew bidla fil- kulur.
If any discolouration or particulate matter is observed, the reconstituted product should be discarded.
Jekk tosserva bidla fil- kulur jew frak li għadhom ma nħallux, il- prodott rikostitwit għandu jintrema.
The reconstituted product is preservative free and should be used immediately after preparation.
Il- prodott rikostitwit ma fihx preservanti u għandu jintuża eżatt wara l- preparazzjoni.
However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25 °C stored in the original vial and/ or a syringe prior to administration, with a maximum of 8 hours in the syringe.
Madankollu, intwera li l- prodott jibqa 'kimikament u fiżikament stabbli waqt l- użu għal 8 sigħat f' temperatura ta' 25 °C sakemm ikun maħżun fil- fjala oriġinali u/ jew siringa qabel ma jingħata, b' massimu ta '8 sigħat fis- siringa.
If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Jekk is- soluzzjoni rikostitwita ma tintużax mal- ewwel, iż - żmien tal- ħażna u l- kondizzjonijiet qabel l- użu huma r- responsabbilità ta ’ min jużaha.
It is not necessary to protect the reconstituted medicinal product from light.
M' hemmx għalfejn tipproteġi l- prodott mediċinal rikostitwit mid- dawl.
ADMINISTRATION
KIF JINGĦATA
• Check the dose in the syringe. • Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein. • 3Flush the peripheral or intravenous catheter with sterile, 9 mg/ ml (0.9%) sodium chloride solution.
• Iċċekkja d- doża fis- siringa. • Injetta s- soluzzjoni bħala injezzjoni bolus ta 'bejn 3 u 5 sekondi minn ġo kateter periferali jew ċentrali fil- vina. • Aħsel il- kateter periferali jew fil- vina b' soluzzjoni sterili 0. 009 mg/ ml (0. 9%) ta' sodium chloride.
DISPOSAL
KIF JINTREMA
A vial is for single use only and remaining solution must be discarded.
Fjala qegħda għal użu darba biss u li jibqa ’ għandu jintrema.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull prodott mhux użat jew skart għandu jintrema skond il- liġijiet lokali.
61 ANNEX IV
61 ANNESS IV
62 GROUNDS FOR ONE ADDITIONAL RENEWAL
62 RAĠUNIJIET GĦAL TIĠDID WIEĦED ADDIZZJONALI
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Velcade remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Fuq bażi ta ’ tagħrif li ġie disponibbli minn meta ngħatat l- Awtorizzazzjoni għat- tqegħid fis- Suq għall - ewwel darba, is- CHMP jikkunsidra li l- bilanċ bejn il- benefiċċji u r- riskji ta ’ Velcade għadu pożittiv, iżda jukkunsidra li l- profil ta ’ sigurtà għandu jiġi mmonitorjat mill- qrib għar- raġunijiet li ġejjin:
− Further data on the possibility that secondary to proteasome inhibition, bortezomib treatment may increase the risk of amyloidosis and/ or may have an adverse impact on its progression and organ manifestations is to be assessed as part of a specific obligation.
− Aktar tagħrif dwar il- possibiltà li kawża tal- inibizzjoni ta ’ proteasome, il- kura b’ bortezomib tista ’ żżid ir- riskju ta ’ amyloidosis u/ jew jista ’ jkollha impatt avvers fuq il- progressjoni tagħha u l- manifestazzjoni fl- organi għandu jiġi stmat bħala parti minn obbligazzjoni speċifika.
Therefore, this safety issue should continue to be carefully monitored.
Għalhekk, din il- kwistjoni ta ’ sigurtà għandha tkompi tiġi mmonitorjata mill- qrib.
− Based on the number and kind of unlisted serious adverse events reported since the initial granting of the marketing authorisation of Velcade, a careful monitoring of any newly emerging safety signals is requested.
− Fuq bażi tan- numru u t- tip ta ’ każijiet avversi serji mhux elenkati minn meta ngħatat l - Awtorizzazzjoni għat- tqegħid fis- Suq ta ’ Velcade għall- ewwel darba, monitoraġġ b’ attenzjoni ta ’ sinjali ta ’ sigurta li jfiġġu ġodda huwa mitlub.
− The CHMP decided that the MAH should continue to submit 6-monthly PSURs.
− Is- CHMP iddeċieda li l- MAH għandu jkompli jissottometti PSURs kull 6 xhur.
Therefore, based upon the safety profile of Velcade, which requires the submission of 6-monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Għalhekk, fuq bażi ta ’ profil ta ’ sigurtà ta ’ Velcade, li jeħtieġ is- sottomissjoni ta ’ PSURs kull 6 xhur, is- CHMP ikkonkluda li l- MAH għandu jissottometti applikazzjoni waħda addizzjonali ta ’ tiġdid fi żmien 5 snin.
What is Velmetia?
X’ inhu Velmetia?
Velmetia is a medicine containing two active substances, sitagliptin and metformin hydrochloride.
Velmetia hija mediċina li fiha ż- żewġ sustanzi attivi sitagliptin u metformin hydrochloride.
What is Velmetia used for?
Għal x' hiex jintuża Velmetia?
Velmetia is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
Velmetia jintuża għat- trattament ta 'pazjenti b' dijabete tat- tip 2, sabiex ittejjeb il- kontroll tal- livelli taz - zokkor fid- demm.
How is Velmetia used?
Kif jintuża Velmetia?
Velmetia is taken twice a day.
Velmetia jiġi meħud darbtejn kuljum.
Patients already taking metformin, with or without a sulphonylurea, should take Velmetia containing the same dose of metformin.
Pazjenti li diġa ’ jieħdu l - metformina flimkien jew mingħajr sulfonilurea għandhom jieħdu l- Velmetia li fiha l- istess doża ta ’ metformina.
Patients already taking sitagliptin and metformin as separate tablets should switch to Velmetia containing the same doses of both active substances.
Pazjenti li diġa ’ qed jieħdu sitagliptin u metformina bħala pilloli separate għandhom jaqilbu għal Velmetia li fiha l- istess dożi taż- żewġ sustanzi attivi.
If Velmetia is taken with a sulphonylurea, the dose of the sulphonylurea may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Jekk Velmetia jiġi meħud flimkien ma ’ sulfonilurea, id- doża ta ’ sulfonilurea jista ’ jkun meħtieġ li tiġi mnaqqsa sabiex tiġi evitata ipogliċemija (livelli baxxi ta ’ zokkor fid- demm).
Velmetia should be taken with food to avoid any stomach problems caused by metformin.
Velmetia għandu jiġi meħud ma ’ l- ikel sabiex jiġu evitati problemi ta ’ l- istonku ikkawwżati mill - metformina.
Velmetia is not recommended for use in children under 18 years of age because of a lack of information on safety and effectiveness in this group.
Velmetia ma huwiex rakkomandat sabiex jintuża fi tfal ta ’ inqas minn 18 – il sena, minħabba nuqqas ta ’ tagħrif fuq is- sigurtà u l- effikaċja f’ dan il- grupp.
How does Velmetia work?
Kif jaħdem Velmetia?
The active substances in Velmetia, sitagliptin and metformin hydrochloride, each have a different mode of action.
Id- dijabete ta ’ Tip 2 hija marda li minħabba fiha, il- frixa ma tagħmilx biżżejjed insulina biex tikkontrolla l- livell ta ’ glukosju (zokkor) fid- demm jew meta l- ġisem ma jkunx jista ’ juża l- insulina b’ mod effettiv.
It works by blocking the breakdown of 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Is- sustanzi attivi f’ Velmetia, sitagliptin u metformina idroklorida kull waħda għandha 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
How has Velmetia been studied?
Kif ġiet studjata Velmetia?
Three studies of Januvia, in patients with type 2 diabetes whose blood glucose levels were not adequately controlled on metformin alone, were used to support the use of Velmetia in the same indications.
Tliet studji ta ’ Januvia, f’ pazjenti b’ dijabete tat- tip 2 li l- livelli tal- glukożju f’ demmhom ma ġewx ikkontrollati b’ mod xieraq mill- metformina biss, ġew użati sabiex isostnu l- użu ta ’ Velmetia fl- istess indikazzjonijiet.
Two ‘ bioequivalence’ studies were also carried out, showing that the active substances in the two strengths of Velmetia were absorbed in the body in the same way as when they were taken as separate tablets.
Saru żewġ studji ‘ bijoekwivalenti ’ li juru li s- sustanzi attivi f’ żewġ qawwiet ta ’ Velmetia ġew assorbiti fil- ġisem bl- istess mod bħal ma kieku kienu meħuda bħala pilloli separati.
What benefit has Velmetia shown during the studies?
Liema benefiċċju wriet Velmetia waqt l- istudji li ġew mwettqa?
What is the risk associated with Velmetia?
X’ inhu r- riskju assoċjat ma ’ Velmetia?
The most common side effect with Velmetia (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
L- aktar effett sekondarju komuni ta ’ Velmetia (muri f’ bejn pazjent u 10 minn 100) huwa n- nawżja (dardir).
For the full list of all side effects reported with Velmetia, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Velmetia, ara l- Fuljett ta 'Tagħrif.
Velmetia should not be used in people who may be hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Velmetia m’ għandux jintuża minn persuni ipersensittivi (allerġiċi) għal sitagliptin, metformina jew għal kull ingredjent ieħor.
Why has Velmetia been approved?
Għaliex ġie approvat Velmetia?
The Committee for Medicinal Products for Human Use (CHMP) decided that Velmetia’ s benefits are greater than its risks for the treatment of patients with type 2 diabetes mellitus.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Velmetia għandu iktar benefiċċji milli riskji fit- trattament tad- dijabete tat- tip 2 mellitus.
The Committee recommended that Velmetia be given marketing authorisation.
Il- Kumitat irrakkomanda li Velmetia jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 The full EPAR for Velmetia can be found here.
2/ 3 Informazzjoni oħra dwar Velmetia:
This summary was last updated in 05-2008.
L- EPAR sħiħ għal Velmetia jista ’ jiġi kkonsultat hawnhekk