qanastek/EMEA-V3 huggingface dataset:
Clofarabine was teratogenic in rats and rabbits.
Clofarabine kien teratoġeniku fil- firien u l- fniek.
Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/ m2/ day) and in rabbits receiving 12 mg/ m2/ day clofarabine.
Żidiet fit- telf ta ’ postimplantazzjoni, nuqqas fil- piż tal- ġisem foetali u tnaqqis fid- daqs tal- boton flimkien ma 'żieda fin- numru ta' malformazzjonijiet (esterni grossi, tessuti rotob), tibdil skeletrali (inkluż ossifikazzjoni ritardata) kienu rrapportati fil - firien li kienu qed jirċievu dożi li pproduċew madwar bejn 2 sa 3 darbiet ta ’ esponiment kliniku (54 mg/ m2/ kuljum) u fi fniek li kienu qed jirċievu 12 mg/ m2/ kuljum ta ’ clofarabine.
(There are no exposure data in rabbits.) The threshold for developmental toxicity was considered to be 6 mg/ m2/ day in rats and 1.2 mg/ m2/ day in rabbits.
(M’ hemmx tagħrif dwar l- esponiment fil- fniek.) Il- livell minimu għat- tossiċità developmentali kienet meqjusa li kienet 6 mg/ m2/ kuljum fil- firien u 1. 2 mg/ m2/ kuljum fil- fniek.
The no-observable effect level for maternal toxicity in rats was 18 mg/ m2/ day and in rabbits was more than 12 mg/ m2/ day.
Il- livell ta ’ l- effett mhux osservat fit- tossiċità maternali fil- firien kien 18 mg/ m2/ kuljum, fil- fniek kien aktar minn 12 mg/ m2/ kuljum.
No fertility studies have been conducted.
Ma sarux studji fuq il- fertilità.
Genotoxicity studies demonstrated that clofarabine was not mutagenic in the bacterial reverse mutation assay, but did induce clastogenic effects in the non-activated chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells and in the in vivo rat micronucleus assay.
Studji ta ’ ġenotossiċità wrew li clofarabine ma kienx mutaġeniku fl- analiżi tal- mutazzjoni riversibbli tal- bakterja, imma induċa effetti klastoġeniċi fl’ aberrazzjoni tal- analiżi tal- kromożomi mhux attivati fiċ- ċelluli ta ’ l- Ovarji tal- Hamster Ċiniż (CHO) u f’ analiżi in vivo mikronuklejuż fil- far.
No carcinogenicity studies have been performed.
Ma sarux studji fuq il- karċinoġeniċità.
Sodium chloride Water for injections
Sodium chloride Ilma għall- injezzjonijiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m' għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
The diluted sterile concentrate is chemically and physically stable for 3 days at 2 to 8°C and at room temperature.
Il- konċentrat sterili dilwit hu stabbli kimikament u fiżikament għal 3 ijiem minn 2 sa 8°C u fit - temperatura tal- kamra.
From a microbiological point of view, it should be used immediately.
Mill- lat mikrobioloġikali, għandu jintuża minnufih.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless dilution has taken place under controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, il- ħin tal- ħażna meta jintuża u l- kondizzjonijiet qabel l- użu huma r- responsabiltà ta ’ min juża l- prodott u normalment ma jkunux aktar minn 24 siegħa f’ minn 2 sa 8°C ħlief meta tkun saret id- dilwazzjoni taħt kondizzjonijiet aseptiċi kkontrollati u validati.
20 ml, Type I glass vial with bromobutyl rubber stopper, polypropylene flip-off cap and aluminium overseal.
20 ml, Tip I kunjett tal- ħġieġ b' tapp tal- lastiku tal- bromobutijl, għatu tal- polipropijlene li tiflippjah u siġill sekondarju ta 'l- aluminju.
The vials contain 20 ml sterile concentrate and are packaged in a box.
Il- kunjetti fihom 20 ml ta ’ konċentrat sterili u jkunu ppakkjati f’ kaxxa.
Each box contains 3, 4, 10 or 20 vials.
Kull kaxxa fiha 3, 4, 10 jew 20 kunjett.
Not all pack sizes may be marketed.
14 Jista ’ jkun li mhux il- pakketti tad- daqsijet kollha jkunu għall- skop kummerċjali.
13 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Evoltra 1 mg/ ml concentrate for solution for infusion must be diluted prior to administration.
Evoltra 1 mg/ ml ta ’ konċentrat għal soluzzjoni għall- infużjoni għandha tkun dilwita qabel ma tingħata.
It should be filtered through a sterile 0.2 micrometre syringe filter and then diluted with sodium chloride 9 mg/ ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
Għandha tkun filtrata permezz ta ’ filter ta ’ sirinġa sterili ta ’ 0. 2 mikrometru u mbagħad dilwita b’ infuzjoni għal ġol- vina ta ’ sodium chloride ta ’ 9 mg/ ml (0. 9%) biex tipproduċi volum totali skond l - eżempji li ngħataw fit- tabella t' hawn taħt.
However, the final dilution volume may vary depending on the patient’ s clinical status and physician discretion.
Imma, il- volum finali tad- dilwazzjoni għandu mnejn ivarja u dan jiddependi mill- istatus klinikali tal- pazjent u diskrezzjoni tat- tabib.
(If the use of a 0.2 micrometre syringe filter is not feasible, the sterile concentrate should be pre-filtered with a 5 micrometre filter, diluted and then administered through a 0.22 micrometre in-line filter.)
(Jekk l- użu ta ’ filtru ta ’ sirinġa ta ’ 0. 2 mikrometru ma jistax jintuża, il- konċentrat sterili għandu jkun pre- filtrat b' filtru ta '5 mikrometru, dilwit u imbagħad mogħti permezz ta' filtru in- linja ta '0. 22 mikrometru.)
Suggested dilution schedule based on the recommended dosage of 52 mg/ m2/ day clofarabine
L- iskeda ssuġġerita ta ’ dilwazzjoni ibbażata fuq id- dożaġġ rrakkomandat ta ’ clofarabine ta ’ 52 mg/ m2/ kuljum L- erja tas- superfiċje tal- ġisem (m2) ≤ 1. 44 1. 45 sa 2. 40 2. 41 sa 2. 50
Body surface area (m2) ≤ 1.44 1.45 to 2.40 2.41 to 2.50
Konċentrat sterili (ml) * ≤ 74. 9 75. 4 sa 124. 8 125. 3 sa 130. 0
Sterile concentrate (ml)* ≤ 74.9 75.4 to 124.8 125.3 to 130.0
Volum
Total diluted volume 100 ml 150 ml 200 ml
totali dilwit 100 ml 150 ml 200 ml
*Each ml of concentrate contains 1 mg of clofarabine.
* Kull ml ta ’ konċentrat fih 1 mg ta ’ clofarabine.
Therefore, for patients with a body surface area ≤ 0.38 m2, the partial contents of a single vial will be required to produce the recommended daily dosage of clofarabine.
Għalhekk, fil- każ tal- pazjenti li għandhom erja ta ’ superfiċje tal- ġisem ta ’ ≤ 0. 38 m2, il- kontenuti parzjali ta ’ kunjett ser ikunu meħtieġa biex jipproduċi id- dożaġġ rrakkomandat ta ’ kuljum ta ’ clofarabine.
However, for patients with a body surface area > 0.38 m2, the contents of between 1 to 7 vials will be required to produce the recommended daily dosage of clofarabine.
Għalhekk, fil- każ tal- pazjenti li għandhom erja ta ’ superfiċje tal- ġisem ta ’ > 0. 38 m2, il- kontenuti ta ’ bejn 1 sa 7 kunjetti ser ikun meħtieġ biex jipproduċi id- dożaġġ rrakkomandat ta ’ kuljum ta ’ clofarabine.
The diluted sterile concentrate should be a clear, colourless solution.
Il- konċentrat sterili dilwit għandu jkun soluzzjoni ċara bla kulur.
Visually inspect for particulate matter and discolouration prior to administration.
Ara jekk hemmx xi fdal ta ’ partikuli jew tibdil fil- kulur qabel ma jingħata.
For single use only.
Użah darba waħda biss.
Any unused product must be discarded.
Kull fdal tal- prodott li ma jkunx intuża għandu jintrema.
Procedures for proper handling of antineoplastic agents should be observed.
Il- proċeduri għall- immaniġġjar sewwa ta 'aġenti antineoplastiċi għandhom ikunu osservati.
Cytotoxic medicinal products should be handled with caution.
Prodotti mediċinali ċitotossiċi għandhom ikunu mmaniġġjati bir- reqqa.
The use of disposable gloves and protective garments is recommended when handling Evoltra.
L- użu ta ’ ingwanti li wara l- użu għandhom jintremew u l- użu tal- ħwejjeġ protettivi hu rrakkomandat meta tkun qed tmiss Evoltra.
If the product comes into contact with eyes, skin or mucous membranes, rinse immediately with copious amounts of water.
Jekk ikun hemm kuntatt tal- prodott ma ’ l- għajnejn, ġilda, membrani mukuża, laħlaq immedjatament bi kwantità kbira ta ’ ilma.
Evoltra should not be handled by pregnant women.
Nisa tqal m’ għandhomx imissu Evoltra.
Genzyme Europe BV Gooimeer 10 1411DD Naarden The Netherlands
Genzyme Europe BV Gooimeer 10 1411DD Naarden L- Olanda
EU/ 1/ 06/ 334/ 001 3 vials EU/ 1/ 06/ 334/ 002 4 vials EU/ 1/ 06/ 334/ 003 10 vials EU/ 1/ 06/ 334/ 004 20 vials
UE/ 1/ 06/ 334/ 001 3 kunjetti UE/ 1/ 06/ 334/ 002 4 kunjetti UE/ 1/ 06/ 334/ 003 10 kunjetti UE/ 1/ 06/ 334/ 004 20 kunjett
29 May 2006.
29 ta ’ Mejju 2006.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta 'l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U A DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA United Kingdom
Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA Ir- Renju Unit
Pharmachemie B. V (PCH) Swensweg 5 Haarlem The Netherlands
Pharmachemie B. V (PCH) Swensweg 5 Haarlem L- Olanda
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal - manifattur responsabbli għall- ħruġ tal- lott konċernat
CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Summary of Product Characteristics, section 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2)
The Marketing Authorisation Holder (MAH) 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 (MAH) għandu jtemm il- programm ta ’ studju li ġejjin fiż- żmien speċifikat, u r- riżultati ta 'dawn l- istudji għandhom iservu ta' bażi għar - rijassessjament annwali tal- profil tal- benefiċċji / riskju
Clinical aspects 1.
Aspetti kliniċi 1.
The MAH has committed to provide data from a population PK analysis of paediatric and adult clofarabine concentrations, as well as additional data, which will support a recommendation of dose adjustments in patients with moderate renal impairment, by 31 March 2009.
L- MAH impenja ruħu li jipprovdi dejta minn analiżi PK tal- popolazzjoni ta ’ konċentrazzjonijiet ta ’ clofarabine fit- tfal u fl- adulti, kif ukoll dejta addizzjonali, li ser tappoġġja rakkomandazzjoni ta ’ aġġustamenti fid- doża f’ pazjenti b’ indeboliment renali moderat, sal- 31 ta ’ Marzu, 2009.
2.
L - MAH ser jikkunsidra wkoll il- ħtieġa ta ’ studju kliniku addizzjonali sa din id- data.
The MAH has committed to monitor and report toxicity in all ongoing and planned clinical trials.
Il- MAH impenja ruħu li jimmonitorja u jirrapporta t- tossiċità fl- provi kliniċi li qed ikomplu u dawk ippjanati.
The marketing authorisation holder will provide updates in accordance with standard PSUR timings.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq ser jipprovdi aġġornamenti skond il- ħinijiet standard stipulati tal- PSUR.
Due date:
Data ta ’ l- għeluq:
Standard PSUR timings.
Il- ħinijiet standard stipulati tal - PSUR.
The MAH has committed to set up a voluntary adverse event reporting system as detailed in the risk management plan.
Il- MAH impenja ruħu li jwaqqaf sistema volontarja ta ’ rapportaġġ ta ’ każijiet avversi hekk kif kien miktub fil- pjan ta ’ l- immaniġġjar tar- riskju.
17 (including concomitant medications) for all registered patients together with information on any serious (especially unexpected) treatment-emergent possibly drug-related events, any emergent CTC grade 3 or higher renal, hepatic, or cardiac events, all possibly drug-related deaths, all cases of suspected tumour lysis syndrome, Systemic Inflammatory Response Syndrome (SIRS) and capillary-leak syndrome, all cases with a suspected drug interaction, all grade 3 or higher possibly drug-related events occurring after 3 or more cycles of use, any suspected cases of veno-occlusive disease (VOD) in patients receiving clofarabine treatment.
L- għan tar- reġistru hu li jiġbor minn dawk li jippreskribu li jieħdu sehem fuq bażi volontarja, it- tagħrif relevanti dwar il- karatteristiċi tal - pazjent u l- marda, u t- trattament (inkluż mediċini konkomitanti) għall- pazjenti kollha rreġistrati flimkien ma 'tagħrif dwar kull każ serju (aktar u aktar jekk ma jkunux mistennija) li jitfaċċa u hu riżultat tat- trattament li possibbilment għandu x' jaqsam mal- mediċina, kwalunkwe każi renali, epatiċi jew kardijaċi ta ’ grad 3 ta ’ CTC jew ogħla, l- imwiet kollha li possibbilment għandhom x' jaqsmu mal- mediċinai, il- każi kollha fejn hemm suspett ta ’ sindrom tal- lysis ta' tumur, Sindrom ta ’ Rispons Infjammattorju Sistemiku (SIRS), u sindrom ta ’ nixxija kapillari, il- każi kollha b’ suspett ta ’ interazzjoni mal- mediċina, il- każi kollha ta ’ grad 3 jew ogħla li possibilment għandhom x’ jaqsmu mal- mediċina li jseħħu wara 3 ċiċkli jew aktar ta ’ użu, kwalunkwe każ suspettuż ta ’ marda veno- okklussiva (VOD) f’ pazjenti li qed jirċievu trattament ta 'clofarabine.
Analyses from the registry will be provided according to standard PSUR timings.
L- analiżi mir- reġistru ser ikunu ipprovduti skond il- ħinijiet standard stipulati tal - PSUR.
The MAH has committed to monitor veno-occlusive disease (VOD) after haematological stem cell transplant (HSCT).
Il- MAH impenja ruħu li jimmonitorja l- marda veno- okklusiva (VOD) wara t- trapjant cellulari steminali ematoloġikali.
Standard PSUR timings.
Il- ħinijiet standard stipulati tal- PSUR.
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
20 A. TIKKETTA
BOX CONTAINING 3, 4, 10 OR 20 VIALS
KAXXA FIHA 3, 4, 10 JEW 20 KUNJETT
Evoltra 1 mg/ ml concentrate for solution for infusion clofarabine
Evoltra 1 mg/ ml konċentrat għal solużjoni għall- infużjoni clofarabine
Each 20 ml vial contains 20 mg of clofarabine,
Kull kunjett ta ’ 20 ml fih 20 mg ta ’ clofarabine.
Sodium chloride and water for injections.
Sodium chloride u ilma għall- injezzjonijiet.
3 x 20 ml vials 4 x 20 ml vials 10 x 20 ml vials 20 x 20 ml vials
3 x 20 ml kunjetti 4 x 20 ml kunjetti 10 x 20 ml kunjetti 20 x 20 ml kunjetti
Dilute before use.
Iddilwixxi qabel l- użu.
Cytotoxic
Ċitotossiku
EXP:
JIS
EU/ 1/ 06/ 334/ 001 3 vials EU/ 1/ 06/ 334/ 002 4 vials EU/ 1/ 06/ 334/ 003 10 vials EU/ 1/ 06/ 334/ 004 20 vials
UE/ 1/ 06/ 334/ 001 3 kunjetti UE/ 1/ 06/ 334/ 002 4 kunjetti UE/ 1/ 06/ 334/ 003 10 kunjetti UE/ 1/ 06/ 334/ 004 20 kunjetti
20 ML VIAL LABEL
TIKKETTA TA ’ KUNJETT TA ’ 20 ML
Evoltra 1 mg/ ml sterile concentrate clofarabine Intravenous use
Evoltra 1 mg/ ml konċentrat sterili clofarabine Għall- użu minn ġol- vina
Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, ask your doctor. • This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib tiegħek. • Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets severe, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • 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 tiegħek.
2.
X’ inhi Evoltra u għalxiex tintuża 2.
Before you use Evoltra.
Qabel ma tuża Evoltra.
How to use Evoltra.
Kif għandek tuża Evoltra.
How to store Evoltra.
Kif taħżen Evoltra.
WHAT EVOLTRA IS AND WHAT IT IS USED FOR
X’ INHI EVOLTRA U GĦALXIEX TINTUŻA
Evoltra is used to treat young patients with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Evoltra tintuża biex tikkura pazjenti żgħar li jbatu minn lewkimja akuta limfoblastika (ALL) meta trattamenti oħra li ntużaw qabel ma ħadmux jew ma baqgħux jaħdmu.
Acute lymphoblastic leukaemia is caused by abnormal growth of some types of white blood cells.
Lewkimja akuta limfoblastika hi kkawżata minn żvilupp anormali ta ’ xi tipi ta ’ ċelluli bojod tad demm.
Clofarabine is one of a family of medicines called cytotoxic medicines.
Clofarabine hu membru mill - familja ta 'mediċini magħrufa bħala mediċini ċitotossiċi.
It works by hindering the growth of these abnormal white blood cells, and eventually kills them.
Jaħdem billi jfixkel l- iżvilupp ta ’ dawn iċ - ċelluli bojod tad demm anormali u eventwalment joqtolhom.
It works best against cells which are multiplying quickly – such as cancer cells.
Jaħdem l- aħjar kontra ċelluli li jkunu qed jimmultiplikaw malajr – bħal ngħidu aħna ċelluli tal- kanċer.
BEFORE YOU USE EVOLTRA
QABEL MA TUŻA L- EVOLTRA
Do not use Evoltra:
Tużax Evoltra:
- if you are allergic (hypersensitive) to clofarabine or any of the other ingredients of Evoltra;
- jekk int allerġiku/ a (tbagħti minn sensittività eċċessiva) għal clofarabine jew sustanzi oħra ta ’
- if you are breast-feeding (please read the section “ Pregnancy and breast-feeding” below);
- jekk qed tredda ’ (jekk jogħġbok aqra is- sezzjoni “ Tqala u treddigħ ” hawn taħt);
- if you have severe kidney or liver problems.
- jekk għandek problemi severi tal- kliewi jew tal- fwied.
Tell your doctor if any of these conditions apply to you.
Għid lit- tabib tiegħek jekk kwalunkwe waħda minn dawn il- kondizzjonijiet jgħoddu għalik.
If you are the parent of a child who is being treated with Evoltra, tell the doctor if any of them apply to your child.
Jekk int ġenitur ta ’ tifel/ tifla li qegħed/ qiegħda jiġi/ tiġi kkurat/ a b’ Evoltra, għid lit- tabib tiegħek jekk kwalunkwe waħda minnhom japplika għat- tifel/ tifla tiegħek.
Take special care with Evoltra:
Oqgħod attent ħafna b’ Evoltra:
- if you have suffered a severe reaction after using this medicine before;
- jekk int batejt minn reazzjoni severa wara li wżajt din il- mediċina qabel:
- if you have kidney disease, or used to have it;
- jekk għandek mard tal- kliewi, jew jekk kellek;
- if you have liver disease; or used to;
- jekk għandek mard tal- fwied; jew kellek;
- if you have heart disease, or used to.
- jekk għandek mard tal- qalb; jew kellek;
Tell your doctor if any of these apply to you.
Għid lit- tabib tiegħek jekk kwalunkwe waħda minn dawn il- kondizzjonijiet japplikaw għalik.
Evoltra may not be suitable for you.
Evoltra għandha mnejn ma tkunx tgħodd għalik.
Tell your doctor or carer immediately if you experience any of the following as you may need to stop treatment:
26 Għid lit- tabib tiegħek jew min jieħu ħsiebek minnufih jekk tħoss kwalunkwe waħda minn dawn il - kondizzjonijiet li ġejjin għax għandek mnejn ikollok bżonn twaqqaf it- trattament:
- If you get a fever or high temperature – because clofarabine reduces the number of blood cells
- Jekk ikollok id- deni jew temperatura għolja – għax clofarabine inaqqas in- numru ta ’ ċelluli tad -
made in the bone marrow, you may be more likely to catch infections;
demm li jsiru fil- mudullun ta ’ l- għadma, int għandek ċans akbar li timbokka infezzjonijiet:
- If you have breathing difficulties, rapid breathing, or breathlessness;
- Jekk issibha bi tqila biex tieħu nifs, tieħu nifs malajr, jew tbagħti minn qtugħ ta ’ nifs;
- If you feel a change in your heart rate;
- Jekk tħoss bidla fir- rata ta ’ qalbek;
- If you suffer from dizziness (light-headedness) or fainting – it may be a symptom of low blood
- Jekk tbati minn stordament (mhux f’ sikktek) jew jaqbdek ħass ħażin - għandu mnejn ikun
pressure;
sintomu ta 'pressjoni baxxa tad- demm;
- If you feel sick or have diarrhoea (loose bowels);
- Jekk tħossok ma tiflaħx jew għandek dijarea (tagħmel imsarnek);
- If your urine is darker than usual – it is important to drink plenty of water to avoid dehydration.
- Jekk l- awrina tiegħek tkun aktar skura mis- soltu – hu importanti li tixrob ħafna ilma biex tevita
If you are the parent of a child who is being treated with Evoltra, tell the doctor if any of the above conditions apply to your child.
Jekk int ġenitur ta ’ tifel/ tifla li qiegħed/ qegħda jiġi/ tiġi kkurat/ a b’ Evoltra, għid lit- tabib tiegħek jekk kwalunkwe waħda mill- kondizzjoni t’ hawn fuq tapplika għat- tifel/ tifla tiegħek.
During treatment with Evoltra, your doctor will carry out regular blood tests and other tests to monitor your health.
Matul it- trattament b’ Evoltra, it- tabib tiegħek ser jagħmel testijiet regolari tad- demm u testijiet oħra biex jimmonitorja lil saħħtek.
Because of the way this medicines works, it will affect your blood and other organs.
Minħabba l- mod kif taħdem din il- mediċina, hi ser taffettwa il- demmek u l- organi l- oħra tiegħek.
Talk to your doctor about contraception.
Għid lit- tabib tiegħek dwar il- kontraċċettivi.
Young men and women must use effective contraception during and after treatment.
Irġiel u nisa żgħażagħ iridu jużaw bilfors kontraċettivi effettivi matul u wara t- trattament.
See the section ‘ Pregnancy and breast-feeding’ below.
Ara s- sezzjoni “ Tqala u treddigħ ’ hawn taħt.
Evoltra may harm both male and female reproductive organs.
Evoltra għandha mnejn tagħmel ħsara lill- organi riproduttivi maskili u dawk feminili.
Ask your doctor to explain what can be done to protect you or allow you to have a family.
Staqsi lit- tabib tiegħek jispjegalek x’ jista ’ isir biex jipproteġik jew biex int tkun tista 'jkollok familja.
Taking other medicines Please tell your doctor if you are taking or have recently taken:
Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu jew ħadt dan l- aħħar:
- medicines for heart disease;
- mediċini ta ’ kontra mard tal- qalb;
- any medicine that changes your blood pressure;
- kwalunwke mediċina li tbiddel il- pressjoni tad- demm tiegħek;
- medicines that affect your liver or kidneys;
- mediċini li jistgħu jaffetwaw il- fwied jew il- kliewi tiegħek;
- any other medicines including those obtained without a prescription.
- kwalunkwe mediċini oħra anki dawk mingħajr riċetta.
Pregnancy and breast-feeding Clofarabine must not be used during pregnancy.
Tqala u treddigħ Clofarabine m’ għandux jintuża matul it- tqala.
Women who are able to get pregnant: you must use effective contraception during and after treatment with clofarabine.
Nisa li jistgħu jsiru tqal: int trid tuża bilfors kontraċċettivi effettivi matul u wara t- trattament bil - clofarabine.
Clofarabine may cause harm to unborn babies when used by pregnant women.
Clofarabine għandu mnejn jagħmel ħsara fi trabi li għadhom ma tweldux meta jkun użat minn nisa tqal.
If you are pregnant or you become pregnant during treatment with clofarabine, get medical advice immediately.
Jekk int tqila jew sirt tqila waqt it- trattament bil- clofarabine, ħu parir mediku minnufih.
Men must also use effective contraception while they or their partner are treated with clofarabine.
L- irġiel iridu jużaw bilfors kontraċettivi effettivi waqt li huma jew is- sieħba tagħhom ikunu qed ikunu kkurati b’ clofarabine.
If you are breast-feeding, you must stop breast-feeding before starting the treatment, and must not breast-feed either during or after your treatment.
Jekk int qed tredda ’, it- treddigħ għandu jitwaqqaf qabel ma jibda l- trattament, u m' għandekx tredda 'matul jew wara t- trattament.
Driving and using machines Do not drive or use any tools or machines if you feel dizzy, light-headed or faint.
Sewqan u tħaddim ta ’ magni M’ għandekx issuq jew tagħmel użu minn għodda jew tħaddem magni jekk tħossok stordut, mhux f’ siktek jew jagħtik ħass ħażin.
Evoltra contains salt Each vial contains 180 mg of sodium chloride.
Evoltra fiha l- melħ Kull kunjett fih 180 mg ta ’ sodium chloride.
This is equivalent to 3.08 mmol (or 70.77 mg) of sodium.
Dan hu ekwivalenti għal 3. 08 mmol (jew 70. 77 mg) ta ’ sodium.
You need to allow for this if you are on a controlled sodium diet.
Int trid taħseb għal dan jekk int tinsab fuq dieta ikkontrollat ta ’ sodium.
HOW TO USE EVOLTRA
KIF GĦANDEK TUŻA EVOLTRA
Your treatment with Evoltra has been prescribed by a qualified doctor experienced in treating leukaemia.
It- trattament tiegħek b’ Evoltra kien mogħti lilek minn tabib kwalifikat li għandu esperjenza fit - trattament tal- lewkimja.
Your doctor will work out the dose that is right for you depending on your height, weight and how well you are.
It- tabib tiegħek ser jikkalkula d- doża li tgħodd għalik u dan ser jiddependi fuq it- tul, piż tiegħek u kemm tħossok tajjeb.
Before Evoltra is given to you, it will be diluted in a sodium chloride solution (salt and water).
Qabel ma tingħata Evoltra, hi ser ikun dilwita f' soluzzjoni ta 'sodium chloride (melħ u ilma).
Tell your doctor if you are on a controlled sodium diet as it could affect how you will be given your medicine.
Għid lit- tabib tiegħek jekk int fuq dieta ikkontrollata ta ’ sodium għax dan jista ’ jolqot kif ser tingħata l- mediċina tiegħek.
26 Your doctor will give you Evoltra once every day for 5 days.
It- tabib tiegħek ser jagħtik Evoltra darba kuljum għal 5 ġranet.
It will be given to you as an infusion through a long thin tube which goes into a vein (a drip), or into your port-a-cath if you have one implanted; the infusion will be given over 2 hours.
Ser tingħatalek bħala infużjoni permezz ta ’ tubu twil irqiq li ser jidħol ġo vina (drip), jew fil - port- a- kat jekk għandek wieħed impjantat; l- infużjoni ser tingħata fuq firxa ta 'sagħtejn.
If you (or your child) weighs less than 20 kg, the infusion time may be longer.
Jekk int (jew it- tifel/ tifla tiegħek) tiżnu inqas minn 20 kg, il- ħin ta 'l- infużjoni għandu mnejn ikun itwal.
Your doctor will monitor your health and may change your dose depending on your response to the treatment.
It- tabib tiegħek ser jimmonitorja s- saħħa tiegħek u għandu mnejn ibiddel id- doża tiegħek dejjem jiddependi mir- rispons tiegħek lejn it- trattament.
It is important to drink plenty of water to avoid dehydration.
Hu importanti li tixrob ħafna ilma biex tevita deidrazzjoni.
If you use more Evoltra than you should If you think you may have been given too much medicine, tell your doctor straight away.
Jekk tuża Evoltra aktar milli suppost Jekk taħseb li għandek mnejn ingħatajt aktar mediċina milli suppost, għid lit- tabib tiegħek mill- ewwel.
If you forget to use Evoltra Your doctor will tell you when you need to be given this medicine.
Jekk tinsa tuża Evoltra It- tabib tiegħek ser jgħidlek meta għandek bżonn tingħata din il- mediċina.
If you think that you have missed a dose, tell your doctor straight away.
Jekk taħseb li għandek mnejn insejt tieħu d- doża, għid lit- tabib tiegħek minnufih.
If you have any further questions on the use of this product, ask your doctor.
Jekk għandek aktar mistoqsijiet dwar l- użu ta’ dan il- prodott, staqsi lit- tabib tiegħek.
POSSIBLE SIDE EFFECTS
EFFETT SEKONDARJI LI JISTA ’ JKOLLU
Like all medicines, Evoltra can cause side effects.
Bħal kull mediċina oħra, Evoltra tista ’ jkollha effetti sekondarji.
Very common side effects These are likely to affect more than 1 in 10 patients:
Effetti sekondarji komuni ħafna Dawn x’ aktarx jolqtu aktar minn pazjent wieħed minn kull 10:
- anxiety, headache, fever, tiredness;
- ansjetà, uġigħ ta ’ ras, deni, għejja;
- feeling and being sick, diarrhoea (loose bowels);
- tħossok u tkun marid, dijarea (tagħmel imsarnek);
- flushing, itching and inflamed skin, inflammation of mucus (moist) linings such as the mouth
ħmura fil- wiċċ, ħakk, ġilda imfjammata, imfjammazzjoni tal- linji mukus (niedjin) bħal ħalq u
and other areas;
-
- you may have more infections than normal because Evoltra can lower the number of certain
partijiet oħra; int għandek mnejn ikollok aktar infezzjonijiet minn normal għax Evoltra tista 'tbaxxi n -
types of blood cells in your body.
numru ta 'ċerti tipi ta' celluli tad- demm f' ġismek.
Other common side effects These are likely to affect more than 1 in every 100 people:
Effetti sekondarji komuni oħra Dawn x’ aktarx jolqtu aktar minn pazjent wieħed minn kull 100:
- infections of the blood, pneumonia, shingles, implant infections, infections of the mouth such as
- infezzjonijiet fid- demm, pnewmonja, ħruq ta ’ Sant Antnin, infezzjonijiet ta ’ l- impjant,
thrush and cold sores;
infezzjonijiet fil- ħalq bħal ngħidu aħna traxx u ‘ cold sores ’
- changes in blood chemistry, changes in white blood cells;
- tibdil fil- kimika tad- demm, tibdil fiċ- ċelluli bojod tad demm;
- allergic reactions;
- reazzjonijiet allerġiċi;
- feeling thirsty and producing darker or less urine than normal, decreased or loss of appetite,
- tħossok bil- għatx u tagħmel awrina aktar skura jew inqas awrina mis- soltu, tnaqqis jew telf ta ’
weight loss;
aptit, tnaqqis fil- piż;
- agitation, irritability, or restlessness;
- aġitazzjoni, irritabilità, dak li jkun ma għandux kwiet f ’ ġismu
- feeling numb or weak in the arms and legs, numbness of the skin, sleepiness, dizziness, tremor;
- tħoss dirgħajk u riġlejk imtarxin u debboli, tirżiħ fil- ġilda, tħoss li trid torqod, tħossok sturdut,
- hearing problems;
- problemi tas- smigħ
- water collecting around the heart, fast heartbeat;
- l- ilma jinġema ’ madwar il- qalb, taħbit mgħaġġel tal- qalb;
- low blood pressure, lump due to bad bruising;
- pressjoni tad- demm baxxa, nefħa minħabba tbenġil serju;
- leaking from tiny blood vessels, rapid breathing, nosebleeds, breathing difficulties,
- tnixxija minn vini żgħar ħafna, tieħu nifs mgħaġġel, tinfaraġ, issibha bi tqila biex tieħu n- nifs,
breathlessness, cough;
qtugħ ta 'nifs, sogħla;
- vomiting blood, stomach ache, pain in the bottom;
- tirrametti d- demm, uġigħ fl- istonku, uġigħ fis- sorm;
- bleeding mouth or gums, mouth ulcers, inflamed mouth lining;
- ħruġ ta ’ demm mill- ħalq jew il- ħanek, ulċeri tal- ħalq, linjament tal- ħalq imfjammat;
- yellowing of the skin and eyes (also called jaundice), or other liver disorders;
- il- ġilda u l- għajnejn jisfaru (magħrufa bħala suffejra), jew mard ieħor tal- fwied;
- skin rashes which may be itchy, red, painful or peeling skin including palms of the hands and
- raxxijiet tal- ġilda li għandu mnejn iġagħlek tħokk, ġilda ħamra, li tweġġgħak jew li qed
soles of the feet, or small reddish or purple spots underneath the skin;
titqaxxar inklużi l- pali ta ’ idejk u l- pali ta ’ saqajk, tikek żgħar li jagħtu fl- aħmar jew vjola taħt il- ġilda;
- bruising, hair loss, changes to skin colour, increased sweating, dry skin, or other skin problems;
- tbenġil, telf ta 'xagħar, tibdil fil- kulur tal- ġilda, tagħraq aktar, ġilda niexfa, jew problemi oħra
- pain in the chest wall or bones, neck or back pain, pain in limbs, muscles, or joints;
- uġigħ fil- qafas ta ’ sidrek jew l- għadam, uġigħ fl- għonq jew fid- dahar, uġigħ fl- idejn jew riġlejn,
- blood in urine;
- demm fl- awrina;
- failure of organs, pain, increased muscle tension, water retention and swelling in parts of the
- falliment fl- organi, uġigħ, żieda fit- tensjoni tal- muskoli, żamma ta ’ l- ilma u nefħa f’ partijiet tal -
body, including the arms and legs, changes in mental state, feeling hot or abnormal;
ġisem, inkluż id- dirgħajn u r- riġlejn, tibdil fl- istat mentali, tħoss sħana jew tħossok anormali;
- clofarabine may affect the levels of certain substances in the blood.
- clofarabine għandu mnejn jolqot il- livelli ta ’ ċerti sustanzi fid- demm.
Your doctor will carry out
It- tabib tiegħek ser
regular blood tests to check whether your body is working properly.
jagħmel testijiet regolari tad- demm ħalli jara jekk ġismek ikunx qed jaħdem sewwa.
Talk to your doctor if you are concerned about any of these side effects or if there is anything you do not understand.
Għid lit- tabib tiegħek jekk int inkwetat dwar kwalunkwe wieħed minn dawn l- effetti sekondarji jew jekk hemm xi ħaġa li ma tifhimx.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 tiegħek.
HOW TO STORE EVOLTRA
KIF TAĦŻEN EVOLTRA
Keep out of the reach and sight of children.
Żommha fejn ma tintlaħaqx u ma tidhirx mit- tfal.
Do not use Evoltra after the expiry date which is stated on the vial label and box after EXP.
Tużax Evoltra wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kunjett u kaxxa wara JIS.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għal aħħar ġurnata ta ’ dak ix- xahar.
Do not freeze.
Tagħmilhiex fil- friża.
Once prepared and diluted, Evoltra should be used straight away or within 24 hours if stored in a refrigerator (at 2 to 8oC).
Malli jkun ippreparat u dilwit, Evoltra għandha tintuża minnufih jew fi żmien 24 siegħa jekk ikun maħżun fi friġġ (f' 2 sa 8oC).
Any unused medicine should be destroyed by your doctor.
Kwalunkwe mediċina mhux użata għandha tinqered mit- tabib tiegħek.
What Evoltra contains The active substance is clofarabine.
X’ fiha Evoltra Is- sustanza attiva hi clofarabine.
Each ml contains 1 mg of clofarabine.
Kull ml fih 1 mg ta ’ clofarabine.
The other ingredients are sodium chloride and water for injections.
Is- sustanzi l- oħra huma sodium chloride u ilma għal injezzjonijiet.
What Evoltra looks like and contents of the pack Evoltra is a concentrate for solution for infusion (sterile concentrate).
Id- dehra ta ’ Evoltra u d- daqs tal- pakkett Evoltra hi konċentrat għal soluzzjoni għall- infużjoni (konċentrat sterili).
It is a clear, almost colourless solution that is prepared and diluted before it is used.
Hi soluzzjoni ċara, kważi bla kulur li hi ppreparata u dilwita qabel ma tintuża.
It is supplied in 20 ml glass vials.
Hi tingħata f’ kunjetti tal- ħġieġ ta ’ 20 ml.
The vials contain 20 mg of clofarabine and are packaged in a box.
Il- kunjetti fihom 20 mg ta ’ clofarabine u huma ppakkjati f’ kaxxa.
Each box contains 3, 4, 10 or 20 vials, but not all pack sizes may be marketed.
Kull kaxxa fiha 3, 4, 10, u 20 kunjett, imma jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Genzyme Europe BV Gooimeer 10 1411DD Naarden The Netherlands
29 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Genzyme Europe BV Gooimeer 10 1411DD Naarden L- Olanda
Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA United Kingdom
Manifattur Penn Pharmaceutical Services Limited Tafarnaubach Industrial Estate Tredegar Gwent NP22 3AA Ir- Renju Unit
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Ελλάδα /Κύπρος Genzyme Hellas Ltd.
30 Ελλάδα/ Κύπρος Genzyme Hellas Ltd.
29 This leaflet was last approved in 06/ 2008
08/ 2008
This medicine has been authorised under “ Exceptional Circumstances”.
Din il- mediċina kienet awtorizzata taħt “ Ċirkustanzi ta ’ Eċċezzjoni ”.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba li l - marda hija rari kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropeja dwar il- mediċini (EMEA) ser tirrevedi kull tip ta 'informazzjoni ġdida li toħroġ kull sena u dan il- fuljett ser jiġi aġġornat skond il- bżonn.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljat dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għall- websites oħra dwar mard rari u kura.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew ikkonsulta lit- tabib jew spiżjar tiegħek Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Evra?
X' inhu Evra?
Evra is a transdermal patch (a patch that delivers a medicine across the skin).
Evra huwa garża trasdermali (garża li tagħti l- mediċina minn ġol- ġilda).
It contains two active substances: norelgestromin (6 mg) and ethinyl estradiol (600 micrograms).
Fih żewġ sustanzi attivi: norelgestromin (6 mg) u ethinyl estradiol (600 mikrogramm).
What is Evra used for?
Għal xiex jintuża Evra?
Evra is a female contraceptive.
Evra huwa kontraċettiv għan- nisa.
Evra is intended for women of fertile age.
Evra huwa maħsub għal nisa f' età fertili.
Its safety and effectiveness have been studied in women aged 18 to 45 years.
Is- sigurtà u l- effikaċja tiegħu ntwerew f' nisa f' età bejn it- 18 u l- 45 sena.
How is Evra used?
Kif jintuża Evra?
Evra is used as one patch per week for three weeks, followed by a fourth week, which is patch-free.
Evra jintuża bħala garża waħda fil- ġimgħa għal perjodu ta ’ tliet ġimgħat, segwit bir- raba 'ġimgħa fejn ma tridx tintuża l- garża.
Patches must always be applied regularly, on the same day of the week.
Il- garżi għandhom jiġu applikati b’ mod regolari, fl- istess jum tal- ġimgħa.
The first patch is applied on day 1, and then changed on day 8.
L - ewwel garża hija applikata f' jum1, imbagħad mibdula f' jum 8.
The second patch is then changed on day 15.
Imbagħad it- tieni garża tinbidel f' jum 15.
The patch-free interval starts on day 22 and lasts for seven days.
L- intervall mingħajr garża jibda f' jum 22 u jibqa 'sejjer għal sebat ijiem.
The patch-free interval must not be longer than seven days; otherwise, additional non-hormonal contraceptive methods must be used, such as condoms.
L- intervall mingħajr garża ma għandux ikun itwal minn sebat ijiem, inkella għandhom jintużaw metodi kontraċettivi mhux ormonali addizzjonali, bħal kondoms.
The effectiveness of Evra may be lower in women weighing over 90 kg.
L- effikaċja ta ’ Evra tista 'tkun inqas f' nisa li jiżnu aktar minn 90 kg.
The patch must be firmly applied to the buttock, abdomen (tummy), upper arm or upper back, but not on the breast, or on skin that is red, irritated or cut.
Il- garża għandha titwaħħal b’ mod sod mal- gluteji (warrani), addome (żaqq), il- parti ta 'fuq ta' l- id jew fil- parti ta 'fuq tad- dahar, iżda mhux fuq is- sider, jew fuq ġilda ħamranija, irritata jew maqsuma.
The same area of skin should not be used for two consecutive patches.
L - istess żona tal- ġilda ma għandhiex tintuża għal żewġ irqajja 'konsekuttivi.
When a patch is taken off, it is important that it is discarded appropriately.
Meta titneħħa l- garża, huwa importanti li din tintrema b' mod adegwat.
The pack has a special device for the patient to stick the old patch before discarding.
Il- pakkett għandu apparat speċjali għall- pazjent sabiex titwaħħal il- garża antika qabel tintrema.
For full instructions on how to use Evra, see the Package Leaflet.
Għall- istruzzjonijiet sħaħ dwar kif għandu jintuża Evra, ara l - Fuljett ta 'Tagħrif.
How does Evra work?
Kif jaħdem Evra?
Evra is a patch version of ‘ the pill ’ (combined oral contraceptive pill).
Evra huwa verżjoni f' għamla ta 'garża tal - ‘ pillola ’ (pillola kontraċettiva orali kombinata).
Using a weekly patch instead of a daily pill may help the patient to stick to using her contraception appropriately.
Garża fil - ġimgħa minflok pillola kuljum tista 'tgħin lill- pazjent ikun regolari fl- użu tal- kontraċettiv b’ mod xieraq.
The active substances in Evra are two hormones, ethinyl estradiol (an oestrogen) and norelgestromin (a progestogen).
Is- sustanzi attivi f' Evra huma żewġ ormoni, ethinyl estradiol (oestrogen) u norelgestromin (proġestoġen).
Ethinyl estradiol has been in use extensively in oral contraceptives for many years, and norelgestromin is very similar to another progestogen, which is also used in some oral contraceptives.
Ethinyl estradiol ilu jintuża b' mod estensiv f' xi kontraċettivi orali għal bosta snin, u norelgestromin huwa simili ferm għal progestogen ieħor, li jintuża wkoll f' kontraċettivi orali oħrajn.
Evra works like the pill by changing the body ’ s hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).
Evra jaħdem bħall- pillola billi jibdel il- bilanċ ormonali tal- ġisem biex jimpedixxi l- ovulazzjoni, billi jibdel il- mukus ċervikali u billi jraqqaq l- endometriju (rita tal- ġuf).
How has Evra been studied?
Reproduction is authorised provided the the source is acknowledged Kif ġie studjat Evra?
Evra has been studied in three main studies in over 3,000 women.
Evra ġie studjat fi tliet studji ewlenin, li fihom ħadu sehem 3, 000 mara.
In two studies, Evra was compared with combined oral contraceptives: in one study, the comparator was a ‘ monophasic’ contraceptive (pills containing constant amounts of the active substances over the first three weeks of the treatment cycle) and in the other study, they were ‘ triphasic’ (with the amount of the active substances in the pills varying through the treatment cycle).
F' żewġ studji, Evra tqabbel ma 'kontraċettivi orali: fi studju wieħed dak li tqabbel ma ’ Evra kien kontraċettiv ‘ monofażiku ’ (pilloli kontraċettivi b' ammonti kostanti tas- sustanzi attivi għall- ewwel tliet ġimgħat taċ- ċiklu ta ’ trattament) u' trifażiku ’ fl- istudju l- ieħor (b’ varjazzjoni ta ’ l- ammont tas- sustanzi attivi fil- pilloli matul iċ- ċiklu ta ’ trattament).
The third study did not compare Evra with any other medicine.
It- tielet studju ma qabbilx Evra ma ’ mediċina oħra.
All of the studies lasted for a year (13 four-week cycles).
L- istudji kollha damu sena (13- il ċiklu ta ’ erba ’ ġimgħat il- wieħed).
The main measure of effectiveness was the number of women who became pregnant.
Il- kejl ewlieni ta 'l- effikaċja kien l- għadd ta' nisa li ħarġu tqal.
What benefit has Evra shown during the studies?
X' benefiċċji ta 'Evra intwerew f' dawn l- istudji?
Overall in the three studies, 15 pregnancies occurred in women taking Evra, 12 of which were the result of a ‘ method failure’ (when a pregnancy occurs despite the contraceptive being used correctly).
B' kollox, fit- tliet studji, seħħew 15- il tqala f' nisa li kienu qegħdin jieħdu Evra, 12 minn dawn kienu riżultat ta '‘ ħsara fil- metodu ’ (meta sseħħ tqala minkejja li l- kontraċettiv ikun ntuża sew).
This gives Evra a ‘ Pearl Index ’ of 0.90.
Dan jagħti lil Evra ‘ Indiċi Pearl ’ ta '0. 90.
The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 woman-years (corresponding to 1,300 cycles).
L- Indiċi Pearl huwa mod standard ta 'kif titkejjel l- effikaċja tal - kontraċettivi, li juri kemm isseħħ tqala mhux mixtieqa f' 100 nisa- snin (korrispondenti għal 1, 300 ċiklu).
The Pearl Indices for the oral contraceptives were 0.57 (monophasic) and 1.28 (triphasic).
L- Indiċi Pearl għall- kontraċettivi orali kienu 0. 57 (monofażiċi) u 1. 28 (trifażiċi).
Five of the pregnancies were in women weighing over 90 kg.
Min- numru total ta ’ nisa li xorta ħarġu tqal, ħamsa kienu nisa jiżnu iktar minn 90 kg.
What is the risk associated with Evra?
X' inhu r- riskju assoċjat ma 'Evra?
During the studies, the most common side effects with Evra (seen in more than 1 patient in 10) were headache, nausea (feeling sick) and breast tenderness.
Matul l- istudji, l- aktar effetti sekondarji komuni b' Evra (li dehru f' aktar minn pazjent 1 minn kull 10) kienu uġigħ ta 'ras, nawżea (dardir) u tenerezza.
For the full list of all side effects reported with Evra, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Evra, ara l- Fuljett ta 'Tagħrif.
Evra should not be used by women who may be hypersensitive (allergic) to norelgestromin, ethinyl estradiol or any of the other ingredients.
Evra m' għandux jintuża minn nisa li huma sensittivi żżejjed (allerġiċi) għal norelgestromin, ethinyl estradiol jew għal xi sustanza oħra tiegħu.
It should not be used when a woman has, or has had, venous or arterial thrombosis (blood clots in the veins or arteries) including a stroke or a heart attack or when a woman has some of the risk factors for thrombosis (severe high blood pressure, diabetes with damage to the blood vessels, high cholesterol levels, or a family history of thrombosis).
Ma għandux jintuża meta mara għandha, jew kellha trombożi fil- vini jew fl- arterji (emboli tad- demm fil- vini jew fl- arterji) inkluż puplesija jew attakk tal - qalb; jew meta mara għandha wħud mill- fatturi tar- riskju għat- trombożi (pressjoni tad- demm għolja ħafna, dijabete bi ħsara għall- vini u l- arterji, livelli għoljin ta 'kolesterol, jew storja familjari ta' trombożi).
It should not be used in women who have migraine with aura (visual or other symptoms), some types of cancer or abnormal bleeding from the genital area whose cause has not been diagnosed.
Ma għandux jintuża f’ nisa li jbatu minn emikranja bl- awra (sintomi viżivi jew oħrajn), xi tipi ta ’ kanċer jew demm mhux tas- soltu li joħroġ mill- parti ġenitali li ma tkunx saret dijanjożi tal - kawża tiegħu.
Why has Evra been approved?
Għaliex ġie approvat Evra?
The Committee for Medicinal Products for Human Use (CHMP) decided that Evra’ s benefits are greater than its risks for female contraception.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Evra huma ikbar mir- riskji tiegħu għall- kontraċettivi għan- nisa.
The Committee recommended that Evra be given marketing authorisation.
Il- Kumitat irrakkomanda li Evra jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Evra:
Tagħrif ieħor dwar Evra:
The European Commission granted a marketing authorisation valid throughout the European Union for Evra to Janssen-Cilag International N. V. on 22 August 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Evra valida fl- Unjoni Ewropea kollha lil Janssen- Cilag International N. V. fit- 22 ta 'Awwissu 2002.
The marketing authorisation was renewed on 22 August 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 22 ta 'Awwissu 2007.
The full EPAR for Evra is available here.
L- EPAR sħiħ għal Evra jista ’ jiġi kkonsultat hawn.
Pharmaceutical form
Isem inventat Qawwa
Transdermal patch
G amla farma ewtika
Transdermal use
Mnejn jing ata
3 transdermal patches
Il- pakkett Daqs tal- pakkett
EU/ 1/ 02/ 223/ 002
EU/ 1/ 02/ 223/ 001 EVRA EU/ 1/ 02/ 223/ 002 EVRA EU/ 1/ 02/ 223/ 003 EVRA
Sachet
_ 1 _ _ 1 _ _ 1 _
Sachet
Gar a li tipprovdi medi ina li tg addi minn ol - ilda U u transdermali Qartas Gar a li tipprovdi medi ina li tg addi minn ol - ilda U u transdermali Qartas Gar a li tipprovdi medi ina li tg addi minn ol - ilda U u transdermali Qartas
18 transdermal patches
3 Gar i li jipprovdu medi ina li tg addi minn ol - ilda 9 Gar i li jipprovdu medi ina li tg addi minn ol - ilda 18 Gar i li jipprovdu medi ina li tg addi minn ol - ilda
Each transdermal patch releases 150 micrograms of NGMN and 20 micrograms of EE per 24 h.
Kull gar a li tipprovdi medi ina li tg addi minn ol - ilda ter i 150 mikrogramma ta ’ NGMN u 20 mikrogramma ta ’ EE kull 24 sieg a.
EVRA transdermal patch
EVRA, Garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda