qanastek/EMEA-V3 huggingface dataset:
2 ml type I glass vial, with bromobutyl rubber stopper and flip-off aluminium over seal, containing 0.5 ml of solution (0.70 ml including overfill).
Kunjetti tal- ħġieġ tat- tip I ta '2 ml, b' tapp ta' lastiku bromobutil u siġill ta 'fuqu tal- aluminju li jinqala', li fih 0. 5 ml soluzzjoni (0. 70 ml inkluża l- parti mfawra).
Each carton contains 14 vials.
Kull pakkett fih 14- il kunjett.
6.6 Special precaution for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
The vials contain 0.5 ml of solution (0.70 ml including overfill) to facilitate the dose extraction of a single 0.5 ml dose.
Il- kunjetti fihom 0. 5 ml soluzzjoni (0. 70 ml inkluża l- parti mfawra) biex tiffaċilita l- estrazzjoni ta 'doża singola ta' 0. 5 ml.
Patients are provided with capped polypropylene syringes and instructed to extract 0.5 ml of solution into the syringe.
Il- pazjenti jingħataw siringi b' tappijiet ta 'polypropylene u jiġu mgħallma kif jiġbdu 0. 5 ml soluzzjoni għal ġewwa siringa.
The solution should be visually inspected for particulate matter and discolouration prior to administration.
Is- soluzzjoni għandha tiġi spezzjonata viżwalment għall- materjal partikolat u għal tindis fil- kulur qabel l- għoti.
The solution must be clear and colourless.
Is- soluzzjoni għandha tkun ċara u bla kulur.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
EpiCept GmbH Goethestrasse 4 D-80336 München Germany
EpiCept GmbH Goethestrasse 4 D- 80336 München Il- Ġermanja
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TAL- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
11 ANNEX II
12 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TAL- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI TAD- DETENTUR TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur( i) risponsabbli għall- ħruġ tal- lott.
Catalent UK Packaging Ltd Lancaster Way, Wingates Industrial Park Westhoughton, Bolton Lancashire, BL5 3XX United Kingdom
Catalent UK Packaging Ltd Lancaster Way, Wingates Industrial Park Westhoughsan, Bolsan Lancashire, BL5 3XX Ir- Renju Unit
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFIKAĊI TAL- PRODOTT MEDIĊINALI
Not applicable.
Ma japplikax
Pharmacovigilance system
Sistema ta 'farmakoviġilanza
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Il- MAH għandu jassigura li s- sistema ta 'farmkoviġilanza, kif deskritta fil- verżjoni 3. 0 ppreżentata f' Modulu 1. 8. 1. tal- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qiegħda tiffunzjona qabel u waqt li l- prodott ikun qiegħed fis- suq.
Risk Management plan
Pjan ta 'Ġestjoni tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Il- MAH jintrabat li jwettaq studji u attivitajiet ta 'faramkoviġilanza addizzjonali ddettaljati fil- Pjan ta' Farmakoviġilanza, kif sar qbil fuqu fil- verżjoni 3. 0 tal- Pjan ta 'Ġestjoni tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2. tal- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornamenti sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skont il- Linja Gwida dwar il- Ġestjoni tar- Riskju għall- prodotti mediċinali għall- użu mill- bniedem tal - CHMP, l- RMP aġġornat għandu jiġi ppreżentat fl- istess waqt tar- Rapport Perjodiku ta 'Aġġornament dwar is- 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 hekk, l- RMP aġġornat għandu jiġi ppreżentat • Meta jasal tagħrif ġdid li jista 'jkollu impatt fuq l- Ispeċifikazzjoni tas- Sigurtà, Pjan ta' Farmokoviġilanza jew attivitajiet ta 'minimizazzjoni ta' riskju attwali • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakovigilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
13 C.
14 Ċ.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊITAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- detentur tal- 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.
Clinical aspects:
Aspetti kliniċi:
Clinical Study to evaluate the Biomarkers and Pharmacologic Endpoints of Ceplene plus low dose Interleukin-2 in approximately 100 Adult Patients stratified by age greater or less than 60 years with Acute Myeloid Leukemia in First Complete Remission (CR), with well characterized Morphologic, Cytogenetic and Molecular profiles (First Patient In Q2, 2009 Final Study Results Q4, 2011)
Studju kliniku biex jevalwa l- Bijomarkers u l- Endpoints Farmakoloġiċi ta 'Ceplene flimkien ma' doża baxxa ta 'Interleukin- 2 f' madwar 100 Pazjent Adult stratifikati skont l- età ikbar jew inqas minn 60 sena b' Lewċemija Mjelojde Akuta fl- Ewwel Remissjoni Kompluta (CR) bi profili Morfoloġiċi, Ċitoġenetiċi u Molekulari kkaratterizzati sewwa (L- Ewwel Pazjent fi Q2, 2009 Riżultati Finali tal - Istudju Q4, 2011)
Clinical study to evaluate Minimal Residual Disease (MRD) for the assessment of the anti-leukaemic activity of Ceplene plus low dose Interleukin-2 in approximately 150 Adult Patients stratified by age greater or less than 60 years with Acute Myeloid Leukemia in First Complete Remission.
Studju Kliniku biex jevalwa Mard Minimu Residwu (MRD) għall- valutazzjoni ta 'attività antilewċemika ta' Ceplene flimkien ma 'doża baxxa ta' Interleukin- 2 f' madwar 150 Pazjent Adult stratifikati skont età ikbar jew inqas minn 60 sena b' Lewċemija Mjelojde Akuta fl- Ewwel Remissjoni Kompluta.
(First Patient In Q3, 2009 Final Study Results Q2, 2012)
(L- Ewwel Pazjent fi Q3, 2009 Riżultati Finali tal- Istudju Q2, 2012)
Determine the feasibility of conducting, in conjunction with collaborative groups in Europe and/ or the United States, a Multicenter Randomized Open-Label Study to Evaluate the Safety and Efficacy of Ceplene plus Interleukin-2 to be determined in approximately 350 adult Patients (stratified by age greater or less than 60 years) with Acute Myeloid Leukemia in First Complete Remission by Q3, 2009.
Determinazzjoni tal- fattibbilità ta 'studju miftuħ, randomizzat u multiċentriku, imwettaq f' kollaborazzjoni ma' gruppi Ewropej u/ jew tal- Istati Uniti biex jevalwa s- sigurtà u l- effikaċja ta 'Ceplene flimkien ma' Interleukin- 2 li għandhom jiġu ddeterminati f' madwar 350 pazjent (stratifikati b' età ikbar jew inqas minn 60 sena) b' Lewċemija mjelojde akuta fl- Ewwel Remissjoni Kompluta bi Q3 tal- 2009.
If this study design is feasible and agreed to by the CHMP, EpiCept commits to conduct the study and to aim for a start of recruitment within 1 year of agreement on protocol synopsis and recruitment of 10 patients/ month.
Jekk id- disinn ta 'dan l- istudju jkun jista' jsir u jiġi aċċettat mis- CHMP, EpiCept timpenja ruħha li tagħmel l- istudju u timmira għal bidu ta 'reklutaġġ fi żmien sena mill- ftehim fuq sinossi tal- protokoll u reklutaġġ ta' 10 pazjenti kull xahar.
14 ANNEX III
15 ANNESS III
LABELLING AND PACKAGE LEAFLET
TIKKETTA U FULJETT TA 'TAGĦRIF
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
Outer carton
Pakkett ta 'barra
Ceplene 0.5 mg/ 0.5 ml solution for injection Histamine dihydrochloride
Ceplene 0. 5 mg/ 0. 5 ml soluzzjoni għall- injezzjoni Istamina dikloridrat
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA/ I ATTIVA/ I
0.5 ml of solution contains 0.5 mg histamine dihydrochloride.
0. 5 ml ta 'soluzzjoni fiha 0. 5 mg ta ’ istamina dikloridrat [dihydrochloride]).
LIST OF EXCIPIENTS
LISTA TA 'SUSTANZI MHUX ATTIVI
Sodium chloride, water for injections, and sodium hydroxide and/ or hydrochloric acid to adjust the pH.
Klorur tas- sodju, ilma għall- injezzjonijiet, u idrossidu tas- sodju u/ jew aċidu idrokloriku għall - aġġustament tal- pH.
Solution for injection 14 x 2 ml glass vials Each vial contains one 0.5 ml dose.
Soluzzjoni għall- injezzjoni 14 x 2 ml kunjetti tal- ħġieġ Kull kunjett fih doża waħda ta '0. 5 ml.
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA 'KIF U MNEJN JINGĦATA
Subcutaneous use only.
Użu għal taħt il- ġilda biss.
Inject slowly over 5-15 minutes.
Injetta bil- mod fuq 5- 15- il minuta.
EXPIRY DATE
DATA TA 'META JISKADI
EXP
Jis.
17 Do not freeze.
18 Tiffriżax.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA 'PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
MARKETING AUTHORISATION NUMBER(S)
NUMRU/ I TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA 'KIF JINGĦATA
18 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Ceplene 0.5 mg/ 0.5 ml solution for injection Histamine dihydrochloride Subcutaneous use only.
Ceplene 0. 5 mg/ 0. 5 ml soluzzjoni għall- injezzjoni Istamina dikloridrat Użu taħt il- ġilda biss.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKONT IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI
Each vial contains one 0.5 ml dose
Kull kunjett fih doża waħda ta '0. 5 ml
20 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
INFORMATION FOR THE USER
21 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again. • If you have further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you.
Jista 'jkollok bżonn terġa' taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew l- ispiżjar tiegħek. • Din il- mediċina ngħatat lilek.
Do not pass it on to others.
Ma għandekx tgħaddiha lil persuni oħra.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Fil- fatt, għall- oħrajn, din il- mediċina 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, għarraf lit- tabib jew lill- ispiżjar tiegħek.
What Ceplene is and what it is used for 2.
X' inhu Ceplene u għal xiex jintuża 2.
Before you use Ceplene 3.
Qabel ma tuża Ceplene 3.
How to use Ceplene 4.
Kif għandek tuża Ceplene 4.
How to store Ceplene 6.
Kif taħżen Ceplene 6.
Further information, instructions for self-injection of Ceplene
Aktar tagħrif, struzzjonijiet kif tinjetta Ceplene lilek inniffsek
WHAT CEPLENE IS AND WHAT IT IS USED FOR
X' INHU CEPLENE U GĦAL XIEX JINTUŻA
What Ceplene is Ceplene belongs to a group of medicines called immunomodulatory medicines.
X' inhu Ceplene Ceplene jagħmel parti minn grupp ta 'mediċini magħrufa bħala mediċini immunomodulatorji.
These medicines help the body’ s immune system fight diseases like cancer by improving the immune system ’ s natural role in fighting disease.
Dawn il- mediċini jgħinu lis- sistema immunitarja tikkumbatti mard bħall- kanċer billi jtejbu l- funzjoni naturali tas- sistema immunitarja fil- ġlieda kontra l- mard.
The active substance in Ceplene is histamine dihydrochloride; it is identical to a naturally occurring substance in the body.
Is- sustanza attiva f' Ceplene hija l- istamina; dikloridrat, din hija identika għal sustanza li tinstab b' mod naturali fil- ġisem.
It is used together with low doses of interleukin-2 (IL-2), another medicine which helps the immune system to fight diseases like cancer.
Tintuża flimkien ma 'dożi baxxi ta' interleukin- 2 (IL- 2), mediċina oħra li tgħin lis- sistema immunitarja tikkumbatti mard bħall- kanċer.
What Ceplene is used for Ceplene is used, together with IL-2, to treat a particular type of leukaemia called acute myeloid leukaemia (AML).
Għal xiex jintuża Ceplene Ceplene jintuża flimkien ma 'IL- 2, għat- trattament ta' tip partikolari ta 'lewċemija, il- lewċemija mjelojde akuta (acute myeloid leukaemia, AML).
It is used to maintain the remission (the period during which the disease is less severe or not detectable).
Jintuża fil- manuteniment tar- remissjoni (il- perjodu li matulu l- marda tkun inqas gravi jew ma tidhirx).
As your doctor has discussed with you, acute myeloid leukaemia is a cancer of blood forming cells in the bone marrow.
Kif iddiskuta miegħek it- tabib, il- lewċemija mijelojde akuta hija kanċer tad- demm li jipproduċi ċelloli fil- mudullun tal- għadam.
Ceplene with IL-2 will help your immune system attack any remaining cancer cells after a previous cancer treatment.
Ceplene flimkien ma 'IL- 2 jgħin lis- sistema immunitarja tiegħek tattakka xi ċelloli tal- kanċer li jkun fadal wara t - trattament preċedenti tal- kanċer.
During your treatment, you will always use IL-2 AND Ceplene.
Waqt it- trattament tiegħek, dejjem għandek tuża KEMM IL- 2 KIF UKOLL Ceplene.
Ask your doctor if you have any questions about Ceplene or IL-2.
Għal kwalunkwe mistoqsija dwar Ceplene jew IL- 2, kellem lit- tabib tiegħek.
BEFORE YOU USE CEPLENE
QABEL MA TUŻA CEPLENE
Do NOT use Ceplene • If you are allergic (hypersensitive) to histamine or any of the other ingredients of Ceplene. • If you have severe heart problems. • If you are receiving one of the following medicines:
TUŻAX Ceplene • Jekk int allerġiku/ a (ipersensittiv[ a]) għall- istamina jew għal sustanzi oħra ta 'Ceplene. • Jekk tbati minn problemi tal- qalb gravi. • Jekk tkun qed tieħu xi waħda minn dawn il- mediċini:
- Steroids such as prednisone and dexamethasone.
- Sterojdi bħal prednisone u dexamethasone.
They are used to inhibit activity of
Dawn jintużaw biex jinibixxu l- attività
the immune system (immunosuppressant) and to reduce inflammation.
tas- sistema immunitarja (mediċini immunosoppressuri) u biex inaqqsu l - infjammazzjoni.
- Clonidine, a medicine used to reduce high blood pressure.
- Klonidina (clonidine), mediċina użata għat- tnaqqis tal- pressjoni għolja.
- H2 blockers such as cimetidine, ranitidine, famotidine or nizatidine which are used to
- Imblokkaturi H2 bħal ċimetidina (cimetidine), ranitidina (ranitidine), famotidina
treat stomach ulcers, indigestion (dyspepsia) or heartburn. • If you have received a stem cell transplant (a kind of bone marrow transplant) from a donor. • If you are pregnant. • If you are breast-feeding.
(famotidine) jew nizatidina (nizatidine) li jintużaw biex jittrattaw l- ulċeri fl- istonku, l - indiġestjoni (dispepsija) jew il- ħruq ta 'stonku. • Jekk tkun irċevejt trapjant ta' ċelloli staminali (tip ta 'trapjant tal- mudullun tal- għadam) minn donatur. • Jekk tkun tqila. • Jekk tkun qiegħda tredda'.
Take special care with Ceplene • Ceplene and IL-2 are not to be injected at the same time.
Oqgħod attent( a) ħafna meta tieħu Ceplene • Ceplene u IL- 2 ma għandhomx jiġu injettati fl- istess ħin.
IL-2 has to be injected first.
IL- 2 għandu jiġi injettat l- ewwel.
Ceplene must be injected 1 to 3 minutes later. • Ceplene must be injected slowly in the layer of tissue just under the skin (subcutaneously), over a period of approximately 5 to 15 minutes.
Ceplene għandu jiġi injettat bejn minuta u 3 minuti wara. • Ceplene għandu jiġi injettat bil- mod f' saff ta 'tessut eżatt taħt il- ġilda, fuq perjodu ta' madwar 5 sa 15- il minuta.
Rapid injection can cause a drop in your blood pressure and make you feel faint or even pass out. • You will start your treatment with Ceplene in the clinic under supervision of a doctor.
Injezzjoni rapida tista 'twaqqagħlek il- pressjoni u tistordik u anke titilfek minn sensik. • Għandek tibda t- trattament tiegħek bi Ceplene fil- klinika taħt is- superviżjoni ta' tabib.
You must be monitored to check how you respond to treatment.
Għandek tiġi sorveljat biex ikun magħruf kif tirrispondi għat- trattament.
Your doctor will check your blood pressure, pulse rate and lung function.
It- tabib jikkontrollalek il - pressjoni, il- polz u l- funzjoni tal- pulmun.
Your doctor will also carry out some blood tests during treatment. • If you have had one of the following conditions you will be monitored in the hospital during the next treatment days or the next cycles of treatment:
It- tabib tiegħek jagħmillek ukoll xi testijiet tad- demm waqt it- trattament. • Jekk għandek jew kellek xi waħda minn dawn il- kundizzjonijiet, se tiġi sorveljat( a) fl- isptar waqt il- jiem ta 'trattament li jmiss jew waqt iċ- ċikli ta' trattament li jmiss:
- bleeding ulcers,
- ulċeri bid- demm,
- stroke,
- puplesija,
- narrowing of the arteries (systemic peripheral arterial disease),
- tidjiq tal- arterji (mard arterjuż periferiku sistemiku),
- heart disease (for severe heart problems see above “ Do NOT use Ceplene”),
- mard tal- qalb (għal problemi gravi tal- qalb ara s- sezzjoni "TUŻAX CEPLENE"
- a history of auto-immune disease (a disease where the immune system attacks the
- storja ta 'mard awtoimmuni (marda fejn is- sistema immunitarja tattakka ċ- ċelloli
body ’ s own cells or tissues, such as systemic lupus, rheumatoid arthritis, inflammatory bowel disease or psoriasis). • If you are taking any other medicines mentioned under “ Taking other medicines ” or if you are to have an operation or special X-ray investigation requiring an injection, talk to your doctor. • If you have an infection your doctor will closely monitor you.
jew it- tessuti tal- ġisem stess, bħal lupus sistemiku, artrite rewmatojde, mard infjammatorju intestinali jew psorijażi). • Jekk qed tieħu kwalunkwe mediċina oħra msemmija taħt "Meta tieħu mediċini oħra" jew jekk se tagħmel xi operazzjoni jew investigazzjoni bir- raġġi X speċjali li għaliha tkun trid tieħu xi injezzjoni, kellem lit- tabib tiegħek. • Jekk tieħu xi injezzjoni, it- tabib se jissorveljak bir- reqqa.
If you have had an infection within 14 days of starting this treatment which required you to take medicines to treat infections (antibiotics, antifungals or antivirals), your doctor will closely monitor you. • If you have kidney problems, talk to your doctor before using this medicine.
Jekk diġà ħadt xi infezzjoni fi żmien 14- il jum mill- bidu ta 'dan it- trattament li minħabba fiha kellek tieħu mediċini għat - trattament tal- infezzjonijiet (antibijotiċi, antifungali jew antivirali), it- tabib tiegħek se jissorveljak bir- reqqa. • Jekk għandek xi problemi tal- kliewi, kellem lit- tabib tiegħek qabel tieħu din il- mediċina.
A decrease of blood pressure may occur. • If you have liver problems, talk to your doctor before using this medicine.
Tista 'tinżillek il- pressjoni. • Jekk għandek xi problemi tal- fwied, kellem lit- tabib tiegħek qabel tuża din il- mediċina.
Your doctor may change your dose.
It - tabib tiegħek jista 'jibdillek id- doża.
Children and adolescents Ceplene use is not recommended in children and adolescents, as there is no information available about using this medicine in this age group.
Tfal u adolexxenti L- użu ta 'Ceplene mhuwiex rakkomandat fit- tfal u fl- adolexxenti, minħabba li mhuwiex disponibbli aktar tagħrif dwar l- użu ta' din il- mediċina f' dan il- grupp.
Taking 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.
23 Meta tieħu mediċini oħra Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk tkun qed tieħu jew tkun ħadt mediċini oħra reċentement, inklużi mediċini mingħajr riċetta tat- tabib.
22 If you are taking any of the following medicines, please be sure to discuss this with your doctor or pharmacist before using Ceplene.
Jekk qed tieħu xi mediċina minn dawn li ġejjin, jekk jogħġbok iddiskuti dan mat- tabib jew mal - ispiżjar tiegħek qabel ma tuża Ceplene.
Some of them must not be taken during treatment with Ceplene or may need special precautions: • Steroids such as prednisone and dexamethasone.
Uħud minnhom ma għandhomx jittieħdu waqt it- trattament b' Ceplene jew jista 'jkollok tieħu prekawzjonijiet speċjali waqt li teħodhom: • Sterojdi bħal prednisone u dexamethasone.
They are used to inhibit activity of the immune system (immunosuppressant) and to reduce inflammation (see above “ Do NOT use Ceplene”). • H2 blockers such as cimetidine, ranitidine, famotidine or nizatidine which are used to treat stomach ulcers, indigestion (dyspepsia) or heartburn (see above “ Do NOT use Ceplene ”). • Antihistamines used to treat allergy. • Certain anti-psychotics such as chlorpromazine, flupenthixol, thoridazine, clozapine and risperidone.
Dawn jintużaw biex jinibixxu l- attività tas- sistema immunitarja (mediċini immunosoppressuri) u biex inaqqsu l- infjammazzjoni (ara s- sezzjoni "TUŻAX Ceplene" hawn fuq). • Imblokkaturi H2- blockers bħal bħal ċimetidina (cimetidine), ranitidina (ranitidine), famotidina (famotidine) jew nizatidina (nizatidine) li jintużaw biex jittrattaw l- ulċeri fl- istonku, l - indiġestjoni (dispepsija) jew il- ħruq ta 'stonku (ara s- sezzjoni "TUŻAX Ceplene" hawn fuq). • Antistamini użati biex jittrattaw l- allerġiji. • Ċerti antipsikotiċi bħal chlorpromazine, flupenthixol, thoridazine, clozapine u risperidone.
They are used to treat mental conditions. • Tricyclic antidepressant medicines such as amitryptiline, imipramine, or monoamine oxidase inhibitors, such as phenelzine, isocarboxazide, tranylcypromine or moclobemide.
Jintużaw biex jittrattaw kundizzjonijiet mentali. • Antidepressivi triċikliċi bħal amitryptiline, imipramine, jew inibituri ta ’ monoamine oxidase, bħal phenelzine, isocarboxazide, tranylcypromine jew moclobemide.
They are used to treat depression. • Malaria or medicines used to treat infections responsible for sleeping sickness. • Beta-blockers, such as propranolol, metoprolol, atenolol for angina and heart beat disorders or any treatment of high blood pressure (for example thiazide diuretics (bendrofluazide), ACE inhibitors (captopril), calcium antagonists (nifedipine) and alpha-blockers (prazosin).
Jintużaw fit - trattament tad- depressjoni. • Malarja jew mediċini użati għat- trattament ta 'infezzjonijiet responsabbli għall- marda tal- irqad. • Imblokkaturi Beta, bħal propranolol, metoprolol, atenolol għall- anġina u d- disturbi tat- taħbit tal- qalb jew għat- trattament kontra l- ipertensjoni (pereżempju diuretiċi thiazide (bendrofluazide), ACE- inibituri (captopril), antagonisti tal- kalċju (nifedipine) u imblokkaturi alpha (prazosine).
Also, if you are to have an operation or special X-ray investigation requiring an injection, first make sure that your doctor knows that you are receiving Ceplene.
Barra minn hekk, jekk se tagħmel operazzjoni jew investigazzjoni bir- raġġi X li teħtieġ injezzjoni, l- ewwel kun żgur( a) li t- tabib tiegħek jaf li qed tieħu Ceplene.
Certain medicines used for an operation (for example neuromuscular blocking medicines and narcotic pain-killers) or dyes used for certain X- rays may interfere with this medicine.
Ċerti mediċini użati għal operazzjoni (pereżempju mediċini li jimblokkaw l- apparat newromuskolari u mediċini narkotiċi għal kontra l - uġigħ) jew sustanzi tal- kulur użati għal ċerti investigazzjonijiet bir- raġġi X jistgħu jinterferixxu ma 'din il- mediċina.
Pregnancy and breast-feeding There is no information about the use of Ceplene in pregnant women.
Tqala u treddigħ M' hemm l- ebda tagħrif dwar l- użu ta 'Ceplene fin- nisa tqal.
Therefore, the treatment with Ceplene and IL-2 must not be used during pregnancy.
Għalhekk, it- trattament b' Ceplene u IL- 2 ma għandux jintuża fit- tqala.
It is not known whether Ceplene appears in breast milk.
Mhux magħruf jekk Ceplene jgħaddix fil- ħalib tas- sider.
Therefore Ceplene and IL-2 must not be used during breast-feeding.
Għalhekk Ceplene u IL- 2 ma għandux jintuża waqt it- treddigħ.
For both men and women using this treatment, contraception must be used as it is important not to conceive a child while being treated with Ceplene and IL-2.
Kemm l- irġiel kif ukoll in- nisa li jkunu qed jużaw dan it- trattament għandhom jużaw metodi kontraċettivi biex jevitaw il- konċepiment waqt it- trattament b' Ceplene u IL- 2.
Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew tal- ispiżjar tiegħek qabel tieħu xi mediċina.
Driving and using machines Do not drive or use machines within one hour after receiving a Ceplene injection as it may reduce blood pressure causing dizziness, light-headedness and blurred vision which can affect your ability to drive and operate machines.
Sewqan u użu ta 'magni Issuqx u tużax mediċini fi żmien siegħa mill- użu ta' Ceplene għax tista 'titbaxxielek il- pressjoni u dan iwassal għal sturdament u vista mċajpra li tista' taffettwalek l- kapaċità li ssuq jew tħaddem magni.
HOW TO USE CEPLENE
KIF GĦANDEK TUŻA CEPLENE
Always use Ceplene exactly as your doctor has instructed.
Dejjem uża Ceplene eżatt kif jgħidlek it- tabib.
You should check with your doctor or pharmacist if you are not sure about this.
Jekk għandek xi dubji, kellem lit- tabib jew lill- ispiżjar tiegħek.
This treatment must be prescribed and supervised by a physician with knowledge of acute myeloid leukaemia.
Dan it- trattament għandu jiġi preskritt u sorveljat minn tabib espert fil- lewċemija mjelojde akuta.
Dosage Since you will be using both IL-2 and Ceplene in a combined treatment, information about both dosages is provided:
Dożaġġ Billi se tkun qed tuża kemm IL- 2 kif ukoll Ceplene fi trattament kombinat, se jingħata tagħrif dwar iż - żewġ dożaġġi:
23 IL-2 is injected twice daily as a subcutaneous injection (in the layer of tissue just under the skin) 1 to 3 minutes before the injection of Ceplene.
Interleukin- 2 (IL- 2) IL- 2 jiġi injettat darbtejn kuljum bħala injezzjoni taħt il- ġilda (fis- saff ta 'tessut eżatt taħt il- ġilda) bejn minuta u 3 minuti qabel l- injezzjoni ta' Ceplene.
Each dose is calculated from your body weight.
Kull doża tiġi kkalkulata fuq il- piż tiegħek.
You should use 16400 IU* per kg bodyweight.
Għandek tuża 16400 UI * għal kull kg piż tal- ġisem.
Your doctor will let you know how much it is and how to inject it.
It- tabib tiegħek se jgħarrfek kemm trid tieħu u kif tinjettah.
*IU=international units, a measurement specifying the amount of IL-2
* UI=unitajiet internazzjonali, kejl li jispeċifika l- ammont ta 'IL- 2
Ceplene The usual dose of Ceplene is 0.5 ml of solution twice a day given as a slow subcutaneous injection (in the layer of tissue just under the skin).
Ceplene Id- doża normali ta 'Ceplene hi 0. 5 ml ta ’ soluzzjoni darbtejn kuljum mogħtija bħala injezzjoni taħt il- ġilda bil- mod (fis- saff ta' tessut eżatt taħt il- ġilda).
Ceplene must be injected 1 to 3 minutes after IL-2.
Ceplene għandu jiġi injettat bejn minuta u 3 minuti wara IL- 2.
The two medicines, IL-2 and Ceplene, are both injected twice a day, with a minimum of 6 hours between injections.
Iż- żewġ mediċini, IL- 2 u Ceplene, jiġu injettati darbtejn kuljum, b' intervall ta 'mill- inqas 6 sigħat bejn iż- żewġ injezzjonijiet.
Treatment periods and treatment breaks The treatment with IL-2 and Ceplene lasts for 81 weeks and is cyclic. • For the first 18 weeks: you will use IL-2 and Ceplene daily for 3 weeks, followed by a 3 week break (no treatment at all). • For the following 63 weeks: you will use IL-2 and Ceplene daily for 3 weeks, followed by a 6 week break (no treatment at all).
Perjodi ta 'trattament u perjodi ta' sospensjoni It- trattament b' IL- 2 u Ceplene idum 81 ġimgħat u huwa ċikliku. • Għall- ewwel 18- il ġimgħa: ħu IL- 2 u Ceplene kuljum għal 3 ġimgħat, segwiti minn waqfa ta '3 ġimgħat (mingħajr ebda trattament). • Għad- 63 ġimgħa ta' wara: ħu IL- 2 u Ceplene kuljum għal 3 ġimgħat, segwiti minn waqfa ta '6 ġimgħat (mingħajr ebda trattament).
Injecting Ceplene yourself Your doctor may decide that it would be more convenient for you to inject IL-2 and Ceplene yourself.
Kif tinjetta Ceplene lilek innifsek It- tabib jista 'jiddeċiedi li jkun iktar konvenjenti għalik li tinjetta IL- 2 u Ceplene lilek innifsek.
Your doctor or nurse will show you how to inject yourself.
It- tabib jew l- infermier tiegħek juruk kif tinjetta lilek innifsek.
Do not try to inject yourself unless a qualified professional has trained you.
Tippruvax tinjetta lilek innifsek jekk qabel ma tkunx ingħatajt struzzjonijiet minn professjonista kwalifikat.
It is recommended that you always have someone with you when injecting this medicine, such as an adult family member, friend or other care provider who could help you if you feel light-headed or faint.
Huwa rrakkomandat li dejjem tkun preżenti persuna oħra meta tinjetta din il- mediċina, bħal membru adult tal- familja, ħabib jew xi ħadd ieħor li jieħu ħsiebek biex jgħinek jekk tħossok se tistordi jew itik ħass ħażin.
For further instructions on how to inject this medicine yourself, please read the section “ INSTRUCTIONS FOR SELF-INJECTION OF CEPLENE ” at the end of this leaflet.
Għal iktar struzzjonijiet fuq kif tinjetta din il- mediċina lilek innifsek, jekk jogħġbok aqra s - sezzjoni "STRUZZJONIJIET BIEX TINJETTA CEPLENE LILEK INNIFSEK" fi tmiem dan il- fuljett.
Your doctor may advise you that it is appropriate to use a syringe pump to regulate the injection of Ceplene.
It- tabib tiegħek jista 'jagħtik parir li jkun aħjar jekk tuża pompa bis- siringa biex tirregola l- injezzjoni ta' Ceplene.
If you are using a syringe pump you must refer to the instructions provided by the pump manufacturer and the training provided by your doctor, nurse and/ or pharmacist.
Jekk qed tuża pompa tas- siringa għandek tirreferi għall- istruzzjonijiet ipprovduti mill - fabbrikant tal- pompa u t- taħriġ ipprovdut mit- tabib, infermier u/ jew spiżjar tiegħek.
If you have used more Ceplene than you should You must use this medicine exactly as it has been prescribed for you.
Jekk tuża aktar Ceplene milli suppost Għandek tuża din il- mediċina eżatt kif ġiet preskritta lilek.
If you accidentally inject more than you were told to, contact your doctor or pharmacist immediately.
Jekk aċċidentalment tinjetta iktar minn dik preskritta, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek immedjatament.
If you forget a dose of Ceplene Do not take any additional dose to make up for the forgotten doses.
25 Jekk tinsa tieħu Ceplene Ma għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Continue with the treatment as prescribed.
Kompli bit- trattament kif preskritt.
If you have missed one of your doses in a day, contact your doctor or pharmacist.
Jekk taqbeż waħda mid- dożi tiegħek, ikkuntattja lit- tabib jew lill- ispiżjar.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta 'dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Ceplene can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Ceplene jista 'jikkawża effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you experience any side effects during or soon after the injection, tell you doctor.
Jekk tesperjenza kwalunkwe effett sekondarju waqt jew ftit wara l- injezzjoni, tkellem mat- tabib tiegħek.
24 Side effects observed when Ceplene is used as described in this package leaflet
Effetti sekondarji osservati meta Ceplene jintuża kif deskritt fuq il- fuljett ta 'tagħrif
Very common side effects (occurs in more than 1 in 10 people who use the medicine)
Effetti sekondarji komuni ħafna (li dehru f' iktar minn persuna 1 minn kull 10 li jużaw din il - mediċina)
• Increase in the number of a certain type of white blood cells in the blood (eosinophilia) and decrease in the number of blood platelets (thrombocytopenia) • Headache, dizziness and tiredness • Altered taste (dysgeusia) • Rapid heart beat (tachycardia) • Flushing and low blood pressure (hypotension) leading to light-headedness and fainting • Cough, difficulty in breathing (dyspnoea) • Nausea, indigestion (dyspepsia) and diarrhoea • Rash • Joint and muscle pain (arthralgia and myalgia) • Inflamed granulated skin at the injection site, fatigue, fever (pyrexia), injection site redness, feeling hot, itching at the injection site, flu-like symptoms, shivering (rigors), injection site inflammation and pain.
• Żieda fl- għadd ta 'ċertu tip ta' ċelloli tad- demm bojod fid- demm (eosinofilija) u tnaqqis fl- għadd ta 'plejtlits (tromboċitopenija) • Uġigħ ta' ras, sturdament u għeja • Bidla fit- togħma (disġewsija) • Żieda fit- taħbit tal- qalb (takikardija) • Fwawar u pressjoni tad- demm baxxa (ipotensjoni) li twassal għal sturdament sa telf mis- sensi u ħass ħażin • Sogħla, tbatija biex wieħed jieħu n- nifs (dispnea) • Nawżea, indiġestjoni (dispepsija) u dijarrea • Raxx • Uġigħ fil- muskoli u fil- ġogi (artralġija u mijalġija) • Infjammazzjoni tal- ġilda bil- formulazzjoni ta 'granulomi fis- sit tal- injezzjoni, għeja, deni (piressija), ħmura fis- sit tal- injezzjoni, sħana, ħakk fis- sit tal- injezzjoni, sintomi qishom tal - influwenza, tertir, infjammazzjoni u wġigħ fis- sit tal- injezzjoni.
Common side effects (occurs in less than 1 in 10 people but more than 1 in 100 people who use the medicine) • Loss of appetite • Difficulty in sleeping (insomnia) • Feeling your own heart beat (palpitations) • Nasal congestion • Vomiting, upper abdominal pain and dry mouth • Abnormal redness of the skin (erythema), increased sweating, night sweats and itching (pruritus) • Pain in limbs and back pain • Hives, bruising, rash and swelling at the injection site, weakness and chest pain
Effetti sekondarji komuni (li dehru f' inqas minn persuna 1 minn kull 10 iżda f' iktar minn persuna 1 minn kull 100) • Nuqqas ta 'aptit • Diffikultà biex torqod (insonnja) • Tħoss it- taħbit tal- qalb (palpitazzjonijiet) • Konġestjoni nażali • Remettar, uġigħ fin- naħa ta' fuq taż- żaqq u ħalq xott • Ħmura anomala fil- ġilda (eritema), żieda fl- għaraq, għaraq bil- lejl u ħakk • Uġigħ fir- riġlejn u d- dirgħajn u wġigħ fid- dahar • Ħorriqija, tbenġil, raxx u nefħa fis- sit tal- injezzjoni, dgħufija u uġigħ fis- sider
Side effects observed when Ceplene was used in other types of treatment
Effetti sekondarji li dehru meta Ceplene ntuża ma 'tipi oħrajn ta' trattament
Very common side effects (occurs in more than 1 in 10 people who use the medicine) • Dry skin • Anxiety • Feeling of general discomfort or unease • Accumulation of fluid in the body especially in the legs and loss of weight
Effetti sekondarji komuni ħafna (li dehru f' iktar minn persuna 1 minn kull 10 li jużaw din il - mediċina) • Ġilda xotta • Ansjetà • Tħossok ħażin jew skumdità ġenerali • Akkumulazzjoni ta 'fluwidu fil- ġisem speċjalment fir- riġlejn u telf ta' piż
Common side effects (occurs in less than 1 in 10 people but more than 1 in 100 people who use the medicine) • Sensation of spinning (vertigo) • Your body does not make enough thyroxine, a body chemical called a hormone (hypothyroidism) • Decrease in the number of red blood cells (anaemia) • Dehydration • Depression • Tingling, prickling or numbness of the skin (paraesthesis) • Hot flushes • Wheezing • Constipation, swollen stomach, inflamed mouth • Pain and formation of extra tissue in the skin around the injection site
26 Effetti sekondarji komuni (li dehru f' inqas minn persuna 1 minn kull 10 iżda f' iktar minn persuna waħda minn kull 100) • Rasek iddur bik (vertigo) • Inkapaċità li l- ġisem jipproduċi biżżejjed thyroxine, sustanza kimika fil- ġisem magħrufa bħala ormon (ipotirojdiżmu) • Tnaqqis fin- numru ta 'ċelloli tad- demm ħomor (anemija) • Diżidratazzjoni • Depressjoni • Tnemnim u titrix fil- ġilda (parestesija) • Fwawar • Tħarħir • Stitikezza, stonku minfuħ, ħalq infjammat • Uġigħ u formazzjoni ta' tessut żejjed fil- ġilda madwar is- sit tal- injezzjoni
25 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk kwalunkwe minn fost l- effetti sekondarji jiggrava, jew jekk tinnota xi effett mhux mixtieq mhux imniżżel f' dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek.
HOW TO STORE CEPLENE
KIF TAĦŻEN CEPLENE
Do not use Ceplene after the expiry date which is stated on the carton and vial label.
Tużax Ceplene wara d- data ta 'skadenza li tidher fuq il- pakkett u fuq it- tikketta tal- kunjett.
The expiry date refers to the last day of that month.
Id- data ta 'skadenza tirreferi għall- aħħar jum ta' dak ix- xahar.
Medicines must not be disposed of via wastewater or household waste.
Il- mediċini ma għandhomx jintremew mal- ilma tad- dranaġġ jew mal- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li ma għandekx tuża.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall - protezzjoni tal- ambjent.
What Ceplene contains • The active substance is histamine dihydrochloride.
Xi jkun fih Ceplene • Is- sustanza attiva hija l- istamina dikloridrat.
One vial contains 0.5 mg histamine dihydrochloride in 0.5 ml solution. • The other ingredients are water for injections and sodium chloride, and it may also contain sodium hydroxide and/ or hydrochloric acid for pH adjustment.
Kunjett wieħed ikun fiha 0. 5 mg istamina dikloridrat (histamine dihydrochloride) f' 0. 5 ml soluzzjoni. • L- ingredjenti l- oħra huma l- ilma għall- injezzjoni u klorur tas- sodju, u jista 'jkun fih ukoll idrossidu tas- sodju u/ jew aċidu idrokloriku għall- aġġustament tal- pH.
What Ceplene looks like and contents of the pack Ceplene is a clear, colourless liquid.
Kif jidher Ceplene u l- kontenut tal- pakkett Ceplene huwa likwidu ċar, bla kulur.
It is provided in a glass vial with a grey rubber stopper and a blue peel flip off aluminium tamper evident over seal.
Huwa disponibbli f' kunjett tal- ħġieġ b' tapp tal- lastiku griż u b' siġill blu tal- aluminju li jitqaxxar minn fuqha.
Ceplene is available in pack sizes of 14 single-use vials.
Ceplene huwa provdut f' pakketti ta '14- il kunjett għal użu ta' darba.
Marketing Authorisation Holder EpiCept GmbH, Goethestrasse 4, D-80336 München, Germany.
Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq EpiCept GmbH, Goethestrasse 4, D- 80336 München, il- Ġermanja.
Manufacturer Catalent UK Packaging Ltd, Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton, Lancashire, BL5 3XX, United Kingdom
Manifattur Catalent UK Packaging Ltd, Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton, Lancashire, BL5 3XX, ir- Renju Unit
This leaflet was last approved in {MM/ YYYY}
{XX/ SSSS}
This medicine has been authorised “ Exceptional circumstances”.
27 Din il- mediċina ġiet awtorizzata f '"Ċirkostanzi Eċċezzjonali".
This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicine.
Dan ifisser li minħabba r- rarità tal - marda ma kienx possibbli li jinkiseb tagħrif komplut fuq din il- mediċina.
The European Medicines Agency (EMEA) will review any new information on this medicine every year and this package leaflet will be updated as necessary.
L- Aġenzija Ewropea għall - Mediċini (EMEA) se tanalizza kull tagħrif ġdid dwar din il- mediċina kull sena u dan il- fuljett ta 'tagħrif se jiġi aġġornat kif meħtieġ.
Detailed information on this medicine is available on the European Medicine Agency (EMEA) website: http/ /: www. emea. europa. eu They are also links to other websites about rare diseases and treatments.
Fuqha hemm ukoll kollegamenti għal siti oħrajn dwar mard rari u trattamenti.
INSTRUCTIONS FOR SELF-INJECTION OF CEPLENE
STRUZZJONIJIET BIEX TINJETTA CEPLENE LILEK INNIFSEK
This section contains information on how to give yourself an injection of Ceplene.
Din is- sezzjoni fiha tagħrif dwar kif tagħti injezzjoni ta 'Ceplene lilek innifsek.
For general information about the dosage and how to use Ceplene and IL-2, please see Section 3, “ HOW TO USE CEPLENE”.
Għal tagħrif ġenerali dwar id- dożaġġ u kif tuża Ceplene u IL- 2, jekk jogħġbok ara s- Sezzjoni 3, "KIF GĦANDEK TUŻA CEPLENE".
26 Read the following instructions carefully.
Aqra dawn l- istruzzjonijiet sewwa.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Huwa importanti li ma tippruvax tinjetta lilek innifsek jekk ma tkunx ingħatajt struzzjonijiet speċjali mit- tabib jew mill- infermier.
If you are not sure about how to give yourself the injection or you have any questions, please ask your doctor or nurse for help.
Jekk m' intix żgur( a) dwar kif tinjetta lilek inifsek jew jekk għandek xi mistoqsijiet, jekk jogħġbok itlob l- għajnuna tat- tabib jew tal - infermier tiegħek.
If you feel faint or dizzy during or after the injections, tell your doctor before injecting your next dose.
Jekk waqt jew wara l- injezzjonijiet tħossok stordut jew titlef sensik, għarraf lit- tabib tiegħek qabel tinjetta d- doża li jmiss.
Your doctor may want to increase the time you take to complete your injection, or change your dose.
It- tabib jista 'jiddeċiedi li jżid il- ħin li għandek tieħu biex tispiċċa l- injezzjoni, jew jibdillek id- doża.
You will have to inject Ceplene and IL-2 twice a day by subcutaneous injection (in the layer of tissue just under the skin), according to the directions provided by your doctor.
Għandek tinjetta Ceplene u IL- 2 darbtejn kuljum b' injezzjoni (fis- saff ta 'tessut eżatt taħt il- ġilda), skont l- istruzzjonijiet mogħtija mit- tabib.
Always inject IL-2 first.
Dejjem injetta IL- 2 l- ewwel.
Ceplene must be injected 1 to 3 minutes later.
Ceplene għandu jiġi injettat bejn minuta u 3 minuti wara.
Ceplene must not be mixed with any other products and must not be diluted.
Ceplene ma għandux jitħallat ma 'prodotti oħra u ma għandux jiġi dilwit.
Your doctor will explain to you how to prepare and inject IL-2.
It- tabib se jispjegalek kif tipprepara u tinjetta IL- 2.
It is recommended that you always have someone with you when injecting Ceplene, such as an adult family member, friend, or other care provider to help you if you feel light-headed or faint.
Huwa rrakkomandat li dejjem tkun preżenti persuna oħra meta tinjetta din il- mediċina, bħal membru adult tal- familja, ħabib jew xi ħadd ieħor li jieħu ħsiebek biex jgħinek jekk tħossok se tistordi.
PREPARATION FOR INJECTION OF CEPLENE
PREPARAZZJONI GĦALL- INJEZZJONI TA 'CEPLENE
To prepare a dose of Ceplene you will need the following: • 1 vial of Ceplene solution (0.5 ml) • 1 sterile syringe with needle • 1 alcohol wipe
Biex tipprepara doża ta 'Ceplene ikollok bżonn dan li ġej: • Kunjett ta' soluzzjoni ta 'Ceplene (0. 5 ml) • Siringa sterili bil- labra • Biċċa mbilla fl- alkoħol biex timsaħ (alcohol wipe[ s]) • Metodu 1 Oħroġ kunjett wieħed mill- pakkett.
Check the expiry date (EXP) on the vial label.
Ara d- data ta 'skadenza (Skad.) fuq it- tikketta tal- kunjett.
Do not use if the date has passed the last day of the month shown.
Tużahx jekk id- data tkun qabżet l- aħħar jum tax- xahar indikat fuq it- tikketta.
Wash your hands thoroughly with soap and water.
Aħsel idejk sew bl- ilma u s- sapun.
Double check the vial label to make sure you are using the correct medicine.
Erġa 'ara t- tikketta fuq il- kunjett biex tkun żgur( a) li qed tuża l- mediċina t- tajba.
The solution must be clear and colourless.
Is- soluzzjoni trid tkun ċara u bla kulur.
If not, use another vial and inform your doctor or pharmacist.
F' każ li ma tkunx, uża kunjett ieħor u informa lit- tabib jew lill- ispiżjar tiegħek.
Remove the plastic cap from the vial, exposing the stopper with the inner rubber circle.
Neħħi t- tapp tal- plastik minn mal- kunjett, biex tesponi ċ- ċirku tal- lastiku ta 'ġewwa.
Use an alcohol wipe to clean the rubber part of the stopper.
Imsaħ bil- biċċa mbilla fl- alkoħol il- parti tal- lastiku tat- tapp.
Do not touch the stopper with your hands.
Tmissx it- tapp b' idejk.
Pick up the sterile syringe.
Iġbor is- siringa sterili.
Notice the numbered marks on it.
Innota l- marki bin- numri.
Each mark (0.1, 0.2, 0.3, etc) represents one-tenth of a millilitre (0.1 ml).
Kull marka (0. 1, 0. 2, 0. 3, etc) tirrappreżenta wieħed minn kull għaxra ta 'millilitru (0. 1 ml).
With the needle cover on, pull back the plunger and draw air into the syringe to the level (number of millilitres) instructed by your doctor.
Mingħajr ma tneħħi l- kappa tal- labra, iġbed il - planġer lura u iġbed l- arja fis- siringa sal- livell (numru ta 'millilitri) li jordnalek it- tabib.
See Figure 1.
Ara l - Figura 1.
Pull the needle cover straight off.
Iġbed il- kappa tal- labra 'l barra.
With the vial standing on a flat surface, insert the needle straight through the rubber stopper into the vial.
Bil- kunjett wieqaf fuq xi wiċċ ċatt, daħħal il- labra dritta ġot- tapp tal- lastiku għal ġol- kunjett.
Push the plunger of the syringe down to inject air into the vial.
Imbotta l- planġer tas- siringa 'l isfel biex tinjetta l- arja fil- kunjett.
See Figure 2.
Ara l- Figura 2.
10 Holding both the vial and the syringe, turn the vial upside down.
10 Waqt li żżomm kemm il- kunjett kif ukoll is- siringa, dawwar il- kunjett rasu 'l isfel.
Adjust the syringe so that the tip of the needle is slightly above the rubber stopper but still within the solution.
Irranġa s- siringa biex il- ponta tal- labra tkun ftit 'il fuq mit- tapp tal- lastiku iżda xorta waħda fis- soluzzjoni.
See Figure 3.
Ara l - Figura 3.
Slowly pull back the plunger to draw the solution into the syringe, filling it to the level (number of millilitres) instructed by your doctor.
Imliha sal- livell (numru ta 'millilitri) li jordnalek it- tabib.
If bubbles appear in the syringe, push the solution slowly back into the vial and withdraw the solution again.
Jekk ikun hemm il- bżieżaq fis- siringa, imbotta s- soluzzjoni bil - mod lura fil- kunjett u iġbed is- soluzzjoni mill- ġdid.
12 Take the needle out of the vial.
12 Oħroġ il- labra 'l barra mill- kunjett.
Do not lay the syringe down or let the needle touch anything.
Tmiddx is- siringa u tħalli l- labra tmissx ma 'mkien.
Replace the cover on the needle.
Erġa 'għatti l- labra bil- kappa.
Place the syringe on a clean flat surface.
Qiegħed is- siringa fuq xi wiċċ ċatt nadif.
There may be a small amount of solution left in the vial.
Jista 'jkun għad fadal ammont żgħir ta' soluzzjoni fil- kunjett.
This is to be returned to the pharmacist for disposal.
Dan għandu jittieħed lura għand l - ispiżjar għar- rimi.
Double check the syringe to make sure that you have withdrawn the correct amount.
Erġa 'kkontrolla s- siringa biex tkun żgur li ġbidt l- kwantità korretta.
Take the syringe and follow the “ INSTRUCTIONS FOR INJECTION” information below.
Oħroġ is- siringa u segwi s- sezzjoni "STRUZZJONIJIET GĦALL- INJEZZJONI" ta 'hawn taħt.
INSTRUCTIONS FOR INJECTION
STRUZZJONIJIET GĦALL- INJEZZJONI
You will usually inject two doses of 0.5 ml in a day, unless your doctor has prescribed a lower dose for you.
Ġeneralment ikollok tinjetta żewġ dożi ta '0. 5 ml kuljum, sakemm it- tabib ma jippreskrivilekx doża anqas.