qanastek/EMEA-V3 huggingface dataset:
201 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
194 RISPONSI TA ’ PAZJENTI B’ ANKYLOSING SPONDYLITIS FI STUDJU KKONTROLLAT BIL- PLAĊEBO Perċentwali ta ’ Pazjenti
202 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Studju 1 kien prova ta ’ Fażi 2 f’ pazjenti bi psorjasi tal- plakka klinikament stabbli imma attiva li tinvolvi ≥ 10% tal- erja tal- wiċċ tal- ġisem li kellhom ≥ 18- il sena.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
195 Studju 2 evalwa 652 pazjent bi psorasi tal- plakka kronika billi ntużaw l- istess kriterji ta ’ inklużjoni bħal fi studju 1 biż- żieda ta ’ minimum psoriasis area and severity index (PASI) ta ’ 10 waqt screening.
203 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Studju 2 kellu wkoll perijodu fejn il- mediċina ma ngħatatx waqt liem żmien pazjenti li kienu kisbu titjib PASI ta ’ mill- anqas 50% f’ ġimgħa 24 kellhom it- trattament imwaqqaf.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
196 Fi studju 3, il- maġġoranza tal- pazjenti (77%) li fil- bidu nett kienu magħżula b’ mod każwali għal 50 mg darbtejn fil- ġimgħa u li kellhom id- doża tagħhom ta ’ Enbrel imnaqqsa f’ ġimgħa 12 għal 25 mg darbtejn fil- ġimgħa żammew ir- rispons PASI 75 tagħhom sa ġimgħa 36.
204 Antibodies to Enbrel
Antikorpi għal Enbrel
In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 3% of subjects with juvenile idiopathic arthritis.
F’ pazjenti kkurati b’ dożi approvati ta ’ etanercept fi provi kliniċi sa 12- il xahar, ir- rati kumulattivi ta ’ antikorpi għal etanercept kienu ta ’ madwar 6% tal- pazjenti b’ artrite rewmatojde, 7. 5% tal- pazjenti
205 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Għalkemm hemm l- eliminazzjoni ta ’ radioattività fl- awrina wara t- tehid ta ’ etanercept immarkat b’ sustanza radju- attiva f’ pazjenti u f’ voluntiera, ma gietx osservata żieda fil- konċentrazzjonijiet ta ’ etanercept f’ pazjenti b’ insuffiċjenza renali jew epatika akuta.
Elderly patients
198 Pazjenti ta ’ età avvanzata
206 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
6.4 Special precautions for storage
Prekawzjonijiet speċjali għall- ħażna 6. 4
6.5 Nature and contents of container
199 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Cartons contain 2, 4 or 12 pre-filled syringes of Enbrel with 4, 8 or 24 alcohol swabs.
Il - pakkett fih 2, 4 jew 12- il siringa mimlija għal- lest ta ’ Enbrel u 4, 8 jew 24- il swabs ta ’ l- alkoħol.
The needle cover contains dry natural rubber (latex) (see section 4.4).
L - għatu tal- labra fih lasktu naturali niexef (latex) (ara sezzjoni 4. 8).
Not all pack sizes may be marketed.
Mhux il- qisien kollha tal- pakkett jistgħu jitqiegħdu fis- suq.
208 ANNEX II
200 ANNESS II
A.
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U A.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
209 A.
201 A.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65 D-88397 Biberach an der Riss Germany
Boehringer Ingelheim Pharma KG Birkendorfer Strasse 65 D- 88397 Biberach an der Riss Ġermanja
Wyeth Medica Ireland Wyeth BioPharma Campus at Grange Castle Grange Castle Business Park Clondalkin Dublin 22 Ireland
Wyeth Medica Ireland Wyeth BioPharma Campus at Grange Castle Grange Castle Business Park Clondalkin Dublin 22 L- Irlanda
Wyeth Pharmaceuticals New Lane Havant Hampshire, PO9 2NG United Kingdom
Wyeth Pharmaceuticals New Lane Havant Hampshire, PO9 2NG Ir- Renju Unit
Medicinal product subject to restricted medical prescription (See Annex I:
(Ara Anness I:
Summary of Product Characteristics, 4.2)
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
The Marketing Authorisation Holder will submit PSURs annually in April.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jkompli jibgħat PSURs kull sena f’ April.
Risk Management Plan
Pjan dwar l- Immaniġġjar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 (02-October-2008) of the Risk Management Plan (RMP), presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur tal- Awtorizzazzjoni tal- Manifattura jintrabat li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 1. 1 (2 ta ’ Ottubru, 2008) tal- Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2. tal- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
210 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 CHPM dwar is- Sistemi tal- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (Periodic Safety Update Report - PSUR) li jkun imiss.
In addition, an updated RMP should be submitted:  When new information is received that may impact 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
202 Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess: • Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
211 ANNEX III
203 ANNESS III
212 A.
204 A.
213 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
205 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON TEXT – EU/ 1/ 99/ 126/ 001
KITBA FUQ IL- KARTUNA – EU/ 1/ 99/ 126/ 001
Enbrel 25 mg powder and solvent for solution for injection etanercept
Enbrel 25mg Trab u solvent għal soluzzjoni għall- injezzjoni Etanercept
Each vial of Enbrel contains 25 mg etanercept.
Kull kunjett ta ’ Enbrel fih 25 mg etanercept.
The other ingredients in Enbrel are:
Is- sustanzi l- oħra f' Enbrel huma:
Solvent:
Mannitol, sukrożju u trometamol Solvent:
4 vials of powder 4 pre-filled syringes of 1 ml solvent 8 alcohol swabs
4 fjali ta 'trab 4 siringi mimlija għal- lest b’ 1ml solvent 8 swabs ta ’ l- alkoħol
For subcutaneous use.
Għal użu taħt il- ġilda.
XX/ YYYY
XX/ SSSS
9.
206 9.
Store in a refrigerator Do not freeze.
Tagħmlux fil- friża.
After preparing the Enbrel solution, immediate use is recommended.
Wara li tipprepara s- soluzzjoni ta 'Enbrel, huwa rrakkomandat li tintuża minnufih.
However, the solution may be use for up to 6 hours when stored in the refrigerator (2 – 8 C)
Madankollu, is - soluzzjoni tista 'tintuża sa 6 sigħat wara meta tinżamm maħżuna fil- friġġ (2° – 8°C).
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 BZONN
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom.
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, Renju Unit.
215 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
207 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR VIAL LABEL – EU/ 1/ 99/ 126/ 001
KITBA FUQ IT- TIKKETTA TAL- FJALA – EU/ 1/ 99/ 126/ 001
Enbrel 25 mg powder for injection etanercept Subcutaneous use
Enbrel 25mg trab għall- injezzjoni etanercept Għall- użu taħt il- ġilda
216 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
208 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR SYRINGE LABEL – EU/ 1/ 99/ 126/ 001
KITBA FUQ IT- TIKKETTA TAS- SIRINGA – EU/ 1/ 99/ 126/ 001
Solvent for Enbrel 1ml water for injections
Solvent għal Enbrel 1ml ilma għall- injezzjonijiet
217 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
209 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 001
KITBA GĦAL WARA TAT- TREJ – EU/ 1/ 99/ 126/ 001
Enbrel 25 mg powder and solvent for solution for injection etanercept
Enbrel 25 mg trab u solvent għal soluzzjoni għall- injezzjoni etanercept
218 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
210 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON TEXT – EU/ 1/ 99/ 126/ 002
KITBA FUQ IL- KARTUNA – EU/ 1/ 99/ 126/ 002
Enbrel 25 mg powder for solution for injection etanercept
Enbrel 25mg Trab għal soluzzjoni għall- injezzjoni Etanercept
Mannitol, sucrose and trometamol.
Mannitol, sukrożju u trometamol.
Powder for solution for injection 4 vials of powder.
Trab għal soluzzjoni għall- injezzjoni.
8 alcohol swabs
4 kunjetti ta 'trab 8 swabs ta' l- alkoħol
After preparing the Enbrel solutione use is recommended.
211 Wara li tipprepara s- soluzzjoni ta 'Enbrel, huwa rakkomandat li tintuża minnufih.
However, the solution may be used for up to 6 hours when stored in the refrigerator (2 C – 8 C).
Madankollu, is - soluzzjoni tista 'tintuża sa 6 sigħat wara meta tinżamm maħżuna fil- friġġ (2°C – 8°C).
You will also need 1 ml of water for injections and a syringe to administer Enbrel
Ara l- fuljett ta ’ tagħrif komplet qabel tuża l- prodott.
220 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
212 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR VIAL LABEL – EU/ 1/ 99/ 126/ 002
KITBA FUQ IT- TIKKETTA TAL- FJALA – EU/ 1/ 99/ 126/ 002
Enbrel 25 mg powder for injection etanercept Subcutaneous use
Enbrel 25 mg trab għall- injezzjoni etanercept Għall- użu taħt il- ġilda
221 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
213 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 002
KITBA GĦAL WARA TAT- TREJ – EU/ 1/ 99/ 126/ 002
Enbrel 25 mg powder for solution for injection etanercept
Enbrel 25 mg trab għal soluzzjoni għall- injezzjoni etanercept
NAME OF THE MARKETING AUTHORISATION HOLDER
SEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
222 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
214 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON TEXT – EU/ 1/ 99/ 126/ 003-005
KITBA FUQ IL- KARTUNA – EU/ 1/ 99/ 126/ 003- 005
Enbrel 25 mg powder and solvent for solution for injection etanercept
Enbrel 25mg trab u solvent għal soluzzjoni għall- injezzjoni Etanercept
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA.
Mannitol, sucrose and trometamol.
Trab: mannitol, sukrożju u trometamol.
4 vials of powder 4 pre-filled syringes of 1 ml solvent 4 stainless steel injection needles 4 vial adaptors 8 alcohol swabs
4 kunjetti ta 'trab 4 siringi mimlija għal- lest b’ 1 ml solvent 4 labar ta ’ l- istainless steel għall- injezzjoni 4 adaptors tal- kunjetti8 swabs ta' l- alkoħol
8 vials of powder 8 pre-filled syringes of 1 ml sovent 8 stainless steel injection needles 8 vial adaptors 16 alcohol swabs
8 kunjetti ta 'trab 8 siringi mimlija għal- lest b’ 1 ml solvent 8 labar ta ’ l- istainless steel għall- injezzjoni 8 adaptors tal- kunjetti 16 swabs ta' l- alkoħol
24 vials of powder 24 pre-filled syringes of 1 ml solvent 24 stainless steel injection needles 24 vial adaptors 48 alcohol swabs
24 kunjetti ta 'trab 24 siringi mimlija għal- lest b’ 1 ml solvent 24 labar ta ’ l- istainless steel għall- injezzjoni 24 adaptors tal- kunjetti 48 swabs ta' l- alkoħol
7.
215 7.
After preparing the Enbrel solution, immediate use is recommended.
Wara li tipprepara s- soluzzjoni ta 'Enbrel, huwa rakkomandat li tintuża minnufih.
However, the solution may be used for up to 6 hours when stored in a refrigerator (2 C – 8 C).
Madankollu, is - soluzzjoni tista 'tintuża sa 6 sigħat wara meta tinżamm maħżuna fi friġġ (2°C – 8°C).
EU/ 1/ 99/ 126/ 003 4 vials EU/ 1/ 99/ 126/ 004 8 vials EU/ 1/ 99/ 126/ 005 24 vials
EU/ 1/ 99/ 126/ 003 4 fjali EU/ 1/ 99/ 126/ 004 8 fjali EU/ 1/ 99/ 126/ 005 24 fjala
225 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
217 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR VIAL LABEL – EU/ 1/ 99/ 126/ 003-005
KITBA FUQ IT- TIKKETTA TAL- KUNJETT – EU/ 1/ 99/ 126/ 003- 005
226 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
218 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR SYRINGE LABEL – EU/ 1/ 99/ 126/ 003-005
KITBA FUQ IT- TIKKETTA TAS- SIRINGA – EU/ 1/ 99/ 126/ 003- 005
METHOD OF ADMINISTRATION
METODU TA ’ GĦANDU KIF JINGĦATA
227 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
219 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 003-005
KITBA GĦAL WARA TAT- TREJ – EU/ 1/ 99/ 126/ 003- 005
228 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
220 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON TEXT – EU/ 1/ 99/ 126/ 006-008 (50 mg Vial only)
KITBA FUQ IL- KARTUNA – EU/ 1/ 99/ 126/ 006- 008 (fjala ta ’ 50 mg biss)
Enbrel 50 mg powder for solution for injection etanercept
Enbrel 50 mg trab u solvent għal soluzzjoni għall- injezzjoni Etanercept
Each vial of Enbrel contains 50 mg etanercept.
Kull kunjett ta ’ Enbrel fih 50 mg etanercept.
Powder for solution for injection
Trab għal soluzzjoni għall- injezzjoni.
4 alcohol swabs
2 kunjetti ta 'trab 4 swabs ta' l- alkoħol
4 vials of powder 8 alcohol swabs
4 kunjetti ta 'trab 8 swabs ta' l- alkoħol
12 vials of powder 24 alcohol swabs
12- il kunjetti ta 'trab 24 swabs ta' l- alkoħol
XX/ YYYY
XX/ SSSS 221 9.
However, the solution may be used for up to 6 hours when stored in the refrigerator (2 C – 8 C).
Madankollu, is - soluzzjoni tista 'tintuża sa 6 sigħat wara meta tinżamm maħżuna fi friġġ (2°C – 8°C).
EU/ 1/ 99/ 126/ 006 - 2 vials EU/ 1/ 99/ 126/ 007 - 4 vials EU/ 1/ 99/ 126/ 008 - 12 vials
EU/ 1/ 99/ 126/ 006 - 2 kunjetti EU/ 1/ 99/ 126/ 007 - 4 kunjetti EU/ 1/ 99/ 126/ 008 - 12- il kunjett
You will also need 1 ml of water for injections and a syringe to administer Enbrel
Se jkollok bżonn ukoll ta ’ 1 ml ta ’ ilma għall- injezzjonijiet u ta ’ siringa biex tieħu Enbrel.
231 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
222 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR VIAL LABEL – EU/ 1/ 99/ 126/ 006-008 (50 mg Vial only)
KITBA FUQ IT- TIKKETTA TAL- KUNJETT – EU/ 1/ 99/ 126 – 006- 008 (fjala ta ’ 50 mg biss)
Enbrel 50 mg powder for injection etanercept Subcutaneous use
Enbrel 50 mg trab għall- injezzjoni etanercept Għall- użu taħt il- ġilda
232 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
223 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 006-008 (50 mg Vial only)
KITBA GĦAL WARA TAT- TREJ - EU/ 1/ 99/ 126/ 006- 008 (fjala ta ’ 50 mg biss)
Enbrel 50 mg powder for solution for injection etanercept
Enbrel 50 mg trab u solvent għal soluzzjoni għall- injezzjoni etanercept
233 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
224 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON TEXT – EU/ 1/ 99/ 126/ 009-011 (50 mg Convenience Pack)
KITBA FUQ IL- KARTUNA – EU/ 1/ 99/ 126 // 009- 011 (Pakkett ta ’ Konvenjenza 50 mg)
Enbrel 50 mg powder and solvent for solution for injection etanercept
Enbrel 50 mg trab u solvent għal soluzzjoni għall- injezzjoni Etanercept
Powder, Mannitol, sucrose and trometamol.
Trab: mannitol, sukrożju u trometamol.
2 vials of powder 2 pre-filled syringes of 1 ml solvent 2 stainless steel injection needles 2 vial adaptors 4 alcohol swabs
2 kunjetti ta 'trab 2 siringi mimlija għal- lest b’ 1 ml solvent 2 labar ta ’ l- istainless steel għall- injezzjoni 2 adaptors tal- kunjetti 4 swabs ta' l- alkoħol
4 vials of powder 4 pre-filled syringes of 1 ml sovent 4 stainless steel injection needles 4 vial adaptors 8 alcohol swabs
4 kunjetti ta 'trab 4 siringi mimlija għal- lest b’ 1 ml solvent 4 labar ta ’ l- istainless steel għall- injezzjoni 4 adaptors tal- kunjetti 8 swabs ta' l- alkoħol
12 vials of powder 12 pre-filled syringes of 1 ml solvent 12 stainless steel injection needles 12 vial adaptors 24 alcohol swabs
12- il kunjetti ta 'trab 12- il siringa mimlija għal- lest b’ 1 ml solvent 12- il labra ta ’ l- istainless steel għall- injezzjoni 12- il adaptor tal- kunjetti 24 swabs ta' l- alkoħol
EU/ 1/ 99/ 126/ 009 – 2 vials EU/ 1/ 99/ 126/ 010 – 4 vials EU/ 1/ 99/ 126/ 011 – 12 vials
EU/ 1/ 99/ 126/ 009 – 2 kunjetti EU/ 1/ 99/ 126/ 010 – 4 kunjetti EU/ 1/ 99/ 126/ 011 – 12- il kunjett
16.
226 16.
236 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
227 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR VIAL LABEL – EU/ 1/ 99/ 126/ 009-011 (50 mg Convenience Pack)
KITBA FUQ IT- TIKKETTA TAL- FJALA – EU/ 1/ 99/ 126/ 009- 011 (Pakkett ta ’ Konvenjenza 50 mg)
237 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
228 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR SYRINGE LABEL – EU/ 1/ 99/ 126/ 009-011 (50 mg Convenience Pack)
KITBA FUQ IT- TIKKETTA TAS- SIRINGA – EU/ 1/ 99/ 126/ 009- 011 (Pakkett ta ’ Konvenjenza 50 mg)
238 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
229 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 009-011 (50 mg Convenience Pack)
KITBA GĦAL WARA TAT- TREJ – EU/ 1/ 99/ 126/ 009- 011 (Pakkett ta ’ Konvenjenza 50 mg)
239 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
230 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON TEXT – EU/ 1/ 99/ 126/ 012 (For paediatric use)
KITBA FUQ IL- KARTUNA – EU/ 1/ 99/ 126/ 012 (għall- użu pedjatriku)
Enbrel 25 mg/ ml powder and solvent for solution for injection for paediatric use etanercept
Enbrel 25 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni għall- użu pedjatriku. etanercept
Each vial of Enbrel contains 25 mg etanercept.
Kull kunjett ta 'Enbrel fih 25 mg etanercept.
When reconstituted, the solution contains 25 mg/ ml etanercept.
Meta rekostitwita, is- soluzzjoni fiha 25 mg/ ml etanercept.
Water for injections and benzyl alcohol (see the package leaflet for further information).
Ilma għall- injezzjonijiet u benzyl alkoħol (ara l- fuljett ta ’ tagħrif għal aktar informazzjoni)
4 vials of powder 4 pre-filled syringes of 1 ml solvent 8 empty syringes 20 stainless-steel injection needles 24 alcohol swabs
4 kunjetti ta 'trab 4 siringi ta' 1 ml solvent mimlija għal- lest 8 siringi vojta 20 labar ta ’ l- istainless steel għall- injezzjoni 24 swabs ta 'l- alkoħol
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tifel/ tifla.
9.
231 9.
241 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
232 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR VIAL LABEL – EU/ 1/ 99/ 126/ 012 (For paediatric use)
KITBA FUQ IT- TIKKETTA TAL- FJALA – EU/ 1/ 99/ 126 // 012 (għall- użu pedjatriku)
242 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
233 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR SYRINGE LABEL – EU/ 1/ 99/ 126/ 012 (For paediatric use)
KITBA FUQ IT- TIKKETTA TAS- SIRINGA – EU/ 1/ 99/ 126/ 012 (għall- użu pedjatriku)
Solvent for Enbrel 1ml bacteriostatic water for injections
Solvent għal Enbrel 1ml ilma batterjostatiku għall- injezzjonijiet
243 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
234 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 012 (For paediatric use)
KITBA GĦAL WARA TAT- TREJ – EU/ 1/ 99/ 126/ 012 (għall- użu pedjatriku)
244 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
235 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON TEXT – EU/ 1/ 99/ 126/ 013-015 (25 mg Pre-filled Syringe)
KITBA FUQ IL- KARTUNA – EU/ 1/ 99/ 126 // 013- 015 (Siringa mimlija għal- lest 25 mg)
Enbrel 25 mg solution for injection in pre-filled syringe etanercept
Enbrel 25 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest etanercept
Each pre-filled syringe of Enbrel contains 25 mg etanercept.
Kull siringa mimlija għal- lest ta ’ Enbrel fih 25 mg etanercept.
Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate and water for injections.
Sukrożju, sodium chloride, L- arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate u ilma għall- injezzjonijiet.
Solution for injection in pre-filled syringe
Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
4 pre-filled syringes 8 alcohol swabs
4 siringi mimlija għal- lest b’ 1 ml ta ’ solvent 8 swabs ta ’ l- alkoħol
8 pre-filled syringes 16 alcohol swabs
8 siringi mimlija għal- lest b’ 1 ml ta ’ solvent 16 swabs ta ’ l- alkoħol
24 pre-filled syringes 48 alcohol swabs
24 siringi mimlija għal- lest b’ 1 ml ta ’ solvent 48 swabs ta ’ l- alkoħol
Injection advice:
Rakkomandazzjoni dwar l- injezzjoni:
Inject the solution after it has reached room temperature (15 to 30 minutes after taking the product from the refrigerator).
Injetta s- soluzzjoni meta tkun laħqet it- temperatura ambjentali tal- kamra (15 sa 30 minuta wara li tkun ħriġt il- prodott minn ġol- friġġ).
Inject slowly, at an angle of 45° to 90° to the skin.
Injetta bil- mod, f’ angolu ta ’ 45° sa 90° minn mal- ġilda.
247 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
237 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT FOR TRAY BACK – EU/ 1/ 99/ 126/ 013-015 (25 mg Pre-filled Syringe)
KITBA GĦAL WARA TAT- TREJ – EU/ 1/ 99/ 126/ 013- 015 (Siringa mimlija għal- lest 25 mg)
248 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
238 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR PRE-FILLED SYRINGE LABEL – EU/ 1/ 99/ 126/ 013-015 (25 mg Pre-filled Syringe)
KITBA FUQ IT- TIKKETTA TAS- SIRINGA MIMLIJA GĦAL- LEST – EU/ 1/ 99/ 126/ 013- 015 (Siringa mimlija għal- lest 25 mg)
Enbrel 25 mg injection etanercept Subcutaneous use
Enbrel 25 mg injezzjoni etanercept Użu subkutaneju
25 mg/ 0.5 ml
25 mg/ 0. 5 ml
249 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
239 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON TEXT – EU/ 1/ 99/ 126/ 016-018 (50 mg Pre-filled Syringe)
KITBA FUQ IL- KARTUNA – EU/ 1/ 99/ 126 // 016- 018 (Siringa mimlija għal- lest 50 mg)
Enbrel 50 mg solution for injection in pre-filled syringe
Enbrel 50 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest etanercept
Each pre-filled syringe of Enbrel contains 50 mg etanercept.
Kull siringa mimlija għal- lest ta ’ Enbrel fih 50 mg etanercept.
Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate and water for injections.
Sukkrożju, sodium chloride, L- arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate u ilma għall- injezzjonijiet.
solution for injection in pre-filled syringe
Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
2 pre-filled syringes 4 alcohol swabs
2 siringi mimlija għal- lest b’ 1 ml ta ’ solvent 4 swabs ta ’ l- alkoħol
12 pre-filled syringes 24 alcohol swabs
12 siringi mimlija għal- lest b’ 1 ml ta ’ solvent 24 swabs ta ’ l- alkoħol
252 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
241 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
TEXT FOR TRAY BACKING – EU/ 1/ 99/ 126/ 016-018 (50 mg Pre-filled Syringe)
KITBA GĦAL WARA TAT- TREJ – EU/ 1/ 99/ 126/ 016- 018 (Siringa mimlija għal- lest 50 mg)
Enbrel 50 mg solution for injection in pre-filled syringe etanercept
Enbrel 50 mg soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest etanercept
253 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
242 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
TEXT FOR PRE-FILLED SYRINGE – EU/ 1/ 99/ 126/ 016-018 (50 mg Pre-filled Syringe)
KITBA FUQ IT- TIKKETTA TAS- SIRINGA MIMLIJA GĦAL- LEST – EU/ 1/ 99/ 126/ 016- 018 (Siringa mimlija għal- lest 50 mg)
Enbrel 50 mg injection etanercept Subcutaneous use
Enbrel 50 mg injezzjoni etanercept Użu subkutaneju
50 mg/ 1.0 ml
50 mg/ 1. 0 ml
254 Enbrel Patient Alert Card
243 Patient Alert Card ta ’ Enbrel
This card contains important safety information that you need to be aware of before you are given Enbrel and during treatment with Enbrel.
Din il- card fiha informazzjoni importanti dwar is- sigurtà li inti jeħtieġ li tkun taf dwarha qabel u matul il - kura b’ Enbrel.
If you do not understand this information, please ask your doctor to explain it to you.
Jekk ma tifhimx din l- informazzjoni, jekk jogħġbok staqsi lit- tabib tiegħek biex ifissirhielek.
 Show this card to any doctor involved in your treatment.  See the Enbrel package leaflet for more information.
• Uri dil- card lil kwalunkwe tabib involut fil- kura tiegħek. • Ara l- fuljett ta ’ tagħrif ta ’ Enbrel għal aktar informazzjoni.
Enbrel may increase your risk of getting infections, which could be serious.
Enbrel jista ’ jżid ir- riskju tiegħek li jkollok infezzjonijiet, li jistgħu jkunu serji.
 You should not use Enbrel if you have an infection.
• M’ għandekx tuża Enbrel jekk għandek xi infezzjoni.
If you are not sure, ask your doctor.  If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.  You should be evaluated for tuberculosis (TB).
Jekk m’ intix ċert/ a, staqsi lit- tabib tiegħek. • Jekk tiżviluppa sintomi li jissuġġerixxu li hemm infezzjonijiet, bħal deni, sogħla persistenti, telf ta ’ piż, jew telqa, fittex attenzjoni medika immedjatament. • Għandek tkun evalwat/ a għat- tuberkulosi (TB).
Ask your doctor to record the dates and the results of your last screening for TB below:
Staqsi lit- tabib tiegħek biex iniżżel id- dati u r- riżultati ta ’ l- aħħar screening tiegħek għat- TB hawn taħt:
Results: ____________________________
Riżultati: ____________________________
 Please ask your physician to list your other medications that may increase your risk of infection.
• Jekk jogħġbok staqsi lit- tabib tiegħek biex iniżżel il- mediċini l- oħrajn tiegħek li jistgħu jżidu r- riskju li tieħu xi infezzjoni.
Congestive Heart Failure
Insuffiċjenza tal- Qalb Konġestiva
 If you have congestive heart failure, and you think your symptoms (e. g., shortness of breath or swelling of the feet) are becoming worse, seek medical attention immediately.
• Jekk għandek insuffiċjenza konġestiva tal- qalb, u taħseb li s- sintomi tiegħek (eż., qtugħ ta ’ nifs jew nefħa tas- saqajn) qed jaggravaw, fittex attenzjoni medika immedjatament.
Other Information (please complete)
Informazzjoni oħra (jekk jogħġbok imla)
Patient’ s Name: ________________________________
Isem tal- Pazjent: _________________________________
Doctor ’ s Name: ________________________________
Isem tat- Tabib: __________________________________
Doctor’ s Phone: ________________________________
Telefon tat- Tabib: ________________________________
 Keep this card with you for 2 months after the last Enbrel dose, since side effects may occur after your last dose of Enbrel.
• Żomm din il- card fuqek għal xahrejn wara l- aħħar doża ta ’ Enbrel, għax l- effetti sekondarji jistgħu jseħħu wara l- aħħar doża tiegħek ta ’ Enbrel.
255 B.
244 B.
256 PACKAGE LEAFLET:
245 FULJETT TA ’ TAGĦRIF:
Enbrel 25 mg powder and solvent for solution for injection Etanercept
Enbrel 25 mg trab u solvent għal soluzzjoni għall- injezzjoni Etanercept
Read all (both sides) of this leaflet carefully before you start using this medicine.  Keep this leaflet.
Aqra sew (iż- żewġ naħat) dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again.  Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Enbrel.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you or a child in your care.
Jista jkollok bżonn terġa ’ taqrah. • It- tabib tiegħek ser jagħtik ukoll Patient Alert Card, li fiha informazzjoni importanti dwar is - sigurtà li inti jeħtieġ li tkun taf dwarha qabel u matul il- kura b’ Enbrel. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek jew lil tifel/ tifla li tinsab taħt il- kura tiegħek.
It may harm them, even if their symptoms are the same as yours or those of the child you are caring for.  If you are concerned about any side effect, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek jew tat- tifel/ tifla li jinsabu taħt il- kura tiegħek. • Jekk inti imħasseb dwar xi effetti sekondarji, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew spiżjar tiegħek.
Information in this leaflet is organised under the following 7 sections:
L- informazzjoni f' dan il- fuljett hi mqassma taħt dawn is- 7 sezzjonijiet li ġejjin:
What Enbrel is and what it is used for 2.
X’ inhu Enbrel u għalxiex jintuża 2.
Before you use Enbrel 3.
Qabel ma tuża Enbrel 3.
How to use Enbrel 4.
Kif għandek tuża Enbrel 4.
How to store Enbrel 6.
Kif taħżen Enbrel 6.
Further information 7.
Aktar tagħrif 7.
Instructions for preparing and giving an injection of Enbrel (See overleaf)
Struzzjonijiet għall- preparazzjoni u kif tagħti injezzjoni ta ’ ENBREL (Ara l- folja ta 'wara)
WHAT ENBREL IS AND WHAT IT IS USED FOR
X’ INHU ENBREL U GĦALXIEX JINTUŻA
Etanercept, the active ingredient in Enbrel, is a biologic medicine that is made from two human proteins.
Etanercept, is- sustanza attiva f' Enbrel, hi mediċina bijoloġika magħmula minn żewġ proteini umani.
It blocks the activity of another protein in the body that causes inflammation.
Hi timblokka l- attività ta 'proteina oħra fil- ġisem li tikkaġuna l- infjammazzjoni.
Etanercept works by reducing the inflammation associated with certain diseases.
Etanercept jiffunzjona billi jnaqqas l- infjammazzjoni assoċjata ma 'ċertu mard.
In adults (aged 18 and over), Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis and moderate or severe psoriasis – in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
F' adulti (ta '18- il sena jew aktar), Enbrel jista' jintuża għal artrite rewmatojde, artrite psorjatika minn moderata sa serja u ankylosing spondylitis severa u psorjasi moderata jew severa – f' kull każ fejn ġeneralment trattamenti użati komunament ma jkunux ħadmu tajjeb biżżejjed jew m' humiex adattati għalik.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you.
Għal artrite rewmatojde, Enbrel ġeneralment jiġi użat flimkien ma 'methotrexate, għalkemm jista' jintuża waħdu jekk it- trattament b' methotrexate mhux adattat għalik.
Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to your joints caused by the rheumatoid arthritis, and improve your ability to do normal daily activities.
Kemm jekk jintuża waħdu jew flimkien ma 'methotrexate, Enbrel jista' jnaqqas il- ħsara fil- ġogi tiegħek ikkawżati mill- artrite rewmatojde, u jttejjeb il- ħila tiegħek biex tagħmel l- attivitajiet normali ta 'kuljum.
For psoriatic arthritis patients with multiple joint involvement, Enbrel can improve your ability to do normal daily activities.
Għal pazjenti li għandhom atrite psorjatika b’ involviment f’ ħafna ġogi, Enbrel jista ’ jtejjeb il- ħila tiegħek biex twettaq l- attivitajiet normali ta ’ kuljum.
For patients with multiple symmetrical painful or swollen joints (e. g. hands, wrists and feet), Enbrel can slow down the structural damage to those joints caused by the disease.
Għal pazjenti li għandhom ħafna mill- ġogi simmetriċi li juġgħuhom jew li jkunu minfuħin (eż. l- idejn, il- polz u s- saqajn), Enbrel jista ’ jgħin biex il- ħsara strutturali kkawżata mill- marda lil dawk il- ġogi ssir aktar bil- mod.
Enbrel is also prescribed for the treatment of the following diseases in children and adolescents:
Enbrel jingħata wkoll b’ riċetta għall- kura tal- mard li ġej fit- tfal u fl- adolexxenti:
257  Polyarticular juvenile idiopathic arthritis (a type of juvenile arthritis that affects many joints) in patients from the age of 4 years who have had an inadequate response to (or are unable to take) methotrexate.
• Artrite idjopatika ġuvenili poliartikulari (tip ta ’ artrite ġuvenili li taffettwa ħafna ġogi) f’ pazjenti mill- età ta ’ 4 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) methotrexate.
 Severe psoriasis in patients from the age of 8 years who have had an inadequate response to (or are unable to take), phototherapies or other systemic therapies.
246 • Psorjasi severa f’ pazjenti mill- età ta ’ 8 snin li kellhom rispons inadegwat għal (jew li ma jistgħux jieħdu) fototerapiji jew terapiji sistemiċi oħrajn.
Enbrel is not effective in the treatment of Wegener’ s granulomatosis, a rare inflammatory disease.
Enbrel mhux effettiv għat- trattament tal- granulomatosi ta 'Wegener, marda infjammatorja rari.
If you or the child in your care have Wegener’ s granulomatosis talk to your doctor.
Jekk int jew it- tifel/ tifla tiegħek għandhom il- granulomatosi ta 'Wegener kellem lit- tabib tiegħek.
BEFORE YOU USE ENBREL
QABEL MA TUŻA ENBREL
Do not use Enbrel
Tieħux Enbrel
 Allergy:
• Allerġija:
If you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Enbrel.
Jekk int, jew it- tifel/ tifla li qed tieħu ħsieb, tkunu allerġiċi għal etanercept jew xi wieħed mis- sustanzi ta 'Enbrel.
If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, and contact your doctor immediately.  Serious blood infection:
Jekk inti jew it- tifel/ tifla jkollhom reazzjonijiet allerġiċi bħal għafis tas- sider, tħarħir, sturdamenti jew raxx, tinjettax aktar Enbrel, u kkuntattja lit- tabib tiegħek minnufih. • Infezzjoni serja tad- demm:
If you or the child have, or are at risk of developing a serious blood infection called sepsis.
Jekk int jew it- tifel/ tifla għandkom, jew tinsabu f' riskju li tiżviluppaw infezzjoni tad- demm serja li tissejjaħ sepsis.
If you are not sure, please contact your doctor.  Infections:
Jekk inti m' intix żgur, jekk jogħġbok ikkuntattja lit- tabib tiegħek. • Infezzjonijiet:
If you or the child have an infection of any kind.
Jekk int jew it- tifel/ tifla għandkom xi infezzjoni ta 'kwalunkwe tip.
If you are unsure, please talk to your doctor.
Jekk m' intix żgur, jekk jogħġbok kellem lit- tabib tiegħek.
Take special care with Enbrel
Oqgħod attent ħafna b' Enbrel
 Infections/ surgery:
• Infezzjonijiet/ kirurġija:
If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Enbrel.  Infections/ diabetes:
Jekk int jew it- tifel/ tifla tiżviluppaw xi infezzjoni ġdida, jew ser ikollkhom intervent kirurġiku maġġuri, it- tabib tiegħek għandu mnejn ikun jixtieq jissorvelja t - trattament tiegħek b' Enbrel. • Infezzjonijiet/ dijabete:
Tell your doctor if you or the child have a history of recurrent infections, or suffer from diabetes or other conditions that increase the risk of infection.  Infections/ monitoring:
Għid lit- tabib tiegħek jekk int jew it- tifel/ tifla għandkhom storja ta 'infezzjonijiet rikorrenti, jew tbatu mid- dijabete jew kundizzjonijiet oħra li jżidu r- riskju ta' infezzjoni. • Infezzjonijiet/ monitoraġġ:
Tell your doctor of any recent travel outside the European region.
Għid lit- tabib tiegħek dwar kwalunkwe vvjaġġar riċenti ’ il barra mir- reġjun Ewropew.
If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately.
Jekk inti jew it- tifel/ tifla tiegħek tiżviluppaw sintomi ta ’ infezzjoni bħal deni, tertir ta ’ bard jew sogħla, avża lit- tabib tiegħek immedjatament.
Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Enbrel.  Tuberculosis:
It- tabib tiegħek jista ’ jiddeċiedi li jkompli jimmonitorja lilek jew lit- tifel/ tifla tiegħek għall- preżenza ta ’ infezzjonijiet wara li inti jew it- tifel/ tifla tieqfu tużaw Enbrel. • Tuberkulosi:
As cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check for signs and symptoms of tuberculosis before starting Enbrel.
Minħabba li każijiet ta ’ tuberkulosi kienu rrappurtati f’ pazjenti kkurati b’ Enbrel, it- tabib tiegħek ser jiċċekkja għal sinjali u sintomi ta ’ tuberkulosi qabel ma jibda l- kura b’ Enbrel.
This may include a thorough medical history, a chest X-ray and a tuberculin test.
Dan jista ’ jinkludi storja medika dettaljata, raġġi- x tas- sider u test ta ’ tuberculin.
The conduct of these tests should be recorded on the Patient Alert Card.
Id - data ta ’ meta jsiru dawn it- testijiet għandha tkun irreġistrata fuq il- patient’ s alert card.
It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis.
Hu importanti ħafna li tgħid lit- tabib tiegħek jekk inti jew it- tifel/ tifla tiegħek qatt kellkom it - tuberkulosi, jew kontu qrib ta ’ xi ħadd li kellu t- tuberkulosi.
If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.  Hepatitis B:
Jekk sintomi ta ’ tuberkulosi (bħal sogħla persistenti, telf ta ’ piż, telqa, deni ħafif), jew kwalunkwe infezzjoni oħra tidher matul jew wara t- terapija, għid lit- tabib tiegħek immedjatament. • Epatite B:
Your doctor may decide to test for the presence of hepatitis B infection before you or the child begin treatment with Enbrel.  Hepatitis C:
It- tabib tiegħek jista ’ jiddeċiedi li jagħmel test għall- preżenza ta ’ infezzjoni ta ’ epatite B qabel int jew it- tifel/ tifla tiegħek tibdew il- kura b’ Enbrel. • Epatite Ċ:
Tell your doctor if you or the child have hepatitis C.
Għid lit- tabib tiegħek jekk inti jew it- tifel/ tifla tiegħek għandkom epatite Ċ.
Your doctor may wish to monitor the treatment with Enbrel in case the infection worsens.  Blood disorders:
Għandu mnejn li t- tabib tiegħek ikun jixtieq li jsir monitoraġġ tal- kura b’ Enbrel f’ każ li l- infezzjoni tmur għall- agħar. • Disturbi tad- demm:
Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Fittex għal parir mediku minnufih jekk inti jew it- tifel/ tifla tiegħek għandkom xi sinjali jew sintomi bħal ta 'deni persistenti, uġigħ fil- griżmejn, tbenġil, fsada jew sfurija.
Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Enbrel.
Sintomi bħal dawn jistgħu jindikaw eżistenza ta 'disturbi tad- demm li jistgħu jkunu ta' periklu għal ħajja, li jistgħu jinħtieġu li jitwaqqaf Enbrel. • Disturbi tas- sistema nervuża u ta 'l- għajnejn:
Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
Għid lit- tabib tiegħek jekk inti jew it- tifel/ tifla tiegħek għandkom is- sklerożi multipla, newrite ottika (infjammazzjoni tan- nervi ta 'l- għajnejn) jew majelite trasversali (infjammazzjoni tal- korda spinali).
Your doctor will determine if Enbrel is an appropriate treatment.  Congestive heart failure:
247 • Insuffiċjenza tal- qalb konġestiva:
Tell your doctor if you or the child have a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.  Vaccinations:
Għid lit- tabib tiegħek jekk int jew it- tifel/ tifla tiegħek għandkom storja ta 'insuffiċjenza tal- qalb konġestiva, peress li Enbrel jeħtieġ li jintuża b' kawtela f' dawn iċ- ċirkostanzi. • Vaċċinazzjonijiet:
If possible, children should be up to date with all vaccinations before using Enbrel.
It- tfal, jekk possibbli, għandhom ikunu aġġornati bil- vaċċinazzjonijiet kollha qabel ma jintuża Enbrel.
Some vaccines, such as oral polio vaccine, should not be given while using Enbrel.
Xi vaċċinazzjonijiet, bħal vaċċin tal- poljo orali, m' għandhomx jingħataw meta jkun qed jintuża Enbrel.
Please consult your doctor before you or the child receive any vaccines.  Chickenpox:
Jekk jogħġbok ikkonsulta mat- tabib qabel ma int jew it - tifel/ tifla tirċievu xi vaċċinazzjonijiet. • Ġidri r- riħ:
Tell your doctor if you or the child are exposed to chickenpox when using Enbrel.
Għid lit- tabib jekk int jew it- tifel/ tifla tiegħek huma esposti għal ġidri r- riħ meta tieħu Enbrel.
Your doctor will determine if preventive treatment for chickenpox is appropriate.  Latex:
It- tabib tiegħek ser jistabbilixxi jekk trattament preventiv għal ġidri r- riħ hux adattat. • Latex:
The needle cover is made from latex (dry natural rubber).
L- għatu tal- labra hu magħmul minn latex (lasktu naturali niexef).
Contact your doctor before using Enbrel if the needle cover will be handled by or Enbrel will be given to someone with a known or possible hypersensitivity (allergy) to latex.
Ikkuntattja lit- tabib tiegħek qabel tuża Enbrel jekk l- għatu tal- labra ser jintuża minn jew Enbrel ser jingħata lil persuna li hi magħrufa li għanda sensittività eċċessiva (allerġija) għal latex.
Tell the doctor or pharmacist if you or the child are taking or have recently taken any other medicines, even those not prescribed by the doctor.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jew tat- tifel/ tifla tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
You or the child should not use Enbrel with medicines that contain the active ingredients anakinra or abatacept.
Inti jew it- tifel/ tifla tiegħek m’ għandkomx tużaw Enbrel ma ’ mediċini li fihom is- sustanzi attivi anakinra jew abatacept.
Taking Enbrel with food and drink
Meta tieħu Enbrel ma ’ l- ikel u max- xorb
Enbrel can be taken with or without food or drink.
Enbrel jista 'jittieħed ma' l- ikel u x- xorb jew fuq stonku vojt.
The effects of Enbrel in pregnant women are not known, and so the use of Enbrel during pregnancy is not recommended.
L- effetti ta 'Enbrel fuq nisa tqal mhux magħruf, u għalhekk l- użu ta' Enbrel waqt it- tqala mhux irrakkomandat.
People using Enbrel should not become pregnant.
Persuni li qed jieħdu Enbrel m' għandhomx jinqabdu tqal.
If the patient becomes pregnant, you should consult the patient's doctor.
Jekk il- pazjenta tinqabad tqila, inti għandek tikkonsulta t- tabib tal- pazjenta.
People using Enbrel should not breast-feed, since it is not known if Enbrel passes into human breast milk.
Persuni li qegħdin fuq Enbrel m' għandhomx ireddgħu peress li mhux magħruf jekk Enbrel jgħaddix fil- ħalib tas- sider.
The use of Enbrel is not expected to affect the ability to drive or use machines.
L- użu ta 'Enbrel mhux mistenni li jaffettwa l- ħila tiegħek biex issuq jew tħaddem magni.
HOW TO USE ENBREL
KIF GĦANDEK TUŻA ENBREL
Always use Enbrel exactly as the doctor has told you.
Dejjem għandek tieħu Enbrel skond il- parir tat- tabib.
You should check with the doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma l- ispiżjar jekk ikollok xi dubju.
If you feel that the effect of Enbrel is too strong or too weak, talk to your doctor or pharmacist.
Jekk inti tħoss li l- effett ta 'Enbrel huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill - ispiżjar tiegħek dwar dan.
259 Dosing for adult patients (aged 18 years or over)
Doża għal pazjenti adulti (ta '18- il sena jew aktar)
Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis
Artrite rewmatojde, artrite psorjatika u ankylosing spondylitis
The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin.
Id- doża ġenerali hi 25 mg li tingħata darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa bħala injezzjoni taħt il- ġilda.
However, your doctor may determine an alternative frequency at which to inject Enbrel.
Madankollu, it- tabib tiegħek jista 'jistabbilixxi frekwenza alternattiva meta għandu jiġi injettat Enbrel.
Plaque psoriasis
248 Psorjasi tal- plakka
The usual dose is 25 mg twice a week or 50 mg once a week.
Id- doża normali hi ta ’ 25 mg darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa.
Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Inkella, 50 mg jistgħu jingħataw darbtejn fil- ġimgħa sa 12- il ġimgħa, segwiti minn 25 mg mogħtija darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa.
Your doctor will decide how long you should take Enbrel and whether retreatment is needed based on your response.
It- tabib tiegħek ser jiddeċidi għal kemm żmien għandek tieħu Enbrel u jekk għandux ikun hemm trattament mill- ġdid skond ir- rispons tiegħek.
If Enbrel has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Jekk Enbrel m' għandux effett fuq il- kundizzjoni tiegħek wara 12- il ġimgħa, it- tabib tiegħek għandu mnejn jgħidlek tieqaf tieħu din il- mediċina.
Dosing for children and adolescents
Doża għat- tfal u l- adoloxxenti
The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease.
Id- doża adattata u l- frekwenza tad- dożaġġ għat- tifel/ tifla jew adolexxenti ser tkun tiddependi fuq il- piż tal- ġisem u l- marda.
The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
It- tabib ser jagħtik istruzzjonijiet dettaljati għall- preparazzjoni u l- kejl tad- doża adattata.
For polyarticular juvenile idiopathic arthritis in patients from the age of 4 years, the dose recommended is 0.4 mg of Enbrel per kg bodyweight (up to a maximum of 25 mg), and should be given twice weekly.
Għal artrite idjopatika ġuvenili poliartikulari f’ pazjenti mill- età ta ’ 4 snin, id- doża rakkomandata hi ta ’ 0. 4 mg ta ’ Enbrel għal kull kg ta ’ piż tal- ġisem (sa massimu ta ’ 25 mg), u għandha tingħata darbtejn f’ ġimgħa.
For psoriasis in patients from the age of 8 years, the dose recommended is 0.8 mg of Enbrel per kg bodyweight (up to a maximum of 50 mg), and should be given once weekly.
Għal psorjasi f’ pazjenti mill- età ta ’ 8 snin, id- doża rakkomandata hi ta ’ 0. 8 mg ta ’ Enbrel għal kull kg ta ’ piż tal- ġisem (sa massimu ta ’ 50 mg), u għandha tingħata darba f’ ġimgħa.
If Enbrel has no effect on the child’ s condition after 12 weeks, your doctor may tell you to stop using this medicine.
Jekk Enbrel ma jkollu l - ebda effett fuq il- kundizzjoni tat- tifel/ tifla wara 12- il ġimgħa, it- tabib tiegħek jista ’ jgħidlek biex tieqaf tuża din il- mediċina.