qanastek/EMEA-V3 huggingface dataset:
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
F’ pazjenti nfetti b’ HIV b’ defiċjenza immuni severa fil- ħin li tinbeda t- terapija antiretrovirali kombinata (CART), tista ’ sseħħ reazzjoni infjammatorja għall- infezzjonijiet mingħajr sintomi jew infezzjonijiet residwali opportunistiċi (ara sezzjoni 4. 4).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
19 Kienu rrappurtati każijiet ta ’ osteonekrożi, speċjalment f’ pazjenti b’ fatturi ta ’ riskju ġeneralment magħrufa, marda ta ’ l- HIV avvanzata jew esponiment fit- tul għal CART.
19 of Normal of > 0.7 x 109/ l] occurred at a higher rate amongst patients in the Fuzeon containing group (12.4 patients with event per 100 patient-years) compared with OB alone regimen (5.6 patients with event per 100 patient-years).
Matul l- 48 ġimgħa, esinofilja [aktar mill- Ogħla Limitu tan- Normal ta ’ > 0. 7 x 109/ 1] seħħet b’ rata ogħla f’ pazjenti fil- grupp b’ Fuzeon (12. 4 pazjent b’ effett għal kull 100 sena ta ’ pazjent) meta mqabbla ma ’ programm ta ’ kura b’ OB waħdu (5. 6 pazjent b’ effett għal kull 100 sena ta ’ pazjent).
Exposure adjusted Grade 3 & 4 laboratory abnormalities among patients on Fuzeon+OB and OB alone regimens, reported at more than 2 patients with event per 100 patient years
Anormalitajiet tal- laboratorju ta ’ Grad 3 & 4 b’ espożizzjoni aġġustata fost pazjenti fuq programm ta ’ kura b’ Fuzeon+OB u OB waħdu, rrapurtati ghal aktar minn 2 pazjenti b’ effett kull 100 sena ta ’ pazjent.
Fuzeon+OB regimen
Gradazzjoni tal- Parametri tal - Programm ta ’ kura b’ Fuzeon+OB Programm ta ’ kura b’ OB waħdu Laboratorju n (Total ta ’ snin ta ’ Espożizzjoni ta ’ pazjent) ALAT
OB alone regimen
kull 100
Grading n (Total Exposure patient years) ALAT
sena ta ’ pazjent 663 (557. 0)
Per 100 patient years 663 (557.0)
kull 100
Per 100 patient years 334 (162.1)
sena ta ’ pazjent 334 (162. 1)
4 (< 6.5 g/ dL) Creatinine phosphokinase
4 (< 6. 5 g/ dL) Krejatinina phosphokinase
It is an inhibitor of the structural rearrangement of HIV-1 gp41 and functions by specifically binding to this virus protein extracellularly thereby blocking fusion between the viral cell membrane and the target cell membrane, preventing the viral RNA from entering into the target cell.
Huwa inibitur ta ’ l- arranġament strutturali mill- ġdid ta ’ gp41 ta ’ HIV- 1 u jaħdem billi jeħel speċifikament ma ’ din il- proteina tal- virus barra miċ- ċellula u b’ hekk iwaqqaf il- fużjoni bejn il - membrana taċ- ċellula tal- virus u l- membrana taċ- ċellula immirata, u jipprevjeni li l- RNA virali tidħol fiċ- ċellula immirata.
Antiviral activity in vitro:
20 Attività antivirali in vitro:
20 In Vitro resistance to enfuvirtide:
Reżistenza In Vitro għal enfuvirtide:
(See table 5)
(Ara Tabella 5)
Due to its novel viral target enfuvirtide is equally active in vitro against both wild-type laboratory and clinical isolates and those with resistance to 1, 2 or 3 other classes of antiretrovirals (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors).
Minħabba l- mira virali ġdida tiegħu, enfuvirtide għandu l- istess livell ta ’ attività in vitro kemm kontra iżolati kliniċi, kontra dawk tal- laboratorju tat- tip salvaġġ, kif ukoll kontra dawk b’ reżistenza għal 1, 2, jew 3 klassijiet oħrajn ta ’ antiretrovirali (impedituri nucleoside reverse transcriptase, impedituri non- nucleoside reverse transcriptase u impedituri protease).
The clinical activity of Fuzeon (in combination with other antiretroviral agents) on plasma HIV RNA levels and CD4 counts have been investigated in two randomised, multicenter, controlled studies (TORO 1 and TORO 2) of Fuzeon of 48 weeks duration.
L- attività klinika ta ’ Fuzeon (mogħti flimkien ma ’ aġenti antiretrovirali oħrajn) fuq livelli ta ’ RNA ta ’ l- HIV fil- plażma u l- għadd CD4 ġiet investigata f’ żewġ studji ta ’ 48 ġimgħa randomised, multiċentrali u kontrollati (TORO 1 u TORO 2) b’ Fuzeon.
The proportion of patients achieving viral load of < 400 copies/ ml at week 48 was 30.4% among patients on the Fuzeon+OB regimen compared to 12% among patients receiving OB regimen only.
Il- proporzjon ta ’ pazjenti li laħqu viral load ta ’ < 400 kopji/ ml f’ ġimgħa 48 kienu 30. 4% fost il - pazjenti fuq programm ta ’ kura b’ Fuzeon+OB meta mqabbel ma ’ 12% fost pazjenti fuq programm ta ’ kura b’ OB waħdu.
The mean CD4 cell count increase was greater in patients on the Fuzeon + OB regimen than in patients on OB regimen only.
Iż- żieda fl- għadd ta ’ ċelluli CD4 medja kien għola f’ pazjenti fuq programm ta ’ kura b’ Fuzeon + OB milli f’ pazjenti fuq programm ta ’ kura b’ OB waħdu.
(see Table 4)
(ara Tabella 4)
Outcomes of randomised treatment at week 48 (pooled studies TORO 1 and TORO 2, ITT)
Riżultati ta ’ kura randomised f’ ġimgħa 48 (studji kombinati ta ’ TORO 1 u TORO 2 ITT)
CD4+ cell count Change from baseline (cells/ mm3)#
Għadd ta ’ ċelluli CD4+ Bidla mill- linja bażi (celluli/ mm3) #
HIV RNA < 400 copies/ ml**
RNA ta ’ HIV < 400 kopji/ ml
40 (12.0%) Odds
(30. 4%)
Ratio 2.36, 5.06 < .0001 3.45
40 (12. 0%) Odds Ratio 2. 36, 5. 06 <. 0001 3. 45
(18.3%)
(18. 3%)
Odds Ratio 1.76, 4.37 < .0001 2.77
26 (7. 8%) Odds Ratio 1. 76, 4. 37 <. 0001 2. 77
Discontinued due to adverse reactions/ intercurrent † illness/ labs
Twaqqfu minħabba reazzjonijiet avversi/ mard fl- istess waqt/ labs
22 Table 5
22 Tabella 5 Proporzjon ta ’ pazjenti li laħqu < 400 kopja/ ml u < 50 kopja/ ml f’ Ġimgħa 48 skond is- sottogrupp (TORO 1 u TORO 2, miġbura flimkien, ITT) Sottogrupp
Proportion of patients achieving < 400 copies/ ml and < 50 copies/ ml at Week 48 by subgroup (pooled TORO 1 and TORO 2, ITT)
RNA ta ’ HIV- 1 < 400
2 Based on GSS score.
Waqfien jew insuffiċjenzi viroloġiċi meqjusa bħala insuffiċjenzi 2 Ibbażat fuq il- punteġġ GSS.
Mean (± SD) Cmax was 4.59 ± 1.5 μ g/ ml, AUC was 55.8 ± 12.1 μ g*hr/ ml.
Cmax medja (± SD) kienet ta ’ 4. 59 ± 1. 5 μg/ ml, AUC kienet ta ’ 55. 8 ± 12. 1 μg* hr/ ml.
The subcutaneous absorption of enfuvirtide is proportional to the administered dose over the 45 to 180 mg dose range.
L- assorbiment minn taħt il- ġilda ta ’ enfuvirtide huwa proporzjonali mad- doża mogħtija fuq il- medda ta ’ dożi minn 45 sa ’ 180 mg.
In four separate studies (N= 9 to 12) the mean steady state trough plasma concentration ranged from 2.6 to 3.4 μ g/ ml.
F’ erba ’ studji separati (N=9 sa ’ 12) il- medja ta ’ konċentrazzjoni l- aktar baxxa fi stat fiss fil- plażma varjat minn 2. 6 sa ’ 3. 4 μg/ ml.
23 half-life of enfuvirtide is 3.8 ± 0.6 h.
23 enfuvirtide kienet ta ’ 3. 8 ± 0. 6 h.
24 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Shelf life after reconstitution:
Żmien kemm idum tajjeb wara r- rikostituzzjoni:
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih, il- perjodu u l- kundizzjonijiet tal- ħażna qabel l- użu huma r- responsabbiltà ta ’ min qed jagħmel użu minnu u normalment m’ humiex aktar minn 24 siegħa f’ temperatura ta ’ 2oC sa ’ 8oC, sakemm ir- rikostituzzjoni ma sseħħx taħt kundizzjonijiet asettiċi kontrollati u validati.
Each pack contains 60 vials of Fuzeon.
Daqsijiet tal- pakkett Kull pakkett fih 60 kunjett ta ’ Fuzeon.
Fuzeon must only be reconstituted with 1.1 ml water for injections.
Fuzeon għandu jiġi rikostitwit b’ 1. 1 ml Ilma għall- Injezzjonijiet biss.
The patient can gently roll the vial between their hands after adding the water for injections until it is fully dissolved and this may reduce the time it takes for the powder to dissolve.
Qabel il- ġbid tas -
Before the solution is withdrawn for administration, the patient should inspect the vial visually to ensure that the contents are fully in solution, and that the solution is clear and without bubbles or particulate matter.
25 soluzzjoni sabiex tittieħed, il- pazjent għandu jifli l- kunjett viżwalment sabiex jiżgura li l- kontenut huwa kollu f’ soluzzjoni, u li s- soluzzjoni hija ċara u mingħajr bżieżaq jew frak.
The injection should be given at a site different from the preceding injection site and
L- injezzjoni għandha tingħata f’ post differenti minn fejn ingħatat id- darba ta ’ qabel u f’ post fejn m’ hemmx reazzjoni għall- injezzjoni.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden CIty AL7 1TW Ir- Renju Unit
26 ANNEX II
26 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL - LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GÓALL- HRUĠ TAL- LOTT
1, D-79639 Grenzach-Wyhlen, Germany
1, D- 79639 Grenzach- Wyhlen, Il- Ġermanja
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ • Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
Summary of Product Characteristics, section 4.2.)
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2)
The Marketing Authorisation Holder will submit the PSURs on a yearly basis
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq se jissottometti PSURs kull sena
28 ANNEX III
28 ANNESS III
OUTER CARTON FOR PACK 1
KARTUNA TA ’ BARRA GĦALL- PAKKETT 1
Fuzeon 90 mg/ ml powder and solvent for solution for injection Enfuvirtide
Fuzeon 90 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni Enfuvirtide
1 ml of reconstituted solutions contains 90 mg enfuvirtide.
1 ml ta ’ soluzzjonijiet rikostitwiti fih 90 mg enfuvirtide
Each vial with powder also contains sodium carbonate (anhydrous), mannitol, sodium hydroxide and hydrochloric acid.
Kull kunjett bit- trab fih ukoll sodium bicarbonate (anhydrous), mannitol, sodium hydroxide u hydrochloric acid.
Each solvent vial contains 2 ml Water for Injections.
Kull kunjett bis- solvent fih 2 ml Ilma għall- Injezzjonijiet.
Contents of the box:
Kontenut tal- kaxxa:
60 vials with powder for solution for injection 60 vials with solvent 60 3 ml syringes 60 1 ml syringes 180 alcohol swabs
60 kunjett bi trab għal soluzzjoni għall- injezzjoni 60 kunjett bis- solvent 60 siringa tat- 3ml 60 siringa ta ’ ml 180 msielaħ bl- alkoħol
Subcutaneous use Read the package leaflet before use
Użu għal taħt il- ġilda Aqra l- fuljett ta ’ tagħrif qabel l- użu
Keep out of the reach and sight of children
Żomm fejn ma ’ jintlaħaqx u ma jidhirx mit- tfal
Keep the vial in the outer carton in order to protect from light After reconstitution store in a refrigerator
Wara r- rikostituzzjoni aħżen fi friġġ
The remaining Water for Injections in the solvent vial after withdrawal of the 1.1 ml required for reconstitution has to be discarded
L- Ilma għall- Injezzjonijiet li jifdal fil- kunjett tas- solvent wara li jittieħed 1. 1 ml meħtieġa għar - rikostituzzjoni għandu jintrema
32 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
IMMEDIATE OUTER CARTON FOR FUZEON VIALS WITHIN PACK 1
KARTUNA TA ’ BARRA LI TMISS MAL- PRODOTT GĦALL- KUNJETTI FUZEON ĠO PAKKETT 1
Fuzeon 90 mg/ ml powder for solution for injection Enfuvirtide
Fuzeon 90 mg/ ml trab għal soluzzjoni għall- injezzjoni Enfuvirtide
1 ml of reconstituted solution contains 90 mg of enfuvirtide.
1 ml ta ’ soluzzjoni rikostitwita fih 90 mg enfuvirtide.
Each vial also contains sodium carbonate (anhydrous), mannitol, sodium hydroxide and hydrochloric acid.
Kull kunjett fih ukoll sodium bicarbonate (anhydrous), mannitol, sodium hydroxide u hydrochloric acid.
60 vials with powder for solution for injection
60 kunjett bi trab għal soluzzjoni għall- injezzjoni
Keep out of the reach and sight of children
Żomm fejn ma ’ jintlaħaqx u ma ’ jidhirx mit- tfal.
Keep the vial in the outer carton in order to protect from light After reconstitution store in a refrigerator
Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl Wara r- rikostituzzjoni aħżen fi friġġ.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
FUZEON VIAL LABEL
TIKKETTA FUQ IL- KUNJETT FUZEON
Fuzeon 90 mg/ ml powder for solution for injection Enfuvirtide Subcutaneous use
Fuzeon 90 mg/ ml trab għal soluzzjoni għall- injezzjoni Enfuvirtide Użu għal taħt il- ġilda
35 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
IMMEDIATE OUTER CARTON FOR WATER FOR INJECTIONS VIALS WITHIN PACK 1
KARTUNA TA ’ BARRA LI TMISS MAL- PRODOTT GĦALL- KUNJETTI BL- ILMA GĦALL- INJEZZJONIJIET ĠO PAKKETT 1
Solvent for solution Water for Injections
Solvent għal soluzzjoni Ilma għall- Injezzjonijiet
Solvent for parenteral use Contained in this box are 60 vials of 2 ml water for injections
Solvent għall- użu parenterali Ġo din il- kaxxa hemm 60 kunjett b’ 2 ml ilma għall- injezzjonijiet
This water for injections is intended for the reconstitution of Fuzeon 90 mg/ ml powder for solution for injection to obtain a solution for subcutaneous use Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
WATER FOR INJECTIONS VIAL LABEL
TIKKETTA FUQ IL- KUNJETT TA ’ L- ILMA GĦALL- INJEZZJONIJIET
Solvent for solution Water for Injections Subcutaneous use
Solvent għal soluzzjoni Ilma għall- Injezzjonijiet Użu għal taħt il- ġilda
OUTER CARTON FOR PACK 2
KARTUNA TA ’ BARRA GĦAL PAKKETT 2
Each vial contains 108 mg enfuvirtide.
Kull kunjett Fuzeon fih 108 mg enfuvirtide.
1 ml of reconstituted solution contains 90 mg of enfuvirtide.
1 ml ta ’ soluzzjoni rikostitwita fih 90 mg enfuvirtide
Each vial with powder contains sodium carbonate (anhydrous), mannitol, sodium hydroxide and hydrochloric acid.
Kull kunjett bit- trab fih ukoll sodium bicarbonate (anhydrous), mannitol, sodium hydroxide u hydrochloric acid.
Each solvent vial contains 2 ml water for injections.
Kull kunjett bis- solvent fih 2 ml ilma għall- injezzjonijiet.
Contents of this box:
Kontenut ta ’ din il- kaxxa:
60 vials with powder for solution for injection 60 vials with solvent
60 kunjett bi trab għal soluzzjoni għall- injezzjoni 60 kunjett bis- solvent
Keep the vial in the outer carton in order to protect from light After reconstitution store in a refrigerator
Wara r- rikostituzzjoni aħżen fi friġġ.
40 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
IMMEDIATE OUTER CARTON FOR FUZEON VIALS WITHIN PACK 2
KARTUNA TA ’ BARRA LI TMISS MAL- PRODOTT GĦALL- KUNJETTI TA ’ FUZEON ĠO PAKKETT 2
Each Fuzeon vial contains 108 mg enfuvirtide.
Kull kunjett fih 108 mg enfuvirtide.
1 ml of reconstituted solution contains 90 mg enfuvirtide.
1 ml ta ’ soluzzjoni rikostitwita fih 90 mg enfuvirtide.
42 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
FUZEON VIAL LABEL
TIKKETTA FUQ IL- KUNJETT TA ’ FUZEON
43 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
IMMEDIATE OUTER CARTON FOR WATER FOR INJECTIONS VIALS WITHIN PACK 2
KARTUNA TA ’ BARRA LI TMISS MAL- PRODOTT GĦALL- KUNJETTI BL- ILMA GĦALL- INJEZZJONIJIET ĠO PAKKETT 2
Water for Injections
Ilma għall- Injezzjonijiet
This water for injections is intended for reconstitution of Fuzeon 90 mg/ ml powder for solution for injection to obtain a solution for subcutaneous use Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
45 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Water for Injections Subcutaneous use
Ilma għall- Injezzjonijiet Użu għal taħt il- ġilda
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON FOR PACKAGE TO CONTAIN FUZEON VIALS ONLY
KARTUNA TA ’ BARRA GĦAL PAKKETT LI FIH KUNJETTI TA ’ FUZEON BISS
Fuzeon 90 mg/ ml powder for solution for injection Enfuvirtide
Fuzeon 90 mg/ ml trab għal soluzzjoni għall- injezzjoniEnfuvirtide
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L - AWTORIŻŻAZZJONI GĦAT- TQEGĦID FIS- SUQ
FUZEON VIAL LABEL
TIKKETTA TAL- KUNJETT TA ’ FUZEON
Fuzeon 90 mg/ ml powder for solution for injection Enfuvirtide Subcutaneous use
Fuezon 90 mg/ ml trab għal soluzzjoni għall- injezzjoni Enfuvirtide Użu għal taħt il- ġilda
You may need to read it again.
Jista 'jkollok bżonn terġa taqrah.
- This medicine has been prescribed for you personally.
- Din il- mediċina ġiet mogħtija għall- użu personali tiegħek.
It may harm
M’ għandekx tgħaddiha lil persuni
them, even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek.
What Fuzeon is and what it is used for 2.
X’ inhu Fuzeon u għalxiex jintuża 2.
Before you use Fuzeon 3.
Qabel ma ’ tuża Fuzeon 3.
How to use Fuzeon 4.
Kif għandek tuża Fuzeon 4.
How to store Fuzeon 6.
Kif taħżen Fuzeon 6.
WHAT FUZEON IS AND WHAT IT IS USED FOR
X’ INHU FUZEON U GĦALXIEX JINTUŻA
What Fuzeon is Fuzeon inhibits the entry of the human immunodeficiency virus (HIV) into the cells that HIV attacks (called CD4 or T-cells) in your blood.
X’ inhu Fuzeon Fuzeon iwaqqaf id- dħul tal- virus ta ’ l- immunodefiċjenza umana (HIV) fiċ- ċelluli li jiġu attakkati mill - HIV (li jissejħu CD4 jew ċelluli- T) fid- demm tiegħek.
It works by preventing the HIV from making contact with the affected cell membrane.
Jaħdem billi ma jħallix li l- HIV jagħmel kuntatt mal- membrana taċ- ċellula affettwata.
This means that the HIV cannot enter the cell and then it cannot multiply.
Dan ifisser li l- HIV ma jistax jidħol fiċ- ċellula u għalhekk ma jistax jitkattar.
This is because HIV needs the DNA in the host cell so it can multiply.
Dan għaliex l- HIV għandu bżonn id- DNA taċ- ċellula li jinfetta sabiex ikun jista ’ jitkattar.
When Fuzeon should be used Fuzeon is used in combination with other antiretroviral medicinal products by persons who are infected with HIV, the virus which causes AIDS.
Meta għandek tuża Fuzeon Fuzeon jintuża f’ taħlita flimkien ma ’ prodotti mediċinali antiretrovirali oħrajn minn persuni infettati bl- HIV, il- virus li jikkawża l- AIDS.
Your doctor has prescribed Fuzeon to help control your HIV infection.
It- tabib tiegħek ordnalek Fuzeon biex jgħinek tikkontrolla l - infezzjoni ta ’ l- HIV.
Fuzeon is not a cure for HIV infection.
Fuzeon mhux kura għall- infezzjoni ta ’ l- HIV.
Never use or share used needles.
M’ għandek qatt tuża jew taqsam ma 'ħaddieħor labar użati.
BEFORE YOU USE FUZEON
QABEL MA TUŻA FUZEON
Do not use Fuzeon
Tużax Fuzeon
(see
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal enfuvirtide jew sustanzi oħra ta ’
section 6).
(ara sezzjoni 6).
Take special care with Fuzeon:
Oqgħod attent ħafna b’ Fuzeon:
Tell your doctor
Għarraf lit- tabib tiegħek
- if you have any other medical conditions,
- jekk tbati minn xi kundizzjonijiet mediċi oħrajn,
- if you have had any lung disease in the past; are currently, or have been, an intravenous drug
- jekk kellek fil- passat mard fil- pulmun; jekk bħalissa jew fil- passat kont tuża drogi li jittieħdu
user; are a smoker,
minn ġol- vini; jekk tpejjep,
- if you have a history of any kidney problems.
- jekk għandek passat ta ’ problemi tal- kliewi.
Fuzeon does not reduce the risk of passing HIV to others through sexual contact or blood contamination.
Fuzeon ma jnaqqasx ir- riskju li tgħaddi l- HIV lill- ħaddieħor permezz ta ’ kuntatt sesswali jew ta ’ kontaminazzjoni tad- demm.
It is important to continue to take appropriate precautions to prevent passing HIV to others.
Huwa importanti li tkompli tieħu l- prekawzjonijiet xierqa sabiex tevita li tgħaddi l- HIV lill- oħrajn.
Fuzeon is not a cure for HIV infection.
Fuzeon mhux kura għall infezzjoni ta ’ l- HIV.
51 In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
51 F’ xi pazjenti b’ infezzjoni ta ’ l- HIV avvanzata (AIDS) u b’ passat ta ’ infezzjonijiet opportunistiċi, jistgħu jseħħu sinjali u sintomi ta ’ infjammazjoni minn infezzjonijiet ta ’ qabel ftit wara li tinbeda l - kura anti- HIV.
It is believed that these symptoms are due to a recovery of the body’ s immune system.
Huwa maħsub li dawn is- sintomi jseħħu minħabba rkupru tas- sistema immuni tal - ġisem.
This improvement enables the body to fight infections that may have been present with no obvious symptoms.
Dan it- titjib jagħmel possibbli li l- ġisem jiġġieled l- infezzjonijiet li setgħu kienu preżenti mingħajr sintomi ovvji.
Patients with chronic hepatitis B and C and treated with antiretroviral therapy are at an increased risk for serious liver problems.
Pazjenti b’ epatite B u Ċ kronika u kkurati b’ terapija antiretrovirali huma f’ riskju akbar ta ’ problemi serji tal- fwied.
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tinnota xi sintomi ta ’ infezzjoni, jekk jogħġbok informa lit- tabib tiegħek minnufiħ.
Bone problems Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Problemi fl- għadam Uħud mill- pazjenti li qed jieħdu terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l - għadam li tissejjaħ osteonekrożi (l- mewt tat- tessut ta ’ l- għadam ikkawżat minn telf fil- provvista ta ’ demm lill- għadam).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul tat- terapija antiretrovirali kombinata, l- użu ta ’ kortikoserojdi, konsum ta ’ l - alkoħol, immunosoppressjoni severa, indiċi tal- massa tal- ġisem ogħla, fost l- oħrajn, jistgħu jkunu uħud mill- fatturi ta ’ riskju għal l- iżvilupp ta ’ din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrożi huma egħbusija, weġgħat u uġigħ fil- ġogi (speċjalment tal- ġenbejn, irkoppa u spalla) u diffikultà fil- moviment.
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Użu ta ’ mediċini oħra Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Fuzeon has been shown not to interact with your other anti-HIV medicines or rifampicin (an antibiotic).
Fuzeon intwera li m’ għandux effett fuq il- mediċini l- oħra kontra l- HIV tiegħek jew fuq rifampiċin (antibijotiku).
Using Fuzeon with food and drink You can take Fuzeon with or without food but you still need to follow the instructions given in the package leaflets for your other medicines.
Meta tuża Fuzeon ma ’ l- ikel u max- xorb Tista ’ tieħu Fuzeon ma 'ikel jew mingħajr ikel, iżda xorta għandek timxi ma ’ l- istruzzjonijiet mogħtija fil- fuljetti ta ’ tagħrif tal- mediċini oħrajn li għandek.
Pregnancy and breast-feeding Pregnant women and breast-feeding mothers should not take Fuzeon unless specifically directed to by their doctor.
Tqala u Treddigħ Nisa tqal u ommijiet li qed ireddgħu m’ għandhomx jieħdu Fuzeon sakemm mhux b’ ordni speċifika mit- tabib tagħhom.
Be sure to tell your doctor immediately if you are or may be pregnant or if you are breast- feeding a baby.
Kun żgur li tavża lit- tabib minnufih jekk inti tqila jew tista ’ tkun tqila jew jekk qed tredda ’ tarbija.
HIV-infected women should not breast-feed their infants because of the risk that your baby can be infected with HIV through your breast milk.
Nisa nfettati bl- HIV m’ għandhomx ireddgħu lit- trabi tagħhom minħabba r- riskju li t - tarbija tiegħek tiġi infettata bl- HIV permezz tal- ħalib ta ’ sidrek.
Driving and using machines Fuzeon has not been specifically tested for its possible effects on your ability to drive a car or operate machines.
Sewqan u tħaddim ta ’ magni Fuzeon ma ġiex ittestjat speċifikament għall- effetti li jista ’ jkollu fuq il- ħila tiegħek biex issuq jew tħaddem magni.
However, if you feel dizzy while taking Fuzeon then please do not drive nor operate machines.
Madankollu, jekk tħossok stordut waqt li qed tieħu Fuzeon, jekk jogħġbok issuqx u tħaddimx magni.
HOW TO USE FUZEON
KIF JINTUŻA FUZEON
Always use Fuzeon exactly as your doctor has told you.
Dejjem għandek tuża Fuzeon skond il- parir tat- tabib.
The usual dose is 90 mg twice a day, given as a 1 ml subcutaneous (just below the skin) injection.
Id- doża normali hija ta '90 mg darbtejn kuljum, mogħtija permezz ta ’ injezzjoni ta ’ 1 ml minn taħt il- ġilda (eżatt taħt il- ġilda).
See further instructions on how to use Fuzeon at the end of this leaflet.
Ara aktar struzzjonijiet dwar kif għandek tuża Fuzeon fl- aħħar ta ’ dan il- fuljett.
There you will find instructions on how to prepare Fuzeon and how to give yourself an injection.
Hemm se ssib struzzjonijiet dwar kif għandek tipprepara l- Feuzon u dwar kif għandek tagħti l- injezzjoni lilek innifsek.
If you take more Fuzeon than you should There is no specific antidote for overdose with Fuzeon.
M’ hemmx antidotu speċifiku għal doża eċċessiva ta 'Fuzeon.
If you take more than the recommended dose please consult your doctor.
Jekk tieħu aktar mid- doża rrakkomandata, jekk jogħġbok avża lit- tabib tiegħek.
If you forget to take Fuzeon Take the dose as soon as you remember and then take your next dose at its regular time.
Ħu d- doża malli tiftakar u wara ħu d- doża li jmiss f' ħinha.
Do not take the forgotten dose if it is less than 6 hours before you are going to take your next regular dose and never take a double dose to make up for a forgotten dose.
Tieħux id- doża li nsejt jekk fadal inqas minn 6 sigħat għad- doża regolari li jmiss u qatt m’ għandek tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, Fuzeon can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Fuzeon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In clinical trials, pneumonia was seen more often in patients treated with Fuzeon.
Fi provi kliniċi, pnewmonja dehret aktar ta ’ spiss f’ pazjenti kkurati b’ Fuzeon.
It is important for you to tell your doctor if you develop a cough with a high temperature, very fast breathing and/ or shortness of breath as these symptoms may mean you are developing pneumonia.
Huwa importanti li tgħarraf lit- tabib tiegħek jekk taqbdek xi sogħla bid- deni, nifs mgħaġġel ħafna u/ jew qtugħ ta ’ nifs peress li dawn is- sintomi jistgħu jfissru li qed tiżviluppa pnewmonja.
The side effect that you may experience most commonly when taking Fuzeon, are reactions at the place on your body where you have given yourself the injection.
L- effett sekondarju li jista ’ jaqbdek b’ mod l- aktar komuni waqt li qed tieħu Fuzeon huma reazzjonijiet fil- post fejn tajt l- injezzjoni lilek innifsek.
You will probably experience one or more of the following mild to moderate reactions at the place where you inject your medicine: ● itchiness ● swelling ● redness ● pain or tenderness ● hardened skin or bumps.
X’ aktarx ikollok esperjenza ta ’ wieħed jew aktar minn dawn ir- reazzjonijiet ħfief għal moderati fil- post fejn tinjetta l- mediċina tiegħek: • ħakk • nefħa • ħmura • uġigħ jew uġigħ kif tmiss • ġilda iebsa jew gundalli.
These reactions can appear within the first week of treatment and generally do not get worse with continued use of Fuzeon.
Dawn ir- reazzjonijiet jistgħu jidhru fl- ewwel ġimgħa tal- kura u ġeneralment ma jmorrux għall- agħar b’ użu kontinwu ta ’ Fuzeon.
Reactions at an individual injection site usually last for equal to or less than 7 days.
Reazzjonijiet fil- post tal- injezzjoni s- soltu jdumu għal sebat ijiem jew anqas.
If you experience reactions at an injection site, it is important not to stop taking Fuzeon until you have talked with your doctor about any concerns you may have.
Jekk ikollok esperjenza ta ’ reazzjonijiet fil- post ta ’ l- injezzjoni, huwa importanti li ma twaqqafx it- teħid ta ’ Fuzeon qabel ma tkun kellimt mat- tabib tiegħek dwar xi tħassib li jista ’ jkollok.
Injection site reactions may be worse when injections are repeated in the same place on the body, or when the injection is given deeper than intended (for example, into a muscle).
Reazzjonijiet fil- post tal- injezzjonijiet jistgħu jkunu agħar meta l- injezzjonijiet jingħataw fl- istess post tal- ġisem, jew meta l- injezzjoni tingħata aktar fil- fond milli maħsub (per eżempju, ġo muskolu).
In rare instances, patients experienced an infection at an individual injection site.
F’ każijiet rari, pazjenti kellhom esperjenza ta ’ infezzjoni f’ xi post ta ’ l- injezzjoni individwali.
To reduce the risk of infection, it is important that you follow the Fuzeon Injection Instructions provided below.
Biex tnaqqis ir- riskju ta ’ infezzjoni huwa importanti li ssegwi l- Istruzzjonijiet dwar kif Tinjetta ’ Fuzeon ipprovduti taħt.
Apart from reactions at the injection site, the side effects most frequently reported in patients receiving antiretroviral treatment with or without Fuzeon are diarrhoea and feeling sick.
Barra r- reazzjonijiet fil- post ta ’ l- injezzjoni, l- effetti sekondarji rrapportati bl- akbar frekwenza f’ pazjenti li jirċievu kura antiretrovirali b’ Fuzeon jew mingħajru huma dijarea u tħossok ma jiflaħx.
Very common side effects (affects more than 1 in 10 persons) are pain and numbness in hands, feet or legs, and loss of weight.
Effetti sekondarji komuni ħafna (jaffettwaw aktar minn persuna waħda minn kull 10) huma uġigħ u tnemnim fl- idejn, saqajn jew riġlejn u telf ta ’ piż.
Common side effects (affects 1 to 10 users in 100) are ● inflammation of the sinuses (cavities in the forehead), ● local swelling on the skin, ● reactions at injection sites, ● pneumonia, ● ear infection, ● swollen glands, ● decreased appetite, ● anorexia, ● increased blood fat values, ● diabetes, ● feeling anxious or irritated, ● nightmares, ● feeling dizzy, ● lack of concentration, ● tremor (shaking), ● inflamed eye lids, ● nasal congestion, ● inflammation of the pancreas, ● heart burn, ● dry skin, ● eczema, ● redness of the skin,
Effetti sekondarji komuni (jaffettwaw persuna waħda sa 10 minn kull 100 li qed jużawh) huma • infjammazzjoni tas- sinusis (spazji fil- ġbin), • nefħa lokalizzata fil- ġilda, • reazzjonijiet fil- post tal- injezzjoni, • pnewmonja, • infezzjoni tal- widnejn, • glandoli minfuħin, • nuqqas ta ’ aptit, • anoreksja, • żieda fil- valuri tax- xaħam fid- demm, • dijabete, • tħossok ansjuż jew irritat, • inkubi, • sturdament, • nuqqas ta ’ konċentrazzjoni, • rogħda (tregħid), • nefħa ta 'tebqet il- għajn,
● ● ● ● ● ●
• • • • • • • • • • • •
acne, muscle pain, kidney stones, 'flu-like' symptoms, feeling weak blood in the urine.
imnieħer miżdud, infjammazzjoni tal- frixa, ħruq ta ’ stonku, ġilda xotta, ekżema, ħmura fil- ġilda, akne, uġigħ fil- muskoli, ġebla fil- kliewi, sintomi ‘ jixbħu lill- influwenza ’, tħossok dgħajjef, demm fl- urina.
Hypersensitivity (allergy) to Fuzeon is rare (affects 1 to 10 users in 10,000).
Sensittività eċċessiva (allerġija) għal Fuzeon hija rari (taffettwa persuna waħda sa 10 minn kull 10, 000 li qed jużawh).
However if you develop symptoms that may suggest that you are allergic to this medicine then you must stop taking it straight away and tell your doctor as soon as possible.
Iżda, jekk tiżżviluppa sintomi li jistgħu jissuġġerrixxu li inti allerġiku għal din il - mediċina għandek tieqaf tużha minnufih u għid lit- tabib tiegħek malajr kemm jista ’ jkun.
Symptoms that you should look out for are rash, a high temperature or chill, feeling sick or being sick and sweating and shaking.
Sintomi li għandek tfittex huma raxx, temperatura għolja jew kesħa, tħossok ma tiflaħx jew tkun ma ’ tiflaħx u togħroq u tirtogħod.
These symptoms do not definitely mean you are allergic to this medicine but you must discuss them with your doctor.
Dawn is- sintomi mhux bilfors ifissru li inti allerġiku għal din il- mediċina iżda għandek tiddiskutihom mat- tabib tiegħek.
HOW TO STORE FUZEON
KIF TAĦŻEN FUZEON
Do not use Fuzeon after the expiry date which is stated on the label of either the Fuzeon or the Water for Injections Vials after EXP.
Tużax Fuzeon wara d- data ta ’ skadenza li tidher fuq it- tikketta tal- kunjett ta ’ Fuzeon jew ta ’ l- Ilma għall- Injezzjonijiet wara JIS.
Once the solution has been prepared for your injection it should be used immediately.
La darba s- soluzzjoni ġiet ippreparata għall- injezzjoni tiegħek għandha tintuża mmedjatament.
If it is not used immediately it must be stored in a refrigerator (2°C – 8°C) and used within 24 hours.
Jekk ma tintużax immedjatament għandha tinħażen fi friġġ (2°C – 8°C) u tintuża fi żmien 24 siegħa.
Do not use Fuzeon if you notice any particles in the powder or the solution once the water for injection has been added.
Tużax Fuzeon jekk tara xi frak fit- trab jew fis- soluzzjoni wara li tkun żidt l- ilma għall- injezzjoni.
Also do not use the water for injections if you see any particles in the vial or if the water is cloudy.
Tużax l- ilma għall- injezzjonijiet jekk tara xi frak fil- kunjett jew jekk l- ilma ma jkunx ċar.
What Fuzeon contains
X’ fih Fuzeon
- The active substance is enfuvirtide.
- Is- sustanza attiva hi enfuvirtide.
After reconstitution
Wara r- rikostituzzjoni mas -
with the solvent provided 1 ml of reconstituted solution contains 90 mg enfuvirtide.
solvent ipprovdut, 1ml tas- soluzzjoni rikostitwita fiha 90 mg enfuvirtide.
Powder Sodium Carbonate, anhydrous Mannitol Sodium Hydroxide Hydrochloric Acid
Trab Sodium Carbonate, anhydrous Mannitol Sodium Hydroxide Hydrochloric Acid
Solvent Water for Injections
Solvent Ilma għall- Injezzjonijiet
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
54 Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull doża, jiġġiefieri essenzjalment ‘ mingħajr sodju ’.
54 What Fuzeon looks like and contents of the pack
Id- Dehra ta ’ Fuzeon u l- kontenuti tal- pakkett:
Fuzeon powder and solvent for solution for injection comes in a carton containing:
Fuzeon trab u solvent għal soluzzjoni għall- injezzjoni jiġu f’ pakkett li fih:
60 vials of Fuzeon 60 vials of Water for Injections that is used to reconstitute the Fuzeon powder 60 3 ml syringes 60 1 ml syringes 180 alcohol swabs.
60 kunjett ta ’ Fuzeon 60 kunjett ta ’ Ilma għall- Injezzjonijiet li jintuża għar- rikostituzzjoni tat- trab Fuzeon 60 siringa tat- 3 ml 60 siringa tal- 1 ml 180 mselħa bl- alkoħol
This pack provides you with everything you need to prepare and take your Fuzeon for 30 days of injections.
Dan il- pakkett fih dak kollu li għandek bżonn sabiex tipprepara u tieħu Fuzeon għal 30 ġurnata ta ’ injezzjonijiet.
Fuzeon is also available in a carton containing 60 vials of Fuzeon and 60 vials of Water for Injections.
Fuzeon huwa disponibbli ukoll f’ pakkett li fih 60 kunjett ta ’ Fuzeon u 60 kunjett b’ Ilma għall - Injezzjonijiet.
The Manufacturer responsible for batch release is
Il- Manifattur responsabbli għall- ħruġ tal- lott
1, D-79639 Grenzach-Wyhlen Germany
1, D- 79639 Grenzach- Wyhlen Il- Ġermanja
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea. europa.eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
HOW TO USE FUZEON
56 KIF TUŻA FUZEON
Always take Fuzeon exactly as your doctor has instructed you.
Għandek dejjem tieħu Fuzeon skond il- parir tat- tabib.
Check with your doctor or pharmacist if you are unsure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
Each injection should be given at a site different from
Id- doża tas- soltu hija ta ’ 90 mg darbtejn kuljum, mogħtija bħala injezzjoni ta ’ 1 ml minn taħt il - ġilda fin- naħa ta ’ fuq tad- driegħ, fin- naħa ta ’ quddiem tal- koxxa jew fl- addome.
56 the last place you injected and never where there is still an injection site reaction from an earlier dose.
Kull injezzjoni għandha tingħata f’ post differenti minn tad- darba ta ’ qabel u qatt fil- post fejn għad hemm reazzjoni għall- injezzjoni minħabba doża ta ’ qabel.
You should not inject your medicine into moles, scar tissue, bruises or your navel.
M’ għandekx tinjetta l- mediċina f’ xi għazza, tessut taċ - ċikatriċi, tbenġil jew fiż- żokra.
When to take Fuzeon It is best to take Fuzeon at the same time each day if you can.
Huwa aħjar li tieħu Fuzeon fl- istess ħin kuljum jekk tista ’.
Try and space the doses evenly apart whenever it is convenient for you.
Fejn tista ’, ipprova qassam id- dożi bl- istess ħin bejniethom.
First thing in the morning and again in the evening are good times.
Ħinijiet tajbin huma l- ewwel ħaġa fil- għodu u mbagħad fil- għaxija.
The following is a basic, step-by-step guide to injecting your medicine.
Dan li ġej huwa gwida pass wara pass, bażiku ta ’ kif għandek tinjetta l- mediċina.
Please contact your doctor or pharmacist if you have any questions about Fuzeon administration.
Jekk jogħġbok tkellem mat- tabib jew ma ’ l- ispiżjar tiegħek jekk għandek xi mistoqsijiet dwar l- għotja ta ’ Fuzeon.
How long should you take Fuzeon for?
Għal kemm żmien għandek tieħu Fuzeon?
You should keep taking your medicine until your doctor tells you to stop.
Għandek tibqa ’ tieħu l- mediċina tiegħek sakemm it- tabib tiegħek jgħidlek biex tieqaf.
If you stop and interrupt your treatment with Fuzeon this may lead to the HIV in your blood becoming resistant to it quicker than if you take it regularly and without treatment interruptions.
Jekk twaqqaf jew tinterrompi l- kura tiegħek b’ Fuzeon, L- HIV fid- demm tiegħek jista ’ jsir reżistenti għalih aktar malajr milli jekk tieħdu b’ mod regolari u mingħajr waqfien.
The HIV virus in your blood may eventually become resistant to Fuzeon and your blood levels of virus begin to rise.
Eventwalment il- virus ta ’ l- HIV fid - demm tiegħek jista ’ jsir reżistenti għal Fuzeon u l- livelli tal- virus f’ demmek jibdew jogħlew.
This is when your doctor may decide to no longer keep treating you with Fuzeon.
Hawn it - tabib tiegħek jista ’ jiddeċiedi li ma jkomplix jikkurak aktar b’ Fuzeon.
Your doctor should discuss this with you at that time.
It- tabib tiegħek għandu jiddiskuti dan miegħek f’ dak il- waqt.
What to do if you are left-handed The illustrations in this leaflet show individuals who are right-handed.
L- illustrazzjonijiet f’ dan il- fuljett juru individwi li huma leminija.
If you are left-handed, do what comes naturally to you.
Jekk inti xellugi, għamel dak li jiġi naturali għalik.
You will probably find it most comfortable to hold the syringe in your left hand and hold the vial between thumb and forefinger of your right hand.
X’ aktarx tħossok l- aktar komdu billi żżomm is- siringa f’ idejk ix- xellugija u żżomm il - kunjett bejn is- saba ’ l- kbir u s- saba ’ l- werrej t’ idejk il- lemminija.
When to have a carer help you Certain injection sites, such as the upper arms, can be difficult to use at first.
Meta għandek titlob għajnuna ta ’ persuna li qed tieħu ħsiebek Fil- bidu xi postijiet għall- injezzjonijiet, per eżempju n- naħa ta ’ fuq ta ’ dirgħajk, jistgħu jkunu diffiċli biex tużahom.
Have your partner, a friend, or a family member with you if you need help.
Jekk għandek bżonn xi għajnuna, ara li jkun hemm is- sieħeb, xi ħabib, jew membru tal - familja miegħek.
To reduce the risk of needlestick injury, you should have a carer attend an injection training session with your healthcare provider.
Sabiex tnaqqas ir- riskju ta ’ korriment minn tingiża ta ’ labra, il- persuna li qed tieħu ħsiebek għandha tattendi sessjoni ta ’ taħriġ dwar l- injezzjonijiet ma ’ min joffrilek is- servizzi tas - saħħa.
Your syringes The syringes supplied with this medicine have a coloured needle protection device that is attached to the needle.
Is- siringi tiegħek Is- siringi li jiġu flimkien ma ’ din il- mediċina għandhom apparat ta ’ protezzjoni kkulurit li hu mwaħħal mal- labra.
This safety device covers the needle after use and reduces the risk of needle-stick injuries.
Dan l- apparat tas- sigurtà jgħatti l- labra u jnaqqas ir- riskju ta ’ feriti minn tingisa ta ’ labra.
Although these syringes offer this safety feature, it is important that you dispose of used syringes properly and according to the instructions given to you by your healthcare provider.
Għalkemm dawn is- siringi għandhom din il- karatteristika ta ’ sigurtà, huwa importanti li tarmi s- siringi wżati kif jixraq u skond l- istruzzjonijiet mogħtija lilek minn min joffrilek is- servizzi tas- saħħa.
Safety Tips
Pariri ta ’ Sigurtà
● Wash your hands well to reduce the risk of bacterial infections.
● Aħsel idejk sew sabiex tnaqqas ir- riskju ta ’ infezzjonijiet minn batterja.
Do not touch anything except the medicine and supplies.
Tmiss xejn ħlief il - mediċina u l- affarjiet li jiġu magħha.
● When handling the syringe, do not touch the needle.
● Meta qed timmanniġġja s- siringa, tmissx il- labra.
Do not touch the tops of the vials once they have been cleaned with alcohol swabs.
Tmissx l- uċuħ tal- kunjetti wara li jkunu tnaddfu b’ imsielaħ bl- alkoħol.
● Make sure none of the items in your kit have been opened.
● Kun ċert/ a li fil- pakkett m’ hemm xejn li nfetaħ.
Do not use opened materials.
Tużax oġġetti miftuħa minn qabel.
● Never use a syringe with a bent or damaged needle.
● Qatt m’ għandek tuża siringa b’ labra mgħawġa jew bil- ħsara.
● Never mix your medicine with tap water.
57 ● Qatt m’ għandek tħallat il- mediċina tiegħek ma ’ l- ilma tal- vit.
● Never inject your medicine with other injectable medicines.
● Qatt m’ għandek tinjetta l- mediċina tiegħek flimkien ma ’ mediċini għall- injezzjoni oħrajn.
● The only recommended route of injection is subcutaneous (under the skin).
● L- uniku mod rakkommandat għat- teħid ta ’ l- injezzjoni huwa minn taħt il- ġilda.
Fuzeon should not be given intravenously (directly into your veins) or intramuscularly (directly into your muscle).
Fuzeon m’ għandux jingħata minn ġol- vini (dirett fil- vini tiegħek) jew fil- muskoli (dirett fil- muskoli tiegħek).
● Throw away used syringes into your dedicated waste container with a lid for the safe disposal of waste materials.
● Armi s- siringi użati fil- kontenitur b’ għatu maħsub għal l- iskart, għar- rimi sikur tal- materjal ta ’ skart.
Consult your doctor if you have any questions about safe disposal of these items.
Kellem lit- tabib tiegħek jekk għandek xi mistoqsijiet dwar ir- rimi b’ mod sikur ta ’ dawn l - oġġetti.
57 STEP 1:
L- EWWEL PASS:
GETTING STARTED
BIDU TAL- PREPARAZZJONI
Gather Supplies
Iġbor l- oġġetti
Gather all of the following supplies:
Iġbor dawn l- oġġetti kollha:
● One vial of Fuzeon (glass container with white powder inside)
● Kunjett ta ’ Fuzeon (reċipjent tal- ħġieġ b’ trab abjad)
● One vial of water for injections (glass container with clear and colourless liquid inside)
● Kunjett ta 'l- ilma għall- injezzjonijiet (reċipjent tal- ħġieġ b’ likwidu ċar u bla kulur)
● One 3 ml syringe (larger syringe) with a 25 mm needle
● Siringa tat- 3 ml (is- siringa l- kbira) b’ labra ta ’ 25 mm
● One 1 ml syringe (smaller syringe) with a 1 3 mm needle
● Siringa tal- 1 ml (is- siringa ż- żgħira) b’ labra ta ’ 13 mm
● 3 Alcohol swabs
● 3 imsielaħ bl- alkoħol
● Dedicated waste container with a lid for the safe disposal of the waste materials.
● Kontenitur b’ għatu maħsub għall- iskart, għar- rimi sikur tal- materjali ta ’ skart
Open Syringe Packages and Remove Vial Caps
Iftaħ il- Pakketti tas- Siringa u Neħħi l- Għotjien tal- Kunjett
● Throw away packages and vial caps into the rubbish.
● Armi l- pakketti u l- għotjien tal- kunjett fiż- żibel.
● Place syringes and vials onto a clean surface.
● Poġġi s- siringi u l- kunjetti fuq wiċċ nadif.
Wash Hands Thoroughly
Aħsel Idejk Sew
● After washing hands, do not touch anything except the injection supplies and the injection site.
● Wara li taħsel idejk, tmiss xejn ħlief l- oġġetti għall- injezzjoni u l- post ta ’ l- injezzjoni.
Clean the Tops of Vials
Naddaf in- Naħa ta ’ Fuq tal- Kunjetti
● Wipe each vial top with a fresh alcohol pad.
● Imsaħ in- naħa ta ’ fuq ta ’ kull kunjett b’ imselħa bl- alkoħol ġdida.
Let the tops air-dry.
Ħalli l- kunjetti jinxfu b’ mod naturali.
● Be sure not to touch the rubber tops after cleaning them.
● Kun ċert li ma tmissx l- uċuħ tal- gomma wara li tnaddafhom.
If you touch them, be sure to clean them again.
Jekk tmisshom, ara li terġa ’ tnaddafhom.
STEP 2:
IT- TIENI PASS:
MIXING FUZEON
IT- TAĦLIT TA ’ FUZEON
Draw Up Water for Injections
Iġbed l- Ilma għall- Injezzjonijiet
Pick up the 3 ml large syringe.
Aqbad is- siringa l- kbira tat- 3 ml.
Using your index finger, push back the coloured needle protection device towards the syringe.
B' subghek il- werrej, imbotta lura l- apparat tas- sigurtà kkulurit tal - labra lejn is- siringa.
To ensure that the needle is secure, hold the clear plastic cap and tighten the needle with a gentle clockwise twist.
58 Biex tassigura li l- labra hija sigura, żomm l- għatu trasparenti tal- plastik u ssika l- labra billi ddawwar bil- mod lejn il- lemin.
Do not use too much force as the needle may loosen.
Tużax wisq saħħa għax il- labra tista ’ tillaxka.
To remove the clear plastic cap push towards the syringe and then pull the cap off.
Biex tneħħi l- għatu trasparenti tal- plastik imbotta lejn is- siringa u mbagħad iġbed u aqla ’ l- għatu.
58 Draw back 1.1 ml of air.
Iġbed lura 1. 1 ml arja.
Insert the syringe needle into the rubber top of the vial of water for injections and press the plunger, injecting the air.
Daħħal il- labra tas- siringa minn ġol- wiċċ tal- gomma tal- kunjett bl- ilma għall- injezzjonijiet u injetta l - arja billi tagħfas il- plunġer.
Turn the vial upside down.
Dawwar il- kunjett rasu l- isfel.
Make sure the tip of the needle is always below the surface of the water for injections to help keep any air bubbles from entering the syringe.
Ara li l- ponta tal- labra tibqa ’ dejjem taħt il- wiċċ ta ’ l- ilma għall - injezzjonijiet sabiex tgħin biex bżieżaq ta ’ l- arja ma jidħlux fis- siringa.
Slowly pull back the plunger until the water reaches the 1.1 ml mark.
Iġbed il- plunġer lura bil- mod sakemm l- ilma jilħaq is- sinjal ta ’ 1. 1 ml.
Please be aware that the vial contains an excess of water for injections (2 ml); you only have to withdraw 1.1 ml of it to prepare your medication properly.
Jekk jogħoġbok għandek tkun taf li l- kunjett fih iż- żejjed ilma għall- injezzjonijiet (2ml); għandek tiġbed biss 1. 1 ml minn dan biex tipprepara l- mediċina tiegħek kif jixraq.
● Tap the syringe gently to make any air bubbles rise to the top.
● Tektek is- siringa bil- mod biex jekk ikun hemm xi bżieżaq ta ’ l- arja jitilgħu fil- wiċċ.
If excess air enters the syringe, gently press the plunger to force any air back into the vial and withdraw the water again, making sure you have 1.1 ml of water for injections in the syringe.
Jekk arja żejda tidħol fis- siringa, agħfas il- plunġer bil- mod biex timbotta l- arja lura fil- kunjett u mbagħad iġbed l- ilma għal darb’ oħra, u tkun żgur li jkollok 1. 1 ml ilma għall- injezzjonijiet fis- siringa.
● Remove the needle from the vial, making sure you never touch the needle with your fingers or any other object.
● Neħħi l- labra mill- kunjett, u ara li qatt ma tmiss il- labra b’ subgħajk jew xi oġġett ieħor.
● Throw away the vial into the rubbish.
59 ● Armi l- kunjett fiż- żibel.
The solvent vial is intended for single use only and the remaining water for injections in the vial after withdrawal of the volume required for reconstitution has to be discarded.
Il- kunjett bis- solvent huwa maħsub għall- użu ta ’ darba biss u l- ilma għall- injezzjonijiet li jifdal fil- kunjett wara li jinġibed il- volum meħtieġ għar- rikostituzzjoni għandu jintrema.