qanastek/EMEA-V3 huggingface dataset:
In the light conditions recommended for the first 15 days after Foscan injection, driving is not recommended, and it may not be practical to operate machines.
Madanakollu, fil- kondizzjonijiet tad- dawl, irrakkomandati għall - ewwel 15- il ġurnata ta ’ wara l- injezzjoni ta ’ Foscan, is- sewqan mhux irrakkomandat u jista ’ ma jkunx prattiku li tħaddem il- magni.
Important information about some of the ingredients of Foscan WARNING:
TWISSIJA:
This product contains 48 vol% ethanol (alcohol), i. e up to 4.2 g per dose, equivalent to 84 ml of beer, 35 ml wine per dose.
48% tal- piż tal- prodott huwa ethanol (alkoħol), i. e sa 4, 2 g kull doża, li hu ekwivalenti għal 84 ml ta ’ birra, 35 ml ta ’ inbid kull doża.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Dan għandu jiġi kkonsidrat f’ nisa tqal jew nisa qed ireddgħu, it- tfal u dawk il- gruppi li jinsabu f’ riskju għoli bħal pazjenti b’ mard tal- fwied u epilessija.
The amount of alcohol in this product may alter the effects of other medicines.
L- ammont ta ’ alkoħol f’ dan il- prodott jista ’ jibdel l- effetti ta ’ mediċini oħra.
HOW TO USE FOSCAN
KIF TUŻA FOSCAN 3.
Your doctor or nurse will give you Foscan by injection into a vein.
It- tabib jew l- infirmiera tiegħek se jagħtuk Foscan b’ injezzjoni ġol- vina.
If necessary, your doctor or nurse may give you another injection at least 4 weeks later.
Jekk ikun meħtieġ, it- tabib jew l- infirmiera tiegħek jistgħu jagħtuk injezzjoni oħra mill- anqas erba ’ ġimgħat wara.
Four days after your injection, your doctor will treat your cancer with laser light.
Erbat ijiem wara l- injezzjoni, it- tabib tiegħek se jittrattalek il- kanċer bid- dawl tal- laser.
If you are given more Foscan than you should You may not be given the laser treatment.
Tista ’ ma tingħatax il- kura bil- laser.
You may be sensitive to light for more than 15 days.
Tista ’ tkun sensittiv għal dawl għal aktar minn 15- il ġurnata.
You must follow carefully the instructions on preventing skin burns.
Għandek issegwi b' attenzjoni l- istruzzjonijiet biex tevita l- ħruq tal- ġilda.
POSSIBLE SIDE EFFECTS
EFFETTI KOLLATERALI LI JISTA ’ JKOLLU 4.
Like all medicines, Foscan can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Foscan jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd.
Everyone who takes Foscan will become sensitive to light for about 15 days after injection.
Kull min jieħu Foscan se jkun sensittiv għad- dawl għal madwar 15- il ġurnata wara l- injezzjoni.
You must follow the instructions given to you to avoid sunlight and bright indoor light.
Int għandek issegwi l- istruzzjonijiet mogħtija lilek biex tevita d- dawl tax- xemx u d- dawl qawwi ta ’ ġewwa.
These instructions are written in this leaflet.
Dawn l- istruzzjonijiet huma miktuba f’ dan il- fuljett.
Your doctor will also tell you what to do.
It- tabib tiegħek se jgħidlek ukoll x’ għandek tagħmel.
If you do not follow these instructions, you may get severe sunburn that leads to permanent scarring.
Jekk ma ssegwix dawn l- istruzzjonijiet jista ’ jkollok ħruq qawwi tax- xemx li jwassal għal marki permanenti.
Very common side effects (likely to occur in more than 1 in 10 patients) You may feel some pain when Foscan is injected.
Effetti kollaterali komuni ħafna (li jistgħu jseħħu f’ aktar minn pazjent 1 f’ 10) Tista ’ tħoss xi wġigħ meta jiġi injettat b’ Foscan.
After the laser treatment, you may feel pain in your face and pain around the treatment area.
Wara l- kura bil- laser tista ’ tħoss xi wġigħ f’ wiċċek u wġigħ madwar l- erja li qed tiġi trattata.
There may also be bleeding, ulcers, swelling, and scarring.
Jista ’ jkun hemm emorraġija, ulċeri, nefħa u marka ta ’ ferita.
These effects may make it difficult to eat and drink.
31 Dawn l- effetti jistgħu jagħmluha diffiċli biex tiekol u tixrob.
You may get constipation.
Tista ’ ssir stitiku.
Common side effects (likely to occur in more than 1 in 100 patients) There may be some irritation, a burning sensation or skin damage where Foscan is injected, but this will not last long.
Effetti kollaterali komuni (li jistgħu jseħħu f’ aktar minn pazjent 1 f’ 100) Jista ’ jkun hemm xi irritazzjoni, sensazzjoni ta ’ ħruq jew ħsara lill- ġilda fejn ġie injettat Foscan, imma dan ma jdumx wisq.
Other effects may
Jista ’ jkollok ukoll xi ulċeri, infafet, ħmura tal- ġilda jew il- ġilda toskura.
29 be vomiting, fever, nausea, anaemia, light sensitivity, sunburn, burns, difficulty with swallowing or giddiness.
Effetti oħra jistgħu jkunu remettar, deni, dardir, anemija, sensittività għad- dawl, ħruq, ħruq tax- xemx, diffikultà biex tibla ’ jew sturdament.
There may be swelling or may have a stiff jaw.
Jista ’ jkun hemm nefħa jew ix- xedaq jibbies.
Some people may get an infection in the treated area.
Xi persuni tista ’ taqbadhom infezzjoni fil- parti kkurata.
If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Jekk tinduna b’ xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE FOSCAN
KIF TAĦŻEN FOSCAN 5.
Do not use after the expiry date stated on the label and the carton.
Tużax Foscan wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
Foscan will be stored at the hospital pharmacy.
Foscan jinħażen fl- ispiżerija ta ’ l- isptar.
Do not store above 25oC.
Taħżinx f’ temperatura ‘ l fuq minn 25C.
FURTHER INFORMATION
AKTAR TAGĦRIF 6.
What Foscan contains
X’ fih Foscan:
- The active substance is temoporfin.
Is- sustanza attiva hi temoporfin.
Each ml contains 1 mg of temoporfin.
Kull ml fih 1 mg ta ’ temoporfin.
- The other ingredients are ethanol anhydrous (E1510) and propylene glycol (E1520).
Is- sustanzi l- oħra huma ethanol (E1510) u propylene glycol (E1520).
What Foscan looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett:
Foscan solution for injection is a dark purple solution in an amber glass vial.
Is- soluzzjoni għall- injezzjoni Foscan hija soluzzjoni vjola skura f’ kunjett tal- ħġieġ ambra.
Each pack contains 1 glass vial and a filter contained in a polyethylene cover.
Kull pakkett fih kunjett tal- ħġieġ wieħed u filtru li jinsab f’ but tal- polyethylene.
30 The following information is intended for medical or healthcare professionals only
32 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku
Foscan 1 mg/ ml solution for injection Temoporfin
FOSCAN 1 mg/ ml Soluzzjoni għall- Injezzjoni Temoporfin
PACK CONTENTS
IL- KONTENUT TAL- PAKKETT
Each pack provides 1 vial containing 1ml, 3ml or 6ml solution for injection.
Kull pakkett jipprovdi kunjett wieħed li fih 1 ml, 3 ml jew 6 ml ta soluzzjoni għall- injezzjoni.
The active substance is temoporfin.
Is- sustanza attiva hi temoporfin.
The excipients are ethanol anhydrous and propylene glycol.
Kull ml ta ’ soluzzjoni fiha 1 mg ta ’ temoforin.
A filter with Luer lock connections for syringe and cannula is provided.
Jingħata wkoll filtru li jeħel mas- siringa u mal - kannula b’ Luer lock.
Each vial represents a single dose and any unused solution must be discarded.
Kull kunjett fih doża waħda u kull soluzzjoni mhux użata għandha tintrema.
CALCULATION OF DOSE
KALKOLAZZJONI TAD- DOŻA
Calculate the required dose of Foscan according to the bodyweight of the patient.
Ikkalkula d- doża meħtieġa ta ’ Foscan skond il- piż tal- ġisem tal- pazjent.
The dose is 0.15 mg/ kg bodyweight.
Id- doża hi ta ’ 0. 15 mg/ kg piż tal- ġisem.
ADMINISTRATION OF FOSCAN (96 hours prior to laser illumination of treatment site)
L- GĦOTI TA ’ FOSCAN (96 siegħa qabel l- illuminazzjoni bil- laser tas- sit li qed jiġi 3. ikkurat)
Foscan must be administered intravenously via an in-dwelling cannula in a large proximal limb vein, preferably in the antecubital fossa.
Foscan għandu jingħata permezz ta ’ kannula f’ vina qrib tar- riġel/ driegħ, preferibbilment fil- fossa antekubitali.
The patency of the in-dwelling cannula should be tested before injection.
Il- kondizzjoni tal- kannula mqegħda għandha tkun eżaminata qabel kull injezzjoni.
The dark purple colour of the solution together with the amber vial makes a visual check for particulates impossible.
Il- kulur vjola skur tas- soluzzjoni, flimkien mal- kunjett kulur ambra, ma jippermettix kontroll viżwali għal xi frak.
Thus, an in-line filter must be used as a precautionary measure and is provided in the package.
Għalhekk, għandu jintuża filtru fis- sistema bħala miżura ta ’ prekawzjoni u dan issibu fil - pakkett.
Draw up the entire contents of the vial containing Foscan into a syringe and expel air (Figure 1).
Iġbed il- kontenut kollu tal- kunjett li fih Foscan f’ siringa u neħħi l- arja (stampa 1).
Figure 1
Stampa 1
Figure 2
Waħħal il- filtru mas- siringa (Stampa 2).
Press the syringe plunger to fill all dead space within the filter.
Agħfas il- planġer tas- siringa biex timla l- ispazju vojt kollu fi ħdan il- filtru.
Continue pressing the plunger to expel excess Foscan until the required volume is left in the syringe, allowing sufficient to cover the dead space in the intravenous cannula (Figure 3).
Kompli agħfas il- planġer biex tneħħi l- ammont żejjed ta ’ Foscan sakemm il- volum meħtieġ jibqa ’ fis- siringa, li jippermetti ammont suffiċjenti biex ikopri l- ispazju vojt fil- kannula ta ’ ġewwa l- vina (Stampa 3).
Figure 3
Stampa 3
Attach the syringe and filter to the cannula.
Waħħal is- siringa u l- filtru mal- kannula.
Administer the required dose of Foscan by slow intravenous injection, over not less than 6 minutes (Figure 4).
Agħti d- doża meħtieġa ta ’ Foscan b’ injezzjoni bil- mod ġol - vina, fuq medda ta ’ mhux anqas minn 6 minuti (Stampa 4).
Figure 4
Stampa 4
Remove the intravenous cannula immediately following the injection.
Neħħi l- kannula minn ġol- vina immedjatament wara l- injezzjoni.
Do NOT flush with aqueous solutions such as sodium chloride 0.9% solution for injection or water for injections.
TLAĦLAĦX b’ soluzzjonijiet akweji bħal soluzzjoni ta ’ 0. 9% sodium chloride jew ilma għall- injezzjonijiet.
Special care should be taken to prevent extravasation at the injection site.
Għandha tingħata attenzjoni speċjali sabiex tevitali joħroġ xi likwidu fis- sit ta ’ l- injezzjoni.
If extravasation occurs, protect the area from light for at least 3 months.
Jekk dan jiġri, ipproteġi din il- parti mid- dawl għal mill- anqas 3 xhur.
There is no known benefit from injecting the extravasation site with another substance.
M’ hemm l- ebda benefiċċju magħruf mill - injezzjoni ta ’ xi sustanza oħra fis- sit fejn ħareġ il- likwidu.
32 Foscan is photosensitive.
Foscan hu fotosensittiv.
Once removed from its packaging it should be administered immediately.
Hekk kif jitneħħa mill- kaxxa tiegħu għandu jingħata immedjatament.
Where delay is unavoidable, the solution must be protected from light.
Meta ma jistax jittieħed mill- ewwel, is- soluzzjoni għandha tkun protetta mid- dawl.
LASER ILLUMINATION OF TREATMENT SITE
ILLUMINAZZJONI BIL- LASER TAS- SIT TAL- KURA
Please refer to the laser user manual, and to the microlens fibre-optic user leaflet.
Jekk jogħġbok irreferi għall- manwal għall- użu tal- laser, u għall- fuljett ta ’ tagħrif tal- mikrolens tal- fibra ottika.
96 hours after the administration of Foscan, the treatment site is to be illuminated with light at 652 nm from an approved laser source.
96 siegħa wara l- għoti ta ’ Foscan, is- sit tal- kura għandu jkun illuminat bid- dawl ta '652 nm minn sors ta ’ laser approvat.
Light must be delivered to the entire surface of the tumour using an approved microlens fibre-optic.
Id- dawl għandu jasal fuq il- wiċċ kollu tat- tumur permezz ta ’ mikrolens tal- fibra ottika, approvat.
Wherever possible, the illuminated area must extend beyond the tumour margin by a distance of 0.5cm.
Kull meta jkun possibli, il- parti lluminata għandha taqbeż il- marġini tat- tumur b’ distanza ta ’ 0. 5 ċm.
The incident light dose is 20J/ cm2, delivered by the microlens fibre-optic in a circular field to the tumour surface at an irradiance of 100mW/ cm2, implying an illumination time of 200 seconds.
Id- doża ta ’ dawl mitfugħ hi ta ’ 20 J/ ċm2, imwassla permezz tal- mikrolens tal- fibra ottika b’ moviment ċirkolari fil- wiċċ tat- tumur b’ irridazzjoni ta ’ 100 mW/ ċm2 fil- wiċċ tat- tumur, li jimplika ħin ta ’ illuminazzjoni ta ’ madwar 200 sekonda.
Each field is to be illuminated once only at each treatment.
Kull parti għandha tiġi lluminata darba biss matul kull trattament.
Multiple non-overlapping fields may be illuminated.
Jistgħu jiġu illuminati aktar minn parti waħda li ma jmissux ma ’ xulxin.
Care must be taken to ensure that no area of tissue receives more than the specified light dose.
Għandha tingħata attenzjoni biex ikun assigurat li l- ebda parti ta 'tessut ma ’ jirċievi aktar mid- doża ta ’ dawl speċifikat.
SAFETY INFORMATION
INFORMAZZJONI DWAR IS- SIGURTÀ
Foscan is non-irritant
Foscan mhux irritanti.
INFORMATION FOR THE USER
35 FULJETT TA ’ TAGĦRIF:
What Foscan is and what it is used for 2.
Qabel ma tuża Foscan 2.
Before you use Foscan 3.
Kif għandek tuża Foscan 3.
- if you are hypersensitive (allergic) to temoporfin or any of the ingredients of Foscan,
Tużax Foscan jekk tbati minn sensittività eċċessiva (allerġija) għal temoporfin jew xi ingredjanti oħra ta ’
You must not let an optician or ophthalmologist examine your eyes with bright lights for 30 days after Foscan injection.
M' għandekx, tħalli lil tekniku jew lil speċjalista tal- għajnejn jeżaminalek għajnejk b’ dawl qawwi, għal 30 jum wara injezzjoni b' Foscan.
34 The table of instructions tells you what to do to prevent skin burns.
36 It- tabella ta ’ struzzjonijiet tgħidlek x’ għandek tagħmel biex tevita l- ħruq tal- ġilda.
You can gradually return to normal indoor lighting.
Int tista ’ ftit ftittirritorna għad- dawl normali fuq ġewwa.
As a precautionary measure, if prolonged outdoor activity is planned, the injection arm should be protected by wearing a long sleeved, coloured shirt.
Bħala miżura ta ’ 38 prekawzjoni, jekk xi attività fuq barra hija ppjanata għal tul ta ’ ħin, id- driegħ injettat għandu jiġi protett billi tintlibes qmis b’ komma twila kkulurita.
35 Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Driving and using machines In the light conditions recommended for the first 15 days after Foscan injection, driving is not recommended, and it may not be practical to operate machines.
Madanakollu, fil- kondizzjonijiet tad- dawl, irrakkomandati għall - ewwel 15- il ġurnata ta ’ wara l- injezzjoni ta ’ Foscan, is- sewqan mhux irrakkomandat u jista ’ ma jkunx prattiku li tħaddem il- magni.
This product contains 48 vol% ethanol (alcohol), i. e up to 1 g per dose, equivalent to 21 ml of beer, 9 ml wine per dose.
48% tal- piż tal- prodott huwa ethanol (alkoħol), i. e sa 1 g kull doża, li hu ekwivalenti għal 21 ml ta ’ birra, 9 ml ta ’ inbid kull doża.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
L- ammont ta ’ alkoħol f’ dan il- prodott jista ’ jibdel l- effetti ta ’ mediċini oħra.
These effects may make it difficult to eat and drink.
39 Dawn l- effetti jistgħu jagħmluha diffiċli biex tiekol u tixrob.
You may also get ulcers, blisters, skin redness, or skin darkening.
Jista ’ jkollok ukoll xi ulċeri, infafet, ħmura tal- ġilda jew il- ġilda toskura.
Other effects may be vomiting, fever, nausea, anaemia, light sensitivity, sunburn, burns, difficulty with swallowing or
Effetti oħra jistgħu jkunu remettar, deni, dardir, anemija, sensittività għad- dawl, ħruq, ħruq tax- xemx, diffikultà biex tibla ’ jew sturdament.
37 The following information is intended for medical or healthcare professionals only
40 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku
Foscan 4 mg/ ml solution for injection Temoporfin
FOSCAN 4 mg/ ml Soluzzjoni għall- Injezzjoni Temoporfin
Each pack provides 1 vial containing 3.5 ml or 5 ml solution for injection.
Kull pakkett fih kunjett wieħed li fih 3. 5 ml jew 5 ml ta soluzzjoni għall- injezzjoni.
Each ml of solution contains 4 mg of temoporfin.
Kull ml ta ’ soluzzjoni fiha 4 mg ta ’ temoforin.
The excipients are ethanol anhydrous and propylene glycol.
Is- sustanzi mhux attivi huma ethanol mhux idrat u propylene glycol.
A filter with Luer lock connections for syringe and cannula is provided.
Jingħata wkoll filtru li jeħel mas- siringa u mal- kannula b’ Luer lock.
CALCULATION OF DOSE
KALKULAZZJONI TAD- DOŻA
ADMINISTRATION OF FOSCAN (96 hours prior to laser illumination of treatment site)
L- GĦOTI TA ’ FOSCAN (96 siegħa qabel l- illuminazzjoni bil- laser tas- sit li qed jiġi 3. kkurat)
Special care should be taken to prevent extravasation at the injection site.
Għandha tingħata attenzjoni speċjali sabiex tevita li joħroġ xi likwidu fis- sit ta ’ l- injezzjoni.
39 Foscan is photosensitive.
Foscan hu fotosensittiv.
What is Fuzeon?
X’ inhu Fuzeon?
Fuzeon is a powder that is made up into a solution for injection.
Fuzeon hu trab fi fjala li jinħall f’ soluzzjoni għall- injezzjoni.
It contains the active substance enfuvirtide (90 mg/ ml).
Fih is- sustanza attiva enfuvirtide (90 mg/ ml).
What is Fuzeon used for?
Għalxiex jintuża Fuzeon?
Fuzeon is an antiviral medicine.
Fuzeon hu mediċina antivirali.
It is used in combination with other antiviral medicines for the treatment of patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma ’ mediċini antivirali oħra fit- trattament ta ’ pazjenti infettati bil- virus ta ’ l- immunodefiċjenza umana tat- tip 1 (HIV 1), virus li jikkawża l- acquired immune deficiency syndrome (AIDS).
It is for use in patients who have stopped responding to, or cannot take, other antiviral medicines.
Jintuża fil- pazjenti li ma jkunux baqgħu jirrispondu għal, jew li ma jkunux jistgħu jieħdu, mediċini antivirali oħra.
These must include at least one medicine from each of the following classes of medicine used to treat HIV infection: protease inhibitors; non-nucleoside reverse transcriptase inhibitors; and nucleoside reverse transcriptase inhibitors.
Dawn ikunu jridu jinkludu ta ’ l- inqas mediċina waħda minn kull waħda mill- klassijiet segwenti ta ’ mediċini wżati fit- trattament ta ’ l- infezzjoni ta ’ l- HIV: protease inhibitors, non- nucleoside reverse transcriptase inhibitors u nucleoside reverse transcriptase inhibitors.
Doctors should only prescribe Fuzeon once they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
It- tobba għandhom jippreskrivu Fuzeon biss wara li jkunu raw x’ mediċini antivirali jkun ħa l- pazjent qabel u l- probabilità li l- vajrus jirrispondi g] all- mediċina.
How is Fuzeon used?
Kif jintuża Fuzeon?
Fuzeon should be prescribed by a doctor who has experience in the treatment of HIV infection.
Fuzeon għandu jingħata minn tabib li jkollu esperjenza fit- trattament ta ’ l- infezzjoni bl- HIV.
The dose for children aged six to 16 years depends on body weight.
Fl- adulti, jingħata bħala injezzjoni waħda ta ’ 90- mg taħt il- ġilda darbtejn kuljum, injettata fil- parti ta ’ fuq tad - dirgħajn, fil- parti ta ’ fuq tal- koxxa jew fiż- żaqq.
Fuzeon is not recommended for use in children under six years of age.
Id- doża fit- tfal ta ’ bejn sitta u 16- il sena tiddependi fuq il- piż tagħhom.
Fuzeon can be injected by the patient or by a carer, provided that the person giving the injection follows the detailed instructions given in the Package Leaflet.
Fuzeon jista ’ jingħata mill- pazjent/ a lilu/ ha nnifsu/ nnifisha jew minn xi ħadd li jkun qed jieħu ħsieb, sakemm il- persuna li tamministra l- injezzjoni ssegwi l- istruzzjonijiet dettaljati mogħtija fil- Fuljett ta ’ Tagħrif.
The site of injection must be changed for each injection.
Is- sit ta ’ l- injezzjoni għandu jinbidel wara kull injezzjoni.
How does Fuzeon work?
Kif jaħdem Fuzeon?
The active substance in Fuzeon, enfuvirtide, is a fusion inhibitor.
Is- sustanza attiva f’ Fuzeon, enfuvirtide, hija inibitur tal- fużjoni.
Fuzeon binds to a protein on the surface of HIV.
Fuzeon jeħel ma ’ proteina fuq il- wiċċ ta ’ l- HIV.
This prevents the virus from attaching to the surface of human cells and infecting them.
Dan ma jħallix lill- vajrus jeħel mal- wiċċ ta ’ ċelloli umani u jinfettahom.
As HIV can only reproduce itself within cells, Fuzeon, taken in combination with other antiviral medicines, reduces the level of HIV in the blood and keeps it at a low level.
Billi l- HIV jista ’ jirriproduċi lilu nnifsu biss fiċ- ċelloli, Fuzeon, meħud flimkien ma ’ mediċini antivirali oħra, inaqqas il- livell ta ’ l- HIV fid- demm u jżommu f’ livell baxx.
Fuzeon does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Fuzeon ma jfejjaqx l- infezzjoni bl- HIV jew l - AIDS, iżda jista ’ jbiegħed il- ħsara lis- sistema immunoloġika u l- iżvilupp ta ’ infezzjonijiet u mardiet marbutin ma ’ l- AIDS.
How has Fuzeon been studied?
Reproduction is authorised provided the source is acknowledged Kif ġie studjat Fuzeon?
The two main studies of Fuzeon included 1,013 patients aged 16 years or over who were infected with HIV and had taken, or were not responding to, other antiviral medicines.
Iż- żewġ studji ewlenin ta ’ Fuzeon inkludew 1, 013- il pazjent minn 16- il sena ’ l fuq li kienu infettati bl - HIV u li kienu ħadu, jew li ma kinux qed jirrispondu għal, mediċini antivirali oħra.
On average, the patients had been given an average of 12 antiviral medicines over a seven-year period.
Bħala medja, il - pazjenti kienu ngħataw medja ta ’ 12- il mediċina antivirali fuq perjodu ta ’ seba ’ snin.
Both studies compared the effects of Fuzeon, in combination with ‘ optimised background therapy’ (a combination of other antiviral medicines chosen for each patient as they had the best chances of reducing the levels of HIV in the blood), compared with optimised background therapy without Fuzeon.
Iż- żewġ studji qabblu l- effetti ta ’ Fuzeon, mogħti flimkien ma ’ ‘ terapija ta ’ sfond ottimizzata ’ (kombinazzjoni ta ’ mediċini antivirali oħra magħżula għal kull pazjent għax kellhom l- ikbar ċans li jnaqqsu l- livelli ta ’ HIV fid- demm), meta imqabbla ma ’ terapija ta ’ sfond ottimizzata mingħajr Fuzeon.
The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) after 48 weeks of treatment.
Il- kejl ewlieni ta ’ l- effikaċja kien it- tibdil fil- livelli ta ’ l- HIV fid- demm (viral load) wara 48 siegħa ta ’ trattament.
Fuzeon has also been studied in 39 children aged between three and 16 years.
Fuzeon ġie studjat ukoll f’ 39 tifel u tifla ta ’ bejn tlieta u 16- il sena.
The studies were still ongoing at the time of the medicine’ s assessment.
L- istudji kienu għadhom għaddejjin fi żmien il- valutazzjoni tal- mediċina.
What benefit has Fuzeon shown during the studies?
X’ benefiċċji ta ’ Fuzeon ħarġu mill- istudji?
Taking Fuzeon with optimised background therapy was more effective at reducing viral loads than optimised background therapy alone.
It- teħid ta ’ Fuzeon ma ’ terapija ta ’ sfond ottimizzata kien iktar effettiv mit- terapija l- oħra waħidha fit - tnaqqis tal- viral loads.
In the first study, viral loads fell by an average of 98% in the patients taking Fuzeon, compared with 83% in the patients not taking Fuzeon.
Fl- ewwel studju, il- viral loads naqsu b’ medja ta ’ 98% fil- pazjenti li kienu qed jieħdu Fuzeon, meta imqabbla ma ’ 83% fil- pazjenti li ma kinux qed jieħdu Fuzeon.
The values in the second study were 96 and 78%, respectively.
Il- valuri fit- tieni studju kienu 96 u 78% rispettivament.
The approved dose of Fuzeon in children brings about similar levels of the active substance in the blood to the approved dose in adults.
Id- doża approvata ta ’ Fuzeon fit- tfal twassal għal livelli ta ’ sustanza attiva fid- demm simili għad- doża approvata fl- adulti.
What is the risk associated with Fuzeon?
X’ riskji huma assoċjati ma ’ Fuzeon?
The most common side effects with Fuzeon (seen in more than 1 patient in 10) are injection site reactions (pain and inflammation at the site of injection), peripheral neuropathy (damage to the nerves in the extremities causing tingling or numbness in the hands and feet) and weight loss.
L- iktar effetti sekondarji komuni b’ Fuzeon (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma reazzjonijiet fis- sit ta ’ l- injezzjoni (ugigħ u infjammazzjoni fis- sit ta ’ l- injezzjoni), newropatija periferali (ħsara lin- nervituri fl- estremitajiet li jikkawża tnemnim fl- idejn u s- saqajn) u telfien fil- piż.
In clinical studies, injection site reactions have been reported in 98% of patients, mostly occurring within the first week of treatment.
Fl- istudji kliniċi kienu rappurtati reazzjonijiet fis- sit ta ’ l- injezzjoni fi 98% tal- pazjenti, u ħafna minnhom dehru fl- ewwel ġimgħa tat- trattament.
It caused mild to moderate pain or discomfort, which did not increase during treatment.
Dan wassal għal uġigħ jew skumditajiet ħfief jew moderati, li ma żdidux matul it- trattament.
For the full list of all side effects reported with Fuzeon, see the Package Leaflet.
Ara l- Fuljett ta ’ Tagħrif għal- lista sħiħa ta ’ l- effetti sekondarji kollha li ġew irrappurtati mat- teħid ta ’ Fuzeon.
Fuzeon should not be used in people who may be hypersensitive (allergic) to enfuvirtide or any of the other ingredients.
Fuzeon m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal entuvirtide jew għal kwalunkwe wieħed mill- ingredjenti l- oħra.
As with all other anti-HIV medicines, patients taking Fuzeon may be at risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal fil- każijiet kollha l- oħra ta ’ mediċini kontra l- HIV, il- pazjenti li jkunu qed jieħdu Fuzeon ikollhom riskju ta ’ osteonekrożi (mewt tat- tessut tal- għadam) jew għas- sindromu tar- riattivazzjoni immunoloġika (sintomi ta ’ infezzjoni kkawżati mis- sistema immunoloġika li tkun qed tirkupra).
Patients who have problems with their liver may be at an elevated risk of liver damage when taking treatment for HIV infection.
Il - pazjenti bi problemi fil- fwied jista ’ jkollhom riskju ikbar ta ’ ħsara fil- fwied waqt it- trattament.
Why has Fuzeon been approved?
Għaliex ġie approvat Fuzeon?
The Committee for Medicinal Products for Human Use (CHMP) decided that Fuzeon’ s benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Fuzeon jisbqu r- riskji tiegħu f’ kombinazzjoni ma ’ prodotti mediċinali antiretrovirali oħra għat - trattament ta ’ pazjenti infettati bl- HIV- 1 li jkunu ngħataw trattament jew li ma jkunux marru għall - aħjar bi programmi ta ’ trattament li jkunu jikkonsistu minn ta ’ l- inqas prodott mediċinali wieħed mill - klassijiet li ġejjin, protease inhibitors, non- nucleoside reverse transcriptase inhibitors u nucleoside reverse transcriptase inhibitors, jew li jkollhom intolleranza għal programmi ta ’ trattament bil - mediċini antiretrovirali ta ’ qabel.
The Committee recommended that Fuzeon be given marketing authorisation.
Il- Kumitat irrakkomanda li Fuzeon jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Fuzeon was originally authorised under ‘ Exceptional Circumstances’, because for scientific reasons it had not been possible to obtain complete information on the medicine.
Fuzeon ġie oriġinarjament awtorizzat taħt “ Ċirkustanzi ta ’ Eċċezzjoni ”, għaliex minħabba raġunijiet xjentifiċi ma kienx possibbli li jinkiseb tagħrif sħiħ dwar il- mediċina.
2008.
Minħabba li l- kumpanija kienet ipprovdiet it- tagħrif ulterjuri li kien mitlub, iċ - ‘ Ċirkustannzi ta ’ Eċċezzjoni ’ intemmu fit- 8 ta ’ Lulju 2008.
Other information about Fuzeon:
Informazzjoni oħra dwar Fuzeon:
The European Commission granted a marketing authorisation valid throughout the European Union for Fuzeon to Roche Registration Limited on 27 May 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Fuzeon lil Roche Registration Limited fis- 27 ta ’ Mejju 2003.
The marketing authorisation was renewed on 27 May 2008.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fis- 27 ta ’ Mejju 2008.
The full EPAR for Fuzeon can be found here.
L- EPAR sħiħ dwar Fuzeon jista ’ jinstab hawn.
This summary was last updated in 07-2008.
Dan is- sommarju kien aġġornat l- aħħar fi 07- 2008.
Fuzeon 90 mg/ ml powder and solvent for solution for injection
Fuzeon 90 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni
Each vial contains 108 mg enfuvirtide.
Kull kunjett fih 108 mg enfuvirtide.
Each ml of reconstituted solution contains 90 mg enfuvirtide.
Kull ml ta ’ soluzzjoni rikostitwita fiha 90 mg enfuvirtide.
White to off-white lyophilised powder.
Trab u solvent għal soluzzjoni għall- injezzjoni Trab lajofilizzat, abjad jagħti fl- offwajt.
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non- nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.
Fuzeon huwa indikat f’ taħlita flimkien ma ’ prodotti mediċinali antiretrovirali oħrajn għall- kura ta ’ pazjenti infettati bl- HIV- 1 li rċievew trattamenti li ma rnexxewx bi programmi ta ’ kura li fihom għall - anqas prodott mediċinali wieħed minn kull klassi antiretrovirali li ġejja: impedituri tal- protease, impedituri ta ’ non- nucleoside reverse transcriptase u impedituri ta ’ nucleoside reverse transcriptase, jew li għandhom intolleranza għall- programmi ta ’ kura antiretrovirali ta ’ qabel.
(see section 5.1)
(ara sezzjoni 5. 1)
In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products.
Biex jiġi deċiż programm ta ’ kura ġdid għal pazjenti li ma rnexxewx bi programm ta ’ kura antiretrovirali, għandha tingħata konsiderazzjoni speċjali lill- kura li ngħatat fil- passat għal kull pazjent individwali, kif ukoll lit- tipi ta ’ mutazzjonijiet assoċjati ma ’ prodotti mediċinali differenti.
Where available, resistance testing may be appropriate.
Fejn ikun disponibbli, jista ’ jkun xieraq li jsiru testijiet għar- reżistenza.
(See sections 4.4 and 5.1)
(Ara sezzjonijiet 4. 4 u 5. 1).
Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection.
Fuzeon għandu jiġi preskritt minn tobba li għandhom esperjenza fil- kura ta ’ l- infezzjoni HIV.
Fuzeon is only to be administered by subcutaneous injection.
Fuzeon għandu jingħata biss permezz ta ’ injezzjoni minn taħt il- ġilda.
Adults and adolescents ≥ 16 years:
Adulti u adoloxxenti ≥ 16- il sena:
The recommended dose of Fuzeon is 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen.
Id- doża rakkomandata ta ’ Fuzeon hija ta ’ 90 mg darbtejn kuljum injettata minn taħt il- ġilda fil- parti ta ’ fuq tad- driegħ, fin- naħa ta ’ wara tal- koxxa jew fl- addome.
There is no experience in patients > 65 years old.
M’ hemmx esperjenza b’ pazjenti > 65 sena.
Children ≥ 6 years and adolescents:
Tfal ≥ 6 snin u adoloxxenti:
The experience in children is limited (See section 5.2).
(Ara sezzjoni 5. 2).
In clinical trials the dosage regimen in table 1 below was used:
Fi provi kliniċi kien użat il- programm ta ’ dożaġġ kif jidher f’ Tabella 1 taħt.
Paediatric Dosing
Dożaġġ Pedjatriku
Weight (kg)
Piż (kg)
(mg/ dose)
Doża kull injezzjoni bid (mg/ doża)
(90 mg enfuvirtide per ml)
Volum ta ’ l- injezzjoni (90 mg enfuvirtide kull ml)
11.0 to 15.5 15.6 to 20.0 20.1 to 24.5 24.6 to 29.0 29.1 to 33.5 33.6 to 38.0 38.1 to 42.5 ≥ 42.6
11. 0 sa ’ 15. 5 15. 6 sa ’ 20. 0 20. 1 sa ’ 24. 5 24. 6 sa ’ 29. 0 29. 1 sa ’ 33. 5 33. 6 sa ’ 38. 0 38. 1 sa ’ 42. 5 ≥42. 6
0.3 ml 0.4 ml 0.5 ml 0.6 ml 0.7 ml 0.8 ml 0.9 ml 1.0 ml
0. 3 ml 0. 4 ml 0. 5 ml 0. 6 ml 0. 7 ml 0. 8 ml 0. 9 ml 1. 0 ml
Fuzeon is not recommended for use in children below age 6 due to insufficient data on safety and efficacy (see section 5.2).
Fuzeon mhux rakkomandat għall- użu fit- tfal taħt l- età ta ’ 6 snin minħabba li mhemmx tagħrif biżżejjed dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
No dose adjustment is required for patients with renal impairment including those receiving dialysis.
M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għal pazjenti li għandhom indeboliment renali inluż dawk li qed jirċievu dijalisi.
(See sections 4.4 and 5.2).
(Ara sezzjonijiet 4. 4 u 5. 2).
No data are available to establish a dose recommendation for patients with hepatic impairment.
M’ hemmx tagħrif sabiex tiġi stabbilita rakkomandazzjoni ta ’ doża għal pazjenti b’ indeboliment tal- fwied.
Fuzeon must be taken as part of a combination regimen.
Fuzeon għandu jittieħed bħala parti minn programm ta ’ kura kombinata.
Please also refer to the respective summary of product characteristics of the other antiretroviral medicinal products used in the combination.
Jekk jogħġbok ara ukoll is - sommarju tal- karatteristiċi tal- prodott tal- prodotti mediċinali antiretrovirali oħrajn użati fit- taħlita.
As with other antiretrovirals, enfuvirtide should optimally be combined with other antiretrovirals to which the patient’ s virus is sensitive.
Bħal antiretrovirali oħrajn, enfuvirtide idealment għandu jitħallat ma ’ antiretrovirali oħrajn li għalihom il- virus tal- pazjent huwa sensittiv.
(See section 5.1)
(Ara sezzjoni 5. 1).
Patients must be advised that antiretroviral therapies including enfuvirtide have not been proved to prevent the risk of transmission to HIV to others through sexual contact or blood contamination.
Il- pazjenti għandhom ikunu avżati li terapiji antiretrovirali inkluż enfuvirtide ma ġewx ippruvati li jevitaw ir- riskju ta ’ tixrid ta ’ l- HIV lill- ħaddieħor permezz ta ’ kuntatt sesswali jew ta ’ kontaminazzjoni tad- demm.
They must continue to use appropriate precautions.
Huma għandhom jibqgħu jużaw il- prekawzjonijiet xierqa.
Patients should also be informed that Fuzeon is not a cure for HIV-1 infection.
Il- pazjenti għandhom jiġu nformati ukoll li Fuzeon mhux kura għall- infezzjoni ta 'HIV- 1.
Animal studies have shown that enfuvirtide may impair some immune functions (see section 5.3).
Studji fuq l- annimali wrew li enfuvirtide jista ’ jnaqqas uħud mill- funzjonijiet immuni (ara sezzjoni 5. 3).
An increased rate of some bacterial infections, most notably a higher rate of pneumonia, has been seen in patients treated with Fuzeon.
Ġiet innotata rata ogħla ta ’ xi infezzjonijiet ta ’ batterji, b’ mod speċjali rata ogħla ta ’ pnewmonja kienet osservata f’ pazjenti kkurati b’ Fuzeon.
Patients should be monitored closely for signs and symptoms of pneumonia.
Il- pazjenti għandhom jiġu ssorveljati b' attenzjoni għal sinjali u sintomi ta ’ pnewmonja.
(See section 4.8)
(Ara sezzjoni 4. 8).
Hypersensitivity reactions have occasionally been associated with therapy with enfuvirtide and in rare cases hypersensitivity reactions have recurred on rechallenge.
Xi kultant reazzjonijiet ta ’ sensittività eċċessiva ġew assoċjati ma ’ terapija b’ enfuvirtide u f’ każijiet rari reazzjonijiet ta ’ sensittività eċċessiva reġgħu seħħew meta l- pazjenti reġgħu ingħataw il- prodott mediċinali.
Events included rash, fever, nausea and vomiting, chills, rigors, low blood pressure and elevated serum liver transaminases in various combinations, and possibly primary immune complex reaction, respiratory distress and glomerulonephritis.
Avvenimenti nkludew raxx, deni, tqalligħ u rimettar, tertir, rogħda ta ’ bard, pressjoni tad - demm baxxa u transaminases tal- fwied għoljin fis- serum f’ diversi taħlitiet, u possibilment reazzjoni primarja ta ’ kumpless immuni, distress respiratorju u glomerulonefrite.
Patients developing signs/ symptoms of a systemic hypersensitivity reaction should discontinue enfuvirtide treatment and should seek medical evaluation immediately.
Il- pazjenti li jiżviluppaw sinjali/ sintomi ta ’ reazzjoni sistematika ta ’ sensittività eċċessiva għandhom iwaqqfu l- kura b’ enfuvirtide u għandhom jagħmlu evalwazzjoni medika minnufih.
Therapy with enfuvirtide should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction considered related to enfuvirtide.
It- terapjia b’ enfuvirtide m’ għandhiex terġa ’ tinbeda wara sinjali u sintomi sistematiċi li jindikaw reazzjoni ta ’ sensittività eċċessiva meqjusa li għandhom x’ jaqsmu ma ’ enfuvirtide.
Risk factors that may predict the occurrence or severity of hypersensitivity to enfuvirtide have not been identified.
Fatturi ta ’ riskju li jistgħu jbassru l - okkorrenza jew is- severita ta ’ reazzjoni ta ’ sensittività eċċessiva għal enfuvirtide ma ġewx identifikati.
The safety and efficacy of enfuvirtide has not been specifically studied in patients with significant underlying liver disorders.
Is- sigurtà u l- effikaċja ta ’ enfuvirtide f’ pazjenti b’ disturbi sinifikanti tal- fwied ma ġewx studjati speċifikament.
Patients with chronic hepatitis B and C and treated with
Fil- provi
Few patients included in the phase III trials were co-infected with hepatitis B/ C.
3 kliniċi ta ’ fażi III kien hemm ftit pazjenti li kienu ko- infettati bl- epatite B/ C.
In these the addition of Fuzeon did not increase the incidence of hepatic events.
F’ dawn il- każijiet, iż - żieda ta ’ Fuzeon ma żidietx l- inċidenza ta ’ avvenimenti epatiċi.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Fil- każ ta ’ terapija antivirali fl- istess waqt għall- epatite B jew C, jekk jogħġbok ara l- informazzjoni tal- prodott rilevanti għal dawn il - prodotti mediċinali.
Administration of Fuzeon to non-HIV-1 infected individuals may induce anti-enfuvirtide antibodies that cross-react with HIV gp41.
L- għotja ta ’ Fuzeon lil individwi li m’ humiex infettati b’ HIV- 1 tista ’ twassal għal anti- korpi anti - enfuvirtide li jkollhom reazzjoni inkroċjata ma 'HIV gp41.
This may result in a false positive HIV test with the anti-HIV ELISA test.
Dan jista ’ jwassal għal riżultat tat- test għall- HIV pożittiv falz bit- test anti- HIV ELISA.
There is no experience in patients with reduced hepatic function.
M’ hemmx esperjenza f' pazjenti b’ funzjoni epatika mnaqqsa.
Data is limited in patients with moderate to severe renal impairment, and in patients maintained on dialysis.
Tagħrif huwa limitat f' pazjenti b’ indeboliment renali moderat għal sever u f’ pazjenti miżmuma fuq dijalisi.
Fuzeon should be used with caution in these populations.
Fuzeon għandu jintuża b’ attenzjoni f’ dawn il- gruppi ta ’ ndividwi.
(See sections 4.2 and 5.2)
(Ara sezzjonijiet 4. 2 u 5. 2)
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
F’ pazjenti nfetti b’ HIV b’ defiċjenza immuni severa fil- ħin li tinbeda t- terapija antiretrovirali kombinata (CART), tista ’ sseħħ reazzjoni infjammatorja għall - patoġeni mingħajr sintomi jew patoġeni residwali opportunistiċi li tista ’ tikkawża kundizzjonijiet kliniċi serji, jew aggravar tas- sintomi.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Normalment, reazzjonijiet bħal dawn kienu osservati fl- ewwel ftit ġimgħat jew xhur mill- bidu ta ’ CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Eżempji rilevanti huma retinite kkawżata minn cytomegalovirus, infezzjonijiet ġeneralizzati u/ jew lokalizzati b’ mycobacterium, u pnewmonja kkawżata minn Pneumocystis carinii.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu infjammatorju għandu jiġi vvalutat u għandha tinbeda kura skond il- bżonn.
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/ or long-term exposure to CART.
Għalkemm l- etjoloġija hija kkunsidrata li ġejja minn ħafna fatturi (inkluż l- użu ta ’ kortikosterojdi, konsum ta ’ alkoħol, immunosoppressjoni severa, indiċi tal- massa tal- ġisem għola), każijiet ta ’ osteonekrożi ġew irrappurtati partikolarment f’ pazjenti b’ marda ta ’ l- HIV avvanzata u/ jew esponiment fit- tul għal terapija antiretrovirali kombinata (CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom jiġu avżati biex iffitxu parir mediku jekk ikollhom esperjenza ta ’ weġgħat u uġigħ fil- ġogi, għebusija fil- ġogi jew diffikultà fil- moviment.
Interactions studies have only been performed in adults.
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru biss fl - adulti.
No clinically significant pharmacokinetic interactions are expected between enfuvirtide and concomitantly given medicinal products metabolised by CYP450 enzymes.
Interazzjonijiet farmakokinetiċi ta ’ sinifikanza klinika mhumiex mistennija bejn enfuvirtide u l- għotja flimkien ta ’ prodotti mediċinali metabolizzati bl- enżimi CYP450.
Influence of enfuvirtide on metabolism of concomitant medicinal products:
L- effett ta ’ enfuvirtide fuq il- metaboliżmu ta ’ prodotti mediċinali li jingħataw fl- istess ħin:
In an in-vivo human metabolism study enfuvirtide, at the recommended dose of 90 mg twice daily, did not inhibit the metabolism of substrates by CYP3A4 (dapsone), CYP2D6 (debrisoquine), CYP1A2 (caffeine), CYP2C19 (mephenytoin), and CYP2E1 (chlorzoxazone).
Fi studju in vivo tal- metaboliżmu uman, enfuvirtide, fid- doża rakkomandata ta ’ 90 mg darbtejn kuljum, ma waqqafx il- metaboliżmu ta ’ substrati permezz ta ’ CYP3A4 (dapsone), CYP2D6 (debrisoquine), CYP1A2 (kaffeina), CYP2C19 (mephenytoin), u CYP2E1 (chlorzoxazone).
Influence of concomitant medicinal products on enfuvirtide metabolism:
L- effett ta ’ prodotti mediċinali li jingħataw fl- istess ħin fuq il- metaboliżmu ta ’ enfuvirtide:
In separate pharmacokinetic interaction studies, co-administration of ritonavir (potent CYP3A4 inhibitor) or saquinavir in combination with a booster dose of ritonavir or rifampicin (potent CYP34A inducer) did not result in clinically significant changes of the pharmacokinetics of enfuvirtide.
Fi studji separati ta ’ interazzjonijiet farmakokinetiċi, l- għotja ta ’ ritonavir (impeditur qawwi ta ’ CYP3A4) jew ta ’ saquinavir flimkien ma ’ doża booster ta ’ ritonavir jew rifampicin (induttur qawwi ta ’ CYP34A) ma wassalx għal tibdil ta ’ sinifikanza klinika fil- farmakokinetika ta ’ enfuvirtide.
There are no adequate and well-controlled studies in pregnant women.
M’ hemmx studji biżżejjed jew kontrollati sew dwar l- użu waqt it- tqala.
Animal studies do not indicate harmful effects with respect to foetal development.
Studji fuq il- bhejjem ma jurux effetti ħżiena fuq l- iżvilupp tal- fetu.
Enfuvirtide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Enfuvirtide għandu jintuża fit- tqala biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
It is not known whether enfuvirtide is secreted in human milk.
4 Mhux magħruf jekk enfuvirtide jitneħħiex mal- ħalib tas- sider uman.
Mothers should be instructed not to breast-feed if they are receiving enfuvirtide because of the potential for HIV transmission and any possible undesirable effects in breast-fed infants.
Ommijiet li qed jieħdu enfuvirtide għandhom jingħataw istruzzjonijiet biex ma jreddgħux minħabba l- potenzjal ta 'trażmissjoni ta' l- HIV u kwalunkwe effetti mhux mixtieq oħra lil trabi li qed jerdgħu.
There is no evidence that enfuvirtide may alter the patient’ s ability to drive and use machines, however, the adverse event profile of enfuvirtide should be taken into account.
M’ hemmx evidenza li enfuvirtide jista ’ jbiddel il- ħila tal- pazjent biex isuq jew iħaddem magni, iżda, wieħed għandu jikkunsidra il- profil ta ’ effetti avversi ta ’ enfuvirtide.
(See section 4.8)
(Ara sezzjoni 4. 8)
Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined (see section 5.1).
Tagħrif ta ’ sigurtà jirreferi l- iżjed għal tagħrif ta ’ 48 ġimgħa minn studji TORO 1 u TORO 2 flimkien (ara sezzjoni 5. 1).
Safety results are expressed as the number of patients with an adverse reaction per 100 patient- years of exposure (except for injection site reactions).
Riżultati ta ’ sigurtà huma espressi bħala n- numru ta 'pazjenti b’ reazzjoni avversa kull 100 sena ta ’ pazjent ta ’ espożizzjoni (ħlief għal reazzjonijiet fil- post tal- injezzjoni)
Injection site reactions
Reazzjonijiet fil- post tal- injezzjoni
Injection site reactions (ISRs) were the most frequently reported adverse reaction and occurred in 98% of the patients (Table 2).
Ir- reazzjonijiet fil- post tal- injezzjoni (ISRs) kienu l- aktar reazzjonijiet avversi rrapportati bi frekwenza u seħħew f ’ 98% tal- pazjenti (Tabella 2).
The vast majority of ISRs occurred within the first week of Fuzeon administration and were associated with mild to moderate pain or discomfort at the injection site without limitation of usual activities.
Il- biċċa l- kbira ta 'ISRs seħħew fl- ewwel ġimgħa ta ’ amministrazzjoni ta ’ Fuzeon u kienu assoċjati ma ’ uġigħ ħafif għal moderat jew skomdu fil- post tal - injezzjoni mingħajr limitazzjonijiet fl- attivitajiet ta' kuljum.
The severity of the pain and discomfort did not increase with treatment duration.
Il- qawwa ta ’ l- uġigħ u ta ’ l- iskomdu ma żdiedux mat- tul tal- kura.
The signs and symptoms generally lasted equal to or less than 7 days.
Is- sinjali u s- sintomi normalment damu sa jew anqas minn sebat ijiem.
Infections at the injection site (including abscess and cellulitis) occurred in 1.5% of patients.
Infezzjonijiet fil- post tal- injezzjoni (inkluż aċċess u ċellulite) seħħew f' 1. 5% tal- pazjenti.
Summary of individual signs/ symptoms characterising local injection site reactions in studies TORO 1 and TORO 2 combined (% of patients) n=663
Sommarju ta ’ sinjali/ sintomi ndividwali li jikkaratterizzaw reazzjonijiet lokali fil - post tal- injezzjoni fl- istudji TORO 1 u TORO 2 flimkien (% tal- pazjenti) n=663 Rata ta ’ Rtirar minħabba ISRs
Event Category
Kategorija ta ’ l- avveniment
Fuzeon
Fuzeon + Sfond
% of Event
% ta ’ l- Episodji li
+Optimised
ottimizzata
comprising
fihom
Pain / discomfort
reazzjonijiet ta ’ reazzjonijiet ta ’ Grad 4 Grad 3 Uġigħ / Skomdu
backgrounda 96.1%
96. 1%
Grade 3 reactions 11.0%b
11. 0% b
Grade
0% b
4 reactions 0%b
90. 8% 90. 2% 80. 4%
Erythema Induration Nodules and cysts Pruritus Ecchymosis a Any severity grade. b
Ħakk Ekkimosi a Kull grad ta ’ qawwa. b
90.8% 90.2% 80.4% 65.2% 51.9%
65. 2% 51. 9%
23.8%c 43.5%d 29.1%e 3.9%f 8.7%g
8. 7% g
10.5%c 19.4%d 0.2%e NA 4.7%g
NA 4. 7% g