qanastek/EMEA-V3 huggingface dataset:
- ritonavir or other CYP3A4 inhibitors (medicines that help control HIV infection)
- ritonavir jew inibituri CYP3A4 oħrajn (mediċini li jgħinu jikkontrollaw l- infezzjoni tal- HIV)
- antidepressants called MAO inhibitors, or have taken them within the last 14 days
- anti- dipressanti magħrufa bhala inibituri MAO, jew jekk ħadthom fl- aħħar 14- il jum
23 Please tell your doctor or nurse if you are taking any other medicines or have recently taken any other medicines including medicines obtained without prescription.
Jekk jogħġbok għid lit- tabib jew lill- infermier tiegħek jekk qed tieħu xi mediċini oħrajn jew jekk ħadt xi mediċini oħrajn riċentement anke mediċini li jingħataw mingħajr riċetta.
Using IONSYS with food and drink Do not drink alcohol whilst you are wearing an IONSYS device.
Tixrobx alkoħol waqt li tkun liebes/ liebsa sistema IONSYS.
Pregnancy and breast-feeding You must tell your doctor before using IONSYS if you are pregnant or planning to become pregnant.
Tqala u Treddigħ Għandek tgħid lit- tabib qabel ma tuża IONSYS jekk inti tqila jew jekk qed tippjana li tinqabad tqila.
Your doctor will discuss the possible risks and potential benefits of using IONSYS while you are pregnant.
It- tabib jiddiskuti miegħek il- possibilità ta ’ riskji u l- benefiċċji potenzjali tal- użu ta ’ IONSYS waqt it- tqala.
IONSYS should not be administered during childbirth.
IONSYS m’ għandux jingħata waqt il- ħlas.
If you are given IONSYS during childbirth your baby may be given an antidote when it is born.
Jekk tingħata IONSYS waqt il- ħlas, it- tarbija tista tingħata antidot meta titwieled.
Prolonged treatment with fentanyl, the active substance in IONSYS, may cause withdrawal in the newborn baby.
Trattament fit- tul bil- fentanyl, is- sustanza attiva f’ IONSYS, jista ’ jwassal għal withdrawal fit- tarbija tat- twelid.
Do not use IONSYS if you are breast-feeding.
Tużax IONSYS jekk qed tredda.
Fentanyl can get into breast milk.
Fentanyl jista ’ jidħol ġol- ħalib tal- omm.
You should not start breast-feeding until the IONSYS system has been removed for 24 hours.
M’ għandekx tibda tredda qabel 24 siegħa minn meta titneħħa s- sistema IONSYS.
Driving and using machines Do not drive or operate machines when you leave hospital after using IONSYS because the painkiller leaves some people feeling dizzy or drowsy.
M’ għandekx tagħmel użu minn għodda jew tħaddem magni wara li titlaq mill- isptar wara li tkun użajt IONSYS għax din il- mediċina kontra l- uġigħ jista ’ tħalli ċerti nies iħossuhom sturduti jew imħeddla.
Do not use any tools or machines.
Tużax għodda jew magni.
HOW TO USE IONSYS
KIF GĦANDEK TUŻA IONSYS
Instructions for proper use
Struzzjonijiet għal użu tajjeb
Do not let your family or friends start the IONSYS device for you.
Tħallix lill- familjari jew ħbieb iħaddmu s- sistema IONSYS għalik.
Only you know how much pain you are having, and only you should operate IONSYS to start a dose of medicine.
Inti biss taf kemm għandek uġigħ, u inti biss għandek tħaddem IONSYS biex tibda doża ta ’ mediċina.
To make sure you get the correct amount of medicine, press the IONSYS system as soon as you start to feel pain.
Biex tkun żgur li tieħu l - ammont tajjeb ta ’ mediċina, għafas is- sistema IONSYS kif tibda tħoss l- uġigħ.
Do not swallow the gels.
Tiblax il- ġell.
Swallowing the fentanyl-containing gel may cause life-threatening breathing difficulties or even death.
Jekk tibla l- ġell li fih il- fentanyl jista ’ jwassal għal diffikultajiet biex tieħu n- nifs li jistgħu ikunu ta ’ periklu għall- ħajja u jisgħu iwasslu għall- mewt.
Do not touch the sticky side of the system or the gels or allow gels to touch your mouth.
Tmissx in- naħa tas- sistema li twaħħal jew il- ġellijiet jew tħallix il- ġellijiet imissu mal- ħalq.
If the medicine in IONSYS gets into the eyes and mouth it could be harmful or even cause death.
Jekk il- mediċina IONSYS tidħol fl - għajnejn jew fil- ħalq tista tagħmel ħsara jew twassal għall- mewt.
Do not touch the sticky side of the system or the gels even after the you have stopped using the system and it has been removed, there is still enough fentanyl in the system to potentially cause life-threatening breathing difficulties or even death.
Tmissx in- naħa tas- sistema li twaħħal jew il- ġellijiet anke wara li tieqaf tuża s- sistema u titneħħa, għad hemm biżżejjed fentanyl fis - sistema biex potenzjalment twassal għal problemi fin- nifs li huma ta ’ periklu għall- ħajja u jistgħu iwasslu għall- mewt.
If you accidentally touch the gels on the underside of the system:
Jekk aċċidentalment tmiss il- ġellijiet fuq in- naħa ta ’ taħt tas- sistema:
- Alert a nurse or doctor right away
- Informa infermier jew tabib immedjatament
- Rinse your hands with large amounts of water
- Aħsel idejk b’ ammonti kbar ta ’ ilma
- Do not use soap, alcohol, or other solvents to remove the gel because they may increase the
- Tużax sapun, alkoħol jew solventi oħrajn biex tneħħi l- ġell minħabba li dawn jistgħu jżidu l -
drug’ s ability to go through the skin.
abilità tad- droga biex tgħaddi minn ġol- ġilda.
The nurse or doctor will put IONSYS on your skin, and take it off or replace it when needed.
L- infermier jew tabib tiegħek iwaħħal IONSYS mal- ġilda tiegħek, u jneħħih jew jibdlu meta jkun hemm bżonn.
The nurse or doctor will also take the system off before you leave the hospital.
L- infermier jew tabib tiegħek ineħħilek is- sistema ukoll qabel ma titlaq mill- isptar.
Don’ t take it off or attempt to put it back on yourself.
Tneħħijiex jew tipprova twaħħalha lura waħdek.
Don’ t let the IONSYS device get wet.
Tħallix is- sistema IONSYS tixxarrablek.
It could stop working or fall off.
Tista ’ tieqaf taħdem jew tinqalalek.
You can take a dose whenever you need it for your pain, or just before you do an activity that may increase your pain (physical therapy, getting out of bed, etc).
Tista tieħu doża meta tkun qed tħoss l- uġigħ, jew qabel ma tagħmel xi attività li tista ’ żżidlek l- uġigħ (terapija fiżika, toħroġ mis- sodda, eċċ).
Each time you are given a new IONSYS system, you may find you need to have more doses to start with, than later on in the treatment time.
Kull darba li tingħata sistema IONSYS ġdida, tista ’ tinduna li għandek iktar dożi biex tibda milli iktar ‘ il quddiem fit- trattament.
24 To start a dose from IONSYS, press the on button firmly, twice.
Biex tibda doża minn IONSYS, agħfas il- buttuna sewwa, darbtejn.
The device will start to deliver a dose of fentanyl over about 10 minutes.
Is- sistema tibda tgħaddi doża fentanyl fuq 10 minuti.
The red light comes on when you start a dose.
23 Il- bozza ħamra tixgħel meta tibda doża.
It stays on while the medicine is being delivered.
Din tibqa tixgħel waqt li tkun qed tgħaddi l- mediċina.
You cannot start another dose while the light is on.
Ma tistax tibda doża oħra waqt li l- bozza tkun qed tixgħel.
The red light will flash between doses.
Il- bozza ħamra tteptep bejn doża u oħra.
When the red light starts to flash, you may start another dose at any time you need it.
Meta l- bozza l- ħamra tibda tteptep, tista ’ tibda doża oħra meta jkollok bżonnha.
Only press the button when you need pain relief.
Agħfas il- buttuna biss meta jkollok bżonn serħan mill- uġigħ.
The flashes tell your nurse about how many doses you have used.
It- teptip juri lill - infermier tiegħek kemm użajt dożi.
You will hear IONSYS beep once each time you start a dose.
Ser tisma ħoss wieħed minn IONSYS ma ’ kull doża li tibda.
If it beeps at any other time, or more than once, tell your nurse or doctor.
Jekk jagħmel ħoss fi kwalunkwe ħin ieħor, jew iktar minn darba, għid lill- infermier jew tabib tiegħek.
They will check that IONSYS is working.
Huma jivverifikaw li IONSYS qed jaħdem.
Each device works for 24 hours from your first dose and contains 80 doses.
Kull sistema taħdem għal 24 siegħa mill- ewwel doża u fiha 80 doża.
The IONSYS system will stop working after 24 hours or after 80 doses have been delivered.
Is- sistema IONSYS tieqaf taħdem wara 24 siegħa jew wara li jkunu ġew mgħoddija 80 doża.
At this time the system should be removed.
F’ dan il- mument is- sistema għanda titneħħa.
Your doctor or nurse will remove the IONSYS system before you leave hospital.
It- tabib jew infermier tiegħek ineħħulek is- sistema IONSYS qabel ma titlaq mill- isptar.
After IONSYS has been removed, it may leave a small reddish mark at the skin site.
Wara li IONSYS jitneħħa, jista ’ jħalli marka żgħira ħamranija fuq il- post fejn kien fuq il- ġilda.
This is common, and nothing to worry about.
Din hi ħaġa komuni u m’ għandekx għalfejn tinkwieta.
The red area will fade over the next few days.
Il- ħmura titlaq wara ftit ġranet.
Always use IONSYS exactly as your doctor has instructed you.
Dejjem uża IONSYS eżattament kif qallek it- tabib tiegħek.
Check with your doctor or nurse if you are unsure.
Ivverifika mat- tabib jew infermier tiegħek jekk m’ intix ċert.
If you use more IONSYS than you should
Jekk tuża IONSYS aktar milli suppost
The device is designed so that you can’ t use too much IONSYS, providing only you operate it, and only when you need pain relief.
Is- sistema hi diżenjata sabiex inti ma tkunx tista ’ tuża IONSYS iktar milli suppost, sakemm tħaddimha waħdek u biss meta jkollok bżonn serħan mill- uġigħ.
However, if you feel faint or have difficulty in breathing, tell a doctor or nurse immediately.
Iżda, jekk tħossok ħażin jew jekk għandek diffikultà tieħu n- nifs, informa lil tabib jew infermier immedjatament.
If you have any further questions on the use of this product, ask your doctor or nurse.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqst lit- tabib jew lill- infermier tiegħek.
IONSYS can have side effects, like any medicine, but not everybody gets them.
Bħal kull mediċina oħra, IONSYS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you feel faint or if you have difficulty in breathing, tell a doctor or nurse immediately.
Jekk tħossok ħażin jew għandek diffikultà tieħu n- nifs, informa tabib jew infermier immedjatament.
The most common side effects (these may affect 10 in every 100 people or more)
L- iktar effetti sekondarji komuni (dawn jistgħu jaffettwaw 10 minn kull 100 persuna jew iżjed)
Feeling or being sick (nausea, vomiting); headache, reddening of skin at the patch site.
Tħossok jew tkun ma tiflaħx (nawżea, irremettar); uġigħ ta ’ ras, ħmura tal- ġilda fuq is- sit tas- sistema
25 Less common side effects (these may affect up to 9 in every 100 people)
24 (dawn jistgħu jaffettwaw sa 9 minn kull 100 persuna)
Dizziness and sleepiness; itching; low blood pressure; constipation; passing wind; low blood oxygen (hypoxia) that may cause dizziness or cramp; blistering of skin at the patch site; retention of urine; fever.
Sturdament u ngħas; ħakk; pressjoni baxxa tad- demm; stitikezza; bass; ossiġnu baxx fid- demm (ipoksja) li jista ’ jwassal għal sturdament jew bugħawwieġ; infafet tal- ġilda fuq is- sit tas- sistema; ritenzjoni tal- awrina; deni.
Uncommon side effects (these may affect fewer than 1 in every 100 people)
Effetti sekondarji mhux komuni (dawn jistgħu jaffettwaw inqas minn 1 minn kull 100 persuna)
Flushing; anxiety; sleeplessness, abnormal dreams; hallucinations; depression; sensitive skin; nervousness, tremor; vertigo; fast, slow or irregular heartbeat; shortness of breath, cough; hiccups; blocked nose; rash; fainting; muscle pain; fluid retention; abnormal blood chemistry; dry mouth; weight loss; passing water more or less frequently than normal; stomach pain; chills; back pain; high blood pressure; low blood sugar; belching.
Fwawar; anzjetà; nuqqas ta ’ rqad, ħolm stramb; alluċinazzjonijiet; dipressjoni; ġilda sensittiva; nervożita`; rogħda; vertiġini; ritmu tal- qalb mgħaġġel, bil- mod jew irregolari; qtugħ ta ’ nifs; sogħla; sulluzzu; imnieħer miżdud; raxx; ħass ħażin; uġigħ fil- muskoli; ritenzjoni ta ’ fluwidi; kimika tad - demm anormali; ħalq xott; telf ta ’ piż; tgħaddi l- ilma iktar jew inqas frekwenti minn- normal; uġigħ fl - istonku; ksieħ; uġigħ fid- dahar; pressjoni għolja fid- demm; livell baxx taz- zokkor fid- demm; tifwiq.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- infermier tiegħek.
HOW TO STORE IONSYS
KIF TAĦŻEN IONSYS
The hospital staff will store IONSYS.
L- istaff tal- isptar jaħzen IONSYS.
The used system should also be disposed of by medical staff.
Is- sistema wżata għanda tintrema mill- istaff mediku.
Keep out of reach and sight of children.
Taħżinx f’ temperatura ’ l fuq minn 25°C Tagħmlux fil- friġġ jew friża Żommu fil- pakkett oriġinali Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
What IONSYS contains
X’ fih IONSYS:
The active substance in IONSYS is fentanyl.
Is- sustanza attiva f’ IONSYS hi fentanyl.
The other ingredients are water, polacrilin, polyvinyl alcohol, citric acid, sodium citrate, sodium chloride, sodium hydroxide, cetylpyridinium chloride.
L- ingredjenti l- oħrajn huma ilma, polacrilin, polyvinyl alcohol, citric acid, sodium citrate, sodium chloride, sodium hydroxide, cetylpyridinium chloride.
The bottom housing is made from glycol-modified polyethylene terephthalate, and contains: anode hydrogel, including fentanyl HCl, polacrilin, purified water, sodium hydroxide, polyvinyl alcohol; cathode hydrogel, including purified water, sodium chloride, sodium citrate, polyvinyl alcohol, anhydrous citric acid, cetylpyridinium chloride; anode electrode, containing layers of silver foil and electrically conductive adhesive tape; cathode electrode consisting of layers of silver chloride composite material, silver foil, and electrically conductive adhesive tape; skin adhesive composed of a mixture of two PIBs, a polybutene, and a resin ester that acts as a tackifier; protective liner which is a polyester film coated on one side with silicone.
L- għata ta ’ taħt huwa magħmul minn glycol- modified polyethylene terephthalate, u fiħ: hydrogel anodiku, inkluż fentanyl HCI, polacrilin, ilma ppurifikat, sodium hydroxide, polyvinyl alcohol; hydrogel katodiku, inkluż ilma ppurifikat, sodium chloride, sodium citrate, polyvinyl alcohol, anhydrous citric acid, cetylpyridinium chloride, elettrodu anodiku, li fih saffi ta ’ fojl tal- fidda u tejp adeżiv li jikkonduċi l- elettriku; elettrodu katodiku konsistenti f’ saffi ta ’ materjal komport ta ’ silver chloride, fojl tal- fidda, u tejp adeżiv li jikkonduċi l- elettriku; adeżiv tal- ġilda kompost minn taħlita ta ’ żewġ PIBs, polybutene, u ester tar- reżina li jaġixxi bħala tackifier; liner protettiv li huwa kisja tal - polyester li minn- naħa minnhom huwa miksi bis- silikon.
What IONSYS looks like and contents of the pack
Id- Dehra ta ’ IONSYS u l- kontenuti tal- pakkett:
IONSYS is an iontophoretic transdermal system (ITS).
IONSYS huwa sistema jontoforetika li tipprovdi mediċina li tgħaddi minn ġol- ġilda (ITS).
The top housing is made of white plastic contains a lithium battery and electronics.
L- għata ta ’ fuq huwa magħmul minn plastik abjad li fih batterija tal- litju u l- elettronika.
The red bottom housing contains the active substance (fentanyl, a strong opioid painkiller) in a gel (called a hydrogel), and an adhesive layer that is used to stick the system onto the skin.
L - għata aħmar ta ’ taħt fih is- sustanza attiva (fentanyl, mediċina qawwija kontra l- uġigħ tat- tip opioid) f’ ġell (magħruf bħala hydrogel), u saff adeżiv li jintuża biex is- sistema teħel mal- ġilda.
26 The bottom of the device is covered by a protective film that is removed before use.
Il- qiegħ tas- sistema huwa mgħotti b’ film protettiv li jitneħħa qabel ma tintuża.
The device and adhesive are latex-free.
Is- sistema u l- adeżiv ma fihomx latex.
Marketing Authorisation Holder:
25 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Janssen Pharmaceutica NV, Turnhoutseweg 30, B- 2340 Beerse, Belgium
Deutschland JANSSEN-CILAG GmbH Tel: +49 2137-955-955
Deutschland JANSSEN- CILAG GmbH Tel: +49 2137- 955
Portugal JANSSEN-CILAG FARMACEUTICA, LDA Tel: +351 21-4368835
Portugal JANSSEN- CILAG FARMACEUTICA, LDA Tel: +351 21 4368835
România JOHNSON AND JOHNSON d. o. o Tel: +40 21 207 1800
România France JOHNSON AND JOHNSON d. o. o JANSSEN- CILAG Tel: +40 21 207 1800 Tel: +33 1 55 00 44 44
27
Island JANSSEN- CILAG AB c/ o Vistor hf.
Island JANSSEN-CILAG Tel: +354 530 7100
Tel: +354 530 7100
Tel: +421 233 552 600
Slovenská republika Johnson & Johnson s. r. o., Tel: +421 233 552 600
This leaflet was last approved in MM/ YYYY Detailed information on this medicine is available on the European Medicines Evaluation Agency (EMEA) website: 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 /
28 IMPORTANT INFORMATION FOR HEALTH CARE PROFESSIONALS
27 INFORMAZZJONI IMPORTANTI GĦAL PROFESSJONISTI FIL- QASAM MEDIKU
IONSYS testing instructions
Struzzjonijiet għal testjar ta ’ IONSYS
Each IONSYS needs to be tested to ensure the system is functional before it is dispensed to a patient.
Kull IONSYS għandha tiġi ttestjata sabiex jiġi żgurat li s- sistema hija funzjonabbli qabel ma tingħata lill- pazjent.
This can be done with the IONSYS still in its sealed sachet.
Dan jista ’ jsir b’ IONSYS ġol- pakkett issiġillat.
No drug is delivered from the system unless IONSYS is applied to the skin.
Ma tgħaddi l- ebda droga mis- sistema sakemm IONSYS ma jkunx applikat fuq il- ġilda.
The full 80 doses and 24 hours of use are still available after the functionality test.
It- 80 doża kollha u l- 24 siegħa ta ’ użu jibqgħu disponibbli wara li jsir it- test ta ’ funzjonalita`.
Hold the unopened foil sachet that contains IONSYS.
Żomm il- pakkett tal- foil magħluq li fih IONSYS.
By feel, determine where the IONSYS system is, and which side of IONSYS is rounded.
Ħoss sabiex issib fejn hi s- sistema IONSYS u liema naħa hi ttundjata.
With the rounded side facing up, run a finger along the unit until you feel the recessed button on one end.
Bin- naħa ttundjata fuq in- naħa ta ’ fuq, mexxi subgħajk tul il- unit sakemm tħoss il- buttuna riċessata f’ tarf minnhom.
Firmly press and release the button twice within 3 seconds
Għafas sew u itlaq il- buttuna darbtejn fi żmien 3 sekondi.
The IONSYS system will emit a single audio beep immediately.
Is- sistema IONSYS temetti ħoss wieħed immedjatament.
This confirms that IONSYS unit is functional and can be dispensed.
Dan jikkonferma li s- sistema IONSYS hi funzjonabbli u tista ’ tingħata.
After 4 minutes, IONSYS will beep repeatedly for about 15 seconds.
Wara 4 minuti, IONSYS tibda ddoqq ripetutament għal madwar 15- il sekonda.
This is normal and indicates that the IONSYS is not in contact with the skin.
Dan hu normali u jindika li IONSYS mhux qiegħed f’ kuntatt mal- ġilda.
This beeping alarm does not impact the functionality of IONSYS.
Dan il- ħoss idoqq m’ għandux impatt fuq il - funzjonalita` ta ’ IONSYS.
If you don’ t hear either the single beep after double-pressing, or the 15 second beeping after 4 minutes, return the IONSYS in its intact package to the manufacturer.
Jekk ma tismax il- ħoss waħdieni wara li tagħfas darbtejn, jew il- ħoss ta ’ 15- il sekonda wara 4 minuti, ibgħat lura IONSYS fil- pakkett intatt lill- manifattur.
Do not open the sachet and do not dispense that IONSYS system to a patient.
Tiftaħx il- pakkett u tagħtix is- sistema IONSYS lill- pazjent.
IONSYS application instructions
Struzzjonijiet dwar kif jiġi applikat IONSYS
The sachet contains one IONSYS system plus a moisture absorber.
Il- qartas fih sistema waħda IONSYS flimkien ma ’ assorbent tal- umidita`.
Apply to intact skin (non-irritated and non-irradiated) on the chest or upper outer arm.
Applika fuq ġilda intatta (mhux irritata u mhux irradjata) fuq is- sider jew in- naħa ta ’ fuq u ta ’ barra tad- driegħ.
- IONSYS should not be placed on abnormal skin sites, such as scars, burns or tattoos.
- IONSYS m’ għandux jiġi applikat fuq siti anormali fuq il- ġilda, bħal ċikatriċi, ħruq jew tatwaġġi.
- Hair at the application site should be clipped (not shaved) before system application.
- Xagħar fuq is- sit tal- applikazzjoni għandu jiġi maqtugħ qasir (mhux imqaxxar) qabel ma s- sistema
Wipe the application site with a standard alcohol swab and allow the skin to dry completely before applying the IONSYS system.
Imsaħħ is- sit tal- applikazzjoni b’ imselħa standard tal- alkoħol u ara li l- ġilda tkun nixfet kompletament qabel ma tapplika s- sistema IONSYS.
- Do not use any soaps, oils, lotions, or any other agents that might irritate the skin or alter its
- Tużax sapun, zjut, lozjonijiet, jew xi aġenti oħrajn li jistgħu jirritaw il- ġilda jew jibdlula l -
absorption characteristics.
karatteristiċi ta ’ assorbiment.
To open the sachet, start tearing at the pre-cut notch, then continue to tear open carefully along the top of the sachet.
Biex tiftaħ il- pakkett, ibda qatta bil- mod minn fejn hemm ix- xaqq diġa maqtugħ imbagħad kompli qatta bil- mod tul il- parti ta ’ fuq tal- pakkett.
The moisture absorber should be discarded after opening the sachet.
L- assorbent tal- umidita` għandu jintrema wara li jinfetaħ il- qartas.
If no moisture absorber is present, or if the moisture absorber is not intact, do not use and return system to the manufacturer.
Jekk m’ hemmx assorbent tal- umidita` jew jekk l- assorbent tal- umidita` mhuwiex intatt, tużaħx u irritorna s- sistema lill- manifattur.
Apply to the skin immediately after removal from the individually sealed package.
Applikah fuq il- ġilda immedjatament wara li tkun neħħejtu minn ġol- pakkett ssiġillat.
- Do not use if the seal on the sachet is broken.
- Tużahx jekk is- siġill fuq il- pakkett huwa mkisser.
Remove and discard the clear plastic liner covering the adhesive.
Neħħi u armi l- liner tal- plastik trasparenti li jgħatti l- adeżiv.
Press the IONSYS system firmly in place on the skin, sticky side down, for at least 15 seconds.
Għafas is- sistema IONSYS sewwa fuq il- post fuq il- ġilda, in- naħa li twaħħal wiċċha l’ isfel għall 15 - il sekonda mill- inqas.
Pressure should be applied with the fingers around the outer edges to ensure adhesion to the skin site for the full 24-hour wearing period.
Għandha tiġi applikata pressjoni bis- swaba madwar it- truf sabiex tiġi żgurata adeżjoni mas- sit tal- ġilda tul l- 24 siegħa li ser tintlibes.
Occasionally, the IONSYS system may loosen.
28 Kultant, is- sistema IONSYS tista tinħall.
If this occurs a non-allergenic tape may be used to be sure all of the system’ s edges make complete contact with the skin.
Jekk jiġri dan, jista ’ jintuża tejp non- allerġeniku sabiex jiġi żgurat li t- truf kollha tas- sistema jagħmlu kuntatt komplet mal- ġilda.
- Take care not to press or tape over the button or red light.
- Oqgħod attent li ma tagħfasx jew tagħmel tejp fuq il- buttuna jew id- dawl aħmar.
IONSYS in use
IONSYS waqt l- użu
Each IONSYS system may be used for 24 hours from the first dose, or until 80 doses have been administered, whichever comes first.
Kull sistema IONSYS tista tintuża għal 24 siegħa mill- ewwel doża, jew sakemm ikunu ġew amministrati 80 doża, skond liema sseħħ l- ewwel.
The system will then shut down and cannot deliver any additional doses.
Is- sistema imbagħad tieqaf taħdem u ma tgħaddix dożi iżjed.
If additional opioid analgesia is required, a new IONSYS system should be applied to a different skin site, after removal and disposal of the previous system.
Jekk hemm bżonn ta ’ iżjed analġeżiku opioid, sistema ġdida IONSYS għandha tiġi applikata fuq sit differenti tal- ġilda, wara li tkun tneħħiet u intremiet is- sistema preċedenti.
A maximum of 3 days’ treatment can be given.
Jista ’ jingħata trattament ta ’ massimu ta ’ 3 ijiem.
Patients should not wear more than one IONSYS system at the same time.
Pazjenti m’ għandhomx jilbsu iktar minn sistema waħda IONSYS f’ ħin wieħed.
Used systems should not be reapplied to patients.
Sistemi użati m’ għandhomx jerġgħu jiġu applikati lill- pazjenti.
Do not submerge in water.
Iddaħħalx fl- ilma.
Prolonged contact with water could cause the system to malfunction or fall off.
Kuntatt prologat mal- ilma jista ’ jikkawża li s- sistema taħdem ħażin jew tinqala.
IONSYS may be removed at any time.
IONSYS jista ’’ jitneħħa fi kwalunkwe ħin.
However, once a system has been removed, the same system should not be reapplied.
Iżda ladarba sistema titneħħa, m’ għandiex terġa tiġi applikata l- istess sistema.
At the end of 24 hours of use or after 80 doses have been delivered, remove the IONSYS system by gently lifting the red tab and loosening the system from the skin application site.
Fit- tmiem ta ’ 24 siegħa ta ’ użu jew wara li jkunu għaddew 80 doża, neħħi s - sistema IONSYS billi tgħolli id- dendula ħamra bil- mod u tħoll is- sistema minn mas- sit tal - applikazzjoni fuq il- ġilda.
If the patient requires additional or continuation of pain relief, a new system may be applied to a new skin site on the upper outer arm or chest.
Jekk il- pazjent għandu bżonn serħan mill- uġigħ addizzjonali jew kontinwat, sistema ġdida għanda tiġi applikata fuq sit ġdid fuq il- ġilda fuq in- naħa ta ’ fuq u ta ’ barra tad- driegħ jew is- sider.
A maximum of 3 days’ treatment can be given, using three separate systems.
Jista ’ jingħata trattament ta ’ massimu ta ’ 3 ijiem, billi jintużaw tlett sistemi separati.
Dose delivery
Beep jindika l- bidu tat- trasmissjoni tad - doża; id- dawl aħmar jixgħel u jibqa mixgħul tul iċ- ċiklu ta ’ trasmissjoni ta ’ 10 minuti.
The red light starts to blink after the 10-minute dose has been delivered.
Id- doża segwenti ma tistax tinbeda qabel ma jkun kompletat iċ- ċiklu: jekk tagħfas il- buttuna waqt it - trasmissjoni ma tibdiex doża oħra.
Approximate number of doses delivered.
Id- dawl aħmar jibda jteptep wara li tkun ġiet trasmessa doża ta ’ 10 minuti.
Between doses, the red light flashes in one-second pulses, which indicate the approximate number of doses administered.
Bejn doża u oħra, l- bozza ħamra tibda t- teptep b’ polzijiet ta ’ sekonda kull waħda, li jindikaw in- numru approssimattiv ta ’ dożi amminsitrati.
Each one-second pulse/ flash of light indicates administration of up to five doses.
Kull polz/ teptipa ta ’ dawl ta ’ sekonda jindika amminstrazzjoni sa ħames dożi.
So:
Għalhekk:
- a single flash represents 1 to 5 doses
- teptipa waħda tirrapreżenta minn 1 sa 5 dożi
- flashing twice represents 6-10 doses
- żewġ teptipiet jirrapreżentaw minn 6- 10 dożi
- flashing three times represents 11-15 doses
- tlett teptipiet jirrapreżentaw minn 11- 15 il- doża
This continues to a maximum of 16 pulses which represent 76-80 doses.
Dan ikompli sa massimu ta ’ 16- il teptipa li jirrapreżentaw 76- 80 doża.
The system may also be queried during delivery of a dose by pressing the button once.
Is- sistema tista tiġi mistoqsija waqt trasmissjoni ta ’ doża billi tagħfas il- buttuna darba.
The red light will pulse as above to indicate the approximate number of doses delivered up to the query.
Id- dawl aħmar iteptep kif jidher hawn fuq sabiex jindika n- numru approssimattiv ta ’ dożi trasmessi sal - mument tal- mistoqsija.
This query will not influence dose delivery.
Dan ma jaffettwax it- trasmissjoni tad- doża.
Each IONSYS system is designed to deliver one on-demand dose of fentanyl over approximately 10 minutes.
29 Kull sistema IONSYS hi magħmula sabiex titrasmetti kull doża fuq rikjesta ta ’ fentanyl fuq medda ta ’ madwar 10 minuti.
If a technical failure with a system is suspected, the staff member or patient should monitor both the illumination of the red light and any audible signals (beeps) over the next dose.
Jekk hemm suspett ta ’ falliment tekniku fis- sistema, il- membru tal- istaff jew pazjent għandu jimmoniterja kemm l- illuminazzjoni tal- bozza ħamra kif ukoll kwalunkwe sinjal awdibli (ħoss) fid- doża segwenti.
Error Description 2 beeps repeated 8 times (approximately 15 seconds) and red light turns off before 10 minutes 4 continuous beeps and red light turns off before 10 minutes
Frekwenza tal- Messaġġ ta ’ żball 2 ħsejjes ripetuti 8 darbiet (madwar 15- il sekonda) u l- LED aħmar jintefa qabel 10 minuti
Red light fails to illuminate
L- LED aħmar ma jixgħelx
Safe disposal of IONSYS
Kif għandu jintrema IONSYS
The used system should be disposed of by medical staff only.
Is- sistema wżata għanda tintrema biss mill- istaff mediku.
Contact with the fentanyl hydrogel can be harmful to humans.
Kuntatt mal- fentanyl hydrogel jista ’ jkun ta ’ ħsara għall- bniedem.
Handle the used system carefully and only by the sides and top housing.
Aqbad is- sistema wżata b’ attenzjoni mill- ġnub jew in- naħa ta ’ fuq biss.
The used patch should be disposed of as medical waste in accordance with local regulations.
L- impjastru wżat għandu jintrema bħala skart mediku skond ir- regolamenti lokali.
If required by local regulations, the design of the system allows separate disposal of the red fentanyl- containing bottom housing and the white electronic/ battery containing top housing.
Jekk ir- regolamenti lokali jirrikjedu, id- disinn tas- sistema jippermetti rimi separat tal- għata l- ħamra t’ isfel li fih il- fentanyl u l- għata l- bajda ta ’ fuq li fiha l- elettronika/ l- batterija.
To segregate a used IONSYS system:
Biex tissepara sistema IONSYS użata:
Pull the red tab to separate the bottom housing from the top housing.
Iġbed it- tab aħmar sabiex tissepara l- għata ta ’ taħt minn mal- għata ta ’ fuq.
Fold the bottom gel-containing housing in half with the sticky side facing in.
Itwi l- housing ta ’ taħt li fih il- ġell fi tnejn bin- naħa li twaħħal fuq in- naħa ta ’ ġewwa.
Dispose of bottom housing in accordance with local legislation.
Armi l - għata ta ’ taħt skond il- leġislazzjoni lokali.
The used bottom housing of IONSYS contains a dangerous amount of fentanyl.
L- għata t’ isfel ta ’ IONSYS fih ammont perikoluż ta ’ fentanyl.
Dispose of top housing, containing electronics, according to local procedures for electronic / battery waste.
Armi l- għata ta ’ fuq, li fiha l- elettronika, skond proċeduri lokali għal skart elettroniku / batteriji.
London, 26 April 2007 Doc.
Londra, 26 ta ’ April 2007 Dok.
EMEA/ 111199/ 2007
EMEA/ 231350/ 2007
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for IPLEX
MISTOQSIJIET U TWEĠIBIET DWAR L- IRTIRAR TA ’ L- APPLIKAZZJONI GĦALL - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ għal IPLEX
International non-proprietary name (INN): mecasermin rinfabate
Isem Internazzjonali Mhux Patentat (INN): mecasermin rinfabate
On 26 March 2007, Insmed Europe Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IPLEX, for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Fis- 26 ta ’ Marzu 2007, Insmed Europe Ltd għarrfet uffiċjalment lill- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li tixtieq tirtira l- applikazzjoni tagħha għall- awtorizzazzjoni għat - tqegħid fis- suq għal IPLEX, għat- trattament ta ’ pazjenti b’ insensittività primarja għall- ormon tat - tkabbir u ta ’ pazjenti bi tħassir tal- ġene ta ’ l- ormon tat- tkabbir li jkunu żviluppaw antikorpi li jinnewtralizzaw l- ormon tat- tkabbir.
What is IPLEX?
X’ inhu IPLEX?
IPLEX is a solution for injection containing 60 mg/ ml mecasermin rinfabate as the active substance.
IPLEX hu soluzzjoni għall- injezzjoni li fiha 60 mg/ ml mecasermin rinfabate bħala s- sustanza attiva.
What was IPLEX expected to be used for?
Għal xiex kien mistenni li jintuża IPLEX?
IPLEX was to be used in children with short stature whose bodies have problems handling growth hormone because: • they have primary insensitivity to the hormone, so that injected growth hormone has no effect. ‘ Primary’ means that there is no known reason for the insensitivity. • they are not able to make growth hormone and have received growth hormone in the past, but have developed neutralising antibodies, special proteins than can prevent injected growth hormone from having an effect.
IPLEX kellu jintuża minn tfal ta ’ statura qasira li ġisimhom ikollu problemi fil- ġestjoni ta ’ l- ormon tat- tkabbir minħabba li: • ikollhom insensittività primarja għall- ormon, u allura jekk jingħataw ormon tat- tkabbir b’ injezzjoni, dan ma jkollu l- ebda effett. ‘ Primarja ’ tfisser li ma tkun magħrufa l- ebda raġuni għall- insensittività. • ma jkunux kapaċi jipproduċu ormon tat- tkabbir u jkunu ngħataw ormon tat- tkabbir qabel, iżda jkunu żviluppaw antikorpi newtralizzanti, proteini speċjali li jipprevjenu li l- ormon tat- tkabbir jagħmel effett.
Because the number of patients with these diseases is low, they are considered ‘ rare’, and mecasermin rinfabate was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 20 June 2006.
Billi l- għadd ta ’ pazjenti b’ dawn it- tipi ta ’ mard huwa wieħed baxx, dawn huma meqjusa ‘ rari ’, u mecasermin rinfabate ġie kkategorizzat bħala ‘ mediċina orfni ’ (mediċina użata f’ mardiet rari) fl- 20 ta ’ Ġunju 2006.
How is IPLEX expected to work?
Kif kien mistenni jaħdem IPLEX?
The active substance in IPLEX, mecasermin rinfabate, is a binary protein made up of two proteins that are normally produced by the body: insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3).
Is- sustanza attiva f’ IPLEX, mecasermin rinfabate, hija proteina binarja magħmula minn żewġ proteini li normalment huma prodotti mill- ġisem: insulin- like growth factor I (IGF- I) u insulin- like growth factor binding protein 3 (IGFBP- 3).
Mecasermin rinfabate is produced by a method known as ‘ recombinant DNA technology’: it is made by bacteria that have received a gene (DNA), which makes them able to produce it.
Mecasermin rinfabate jiġi prodott b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: jiġi prodott minn batterji li jkunu rċevew ġene (DNA), li jagħmilha possibbli li jipproduċuha.
IGF-I then stimulates the bones to grow.
Fil- ġisem, l- ormon tat- tkabbir naturali jippromwovi t- tkabbir fit- tfal billi jistimula l- ġisem sabiex jipproduċi IGF- I.
In IPLEX, IGF-I is bound to IGFBP-3 because this mimics the way in which IGF-1 is carried in the body.
Imbagħad IGF- I jeħel ma ’ IGFBP- 3 għax dan jimita l- mod li bih IGF- 1 jinġarr fil - ġisem.
This may allow IGF-I to circulate in the body at higher levels and for longer periods than unbound IGF-I.
Dan jippermetti lil IGF- I jiċċirkula fil- ġisem f’ livelli ogħla u għal perjodi itwal ta ’ ħin meta mqabbel ma ’ IGF- I mhux imwaħħal.
What documentation did the company present to support its application to the CHMP?
X’ dokumentazzjoni ippreżentat il- kumpannija biex issaħħaħ l- applikazzjoni tagħha lis- CHMP?
The effects of IPLEX were first tested in experimental models before being studied in humans.
L- effetti ta ’ IPLEX għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fin - nies.
Its effectiveness has been studied in one clinical trial, which is still ongoing.
L- effettività tiegħu ġiet studjata fi studju kliniku, li għadu għaddej.
In the study, 27 children (aged 3 to 15 years) have been receiving IPLEX for up to one year.
Fl- istudju, 27 tifel u tifla (ta ’ bejn 3 u 15- il sena) qiegħdin jingħataw IPLEX għal perjodu ta ’ mhux iktar minn sena.
The main measure of effectiveness was based on the speed of growth during the study, compared to that in the year before the study began.
Il- mezz ewlieni tal- kejl ta ’ l- effettività hu bbażat fuq il- ħeffa tat- tkabbir matul l- istudju, meta mqabbel ma ’ dak fis - sena ta ’ qabel inbeda l- istudju.
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How far into the evaluation was the application when it was withdrawn?
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Sa fejn kienet waslet l- evalwazzjoni ta ’ l- applikazzjoni meta ġiet irtirata?
The application was at day 120 when the company withdrew.
L- applikazzjoni kienet waslet fil- 120 jum meta l- kumpannija rtiratha.
The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Is- CHMP kien ifformula lista ta ’ mistoqsijiet biex jitwieġbu mill- kumpannija, iżda l- kumpannija kienet għadha ma weġbithomx.
The CHMP normally takes up to 210 days to evaluate a new application.
Is- CHMP normalment jieħu sa mitejn u għaxart ijiem biex jevalwa applikazzjoni ġdida.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Abbażi tal - valutazzjoni tad- dokumentazzjoni inizjali, is- CHMP iħejji lista ta ’ mistoqsijiet fil- 120 jum, u din il - lista tintbagħat lill- kumpannija.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ladarba l- kumpannija tkun tat it- tweġibiet għall- mistoqsijiet, is - CHMP janalizzahom u jista ’, qabel ma jagħti opinjoni, jistaqsi xi mistoqsijiet oħra fil- 180 jum.
Following the CHMP’ s opinion, it usually takes around 2 months for the European Commission to grant a licence.
Wara l- opinjoni tas- CHMP, ġeneralment iridu jgħaddu madwar xahrejn biex il- Kummissjoni Ewropea toħroġ liċenzja.
What was the recommendation of the CHMP at that time?
X’ kienet ir- rakkomandazzjoni tas- CHMP f’ dan iż- żmien?
Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that IPLEX could not have been approved for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Abbażi ta ’ l- analiżi tad- dejta fi żmien l- irtirar, is- CHMP kellu xi tħassib u kien ta ’ l- opinjoni proviżorja li IPLEX ma setax jiġi approvat għat- trattament ta ’ pazjenti b’ insensittività primarja għall - ormon tat- tkabbir u ta ’ pazjenti bi tħassir tal- ġene ta ’ l- ormon tat- tkabbir li jkunu żviluppaw antikorpi li jinnewtralizzaw l- ormon tat- tkabbir.
What were the main concerns of the CHMP?
X’ kienu l- preokkupazzjonijiet ewlenin tas- CHMP?
The CHMP had major concerns regarding the way the medicine is manufactured, and they were unsure that the medicine that would have been marketed would have been comparable to the one used in the clinical trial.
Is- CHMP kellu preokkupazzjonijiet ewlenin dwar il- mod li bih tiġi manifatturata l- mediċina, u ma kienx ċert jekk il- mediċina li kienet se tiddaħħal fis- suq kinitx tista ’ titqabbel ma ’ dik użata fl- istudju kliniku.
They also had major concerns regarding the way in which the medicine’ s effectiveness had been assessed, especially regarding the type of patients that have been included in the clinical trial.
Kellu wkoll tħassib dwar il- mod li bih kienet ġiet valutata l- effettività tal- mediċina, speċjalment dwar it- tip ta ’ pazjenti li kienu inklużi fl- istudju kliniku.
Patients had also not been treated for long enough to show that the medicine’ s effect continues when used for longer than one year.
Barra minn hekk, il- pazjenti ma kinux ġew trattati għal żmien twil biżżejjed biex ikun jista ’ jintwera li l- effett tal- mediċina ikompli meta dan jibqa ’ jintuża għal iktar minn sena.
Therefore, at the time of the withdrawal, the CHMP’ s view was that the benefit of IPLEX had not been sufficiently demonstrated and did not outweigh the identified risks.
Għalhekk, fi żmien l- irtirar, l- opinjoni tas- CHMP kienet li l- benefiċċju ta ’ IPLEX ma kienx intwera biżżejjed u li ma għelibx ir- riskji identifikati.
What were the reasons given by the company to withdraw the application?
X’ kienu r- raġunijiet mogħtija mill- kumpannija għall- irtirar ta ’ l- applikazzjoni?
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
L- ittra li biha l- kumpannija għarrfet lill- EMEA bl- irtirar ta ’ l- applikazzjoni tinsab hawn.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with IPLEX?
X’ inhuma l- konsegwenzi ta ’ l- irtirar għal pazjenti li qed jieħdu sehem fl- istudji kliniċi / programmi ta ’ użu li jaqblu ma ’ IPLEX?
The company informed the CHMP that the withdrawal will have no impact on the ongoing clinical study of the safety and efficacy of IPLEX in the treatment of Growth Hormone Insensitivity Syndrome.
Il- kumpannija għarrfet lis- CHMP li l- irtirar m’ hu se jkollu l- ebda effett fuq l- istudju kliniku li hu għaddej dwar is- sigurtà u l- effikaċja ta ’ IPLEX fit- trattament tas- Sindromu ta ’ l- Insensittività għall - Ormon tat- Tkabbir.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Jekk int qed tieħu sehem fi studju kliniku jew fi programm ta ’ użu li jaqbel u teħtieġ iktar tagħrif dwar it- trattament tiegħek, ikkuntattja lit- tabib li qed jagħtik din il- mediċina.
What is Irbesartan BMS?
X' inhu Irbesartan BMS?
Irbesartan BMS is a medicine that contains the active substance irbesartan.
Irbesartan BMS huwa mediċina li fiha s- sustanza attiva irbesartan.
It is available as white, oval tablets (75, 150 and 300 mg).
Huwa disponibbli f' pilloli ovali bojod (75, 150 u 300 mg).
This medicine is the same as Karvea, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Karvea, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Karvea has agreed that its scientific data can be used for Irbesartan BMS.
Il - kumpanija li tipproduċi Karvea qablet li t- tagħrif xjentifiku tagħha jista 'jintuża għal Irbesartan BMS.
What is Irbesartan BMS used for?
Għal xiex jintuża Irbesartan BMS?
Irbesartan BMS is used in patients who have essential hypertension (high blood pressure). ‘ Essential ’ means that the high blood pressure is not caused by any other condition.
'Essenzjali' tfisser li l- pressjoni għolja ma tkunx ikkawżata minn xi kundizzjoni oħra.
Irbesartan BMS is also used to treat renal (kidney) disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Irbesartan BMS jintuża wkoll għat- trattament tal- mard renali (tal- kliewi) f' pazjenti b' ipertensjoni u b' dijabete mellitu tat- tip 2 (dijabete li mhix dipendenti fuq l- insulina).
Irbesartan BMS is not recommended for use in patients below 18 years of age.
Irbesartan BMS mhuwiex rakkomandat għall- użu f' pazjenti taħt l- età tat- 18- il sena.
How is Irbesartan BMS used?
Kif jintuża Irbesartan BMS?
Irbesartan BMS is taken by mouth, with or without food.
Irbesartan BMS jittieħed b' mod orali, anki fuq stonku vojt.
The usual recommended dose is 150 mg once a day.
Id- doża normalment rakkomandata hija ta '150 mg darba kuljum.
If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Jekk il- pressjoni tad- demm ma tkunx ikkontrollata adegwatament, id- doża tista 'tiżdied għal 300 mg kuljum jew inkella jistgħu jingħataw mediċini antipertensivi oħra, bħal l - idroklorotijażide (hydrochlorothiazide).
A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Doża inizjali ta '75 mg tista' tintuża fil- pazjenti li għaddejjin minn emodijaliżi (teknika ta 'tisfija tad- demm) jew f' pazjenti li għandhom iktar minn 75 sena.
In patients with hypertension and type 2 diabetes, Irbesartan BMS is added to other treatments for hypertension.
Fil- pazjenti b' ipertensjoni u b' dijabete tat- tip 2, Irbesartan BMS jiżdied ma 'trattamenti oħra għall - ipertensjoni.
Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
It- trattament jinbeda b' doża ta '150 mg darba kuljum u normalment tiżdied għal 300 mg darba kuljum.
How does Irbesartan BMS work?
Kif jaħdem Irbesartan BMS?
The active substance in Irbesartan BMS, irbesartan, is an ‘ angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II.
Is- sustanza attiva f' Irbesartan BMS, irbesartan, hija tip ta '' antagonist tar- riċetturi ta 'l- anġjotensina II' li tfisser li jimblokka l- azzjoni ta 'l- ormon fil- ġisem imsejjaħ anġjotensina II.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
L- anġjotensina II hija sustanza qawwija li ddejjaq l- arterji u l- vini (vasoconstrictor).
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Billi jimblokka r- riċetturi li magħhom l - anġjotensina II teħel normalment, irbesartan iwaqqaf l- ormon milli jkollu effett, b' hekk iħalli l- arterji u l- vini jitwessgħu.
This allows the blood pressure to drop, reducing the risk of damage caused by high blood pressure, such as having a stroke.
Dan jippermetti li titbaxxa l- pressjoni tad- demm u b' hekk jitnaqqas ir- riskju ta 'ħsara kkawżat mill- pressjoni tad- demm għolja, bħal ma hi l- puplesija.
How has Irbesartan BMS been studied?
Kif ġie studjat Irbesartan BMS?
Irbesartan BMS was originally studied in 11 trials for its effects on blood pressure.
Irbesartan BMS ġie għall- ewwel studjat fi 11- il prova li saru biex jivvalutaw l- effetti tiegħu fuq il - pressjoni tad- demm.
Irbesartan BMS was compared with placebo (a dummy treatment) in 712 patients, and compared with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Irbesartan BMS tqabbel mal- plaċebo (trattament finta) f' 712- il pazjent u tqabbel ma 'mediċini antipertensivi oħra (atenolol, enalapril jew amlodipina) fi 823 pazjent.
Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
L- użu tiegħu ġie eżaminat fil- kombinazzjoni ma 'l- idroklorotijażide f' 1, 736 pazjent.
The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Il- kejl ewlieni ta 'l- effikaċja kien it - tnaqqis tal- pressjoni tad- demm dijastolika (pressjoni tad- demm mkejla bejn żewġ taħbitiet tal- qalb).
Irbesartan BMS was used for two years or more.
Għat- trattament tal- mard tal- kliewi, Irbesartan BMS ġie eżaminat f' żewġ studji fuq skala kbira li involvew total ta '2, 326 pazjent bid- dijabete tat- tip 2, li damu sentejn jieħdu l- mediċina jew aktar.
One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
Wieħed mill- istudji eżamina l- markaturi tal- ħsara epatika billi kejjel l- ammont tal- proteina albumina mneħħija fl- awrina.
The second study looked at whether Irbesartan BMS increased the time taken until the patients ’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
L- għan tat- tieni studju kien dak li jeżamina jekk Irbesartan BMS għenx biex ittardja l- mument li fih il- pazjenti rduppjaw il- livelli ta 'kreatinina fid- demm (markatur tal- marda tal - kliewi), biex ittardja l- bżonn ta' trapjant ta 'kilwa jew dijaliżi jew tawwal iż- żmien qabel il- mewt tal - pazjent.
In this study, Irbesartan BMS was compared with placebo and with amlodipine.
F' dan l- istudju, Irbesartan BMS tqabbel mal- plaċebo u ma 'l- amlodipina.
What benefit has Irbesartan BMS shown during the studies?
X' benefiċċji wera Irbesartan BMS waqt l- istudji mwettqa?
In the blood pressure studies, Irbesartan BMS was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Fl- istudji dwar il- pressjoni tad- demm, irriżulta li Irbesartan BMS kien aktar effikaċi mill- plaċebo biex inaqqas il- pressjoni tad- demm dijastolika u kellu effetti simili għall- mediċini antipertensivi oħra.
When used with hydrochlorothiazide, the effects of the two medicines were additive.
Meta użat ma 'l- idroklorotijażide, l- effetti taż- żewġ mediċini kienu addittivi.