qanastek/EMEA-V3 huggingface dataset:
Medicines that can interact with saquinavir and/or ritonavir include:
Mediċini li jista ’ jkollhom interazzjoni ma ’ saquinavir u/ jew ritonavir jinkludu: sustanzi antivirali għal- HIV oħra (e. ż. nelfinavir, indinavir, nevirapine, delavirdine, efavirenz),
- other HIV antiviral agents (e.g. nelfinavir, indinavir, nevirapine, delavirdine, efavirenz),
-
- some medicines affecting the immune system (e.g. ciclosporin, sirolimus (rapamycin),
- xi mediċini b’ effett fuq is- sistema immunitarja (e. ż. ciclosporin, sirolimus (rapamycin),
- various steroids (e.g. dexamethasone, ethinyl estradiol, fluticasone),
- diversi sterojdi (e. ż. dexamethasone, ethinyl estradiol, fluticasone),
- certain heart medicines (e.g. calcium channel blockers, quinidine, digoxin),
- xi mediċini għall- qalb (e. ż. imblokkaturi tal- kanali tal- kalċju, quinidine, digoxin),
- medicines used to lower blood cholesterol (e.g. statins),
- mediċini użati biex ibaxxu l- kolesterol fid- demm (e. ż. statins),
- antifungals (ketoconazole, itraconazole),
- mediċini kontra l- moffa (ketoconazole, itraconazole),
- anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine),
- antikonvulsivi (e. ż. phenobarbital, phenytoin, carbamazepine),
- sedative agents (e.g. midazolam administered by injection),
- aġenti sedattivi (e. ż. midazolam mogħti permezz ta ’ injezzjoni),
- certain antibiotics (e.g. clarithromycin, erythromycin, quinupristin/dalfopristin, dapsone,
- xi antibijotiċi (e. ż. clarithromycin, erythromycin, quinupristin/ dalfopristin, dapsone, rifabutin),
- medicines used to treat erectile dysfunction (sildenafil, vardenafil, tadalafil),
- mediċini użati biex jikkuraw funzjoni erettili ħażina (sildenafril, vardenafil, tadalafil),
- medicines to treat depression (e.g. nefazodone, tricyclic antidepressants),
- mediċini biex jikkuraw id- depressjoni (e. ż. nefazodone, antidepressivi tricyclic),
- medicines for anticoagulation (warfarin),
- mediċini kontra l- koagulazzjoni (warfarin),
- herbal preparations containing St.
- preparazzjonijiet mill- ħxejjex li fihom St.
John’s wort or garlic capsules.
John’ s Wort jew kapsuli tat- tewm,
- some medicines that treat diseases related to the acid in the stomach (e.g. omeprazole or other
- xi mediċini li jikkuraw mard relatat ma ’ l- aċidu fl- istonku (e. ż. omeprazole jew inibituri oħra
proton pump inhibitors).
tal- proton pump).
Therefore you should not take Invirase/ritonavir with other medicines without your doctor’s consent.
Għalhekk m’ għandekx tieħu Invirase/ ritonavir ma ’ mediċini oħrajn mingħajr il- kunsens tat- tabib tiegħek.
If you are taking sildenafil, vardenafil, or tadalafil with Invirase/ritonavir talk to your doctor about possible interactions between these medicines and the possible side effects.
Jekk qed tieħu sildenafil, vardenafil, jew tadalafil flimkien ma ’ Invirase/ ritonavir kellem lit- tabib tiegħek dwar l- interazzjonijiet possibli bejn dawn il- mediċini u l- effetti sekondarji possibli.
If you take sildenafil, vardenafil, or tadalafil together with Invirase/ritonavir, you may be at a risk of side effects such as low blood pressure, passing out, visual changes and penile erection lasting for more than 4 hours.
Jekk tieħu sildenafil, vardenafil, jew tadalafil flimkien ma ’ Invirase/ ritonavir, tista ’ tkun f’ riskju ta ’ effetti sekondarji bħal pressjoni tad- demm baxxa, tintilef minn sensik, bidliet fil- vista u erezzjoni tal- pene li ddum aktar minn 4 sigħat.
If an erection lasts longer than 4 hours, you should get medical help immediately to avoid permanent damage to your penis.
Jekk erezzjoni ddum aktar minn 4 sigħat, għandek issejjah għajnuna medika immedjatament biex tevita ħsara permanenti lill- pene tiegħek.
Your doctor can explain these symptoms to you.
It- tabib tiegħek jista ’ jispjegalek dawn is- sintomi.
If you are taking an oral contraceptive to prevent pregnancy, you should use an additional or different type of contraception since ritonavir may reduce the effectiveness of oral contraceptives.
Jekk qed tieħu kontraċettiv mill- ħalq biex tevita tqala, għandek tuża kontraċettiv ieħor jew ta ’ tip differenti għax ritonavir jista ’ jnaqqas l- effettività ta ’ kontraċettivi mill- ħalq
Taking Invirase with food and drink Invirase must be taken together with ritonavir and with or after food.
Meta tieħu Invirase ma ’ l- ikel u max- xorb Invirase għandu jittieħed flimkien ma ’ ritonavir u ma ’ l- ikel jew wara l- ikel.
Inform your doctor if you are pregnant or planning to become pregnant.
Għarraf lit- tabib tiegħek jekk inti tqila jew jekk qed tippjana li toħroġ tqila.
This medicine should be taken during pregnancy only after consultation with your doctor.
Din il- mediċina għandha tittieħed waqt it- tqala biss wara konsultazzjoni mat- tabib tiegħek.
You should not breast-feed your baby if you are taking Invirase/ritonavir.
M’ għandekx tredda ’ lit- tarbija tiegħek jekk qed tieħu Invirase/ ritonavir.
Driving and using machines Invirase has not been tested for its effect on your ability to drive a car or operate machinery.
Sewqan u tħaddim ta ’ magni Invirase ma ġiex studjat għall- effetti tiegħu fuq l- abilità tiegħek li ssuq karozza jew tħaddem magni.
However, dizziness and fatigue have been reported during treatment with Invirase.
Iżda, sturdament u għejja ġew irrapurtati waqt kura b’ Invirase.
Do not drive or operate machines if you experience these symptoms.
M’ għandekx issuq jew tħaddem magni jekk ikollok dawn is- sintomi.
Important information about an ingredient of Invirase Each capsule contains lactose (anhydrous) 6 3.3 mg.
Tagħrif importanti dwar sustanza ta ’ Invirase Kull pillola miksija b’ rita fiha 38. 5mg lactose (monohydrate).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu din il- mediċina.
HOW TO TAKE INVIRASE
KIF GĦANDEK TIEĦU INVIRASE
Always take Invirase/ritonavir exactly as your doctor has told you.
Dejjem għandek tieħu Invirase eżatt kif qallek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk m’ intix ċert/ a.
Invirase is provided as 200 mg capsules.
Għall- pazjenti li ma tgħoddx għalihom pillola ta ’ 500 mg, Invirase huwa wkoll ipprovdut bħala kapsula iebsa ta ’ 200 mg.
Your doctor will prescribe Invirase in combination with Norvir (ritonavir) and other HIV medicines.
It- tabib tiegħek se jippreskrivilek Invirase flimkien ma ’ Norvir (ritonavir) u mediċini għall- HIV oħrajn.
The dosage of Invirase is five 200 mg capsules with one 100 mg capsule of Norvir (ritonavir) two times daily.
Id- dożaġġ ta ’ Invirase huwa ta ’ żewġ pilloli miksija b’ rita ta ’ 500 mg flimkien ma ’ kapsula waħda ta ’ 100 mg ta ’ Norvir (ritonavir) darbtejn kuljum.
Invirase should be taken at the same time as Norvir (ritonavir) and with or after food.
Invirase għandu jittieħed fl- istess ħin ma ’ Norvir (ritonavir) u ma ’ l- ikel jew wara l- ikel.
The capsules should be swallowed whole together with water.
Il- pilloli miksija b’ rita għandhom jimbelgħu sħaħ flimkien ma ’ l- ilma.
If you take more Invirase than you should If you have taken more than the prescribed dose of Invirase/ritonavir you must contact your doctor or pharmacist.
Jekk tieħu Invirase aktar milli suppost Jekk inti ħadt Indinavir/ ritonavir aktar mid- doża preskritta, għandek tkellem lit- tabib jew lill- ispiżjar tiegħek.
59 If you forget to take Invirase Do not take a double dose to make up for a forgotten individual dose.
Jekk tinsa tieħu Invirase M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you forget to take one dose, take this dose as soon as you remember together with some food.
Jekk tinsa tieħu doża waħda, ħu din id- doża hekk kif tiftakar, ma ’ ftit ikel.
Then go on with the regular schedule as prescribed.
Wara kompli bl- iskeda regolari kif preskritt.
Do not change the prescribed dose yourself.
Tbiddilx id- doża preskritta minn rajk.
If you stop taking Invirase Continue to take this medicine until your doctor tells you otherwise.
60 Jekk tieqaf tieħu Invirase Kompli ħu din il- mediċina sakemm it- tabib tiegħek jgħidlek mod ieħor.
Like all medicines, Invirase/ritonavir can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Invirase/ ritonavir jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection it is not always possible to differentiate between unwanted effects caused by Invirase or by any other medicines you take at the same time or by the complications of the infection.
Meta tkun qed tikkura infezzjoni ta ’ l- HIV mhux dejjem possibbli li tiddistingwi bejn l- effetti mhux mixtieqa kkawżati minn Invirase jew minn xi mediċini oħrajn li int tieħu fl- istess ħin jew il - kumplikazzjonijiet ta ’ l- infezzjoni.
For these reasons it is very important to inform your doctor of any change in your condition.
Għal dawn ir- raġunijiet huwa importanti ħafna li tgħarraf lit- tabib tiegħek b’ xi bidla fil- kundizzjoni tiegħek.
The most frequently (in more than ten in a hundred) reported side effects of saquinavir taken with ritonavir concern the gastrointestinal tract, with feeling sick, diarrhoea, tiredness, vomiting, wind and abdominal pain being the most common.
L- aktar effetti sekondarji irrappurtati b’ frekwenza (f’ aktar minn għaxra f’ kull mija) ta ’ saquinavir meħud flimkien ma ’ ritonavir, jikkonċernaw il- kanal gastrointestinali, b’ dardir, dijareja, għejja, remettar, gass u uġigħ ta ’ żaqq bħala l- aktar komuni.
Also, changes in laboratory markers (e.g., blood or urine tests) have been reported very commonly.
Bidla fil- markaturi tal- laboratorju (e. ż., testijiet tad- demm jew tal- awrina) ukoll ġew irrapurtati b’ mod komuni ħafna.
Other, less frequently reported side effects (in more than one in a hundred but less than one in ten persons), which may occur are: rash, itching, eczema and dry skin, hair loss, dry mouth, headache, peripheral neuropathy (a disturbance of the nerves in the feet and hands that may take the form of numbness, pins and needles, shooting or burning pain), co-ordination problems, fainting, confusion, weakness, dizziness, depression, anxiety, mood swings, night sweats and hot flushes, inability to sleep, libido problems, taste alteration, warts, mouth ulcers, dehydration, abdominal discomfort, indigestion, fever, pain, constipation, decreased as well as increased appetite, inflammation of gastrointestinal tract, piles, discoloured faeces, visual disturbance, eye pain, raised blood pressure, infections of the respiratory tract, muscle spasms, joint pain, blood collection in the joint, painful urination and infections of the urinary tract, fever and shivering, shortness of breath and chest pain.
Effetti mhux mixtieqa oħrajn irrappurtati inqas ta ’ spiss (f’ aktar minn wieħed kull mija iżda f’ anqas minn wieħed f’ kull għaxar persuni) li jistgħu jseħħu huma: raxx, ħakk, ekżema u ġilda xotta, jaqgħa x - xahar, ħalq xott, uġigħ ta ’ ras, newropatija periferali (disturbi tan- nervaturi fis- saqajn u fl- idejn li jistgħu jieħdu forma ta ’ tnemnim, tingis bħal labar, uġigħ qisu ħruq jew li jiġri mal- ġisem), problemi ta ’ ko- ordinazzjoni, ħass ħażin, konfużżjoni, dgħjufija, sturdament, dipressjoni, ansjetà, tibdil f’ daqqa fil- burdata, għaraq bil- lejl, u fwawar, ma tistax torqod, problemi ta ’ libido, tibdil fit- togħma, felul, ulċeri fil- ħalq, deidratazzjoni, skomdu addominali, indiġestjoni, deni, uġigħ, stitikezza, nuqqas kif ukoll żjieda fl- aptit, infjammazzjoni fil- kanal gastrointestinali, murliti, feċi bla kulur, disturbi fil- vista, uġigħ fl- għajnejn, pressjoni tad- demm għolja, infezzjonijiet respiratorji, spażmi tal- muskoli, uġigħ fil - ġogi, ġbir ta ’ demm fil- ġogi, tgħaddi l- awrina bl- uġigħ u infezzjonijiet fil- kanal ta ’ l- awrina, deni u rogħda, qtugħ ta ’ nifs u uġigħ fis- sider.
Furthermore, inflammation of the liver, fits, allergic reactions, sleepiness and abnormal renal function have been reported.
Barra minn hekk, ġew irrapurtati infjammazzjoni tal- fwied, eċċessjonijiet, reazzjonijiet allerġiċi, ngħas, u funzjoni mhux normali tal- kliewi.
Your doctor will test your blood regularly to detect possible abnormalities.
It- tabib tiegħek se jeżamina d- demm tiegħek b’ mod regolari għal xi abnormalitajiet possibbli.
Cases of diabetes mellitus or increased blood sugar levels have been reported in patients receiving this treatment or another protease inhibitor.
Każijiet ta ’ dijabete mellitus jew żjieda fil- livelli taz- zokkor fid- demm ġew irrapurtati f’ pazjenti li qed jircievu din il- kura jew inibitur tal- protease ieħor.
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor.
F’ pazjenti b’ emofilja tat- tip A u B, kien hemm rapporti ta ’ żjieda ta ’ fsad ta ’ demm waqt li qed jieħdu din il- kura jew xi inibitur tal- protease ieħor.
Should this happen to you, seek immediate advice from your doctor.
Jekk dan jiġri lilek, għandek tieħu parir tat- tabib tiegħek immedjatament.
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Terapija antiretrovirali kkombinata tista ’ tikkawża bidliet fil- forma tal- ġisem minħabba bidliet fid - distribuzzjoni tax- xaħam.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (’buffalo hump’).
Dawn jistgħu jinkludi telf ta ’ xaħam mir- riġlejn, dirgħajn u l- wiċċ, żjieda fix- xaħam fl- addome (żaqq) u f’ organi interni oħrajn, tkabbir tas- sider u ħotob tax- xaħam fuq in- naħa ta ’ wara ta ’ l- għonq (buffalo hump).
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fit- tul fuq is- saħħa ta ’ dawn il- kundizzjonijiet mhumiex magħrufa bħalissa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
Terapija antiretrovirali kkombinata tista ’ wkoll tikkawża żjieda fl- aċidu lattiku u taz- zokkor fid- demm, iperlipemja (żjieda tax- xaħmijiet fid- demm) u reżistenza għall- insulina.
There have been reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues.
Kien hemm rapporti ta ’ uġigħ fil- muskoli, uġigħ mal- mess jew dgħjufija, speċjalment b’ terapija antiretrovirali kkombinata li tinkludi inibituri tal- protease u analogi tan- nucleoside.
On rare occasions these muscle disorders have been serious (rhabdomyolysis).
F’ okkażjonijiet rari dan il- mard tal- muskoli kien serju (rhabdomyolysis).
60 If you experience any side effects that are not in this leaflet, please tell your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji oħra li mhumiex imsemmija f’ dan l- fuljett, jekk jogħġbok għid lit - tabib jew lill- ispiżjar tiegħek.
Also, tell your doctor if you have any severe or unusual symptoms or if any side effect that you think you may have gets worse or persists.
Għid ukoll lit- tabib tiegħek jekk ikollok xi sintomi serji jew mhux tas - soltu jew jekk xi effetti sekondarji li taħseb li għandek jiggrava jew jippersisti.
HOW TO STORE INVIRASE
KIF TAĦŻEN INVIRASE
Store in the original container.
Invirase m’ għandux bżonn xi kundizzjonijiet speċjali tal- ħażna.
What Invirase contains
X’ fih Invirase
- The active substance is saquinavir.
- Is- sustanza attiva hi saquinavir.
One capsule of Invirase contains 228.7 mg of saquinavir
Kapsula ta ’ Invirase fiha 228. 7 mg of saquinavir mesilate li
mesilate corresponding to 200 mg saquinavir.
tikkorrespondi għal 200 mg saquinavir.
- The other ingredients are lactose (anhydrous) 63.3 mg, microcrystalline cellulose, povidone,
- Is- sustanzi l- oħra huma lactose (anhydrous) 63. 3 mg, microcrystalline cellulose, povidone,
sodium starch glycollate, talc and magnesium stearate.
sodium starch glycollate, talc u magnesium stearate.
The capsule shell consists of gelatine, iron oxide black, red and yellow (E172), indigocarmine (E132), titanium dioxide (E171), and the printing ink contains titanium dioxide (E 171), shellac, soya lecithin, polydimethylsiloxane.
Il- qoxra tal- kapsula tikkonsisti minn gelatine, iron oxide iswed, aħmar u isfar (E172), indigocarmine (E132), titanium dioxide (E171), u l- linka għall- istampar tikkonsisti minn titanium dioxide (E 171), shellac, soya lecithin, polydimethylsiloxane.
What Invirase looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Invirase 200 mg hard capsules are light brown and green.
Invirase 200 mg kapsuli iebsa huma kannella ċar u aħdar.
Each half of the capsule shell is marked with the printing “ROCHE” and the code “0245”.
Kull nofs tal- qoxra tal- kapsula hija stampati bl- ittri ” ROCHE ” u l- kodiċi ” 0245 ”.
Invirase is available in an amber glass bottle containing 270 capsules.
Invirase huwa disponibbli fi fliexken tal- ħġieġ amber li fih 270 kapsula.
Marketing Authorisation Holder Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- Renju Unit
Manufacturer Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.
Manifattur Roche Pharma AG, Emil- Barell- Strasse 1, 79639 Grenzach- Wyhlen, Il- Ġermanja.
Tel: +420 - 2 20382111
62 Malta Česká republika (See United Kingdom) Roche s. r. o.
62 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
Invirase 500 mg film -coated tablets Saquinavir
Invirase 500 mg pilloli miksija b’ rita Saquinavir
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex -
Do not take Invirase • if you are allergic (hypersensitive) to saquinavir, ritonavir or any of the other ingredients (see section “Important information about an ingredient of Invirase” and section “What Invirase contains”). • if you have liver disease with severe disease symptoms (e.g. jaundice or hepatitis with ascites, mental confusion and/or bleeding from veins of the oesophagus). • if you are currently taking any of the following medicines:
Tieħux Invirase • jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal saquinavir jew sustanzi oħra (ara sezzjoni “ Tagħrif importanti dwar sustanza ta ’ Invirase ” u sezzjoni “ X’ fih Invirase ”). • jekk għandek mard tal- fwied b’ sintomi severi tal- marda (e. ż. suffejra, jew epatite b’ axxite, konfużjoni mentali u/ jew fsad ta ’ demm mill- vini ta ’ l- esofagu. • jekk qed tieħu xi mediċini msemmija hawn taħt:
64 Treatment with Invirase/ritonavir has not been shown to reduce the risk of transmission of HIV to others through sexual contacts or contamination with blood.
Ma jidhirx li l- kura b’ Invirase/ ritonavir tnaqqas ir- riskju li l- HIV jgħaddi lil oħrajn b’ kuntatti sesswali jew b’ kontaminazzjoni bid- demm.
At present, there is only limited information on the use of Invirase/ritonavir in children under the age of 16 years and in adults over 60 years.
64 Fil- preżent, hemm biss informazzjoni limitata dwar l- użu ta ’ Invirase/ ritonavir fi tfal taħt l- età ta ’ 16 - il sena u f’ adulti ta ’ aktar minn 60 sena.
- anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine),
- mediċini użati biex jikkuraw funzjoni erettili ħażina (sildenafril, vardenafil, tadalafil),
- sedative agents (e.g. midazolam administered by injection),
- mediċini biex jikkuraw id- depressjoni (e. ż. nefazodone, antidepressivi tricyclic),
Important information about an ingredient of Invirase Each film-coated tablet contains lactose (monohydrate) 38.5 mg.
Tagħrif importanti dwar sustanza ta ’ Invirase Kull pillola miksija b’ rita fiha 38. 5mg lactose (monohydrate).
Invirase is provided as 500 mg film-coated tablet.
Invirase huwa pprovdut bħala pillola ta ’ 500 mg miksija b’ rita.
For patients in whom the 500 mg film-coated tablet is not suitable, Invirase is also available in the form of 200 mg hard capsules.
Għall- pazjenti li ma tgħoddx għalihom pillola ta ’ 500 mg, Invirase huwa wkoll ipprovdut bħala kapsula iebsa ta ’ 200 mg.
The dosage of Invirase is two 500 mg film-coated tablets with one 100 mg capsule of Norvir (ritonavir) two times daily.
Id- dożaġġ ta ’ Invirase huwa ta ’ żewġ pilloli miksija b’ rita ta ’ 500 mg flimkien ma ’ kapsula waħda ta ’ 100 mg ta ’ Norvir (ritonavir) darbtejn kuljum.
The film-coated tablets should be swallowed whole together with water.
Il- pilloli miksija b’ rita għandhom jimbelgħu sħaħ flimkien ma ’ l- ilma.
66 If you forget to take Invirase Do not take a double dose to make up for a forgotten individual dose.
Jekk tinsa tieħu Invirase M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop taking Invirase Continue to take this medicine until your doctor tells you otherwise.
66 Jekk tieqaf tieħu Invirase Kompli ħu din il- mediċina sakemm it- tabib tiegħek jgħidlek mod ieħor.
67 If you experience any side effects that are not in this leaflet, please tell your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji oħra li mhumiex imsemmija f’ dan l- fuljett, jekk jogħġbok għid lit - tabib jew lill- ispiżjar tiegħek.
Invirase does not require any special storage conditions.
Invirase m’ għandux bżonn xi kundizzjonijiet speċjali tal- ħażna.
- The active substance is saquinavir.
Is- sustanza attiva hi saquinavir.
saquinavir as saquinavir mesilate.
Pillola waħda miksija b’ rita ta ’ Invirase fiha 500mg ta ’ saquinavir bħala saquinavir mesilate.
(monohydrate) 38.5 mg, magnesium stearate, hypromellose, titanium dioxide (E 171), talc, glycerol triacetate, iron oxide yellow (E172) and iron oxide red (E172).
Is- sustanzi l- oħra huma microcrystalline cellulose, croscarmellose sodium, povidone, 38. 5mg lattosju (monohydrate), magnesium stearate, hypromellose, titanium dioxide (E171), talc, glycerol triacetate, iron oxide isfar (E172) u iron oxide aħmar (E172).
Invirase 500 mg film-coated tablets are light orange to greyish or brownish orange tablets of oval shape with the marking "SQV 500" on the one side and "ROCHE" on the other side.
Invirase 500 mg, pilloli miksija b’ rita huma pilloli oranġju ċar għal oranġju fil- gris jew fil- kannella, ta ’ forma ovali, b’ marka “ SQV 500 ” fuq naħa waħda u ‘ ROCHE ’ fuq in- naħa l- oħra.
One plastic (HDPE) bottle contains 120 tablets.
Flixkun tal - plastik (HDPE) fih 120 pillola.
Manufacturer Roche Pharma AG, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.
1, 79639 Grenzach- Wyhlen, Il- Ġermanja.
Tel: +420 - 2 20382111
68 Malta Česká republika (See United Kingdom) Roche s. r. o.
69 This leaflet was last approved in
69
What is IONSYS?
X’ inhi IONSYS?
IONSYS is an iontophoretic transdermal system (ITS), which delivers the active substance, fentanyl hydrochloride, into the body through the skin.
IONSYS hija sistema transdermali jontoforetika (ITS), li twassal is- sustanza attiva, fentanyl hydrochloride, għal ġol- ġisem minn ġol- ġilda.
What is IONSYS used for?
Għal xiex tintuża IONSYS?
IONSYS is used to control pain after an operation, in patients who are in hospital.
IONSYS tintuża biex tikkontrolla l- uġigħ wara operazzjoni, f’ pazjenti li qegħdin l- isptar.
How is IONSYS used?
Kif tintuża IONSYS?
IONSYS is given to the patient after an operation.
IONSYS tingħata lill- pazjent wara operazzjoni.
It is given using a system that is operated by the patient.
Hija tingħata bl- użu ta ’ sistema li hija mħaddma mill - pazjent.
A doctor or a nurse applies the transdermal system to the patient ’ s skin on the chest or upper arm.
Tabib jew infermiera japplikaw is- sistema transdermali mal- ġilda tal- pazjent fuq is- sider jew in- naħa ta ’ fuq tad- driegħ.
When in pain, the patient uses a button on the IONSYS system to start the delivery of a dose of fentanyl (40 micrograms).
Meta jkun muġugħ, il- pazjent juża buttuna fuq is- sistema IONSYS biex jingħata doża ta ’ fentanyl (40 mikrogramma).
IONSYS can be used up to six times in one hour, but for no more than 80 doses within a 24-hour period.
IONSYS tista ’ tintuża sa sitt darbiet f’ siegħa, iżda għal mhux aktar minn 80 doża fi żmien perijodu ta ’ 24 siegħa.
The system will stop working 24 hours after the first dose or after 80 doses have been delivered.
Is- sistema tieqaf taħdem 24 siegħa wara l - ewwel doża jew wara li jkunu ngħataw 80 doża.
It must then be removed by a doctor or nurse.
Imbagħad hija għandha titneħħa minn tabib jew infermiera.
How does IONSYS work?
Kif taħdem IONSYS?
IONSYS contain the active ingredient fentanyl, which is a strong painkiller.
IONSYS fiha s- sustanza attiva fentanyl, li hija mediċina qawwija kontra l- uġigħ.
Fentanyl is derived from opium.
Fentanyl huwa imnissel mil- loppju.
It is a well-known substance, which has been used to control pain for many years.
Hija sustanza magħrufa sew, li ilha tintuża biex tikkontrolla l- uġigħ għal bosta snin.
The fentanyl is contained inside a reservoir.
Il- fentanyl jinżamm ġewwa parti mis- sistema fejn titqiegħed il- mediċina.
When the patient activates IONSYS, a small electrical current moves a dose of fentanyl from the reservoir through the skin and into the bloodstream.
Meta l- pazjent jattiva IONSYS, kurrent żgħir ta ’ l- elettriku jmexxi doża ta ’ fentanyl mill- parti tas- sistema fejn titqiegħed il - mediċina minn ġol- ġilda għal ġon- nixxiegħa tad- demm tal- ġisem.
Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to prevent pain.
Ladarba jkun fin- nixxiegħa tad - demm tal- ġisem, fentanyl jaħdem fuq riċetturi fil- moħħ u l- korda spinali biex jimpedixxi l- uġigħ.
How has IONSYS been studied?
Kif ġiet studjata IONSYS?
The effects of IONSYS were first tested in experimental models before being studied in humans.
L- effetti ta ’ IONSYS kienu l- ewwel ittestjati f’ mudelli esperimentali qabel ma ġew studjati fil - bnedmin.
Four main studies were performed in about 800 patients after an operation.
Saru erba ’ studji ewlenin f’ madwar 800 pazjent wara operazzjoni.
In three of them, IONSYS was compared with placebo (a transdermal system identical to IONSYS, but from which the medicine could not be released).
Fi tlieta minnhom, IONSYS kienet imqabbla ma ’ plaċebo (sistema transdermali identika għal IONSYS, iżda minn liema ma setgħetx tiġi rilaxxata l- mediċina).
These studies measured the number of patients who stopped treatment because they were not getting enough pain relief.
Dawn l- istudji kejlu n- numru ta ’ pazjenti li waqqfu l- kura għaliex ma kienx qed ikollhom biżżejjed serħan mill- uġigħ.
The fourth study compared IONSYS to morphine given by injection into a vein, and looked at the number of patients who judged their pain relief as ‘ good’ or ‘ excellent’.
Ir- raba ’ studju qabbel IONSYS ma ’ morfina mogħtija permezz ta ’ injezzjoni ġo vina, u studja n - numru ta ’ pazjenti li qiesu s- serħan mill- uġigħ tagħhom bħala ‘ tajjeb ’ jew ‘ eċċellenti ’.
(44-20) 74 18 84 00 Fax (44-20) 74 18 85 45 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has IONSYS shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 85 45 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged X’ benefiċċju wriet IONSYS waqt l- istudji?
In the studies where IONSYS was compared to placebo, the proportion of patients who stopped treatment because their pain was not controlled was lower in patients treated with IONSYS than those treated with placebo.
Fi studji fejn IONSYS kienet imqabbla ma ’ plaċebo, il- proporzjon ta ’ pazjenti li waqqfu l- kura minħabba li l- uġigħ tagħhom ma kienx ikkontrollat, kien aktar baxx f’ pazjenti ikkurati b’ IONSYS milli f’ dawk ikkurati bi plaċebo.
These results show that IONSYS has a benefit in controlling pain after an operation.
Dawn ir- riżultati juru li IONSYS għandha benefiċċju f’ li tikkontrolla l- uġigħ wara operazzjoni.
The results of the study comparing IONSYS with morphine were insufficient to determine whether the two medicines were of similar effectiveness in relieving pain or not.
Ir- riżultati ta ’ l- istudju li qabbel IONSYS ma ’ morfina ma kinux biżżejjed biex jiddeterminaw jekk iż - żewġ mediċini kinux ta ’ effettività simili f’ li jserrħu l- uġigħ jew le.
What is the risk associated with IONSYS?
X’ inhu r- riskju assoċjat ma ’ IONSYS?
The most common side effects with IONSYS (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, headache and erythema (redness of the skin) at the site of application.
L- aktar effetti sekondarji b’ IONSYS (dehru f’ aktar minn pazjent 1 f’ 10) huma nawżja (dardir), remettar, uġigħ ta ’ ras u eritima (ħmura tal- ġilda) fis- sit ta ’ l- applikazzjoni.
For the full list of all side effects reported with IONSYS, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji irrapportati b’ IONSYS, ara l- Fuljett ta ’ Tagħrif.
Fentanyl, the active substance in IONSYS, can be abused.
Fentanyl, is- sustanza attiva f’ IONSYS, tista ’ tkun abbużata.
However, the risk with IONSYS is low, as the medicine is for short-term use.
Madankollu, ir- riskju b’ IONSYS huwa baxx, peress li l- mediċina hija għal użu ta ’ qasir żmien.
IONSYS must only be used in hospital, and it must not be used in patients who have respiratory problems (such as breathing difficulties), or heart, liver or kidney problems.
IONSYS għandha tintuża biss fl- isptar, u m’ għandhiex tintuża f’ pazjenti li għandhom problemi respiratorji (bħalma huma diffikultajiet fit- teħid tan- nifs), jew problemi bil- qalb, fwied jew kliewi.
Why has IONSYS been approved?
Għaliex giet approvata IONSYS?
The Committee for Medicinal Products for Human Use (CHMP) concluded that IONSYS offers potential benefits compared to systems where the pain relief is given via a vein: it is non-invasive, needle-free and pre-programmed, and it can be activated by the patient.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li IONSYS toffri benefiċċji potenzjali meta mqabbla ma ’ sistemi fejn is- serħan ta ’ l- uġigħ jingħata minn vina: mhijiex invażiva, hija mingħajr labar u ipprogrammata minn qabel, u hija tista ’ tiġi attivata mill- pazjent.
Therefore, the Committee decided that IONSYS’ s benefits are greater than its risks for the management of acute moderate to severe post-operative pain for use in a hospital setting only.
Għaldaqstant, il- Kumitat iddeċieda li l- benefiċċji ta ’ IONSYS huma akbar mir- riskji tagħha għall - ġestjoni ta ’ uġigħ akut moderat għal sever ta ’ wara operazzjoni għal użu f’ sitwazzjoni ta ’ sptar biss.
The Committee recommended that IONSYS be given marketing authorisation.
Il - Kumitat irrikkmanda li IONSYS tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of IONSYS?
X’ miżuri qed jittieħdu biex jassiġuraw l- użu sikur ta ’ IONSYS?
The company that makes IONSYS will monitor the key safety risks associated with IONSYS such as overdose, abuse, addiction or misuse, and will provide an educational plan for patients, doctors and healthcare providers, aimed at minimising the risk and supporting the safe and effective use of the medicine.
Il- kumpanija li tagħmel IONSYS se tissorvelja r- riskji ta ’ sigurtà ewlenin assoċjati ma ’ IONSYS bħalma huma teħid eċċessiv, abbuż, vizzju jew użu ħażin, u se tipprovdi pjan edukattiv għal pazjenti, tobba u għal dawk li jipprovdu kura tas- saħħa, immirat li jċekken ir- riskju u jappoġġja l- użu sikur u effettiv tal- mediċina.
Other information about IONSYS:
Tagħrif ieħor dwar IONSYS:
The European Commission granted a marketing authorisation valid throughout the European Union for IONSYS to Janssen-Cilag International NV on 24 January 2006.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal IONSYS valida fl- Unjoni Ewropea kollha lil Janssen- Cilag International NV fl- 24 ta ’ Jannar 2006.
The full EPAR for IONSYS can be found here.
L- EPAR sħiħ għal IONSYS huwa disponibbli minn hawn.
Invented name
Isem Inventat
Pharmaceutical Form
G amla Farma ewtika
EU/ 1/ 05/ 326/ 001
EU/ 1/ 05/ 326/ 001 Ionsys
40 µg/ dose
40 µg/ do a
Iontophoretic transdermal system
Sistema transdermali Ijontoforetika
Transdermal Use
U u transdermali
sachet Nylon/ Alu/ copolymer of polyethylene and polymethacrylic acid
qartas Najlon/ Alu/ kopolimer ta ’ polyethylene u polymethacrylic acid
1 sachet in carton
Qartas 1 f’ kartuna
IONSYS 40 micrograms per dose iontophoretic transdermal system.
IONSYS 40 mikrogramma għal kull doża sistema jontoforetika li tipprovdi mediċina li tgħaddi minn ġol- ġilda.
Each IONSYS system contains 10.8 mg fentanyl hydrochloride equivalent to 9.7 mg of fentanyl and delivers 40 micrograms fentanyl per dose, to a maximum of 3.2 mg (80 doses).
Kull sistema IONSYS fiha 10. 8mg fentanyl hydrochloride ekwivalenti għal 9. 7mg ta ’ fentanyl u jgħaddi 40 mikrogramma fentanyl għal kull doża, għal massimu ta ’ 3. 2mg (80 doża)
Iontophoretic transdermal system (ITS).
Sistema jontoforetika li tipprovdi mediċina li tgħaddi minn ġol- ġilda..
IONSYS is composed of a compact electronic controller and two hydrogel reservoirs, one of which contains fentanyl hydrochloride in a gel formulation for needle free, on-demand delivery.
IONSYS hu kompost minn kontrollur elettroniku kompatt u żewġ depożiti ta ’ hydrogel, li waħda minnhom fiha fentanyl hydrochloride f’ formulazzjoni ta ’ ġell li jintreħa mingħajr użu ta ’ labar meta jkun hemm domanda għalih.
The upper part of the product is white and contains the identifier ‘ IONSYS™’.
Il- parti ta ’ fuq tal- prodott hija bajda u fiha l- identifikatur ‘ IONSYS™ ’.
IONSYS is indicated for the management of acute moderate to severe post-operative pain for use in a hospital setting only.
IONSYS huwa indikat għall- maneġġjar ta ’ uġigħ akut post- operazzjoni moderat għal sever għal użu fi sptar biss.
IONSYS should be restricted to hospital use only.
IONSYS għandu jkun użatt strettament fi sptarijiet biss.
Due to the well known potential of abuse of fentanyl physicians should evaluate patients for a history of drug abuse (see section 4.4).
Minħabba l- potenzjal magħruf ta ’ abbuż ta ’ fentanyl, tobba għandhom jevalwaw il- pazjenti għal storja ta ’ abbuż ta ’ drogi (ara sezzjoni 4. 4).
IONSYS should only be activated by the patient.
Prekawzjonijiet speċjali ta ’ kif jintrema għandhom jiġu segwiti (ara sezzjoni 6. 6) IONSYS għandu jiġi attivat mill- pazjent biss.
Before any surgery, the healthcare professional should ensure that the patient has been properly informed on how to use IONSYS post-operatively.
Qabel kull operazzjoni, il- professjonista tas- saħħa għandu jiżgura li l- pazjent ġie infurmat sew dwar kif juża IONSYS wara l- operazzjoni.
IONSYS delivers 40 micrograms per on-demand dose up to a maximum of 240 micrograms (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period.
IONSYS jgħaddi 40 mikrogramma għal kull doża rikjesta għal massimu ta ’ 240 mikrogrammi (6 dożi kull wieħed b’ durata ta ’ 10 minuti) kull siegħa imma mhux iktar minn massimu ta ’ 80 dożi f’ perjodu ta ’ 24 siegħa.
Patients should be titrated to an acceptable level of analgesia prior to initiating use of IONSYS.
Pazjenti għandhom ikunu titrati sa livell aċċettabbli ta ’ analġeżija qabel ma jinbeda l - użu ta ’ IONSYS.
The system should only be activated by the patient in response to pain.
Is- sistema għandha tiġi attivata mill- pazjent meta jħoss l- uġigħ.
IONSYS will operate for 24 hours following completion of the first dose or for 80 doses, whichever comes first, and then becomes inoperative.
IONSYS jopera għal 24 siegħa wara l- kompletazzjoni ta ’ l- ewwel doża jew għal 80 doża, skond liema jiġi l- ewwel, imbagħad ma jibqax jopera.
If the patient attempts to initiate a dose after 80 doses or 24 hours from the first dose, the system will not respond (i. e. no red light, no beep).
Jekk il- pazjent jipprova jinizja doża wara 80 doża jew 24 siegħa wara l- ewwel doża, is- sistema ma tirrispondix (i. e. ebda dawl aħmar, ebda ħoss).
The maximum treatment duration is 72 hours (3 systems), although the majority of patients should only need one system.
Id- durata massima tat- trattament hija ta ’ 72 siegħa (3 sistemi), għalkemm il- maġġoranza tal- pazjenti jkollhom bżonn sistema waħda biss.
Patients should not wear more than one system at a time.
Pazjenti m’ għandhomx jilbsu iktar minn sistema waħda fl- istess ħin.
Used systems should not be reapplied to a patient.
Sistemi użati m’ għandhomx jiġu applikati mill- ġdid fuq pazjenti.
Patients should not get the IONSYS system wet.
Pazjenti m’ għandhomx ixarrbu s- sistema IONSYS.
Prolonged contact with water could affect system performance and cause the system to malfunction or fall off.
Kuntatt dewwiemi ma ’ l- ilma jista ’ jaffettwa l - mod kif taħdem is- sistema u jista ’ jikkawża li s- sistema tiffunzjona hażin jew taqa.
IONSYS should be removed before the patient is discharged.
IONSYS għandu jitneħħa qabel il- pazjent jitlaq mill- isptar.
2 Children and adolescents
2 Tfal u adoloxxenti
IONSYS is not recommended for use in children below age 18 years due to insufficient data on safety and efficacy.
IONSYS mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurta` u l- effikaċja.
Limited data on pharmacokinetics, safety and efficacy are available for the use of IONSYS in patients > 75 years.
Hemm informazzjoni limitata dwar farmakokinetika, sigurtà u effikaċja għall- użu ta ’ IONSYS f’ pazjenti > 75 sena.
Elderly patients should be observed carefully for signs of fentanyl toxicity.
Pazjenti anzjani għandhom jiġu osservati b’ attenzjoni għal sinjali ta ’ tossiċitaà ta ’ fentanyl.
IONSYS Testing Instructions for the Pharmacist or Other Health Care Professional (To be Performed Prior to Dispensing):
Struzzjonijiet dwar ittestjar ta ’ IONSYS għall- Ispiżjar jew Professjonista tas- Saħħa ieħor (Li għandhom isiru qabel ma jingħata):
Please refer to section 6.6.
Jekk jogħġbok ara sezzjoni 6. 6.
Method of Application
Metodu ta ’ applikazzjoni
The IONSYS system should not be used if the seal on the sachet is broken.
Is- sistema IONSYS m’ għandux jintuża jekk is- siġill fuq il- qartas huwa mkisser.
LED = Light Emitting Diode
LED = Dajowd li jarmi d- dawl
IONSYS should be applied to intact, non-irritated and non-irradiated skin on the chest or upper outer arm.
IONSYS għandu jiġi applikat fuq ġilda intatta, mhux irritata u mhux irradjata, fuq is- sider jew fuq in - naħa ta ’ fuq ta ’ barra tad- driegħ.
IONSYS should not be placed on abnormal skin sites, such as scars, burns, tattoos, etc.
IONSYS m’ għandux jiġi applikat fuq siti fejn il- ġilda hi anormali bħal ċikatriċi, ħruq, tpinġija, eċċ.
Hair at the application site should be clipped (not shaved) before system application.
Xagħar fuq is- sit fejn ser jiġi applikat għandu jiġi maqtugħ (mhux imqaxxar) qabel ma tiġi applikata is- sistema.
IONSYS should not be applied to a previously used skin site.
IONSYS m’ għandux jiġi applikat fuq sit fuq il- ġilda fejn ġie applikat qabel.
The application site should be wiped with a standard alcohol swab, the skin allowed to dry completely before the IONSYS system is applied.
Is- sit fejn ser jiġi applikat għandu jintmesaħ b’ imselħa standard tal- alkoħol, il- ġilda għanda titħalla tinxef kompletament qabel ma tiġi applikata s- sistema IONSYS.
No soaps, oils, lotions, or any other agents that might irritate the skin or alter its absorption characteristics, should be used.
M’ għandux jintuża sapun, żejt, lozjoni jew xi aġenti oħrajn li jistgħu jirritaw il- ġilda jew jibdlu l- karatteristiċi ta ’ assorbiment.
The sachet containing IONSYS should be opened starting at the pre-cut notch, then by carefully tearing along the top of the sachet.
Il- qartas li fih IONSYS għandu jinfetaħ billi tibda tqatta ’ bil- mod minn fejn hemm ix- xaqq diġa maqtugħ tul il- parti ta ’ fuq tal- pakkett.
The system should be removed from the sachet and used immediately.
Is- sistema għanda tinħareġ mill- qartas u tintuża immedjatament.
The moisture absorber should be discarded after opening the sachet.
L- assorbent tal- umidità 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 manufacturer.
Jekk m’ hemmx assorbent tal- umidità jew jekk l- assorbent tal- umidità mhuwiex intatt, tużaħx u rritorna s - sistema lill- manifattur.
The clear plastic liner covering the adhesive should be removed and discarded with care taken not to touch the gels.
Il- liner ta ’ plastik ċara li jgħatti l- parti ti teħel għandu jinqala u jintrema b’ attenzjoni mogħtija sabiex ma jintemssux il- ġellijiet.
The IONSYS system should be pressed firmly in place with the sticky side down on the skin for at least 15 seconds.
Is- sistema IONSYS għanda tingħafas sewwa bin- naħa li twaħħal wiċċha l- isfel fuq il- ġilda għal 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.
Pressjoni għanda tiġi applikata bl- iswaba fuq it- truf ta ’ barra sabiex jiġi aċċertat li s- sistema twaħħlet sew fuq il- ġilda ghad- durata tal- 24 siegħa li għanda tintlibes.
Occasionally, the IONSYS system may loosen; 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.
Xi kultant, is- sistema IONSYS tista tinħall; jekk dan jiġri għandu jintuża tejp non- allerġeniku sabiex ikun aċċertat li t- truf tas- sistema jagħmlu kuntatt komplet mal- ġilda.
Care should be taken not to press or tape over the button or red light.
Għandha tingħata attenzjoni li ma jingħafasx jew jitpoġġa tejp fuq il- buttuna jew id- dawl aħmar.
3 Dose Delivery
3 Trasmissjoni tad- doża
A recessed on-demand dosing button and red light are located on the top housing of the IONSYS system.
Buttuna imdaħħla ta ’ dożaġġ fuq rikjesta u bozza ħamra huma posizzjonati fuq in- naħa ta ’ fuq tal - għata tas- sistema IONSYS.
To initiate administration of a fentanyl dose, the patient should press the on-demand button twice within 3 seconds.
Sabiex tinbeda l- għoti ta ’ doża fentanyl, il- pazjent għandu jagħfas il - buttuna tar- rikjesta darbtejn fi 3 sekondi.
IONSYS should only be activated by the patient.
IONSYS għandu jiġi attivat mill- pazjent biss.
A beep indicates the start of delivery of the dose; the red light remains on throughout the 10-minute dosing interval.
Ħoss jindika l- bidu tat- trasmissjoni tad- doża; id- dawl aħmar jibqa jixgħel tul l- interval ta ’ dożaġġ ta ’ 10 minuti.
The next dose cannot be initiated until the previous 10-minute delivery cycle is complete.
Id - doża segwenti ma tistax tinbeda qabel ma jkun kompletat iċ- ċiklu preċedenti ta ’ trasmissjoni ta ’ 10 minuti.
Pressing the button during delivery of a dose will not result in additional medicinal product being administered.
Jekk tingħafas il- buttuna waqt it- trasmissjoni ta ’ doża ma jwassalx għall- għoti ta ’ prodott mediċinali addizzjonali.
The red light turns off after the 10-minute dose has been delivered.
Id- dawl aħmar jintefa wara li d- doża ta ’ 10 minuti tkun ġiet trasmessa.
Determining Approximate Number of Doses Delivered
Kif jigi stabbilit in- numru approssimattiv ta’ dożi trasmessi
Between doses, the red light will blink in one-second pulses to indicate the approximate number of doses administered up to the present time.
Bejn doża u oħra, id- dawl aħmar iteptep f’ polzijiet ta ’ sekonda kull waħda sabiex jindika n- numru approssimattiv ta ’ dożi mogħtija sal- ħin preżenti.
Each one-second pulse of light indicates administration of up to five doses.
Kull polz ta ’ sekonda ta ’ dawl jindika għoti ta ’ massimu ta ’ ħames dożi.
Thus, a single one-second pulse of light represents 1 to 5 doses; two pulses represent 6-10 doses; three pulses represent 11-15 doses; up to 16 pulses which represents 76-80 doses delivered.
Għalhekk, polz ta ’ dawl ta ’ sekonda tirraprezenta bejn doża 1 u 5 dożi; żewġ polzijiet jirrapreżentaw bejn 6- 10 dożi; tlett polzijiet jirrapreżentaw bejn 11- 15- il doża; sa 16- il polz li jirraprezentaw bejn 76- 80 doża trasmessi.
The system may also be queried during delivery of an on-demand dose by pressing the button once.
Is- sistema tista tiġi mistoqsija waqt trasmissjoni ta ’ doża fuq rikjesta billi tagħfas il- buttuna darba.
The red LED will pulse as outlined above to indicate the approximate number of on-demand doses delivered up to the query.
L- LED aħmar jagħmel polz kif indikat hawn fuq biex jindika l- ammont approssimattiv ta ’ dożi fuq rikjesta trasmessi sal- mistoqsija.
This query will not influence dose delivery.
Din il- mistoqsija ma tinfluwenzax it- trasmissjoni tad- doża.
Removal
Tneħħija
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 titneħħa sistema, m’ għandiex terġa titwaħħal l- istess waħda.
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.
Wara 24 siegħa ta ’ użu jew wara t- trasmissjoni ta ’ 80 doża, neħħi s- sistema IONSYS billi tgħolli d- dendula l- ħamra bil- mod u tħoll is- sistema mill- post fuq il- ġilda fejn is- sistema ġiet applikata.
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 addizzjonali jew kontinwat mill- uġigħ, sistema ġdida tista tiġi applikata f’ post ieħor fuq il- ġilda tan- naħa ta ’ barra u ta ’ fuq tad- driegħ jew is- sider.
Troubleshooting
Kif issolvi problemi tekniċi
Each IONSYS system is designed to deliver every on-demand dose of fentanyl over approximately 10 minutes.
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 LED and any audible signals (beeps) over the next dose.
Jekk hemm suspett ta ’ falliment tekniku fis- sistema, il- membru ta ’ l- istaff jew il - pazjent għandu jimmoniterja kemm l- illuminazzjoni tal- LED aħmar kif ukoll kwalunkwe sinjal li jinstema (ħoss) fid- doża li jmiss.
The table below represents the different error messages that may occur, together with the appropriate action to be taken:
Il- kaxxa hawn taħt tirrapreżenta l- messaġġi ta ’ żball differenti li jistgħu iseħħu, u l- azzjoni li għanda tittieħed:
Error Message Frequency 2 beeps repeated 8 times (approximately 15 seconds) and red LED turns off before 10 minutes 4 continuous beeps and red LED 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
Action Up to 2 more attempts may be made to request new delivery.
Azzjoni Jistgħu isiru sa 2 tentattivi oħra biex tirrikjedi trasmissjoni ġdida.
If all attempts fail, the system should be removed and a new system applied to a new skin site.
Jekk it - tentattivi kollha jfallu, is- sistema għanda titneħħa u sistema ġdida tiġi applikata fuq sit ieħor fuq il- ġilda.
The system cannot be restarted.
Is- sistema ma tistax tinxtegħel mill- ġdid.
It should be removed and a new system applied to a new skin site.
Din għanda titneħħa u sistema ġdida tiġi applikata fuq sit ieħor fuq il- ġilda
Red LED fails to illuminate
L- LED aħmar ma jixgħelx
The system should be removed and a new system applied to a new skin site.
Is- sistema għanda titneħħa u sistema ġdida tiġi applikata fuq sit ieħor fuq il - ġilda
Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
IONSYS should only be activated by the patient, to avoid potential overdosing.
IONSYS għandu jiġi attivat mill- pazjent biss, biex jiġi evitat il- potenzjal ta ’ dożi eċċessivi.
4 IONSYS should be restricted to hospital use only.
4 IONSYS għandu jiġi ristrett għal użu fl- isptar biss.