qanastek/EMEA-V3 huggingface dataset:
Follow the instructions and recommendations from your doctor regarding the use of Velosulin in a du
Segwi l- istruzzjonijiet u r- rakkomandazzjonijiet tat- tabib tieg ek dwar l- u u ta ’ Velosulin f’ pompa. tm
Velosulin should never be mixed with any other insulin when used in a pump. ro
Velosulin m’ g andu qatt jit allat ma ’ kwalunkwe insulina o ra meta jintu a f’ pompa.
Read and follow carefully the instructions that accompany your insulin pump.
Aqra u segwi bl- attenzjoni l- istruzzjonijiet li jkun hemm mal- pompa ta ’ l- insulina tieg ek.
Always have ordinary syringes available in case of pump interruption or failure. lp
Dejjem g andu jkollok siringi normali disponibbli f’ ka ta ’ interruzzjoni jew sara fil- pompa. ot
Use in syringes a in
L- u u fis- siringi od
Velosulin is for injection under the skin (subcutaneously).
Velosulin hu mag mul biex ikun injettat ta t il - ilda.
Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
tevita li jifformaw l- g oqiedi (ara 5 Effetti sekondarji li jista ’ jkollu).
Your insulin will work more ed
L- a jar postijiet minn fejn tinjetta lilek innifsek huma: in- na a ta ’ quddiem ta ’ qaddek (i - aqq); il- warrani; in- na a ta ’ quddiem tal- koxox jew in- na a ta ’ fuq ta ’ dirg ajk.
quickly if you inject it around the waist.
L- insulina tieg ek ta dem aktar malajr jekk tinjetta madwar il- qadd.
M
Il- kunjetti ta ’ Velosulin huma g all- u u ma ’ siringi ta ’ l- insulina bl- iskala korrispondenti ta ’ l- unità.
Velosulin may also be administered intravenously in special situations by medical professionals.
Velosulin jista ’ wkoll jing ata minn ol- vina f’ sitwazzjonijiet spe jali minn professjonisti fil- qasam mediku.
To inject Velosulin on its own
24 Biex tinjetta Velosulin wa du
Draw air into the syringe, in the same amount as the dose of insulin you need 2.
I bed l- arja os- siringa, fl- istess ammont b ad- do a ta ’ l- insulina li te tie 2.
Inject the air into the vial: push the needle through the rubber stopper and press the plunger 3.
Injetta l- arja ol- kunjett: imbotta l- labra minn ot- tapp tal- lastku u ag fas il- plan er 3.
Turn the vial and syringe upside down 4.
Dawwar il- kunjett u s- siringa ta ’ ta t fuq 4.
Draw the right dose of insulin into the syringe 5.
I bed id- do a korretta ta ’ l- insulina os- siringa 5.
Pull the needle out of the vial 6.
I bed il- labra ‘ l barra mill- kunjett 6.
Make sure there is no air left in the syringe: point the needle upwards and push the air out 7.
A erta ru ek li ma jkunx baqa ’ arja fis- siringa: ipponta l- labra ’ l fuq u imbotta l- arja ‘ l barra 7.
Check you have the right dose 24 8.
I ekkja li g andek id- do a korretta.
Inject the insulin straight away under the skin.
Injetta l- insulina minnufih ta t il - ilda.
Use the injection technique advised by your doctor or diabetes nurse 9.
U a t- teknika ta ’ l- injezzjoni kif tak parir it- tabib jew l -
Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
za 9. omm il- labra ta t il - ilda tieg ek g al mill- anqas 6 sekondi biex ti gura li d- do a s i a tkun ing atat.
To mix Velosulin with long acting insulin
riz Biex t allat Velosulin ma ’ l- insulina li ta dem fit- tul
Follow the instructions of your doctor or diabetes nurse concerning the correct mixing procedure.
to Segwi l- istruzzjonijiet tat- tabib tieg ek jew ta ’ l- infermier/ a tad- dijabete dwar il- pro edura korretta
4.
x 4.
ed If you get a hypo
du Jekk ikollok ipo ħa Ipo tfisser li l- livell taz- zokkor fid- demm tieg ek hu baxx wisq. ’ g
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin;
Is- sinjali ta ’ twissija ta ’ ipo jistg u jigu g al g arrieda u jistg u jinkludu: g araq kiesa; ilda kies a u pallida; u ig ta ’ ras; ta bit mg a el tal- qalb; t ossok imqalla ’; t oss u kbir; tibdil m
or headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling
temporanju fil- vista; ng as; g eja mhux tas- soltu u dg jufija; nervo ità jew rog da; t ossok ansju / a; t ossok konfu / a; diffikultà biex tikkon entra. li
th confused; difficulty in concentrating.
Jekk ikollok xi wie ed minn dawn is- sinjali, kul pilloli tal- glukosju jew ikla afifa li fiha afna li
au If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
zokkor (elu, gallettini, meraq tal- frott), u mbag ad strie. a
Don’ t take any insulin if you feel a hypo coming on.
Ti ux insulina jekk t oss li ejja ipo. in
er Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
omm fuqek pilloli tal- glukosju, elu, gallettini jew meraq tal- frott, fil- ka li jkollok b onnhom.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they ng must: turn you on your side and seek medical advice straight away.
G id lill- qraba, il - bieb u l- kollegi tieg ek li jekk tintilef minn sensik (i ossok a in), huma iċ
They must not give you any food or drink as it could choke you. lo
g andhom: idawruk fuq enbek u j ibu g ajnuna medika immedjatament.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death no
Jekk ipogli emija severa ma tkunx ikkurata, din tista ’ tikkaw a sara fil- mo (temporanja tm
If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
jew permanenti) u anki l- mewt Jekk ikollok ipo li ieg lek tintilef minn sensik, jew afna ipos, kellem lit- tabib tieg ek.
The amount or timing of insulin, food or exercise may need to be adjusted. ct
L - ammont jew il - in li fih tie u l- insulina, l- ikel jew l- e er izzju fi iku, jista ’ jkun li jkollhom ot
Using glucagon du
Kif tu a l- glucagon Pr
You may recover more quickly from unconsciousness with an injection of the hormone glucagon by ro
Jekk tintilef minn sensik tista ’ tirkupra aktar malajr b’ injezzjoni ta ’ l- ormon glucagon minn xi add li jaf kif ju ah.
If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
Jekk ting ata l- glucagon, ser ikollok b onn il- glukosju jew ikla afifa li jkun fiha z - zokkor malli ter a ’ ti i f’ sensik.
If you do not respond to glucagon treatment, you will have to be treated lp
Jekk ma tirrispondix g all- kura bi glucagon, ser ikollok b onn ta ’ kura fi sptar.
Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more. a in
Fittex parir mediku wara injezzjoni tal- glucagon; ser ikollok b onn issib ir- ra uni g all - ipo tieg ek biex tevita li jkollok aktar minnhom.
Causes of a hypo ic
Il- kaw i ta ’ ipo
• If you take too much insulin • If you eat too little or miss a meal M
Ikollok ipo jekk il- livell taz- zokkor fid- demm tieg ek jitbaxxa • Jekk tie u wisq insulina • Jekk tiekol ftit wisq jew taqbe xi ikla 25 • Jekk tag mel aktar e ercizzju mis- soltu.
• If you exercise more than usual.
Dan jista ’ ji ri:
They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
Dawn jinkludu: tag mel l- awrina aktar ta ’ spiss; t ossok bil- g atx; titlef l- aptit; t ossok imqalla ’ (nawsja jew rimettar); t ossok bi ng as jew g ajjien/ a; fwawar, ilda xotta; alq xott u nifs li jkollu ri a ta ’ frott (acetone).
If you don’ t treat it, this could lead to diabetic coma and death.
t din tista ’ twassal g al koma dijabetika u g al mewt.
25 Causes of hyperglycaemia
za Il- kaw i ta ’ ipergli emija
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever • Eating more than usual • Less exercise than usual.
to • Li ripetutament tie u anqas insulina milli g andek b onn • Ikollok infezzjoni jew deni
ed Like all medicines, Velosulin can cause side effects, although not everybody gets them.
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU ħa B al kull medi ina o ra, Velosulin jista ’ jkollu effetti sekondarji, g alkemm ma jidhrux fuq kul add.
Velosulin may cause hypoglycaemia (low blood sugar).
Velosulin jista ’ jikkaw a l- ipogli emija (livell baxx ta ’ zokkor fid- demm).
See the advice in 4 What to do in an emergency.
Ara l- pariri f’ 4 X’ g andek ’ g
is Side effects reported uncommonly (in less than 1 patient in 100)
Effetti sekondarji rrappurtati b’ mod mhux komuni (anqas minn pazjent 1 minn kull 100) li
or Vision problems.
Problemi tal- vista.
When you first start your treatment, it may disturb your vision, but the reaction
G all- ewwel li tibda l- kura bl- insulina, dan jista ’ jikkaw a disturb fil- vista li
th usually disappears.
tieg ek, i da din ir- reazzjoni normalment tmur. a in
au Changes at the injection site (Lipodystrophy).
Kambjament fis- sit ta ’ l- injezzjoni (Lipodistrofija).
If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy).
Jekk tinjetta lilek innifsek ta ’ spiss wisq fl - istess sit, it- tessut tax- xa am ta t il - ilda f’ dan is- sit jista ’ jirqaq (lipoatrofija) jew je xien iċ
Changing the
(lipoipertrofija).
er site with each injection may help to prevent such skin changes.
Jekk tinnota li- fis- sit ta ’ l- injezzjoni l - ilda qieg da tit affer jew qieg da te xien, g id lit- tabib tieg ek jew lill- infermier/ a tad- dijabete, g ax dawn ir- reazzjonijiet jistg u jsiru aktar serji, jew jekk l - tm
If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can become ng more severe, or they may change the absorption of your insulin if you inject in such a site. lo
injezzjoni ssir f’ sit b al dan jistg u jbiddlu l- assorbiment ta ’ l- insulina tieg ek.
Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions).
Jistg u jse u reazzjonijiet (mura, nef a, akk) fis- sit ta ’ l- injezzjoni ot
If they do not disappear, no
Dawn normalment jg ibu wara ftit img at minn meta tibda tie u l - insulina.
Seek medical advice immediately: • if signs of allergy spread to other parts of the body, or ct
Jekk ma jg ibux, kellem lit- tabib tieg ek. od
• if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty du
Fittex parir mediku immedjatament: • jekk is- sinjali ta ’ l- aller ija jinfirxu g al partijiet o ra ta ’ ismek, jew Pr
in breathing; have a rapid heart beat; feel dizzy; feel like fainting.
• jekk f’ daqqa wa da ma t ossokx tajjeb/ tajba u: tibda teg req; tibda t ossok imdardar/ imdardra (tirremetti); ikollok diffikultà biex tie u n- nifs; ikollok ta bit mg a el tal- qalb; t ossok stordut/ a; t ossok li ej xi ass a in.
You may have a very rare serious allergic reaction to Velosulin or one of its ingredients (called a ro
Inti jista ’ jkollok reazzjoni aller ika serja rari afna g al Velosulin jew g al xi wie ed mill - ingredjenti tieg u (imsej a reazzjoni aller ika sistemika).
See also warning in 2 Before you use Velosulin. lp
Ara wkoll it- twissija f’ 2 Qabel ma tu a Velosulin.
Painful neuropathy (nerve related pain).
Newropatija bl- u ig (u ig marbut man- nervaturi).
If a
Din il- kundizzjoni hi msej a newropatija akuta bl- u ig, u normalment tispi a fix- xejn.
it does not disappear, see your doctor. in
Jekk tibqa ’ hemm kellem lit- tabib tieg ek.
When you start taking insulin, water retention may cause swelling around your ankles ic
Din malajr tmur.
and other joints.
Retinopatija dijabetika (tibdil fuq in- na a ta ’ ewwa ta ’ l- g ajn).
This soon disappears. ed
Staqsi lit- tabib tieg ek dwar dan.
Side effects reported very rarely (in less than 1 patient in 10,000) M
Jekk xi wie ed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex
If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse.
t imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib, lill- infermier/ a tad- dijabete jew lill- ispi jar
Ask your doctor about this.
za tieg ek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or pharmacist.
KIF TA
26 6 HOW TO STORE VELOSULIN
EN VELOSULIN
Keep out of the reach and sight of children.
to omm fejn ma jintla aqx u ma jidhirx mit- tfal.
Do not use Velosulin after the expiry date which is stated on the label and the carton.
aw Tu ax Velosulin wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna.
The vials that is not being used is to be stored in a refrigerator (2°C - 8°C).
x Il- kunjetti li ma jkunux qed jintu aw g andhom jin a nu fi fri (2°C - 8°C).
Do not store them in or too near the freezer section or cooling element.
du Ta inhomx fil- fri a jew qrib afna tal- kompartiment tal- fri a jew ta ’ l- element li jkessa.
Keep the vials in the original package.
Tag milhomx fil- fri a. ħa omm il- kunjetti fil- pakkett ori inali.
ed The vials that are being used or about to be used is not to be kept in a refrigerator.
Il- kunjetti li jkunu qed jintu aw jew li ser jintu aw, m’ g andhomx jin ammu fil- fri.
You can keep it in the pump reservoir for 6 days at up to 37°C (close to the body).
Tista ’ ’ g
is temperature (not above 25°C) for 6 weeks after first opening.
ommhom fit- tank tal- pompa g al 6 ijiem f’ temperatura sa 37°C (qrib dik tal - isem).
Always keep the vial in the outer carton when you’ re not using it in order to protect it from light.
Il- kunjett jista ’ jin amm fit- temperatura tal- kamra (ta t 25°C) g al 6 img at wara li jkun infeta g all- ewwel darba. m
or Velosulin must be protected from excessive heat and sunlight.
Velosulin g andu jkun protett minn s ana e essiva u mid- dawl tax- xemx. li li
th Velosulin should not be disposed of via wastewater or household waste.
Velosulin m’ g andux jintrema ma ’ l- ilma tad- drana jew ma ’ l- iskart domestiku.
Ask your pharmacist how to
Staqsi lill- ispi jar a
au dispose of medicines no longer required.
dwar kif g andek tarmi medi ini li m’ g andekx b onn.
These measures will help to protect the environment.
Dawn il- mi uri jg inu g al protezzjoni ta ’ l - in
FURTHER INFORMATION ng What Velosulin contains lo
X’ fih Velosulin
– The active substance is insulin human made by recombinant biotechnology.
Millilitru – ot
1 ml contains 100 IU of insulin human.
fih 100 UI ta ’ insulina umana.
1 vial contains 10 ml equivalent to 1000 IU no
Kunjett fih 10 ml, ekwivalenti g al 1000 UI od
– The other ingredients are zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections. ct du
Pr
What Velosulin looks like and contents of the pack The solution for injection or infusion comes as a clear, colourless, aqueous solution. ro
Id- dehra ta ’ Velosulin u l- kontenut tal- pakkett Is- soluzzjoni g all- injezzjoni jew infu joni ti i b ala soluzzjoni akweja, ara u bla kulur.
Not all packs may be marketed. lp
Mhux il- pakketti kollha jistg u jkunu g all- bejg.
Marketing Authorisation Holder and Manufacturer a
27 Id- detentur ta ’ l- awtorizzazzjoni g at- tqeg id fis- suq u l- manifattur
Novo Nordisk A/ S in
Novo Nordisk A/ S Novo Allé, DK- 2880 Bagsværd, Id- Danimarka
Novo Allé, DK-2880 Bagsværd, Denmark ic
Dan il- fuljett kien approvat l- a
This leaflet was last approved in ed M
t za riz to aw x du ħa ’ g m li li a in iċ ed tm ot od Pr
EPAR summary for the public
SOMMARJU TA L- EPAR GĦALL- PUBBLIKU
What is Ventavis?
X’ inhu Ventavis?
Ventavis is a solution for inhalation using a nebuliser.
Ventavis huwa soluzzjoni ċara għall- inalazzjoni permezz ta ’ nebulizzatur.
It contains the active substance iloprost.
Huwa fih is- sustanza attiva iloprost.
What is Ventavis used for?
Għal x’ hiex jintuża Ventavis?
Ventavis is used for the treatment of adult patients with class III primary pulmonary hypertension to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Ventavis jintuża fit- trattament ta ’ pazjenti adulti bi pressjoni għolja pulmonari primarja klassi III sabiex itejjeb il- kapaċità u s- sintomi waqt l- eżerċizzju (l- abilità li ssir attività fiżika).
Pulmonary hypertension is abnormally high blood pressure in the arteries of the lungs. ‘ Primary ’ means that there are no other diseases of the heart or lungs causing the high blood pressure, and the ‘ class’ reflects the severity of the symptoms caused by the disease: ‘ class III’ involves marked limitation of physical activity.
Pressjoni għolja pulmonari hija pressjoni fid- demm li tkun għolja iktar min- normal fl- arterji tal- pulmuni. ‘ Primarja ’ tfisser li ma hemm l- ebda mard ieħor tal- qalb jew tal- pulmun li jikkaġuna pressjoni għolja tad- demm, u l - ‘ klassi ’ tirrifletti l- gravità tas- sintomi kkawżati mill- marda: ‘ klassi III ’ tinvolvi limitazzjoni immarkata ta ’ attività fiżika.
Because the number of patients with primary pulmonary hypertension is low, the disease is considered ‘ rare’, and Ventavis was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 29 December 2000.
Minħabba li n- numru ta ’ pazjenti bi pressjoni għolja pulmonari primarja huwa wieħed baxx, il- marda hija kkunsidrata ‘ rari ’, u Ventavis kien meqjus bħala ‘ mediċina orfni ’ (mediċina wżata f’ mard rari) fid- 29 ta ’ Diċembru 2000.
How is Ventavis used?
Kif jintuża Ventavis?
Ventavis is given by inhalation using a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).
Ventavis jingħata permezz ta ’ l- inalazzjoni bl- użu ta ’ nebulizzatur (magna speċjali li tbiddel soluzzjoni f’ ajrusol li l- pazjent jista ’ jiġbed man- nifs ’ il ġewwa).
Treatment with Ventavis should be started and monitored by a doctor who has experience in the treatment of pulmonary hypertension.
It- trattament b’ Ventavis għandu jinbeda u jiġi ssorveljat minn tabib li għandu esperjenza fit- trattament ta ’ pressjoni għolja pulmonari.
The recommended dose is 2.5 or 5.0 micrograms.
Id- doża rrakkomandata hija ta ’ 2. 5 mikrogrammi jew 5. 0 mikrogrammi.
Patients should start with the low dose of 2.5 micrograms for the first inhalation, followed by 5.0 micrograms for the second.
Il- pazjenti għandhom jibdew b’ doża baxxa ta ’ 2. 5 mikrogrammi għall- ewwel inalazzjoni mbagħad segwita b’ 5. 0 mikrogrammi għat- tieni waħda.
The dose can then be reduced to 2.5 micrograms again if the patient cannot tolerate the higher dose.
Id- doża tista ’ imbagħad terġa titnaqqas għal 2. 5 mikrogrammi jekk il- pazjent ma jittollerax doża aktar għolja.
The medicine must be given using a type of nebuliser known as a ‘ dosimetric’ nebuliser, which stops automatically when the correct dose has been delivered.
Il- mediċina trid tingħata bl- użu ta ’ tip ta ’ nebulizzatur magħruf bħala nebulizzatur ‘ dożimetriku ’, li jieqaf awtomatikament meta d- doża korretta tkun ingħatat.
It is taken six to nine times a day.
Dan jingħata minn sitta sa disa ’ darbiet kuljum.
Doses are lower if the patient has liver problems.
Id- dożi huma aktar baxxi jekk il- pazjent ikollu problemi fil- fwied.
How does Ventavis work?
Kif jaħdem Ventavis?
Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Pressjoni għolja arterjali pulmonarja hija marda li tiddebbulixxi meta jkun hemm restrizzjoni (tidjiq) fl- arterji u l- vini tad- demm tal- pulmun.
By dilating these blood vessels, the blood pressure is reduced and symptoms are improved.
Dan jikkaġuna pressjoni għolja fl- arterji u fil- vini li jieħdu d - demm min- naħa tal- lemin tal- qalb għal pulmuni.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Ventavis hija formulazzjoni inalata ta ’ iloprost, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. sustanza li hija simili ħafna għal prostacyclin, molekula li hija prodotta b’ mod naturali li tikkaġuna li l- ftuħ (espansjoni) tal- vini u l- arterji tad- demm.
How has Ventavis been studied?
Kif ġie studjat Ventavis?
Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adult patients with stable class III or IV pulmonary hypertension that was either primary or caused by another condition.
Ventavis ġie pparagunat ma ’ plaċebo (trattament finta) fi studju wieħed li kien jinvolvi 203 pazjent adult bi pressjoni għolja pulmonari stabbli ta ’ klassi III jew IV li tkun jew primarja jew ikkawżata minn kundizzjoni oħra.
A ‘ response’ was defined as a combination of a 10% improvement in exercise capacity (measured by looking at how far the patient could walk in six minutes) and an improvement of the patient ’ s condition (the severity of the disease going down by at least one class), without a worsening of pulmonary hypertension or death.
Il- kejl ewlieni ta ’ l- effikaċja kien in- numru ta ’ pazjenti li kienu irrispondew għat- trattament wara 12 - il ġimgħa. ‘ Rispons ’ kien iddefinit bħala kombinazzjoni ta ’ 10% titjib fil - kapaċità ta ’ eżerċizzju (mkejla permezz ta ’ test ta ’ mixja ta ’ sitt minuti) u t- titjib tal- kundizzjoni tal - pazjent (is- severità tal- marda tinżel b’ minn ta ’ l- inqas klassi waħda) mingħajr deterjorament tal - pressjoni għolja pulmonarja jew mewt.
What benefit has Ventavis shown during the studies?
X’ benefiċċju wera Ventavis waqt l- istudji?
Ventavis was significantly more effective than placebo:
Ventavis wera b’ mod sinjifikanti li huwa aktar effikaċi minn plaċebo:
17% of the patients taking Ventavis responded to treatment (17 out of 101), compared with 5% of the patients taking placebo (5 out of 102).
17% tal- pazjenti li kienu qed jieħdu Ventavis irrispondew għat- trattament (17 minn 101), meta mqabbel ma ’ 5% tal- pazjenti li kienu qed jieħdu plaċebo (5 minn 102).
However, when looking at different groups of patients in this study, a benefit of Ventavis that would be relevant for patients was only shown in patients with class III primary pulmonary hypertension.
Madanakollu, meta wieħed iħares lejn id- diversi gruppi ta ’ pazjenti f’ dan l- istudju, benefiċċju ta ’ Ventavis li jkun relevanti għall- pazjenti intwera biss f’ pazjenti bi pressjoni għolja pulmonarja primarja klassi III.
What is the risk associated with Ventavis?
X’ inhu r- riskju assoċjat ma ’ Ventavis?
The most common side effects with Ventavis (seen in more than 1 patient in 10) are vasodilation (blood vessels becoming wider causing flushing or reddening of the face), hypotension (low blood pressure) and cough.
L- aktar effetti sekondarji komuni b’ Ventavis (li dehru f’ aktar minn pazjent 1 minn 10) huma vażodilatazzjoni (il- vini u l- arterji tad- demm jitfetħu u jikkaġunaw fwawar jew ħmura tal- wiċċ), pressjoni baxxa u sogħla.
For the full list of all side effects reported with Ventavis, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Ventavis, ara l - Fuljett ta ’ Tagħrif.
Ventavis should not be used in people who may be hypersensitive (allergic) to iloprost or any of the other ingredients.
Ventavis m’ għandux jintuża f’ pazjenti li jistgħu jkunu allerġiċi għal iloprost jew kwalunkwe mis - sustanzi oħra.
It must not be used in patients who are at risk of bleeding, who have certain heart problems, who have recently had a stroke, or whose pulmonary hypertension is caused by a blocked or narrow vein.
M’ għandux jintuża f’ pazjenti li huma f’ riskju ta ’ fsada, li għandhom ċerti problemi tal - qalb, li riċentement kellhom stroke jew li jkollhom pressjoni għolja pulmonari minħabba vina miżduda jew dejqa.
It must also not be used in women who are pregnant or breast-feeding.
Ventavis m’ għandux ukoll jintuża f’ nisa li huma tqal jew li qed irreddgħu.
Why has Ventavis been approved?
Għaliex ġie approvat Ventavis?
The Committee for Medicinal Products for Human Use (CHMP) decided that, despite the limited data available, Ventavis’ s benefits are greater than its risks for the treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li minkejja d- dejta limitata disponibbli, il- benefiċċji ta ’ Ventavis jisbqu r- riskji tiegħu għat- trattament ta ’ pazjenti bi pressjoni għolja pulmonari primarja, klassifikata bħala NYHA klassi III, fit- titjib tal- kapaċità ta ’ l - eżerċizzju u s- sintomi.
The Committee recommended that Ventavis be given marketing authorisation.
Il- Kumitat irrakkomanda li Ventavis jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Ventavis has been authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
Ventavis ġie awtorizzat taħt “ Ċirkostanzi ta ’ Eċċezzjoni ”, minħabba, li billi l- marda hija rari, ma kienx possibbli li jinkiseb tagħrif komplut fuq il- mediċina.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea għall- Mediċini (EMEA) se tirrevedi kull tagħrif ġdid li jista ’ jsir disponibbli u dan is- sommarju jiġi aġġornat skond dak li jkun hemm bżonn.
Which information is still awaited for Ventavis?
X’ tagħrif għadu mistenni għal Ventavis?
The company that makes Ventavis will carry out further studies to collect data on the long-term use of the medicine.
Il- kumpanija li tagħmel Ventavis se twettaq aktar studji sabiex tiġbor tagħrif dwar l- użu tal- mediċina fuq perjodu ta ’ żmien twil.
Other information about Ventavis:
Informazzjoni oħra dwar Ventavis:
The European Commission granted a marketing authorisation valid throughout the European Union for Ventavis to Bayer Schering Pharma AG on 16 September 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Ventavis lil Bayer Schering Pharma AG fis- 16 ta ’ Settembru 2003.
The marketing authorisation was renewed on 16 September 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 16 ta ’ Settembru 2008.
The record of Ventavis’ s designation as an orphan medicine is available here.
Ir- rekord tan- nominazzjoni ta ’ Ventavis bħala mediċina orfni huwa disponibbli minn hawn.
The full EPAR for Ventavis can be found here.
L- EPAR sħiħ għal Ventavis jista ’ jinstab minn hawn.
This summary was last updated in 09-2008.
Dan is- sommarju kien aġġornat l- aħħar fi: 09- 2008.
Pharmaceutical Form
ampulla (ħġieġ)
Route of Administration
ampulla (ħġieġ)
Packaging
30 ampulla
Package size
168 ampulla
Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use
Soluzzjoni għan - nebulizzatur
ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass)
ampulla (ħġieġ)
Ventavis 10 microgram/ ml nebuliser solution
Ventavis ta ’ 10 mikrogrammi/ ml soluzzjoni għan- nebulizzatur.
1 ml solution contains 10 micrograms iloprost (as iloprost trometamol).
Soluzzjoni ta ’ 1 ml fiha 10 mikrogrammi ta ’ iloprost (bħala iloprost trometamol).
Each ampoule with 2 ml contains 20 micrograms iloprost.
Kull ampulla ta ’ 1 ml fiha 10 mikrogrammi ta ’ iloprost Kull ampulla ta ’ 2 ml fiha 20 mikrogramma ta ’ iloprost
Ethanol 96% 0,81 mg per ml.
Ethanol 96% 0, 81 mg kull ml.
Nebuliser solution.
Soluzzjoni għan- nebulizzatur.
Treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Kura ta ’ pazjenti bi pressjoni pulmonari għolja primarja, ikklassifikata bħala klassi funzjonali III ta ’ NYHA, biex itejjeb il- kapaċità ta ’ l- eżerċizzju u s- sintomi.
Ventavis should only be initiated and monitored by a physician experienced in the treatment of pulmonary hypertension.
Ventavis għandu jinbeda biss u jiġi mmonitorjat minn tabib li għandu esperjenza fil- kura ta ’ pressjoni pulmonari għolja.
Ventavis is intended for inhalation use by nebulisation (see section 6.6).
Ventavis huwa maħsub biex jinġibed min- nifs permezz ta ’ nebulizzazzjoni (ara sezzjoni 6. 6).
• Dose per inhalation session:
• Doża kull sessjoni ta ’ ġbid tan- nifs għal ġol- pulmuni:
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser), starting with the low dose of 2.5 microgram for the first inhalation, followed by 5.0 micrograms for the second inhalation.
Id- doża rakkomandata hija ta ’ 2. 5 mikrogrammi jew 5. 0 mikrogrammi ta ’ iloprost miġbud man- nifs (hekk kif imwassal sal- biċċa tal- ħalq tan- nebulizzatur), jinbeda bid- doża baxxa ta ’ 2. 5 mikrogrammi għal l- ewwel ġibda man- nifs, segwiti b’ 5. 0 mikrogrammi għat- tieni ġibda man- nifs.
In case of poor tolerability of the 5.0 microgram dose, the dose should be reduced to 2.5 micrograms.
F’ każ ta ’ tollerabilità ħażina għad- doża ta ’ 5. 0 mikrogrammi, id- doża għandha titnaqqas għal 2. 5 mikrogrammi.
Two compressed air nebuliser systems, HaloLite and Prodose, have been shown to be suitable nebulisers for the administration of Ventavis.
Żewġ sistemi ta ’ nebulizzazzjoni b’ arja kkompressata, HaloLite u Prodose, intwera li huma nebulizzaturi adattati għall- għotja ta ’ Ventavis.
With both systems the mass median aerodynamic diameter of the aerosol droplet (MMAD) with iloprost was between 2.6 and 2.7 micrometres.
Biż- żewġ sistemi, id- dijametru tal- piż medjan aerodinamiku tal- qtajra ta ’ l- aerosol (MMAD) ma ’ ijloprost kien bejn 2. 6 u 2. 7 mikrometri.
For each inhalation session the content of one ampoule containing 2 ml of Ventavis nebuliser solution will be transferred into the nebuliser medication chamber immediately before use.
Għal kull sessjoni ta ’ ġbid tan- nifs għal ġol- pulmuni, il- kontenut ta ’ ampulla waħda ta ’ 2 ml ta ’ Ventavis jkun trasferit fil- kompartiment tal- medikazzjoni tan- nebulizzatur eżatt qabel l- użu.
HaloLite and Prodose are dosimetric systems.
HaloLite u Prodose huma sistemi dożimetriċi.
They stop automatically after the pre-set dose has been delivered.
Huma jieqfu awtomatikament wara li d- doża ssettjata minn qabel tkun mogħtija.
The inhalation time depends on the patient ’ s breathing pattern.
Il- ħin ta ’ ġbid tan- nifs għal ġol- pulmuni jiddependi mill- mod ta ’ kif il- pazjent jieħu n- nifs.
Device
Apparat
Dose of iloprost at
Doża
Estimated inhalation time
ta ’
mouthpiece
iloprost fil- biċċa tal- ħalq
(frequency of 15 breaths per minute)
Stima tal- ħin ta ’ ġbid tan- nifs għal ġol- pulmuni (frekwenza ta ’ 15- il nifs kull minuta)
2.5 micrograms
2. 5
4 to 5 min
4 sa 5 minuti
8 to 10 min
8 sa 10 minuti
For a dose of 5 micrograms iloprost at mouthpiece it is recommended to complete two inhalation cycles with 2.5 micrograms pre-set dose program with a filling of one ampoule containing 2 ml Ventavis nebuliser solution, which shows two coloured rings (white – pink).
Għal doża ta ’ 5 mikrogrammi ta ’ iloprost fil- biċċa tal- ħalq huwa rrakkomandat li tagħmel żewġ ċikli sħaħ ta ’ ġbid tan- nifs għal ġol- pulmuni b’ programm ta ’ doża ssettjata minn qabel ta ’ 2. 5 mikrogrammi bil- mili ta ’ ampulla waħda ta ’ 2 ml.
Venta-Neb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis.
Flimkien ma ’ dan, Venta- Nab, nebulizzatur ultrasoniku li jista ’ jinġarr u li jaħdem bil- batteriji, intwera li hu adattat għall- għoti ta ’ Ventavis.
The measured MMAD of the aerosol droplets was 2.6 micrometres.
L- MMAD imkejjel tal- qtar ta ’ l- aerosol kien ta ’ 2. 6 mikrometri.
For each inhalation session, the content of one ampoule containing 2 ml Ventavis nebuliser solution and showing two coloured rings (white – pink) will be transferred into the nebuliser medication chamber immediately before use.
Għal kull sessjoni tal- ġbid man- nifs għal ġol- pulmuni, il- kontenut ta ’ ampulla waħda ta ’ 2 ml ta ’ Ventavis soluzzjoni għan- nebulizzatur u li turi żewġ ċrieki kkuluriti (abad – roża) ser ikun trasferit fil- kompartiment tal- medikazzjoni tan - nebulizzatur dritt qabel l- użu.
Two programs can be operated:
Żewġ programmi jistgħu jitħaddmu:
P1 Program 1:
Programm PI 1:
5.0 micrograms active substance on the mouth piece 25 inhalation cycles.
5. 0 mikrogrammi ta ’ sustanza attiva fuq il- biċċa tal- ħalq 25 ċiklu ta ’ ġbid tan- nifs.
P2 Program 2:
Programm P2 2:
2.5 micrograms active substance on the mouth piece 10 inhalation cycles.
2. 5 mikrogrammi ta ’ sustanza attiva fuq il- biċċa tal- ħalq 10 ċikli ta ’ ġbid tan- nifs.
The selection of the pre set program is made by the physician.
L- għażla tal- programm issettjat minn qabel issir mit- tabib.
Venta-Neb prompts the patient to inhale by an optical and an acoustic signal.
Venta- Neb jiggwida lil pazjent biex jieħu n- nifs permezz ta ’ sinjal ottiku u akustiku.
It stops after the pre-set dose has been administered.
Hu jieqaf awtomatikament wara li d- doża ssettjata minn qabel tkun ingħatat.
To obtain the optimal droplet size for the administration of Ventavis the green baffle plate should be used.
Biex tikseb l- aħjar daqs tal- qtar għall- għoti ta ’ Ventavis, il- baffle plate aħdar għandu jintuża.
For details refer to the instruction manual of the Venta-Neb nebuliser.
Għal aktar dettalji, jekk jogħġbok irreferi għal manwal ta ’ l- istruzzjonijiet tan- nebulizzatur Venta- Neb.
Dose of iloprost at mouthpiece
iloprost fil- biċċa tal- ħalq
Estimated Inhalation time
Ħin stmat tal- Ġbid tan- Nifs
The I-Neb AAD System is a portable, hand-held, vibrating mesh technology nebuliser system.
Is- Sistema I- Neb AAD hi sistema tan- nebulizzatur portabbli, li tinżamm fl- idejn, tat- tip vibrating mesh technology (teknoloġija ta ’ xibka li tivvibra).
This system generates droplets by ultrasound, which is forcing the solution through a mesh.
Din is- sistema tiġġenera taqtir żgħir permezz ta ’ mwieġ ultrasoniċi, u mbagħad is- soluzzjoni tiġi sfurzata minn ġox- xibka.
The I-Neb AAD nebuliser has also been shown to be suitable for the administration of Ventavis.
Intwera wkoll li n- nebulizzatur I - Neb AAD hu adattat għall- għoti ta ’ Ventavis.
The measured MMAD of the aerosol droplets was 2.1 micrometres.
L- MMAD imkejjel tal- qtar ta ’ l- aerosol kien ta ’ 2. 1 mikrometri.
This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 2.5 or 5 micrograms iloprost.
Dan in- nebulizzatur jimmonitorja l- mod ta ’ kif il- pazjent jieħu n- nifs biex jistabbilixxi l- ħin tal- polz ta ’ l- aerosol meħtieġ biex iforni d- doża ssettjata minn qabel ta ’ 2. 5 jew 5 mikrogrammi ta ’ iloprost.
The pre-set dose provided by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc.
Id- doża ssettjata minn qabel ipprovduta mis- sistema I- Neb AAD hi kkontrollata mill- kompartiment tal- mediċina flimkien ma ’ disk tal- kontroll.
There are two different colour coded medication chambers.
Hemm żewġ kompartimenti tal- mediċina li għandhom kodiċi tal- kulur.
For each medication chamber there is a corresponding colour coded control disc:
Għal kull kompartiment tal- mediċina hemm disk tal- kontroll b’ kodiċi ta ’ kulur korrispondenti.
For the 2.5 micrograms dose the medication chamber (350 microliter) with the red latch is used together with the red control disc.
Għad- doża ta ’ 2. 5 mikrogrammi, il- kompartiment tal- mediċina (350 mikrolitri) bil- lukkett l- aħmar jintuża flimkien mad- disk tal- kontroll l- aħmar.
For the 5 micrograms dose the medication chamber (650 microliter) with the purple coloured latch is used together with the purple control disc.
Għad- doża ta ’ 5 mikrogrammi, il- kompartiment tal- mediċina (650 mikrolitri) bil- lukkett ta ’ kulur vjola jintuża flimkien mad- disk tal- kontroll il- vjola.
For each inhalation session with the I-Neb AAD, the content of one 1-ml ampoule of Ventavis, showing three coloured rings (pink – red- red), will be transferred into the appropriate nebuliser medication chamber immediately before use.
Għal kull sessjoni ta ’ ġbid man- nifs bl- I- Neb AAD, il- kontenut ta ’ ampulla waħda ta ’ 1 ml ta ’ Ventavis, li fiha tliet ċrieki tal- kulur (roża - aħmar - aħmar), ser ikun ittrasferit ġol- kompartiment li suppost tal- mediċina tan- nebulizzatur immedjatament qabel l- użu.
Dose of iloprost at mouthpiece
Doża
Estimated
ta ’
Inhalation time
Stima tal- ħin ta ’ Ġbid għal ġol - Pulmuni
3.2 min
3. 2 min
6.5 min
6. 5 min
Since the I-Neb nebuliser has been shown to produce an aerosol with slightly different physical characteristics to those of HaloLite, Prodose and VentaNeb devices and a faster delivery of the solution (see section 5.2), patients stabilized on one nebuliser should not switch to another nebuliser without supervision by the treating physician.
Minħabba li ntwera li n- nebulizzatur I- Neb jipproduċi aerosol li għandu karatteristiċi fiżiċi li huma ftit differenti minn dawk ta ’ l- apparat HaloLite, Prodose u VentaNeb u twassil aktar malajr tas- soluzzjoni (ara sezzjoni 5. 2), il- pazjenti li jkunu stabilizzati fuq nebulizzatur wieħed, m’ għandhomx jinqalbu għal fuq nebulizzatur ieħor mingħajr is- superviżjoni tat- tabib li jkun qed jagħti l- kura.
The efficacy and tolerability of inhaled iloprost when administered with other nebulising systems, which provide different nebulisation characteristics of iloprost solution, have not been established.
L- effikaċja u t- tollerabilità ta ’ iloprost miġbud man- nifs, meta mogħti b’ sistemi oħra ta ’ nebulizzazzjoni, li jipprovdu karatteristiċi differenti ta ’ nebulizzazzjoni tas- soluzzjoni ta ’ iloprost, ma ġewx stabbiliti.
• Daily dose:
• Doża ta ’ kuljum:
The dose per inhalation session should be administered 6 to 9 times per day according to the individual need and tolerability.
Id- doża għal kull sessjoni ta ’ ġbid tan- nifs għal ġol- pulmuni għandha tkun mogħtija minn 6 sa 9 darbiet kuljum skond il- bżonn u t- tollerabilità ta ’ l- individwu.
• Duration of treatment:
• Tul ta ’ kura:
The duration of treatment depends on clinical status and is left to the physician’ s discretion.
It- tul tal- kura jiddependi mill- istat kliniku tal- pazjent u jitħalla għad- diskrezzjoni tat- tabib.
Should patients deteriorate on this treatment intravenous prostacyclin treatment should be considered.
Jekk il - pazjenti jmorru għall- agħar meta jkunu qed jieħdu din il- kura, kura b’ prostacycline ġol- vina għandha tkun ikkunsidrata.
Iloprost elimination is reduced in patients with hepatic dysfunction (see section 5.2).
It- tneħħija ta ’ iloprost hija mnaqqsa f’ pazjenti b’ indeboliment tal- fwied (ara sezzjoni 5. 2).
To avoid undesired accumulation over the day, special caution has to be exercised with these patients during initial dose titration.
Biex tevita akkumulazzjoni mhux mixtieqa matul il- jum, attenzjoni speċjali trid tingħata lil dawn il - pazjenti waqt it- titrazzjoni tad- doża fil- bidu.
6 times per day).
Fil- bidu, dożi ta ’ 2. 5 mikrogrammi għandhom jingħataw b’ intervalli ta ’ bejn id- dożi ta ’ mill- inqas 3 siegħat (li jikkorrispondu għall- għotja massima ta ’ 6 darbiet kuljum).
Thereafter, dosing intervals may be shortened cautiously based on individual tolerability.
Wara dan, l- intervalli ta ’ bejn id- dożi jistgħu jitqassru b’ attenzjoni bbażati fuq it- tollerabilità ta ’ l- individwu.
If a further increase in the dose up to 5.0 micrograms is indicated, again dosing intervals of at least 3 hours should be chosen initially and shortened according to individual tolerability.
Jekk żjieda oħra fid- doża sa 5. 0 mikrogrammi hija indikata, mill- ġdid, intervalli ta ’ bejn id- dożi ta ’ mill- inqas 3 siegħat għandhom jintagħżlu fil- bidu u jitqassru skond it - tollerabilità ta ’ l- individwidu.
A further undesired accumulation of the medicinal product following treatment over several days is not likely due to the overnight break in administration of the medicinal product.
Aktar akkumulazzjoni mhux mixtieqa tal- prodott mediċinali wara kura fuq tul ta ’ diversi ġranet mhijiex mistennija, minħabba l- waqfien fl- għotja tal- prodott mediċinali matul il- lejl.
Patients with renal impairment
Pazjenti b’ indeboliment renali
There is no need for dose adaptation in patients with a creatinine clearance > 30 ml/ min (as determined from serum creatinine using the Cockroft and Gault formula).
Mhemmx bżonn għal adattament tad- doża f’ pazjenti bi tneħħija ta ’ kreatinina ta ’ > 30 ml/ min (kif iddeterminat mil- kreatinina fis- serum bl- użu tal- formula ta ’ Cockroft u Gault).
Patients with a creatinine clearance of ≤ 30 ml/ min were not investigated in the clinical trials.
Pazjenti bi tneħħija ta ’ kreatinina ta ’ ≤ 30 ml/ min ma kinux investigati fi provi kliniċi.
There is no experience with Ventavis in children or adolescents.
Ma hemm l- ebda esperjenza b’ Ventavis fit- tfal u adolexxenti.
− Hypersensitivity to the active substance or to any of the excipients. − Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e. g. active peptic ulcers, trauma, intracranial haemorrhage). − Severe coronary heart disease or unstable angina; − Myocardial infarction within the last six months; − Decompensated cardiac failure if not under close medical supervision;
Kondizzjonijiet fejn l- effetti ta ’ Ventavis fuq il- plejtlets jistgħu jżidu r- riskju ta ’ emorraġija (eż. ulċeri attivi fl- istonku, trawma, emorraġija intrakranjali).
4 − Severe arrhythmias; cerebrovascular events (e. g. transient ischaemic attack, stroke) within the last 3 months. − Pulmonary hypertension due to venous occlusive disease. − Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. − Pregnancy and lactation (see section 4.6).
- Difetti mit- twelid jew miksuba tal- valvoli b’ mard klinikament rilevanti tal- funzjoni mijokardjali li
4.4 Special warnings and precautions for use
mhux relatati ma ’ pressjoni pulmonari għolja.
The use of Ventavis is not recommended in patients with unstable pulmonary hypertension, with advanced right heart failure.
L- użu ta ’ Ventavis mhuwiex rakkomandat f’ pazjenti bi pressjoni pulmonari għolja mhux stabbli, b’ kollass avvanzat tal- funzjoni tan- naħa tal- lemin tal- qalb.
In case of deterioration or worsening of right heart failure transfer to other medicinal products should be considered.
F’ każ ta ’ deterjorament tal- funzjoni f ’ kollass tan- naħa tal- lemin tal- qalb, jew jekk dan imur għall- agħar, bidla għall- prodotti mediċinali oħra għandha tkun ikkunsidrata.
The pulmonary vasodilatory effect of inhaled iloprost is of short duration (one to two hours).
L- effett ta ’ vasodilatazzjoni pulmonari ta ’ iloprost miġbud man- nifs idum żmien qasir (minn siegħa sa sagħtejn).
Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion.
Pazjenti li jkollhom esperjenza ta ’ sinkope flimkien ma ’ pressjoni pulmonari għolja għandhom jevitaw kwalunkwe strapazz eċċezzjonali, per eżempju waqt strapazz fiżiku.
Before physical exertion it might be useful to inhale.
Qabel strapazz fiżiku jista ’ jkun ta ’ ġid li tieħu n- nifs.
The occurrence of a nocturnal or exertional syncope reflects therapeutic gaps and/ or insufficient efficiency, and the need to adapt and/ or change the therapy should be considered (see section 4.8).
L- okkorrenza ta ’ sinkope matul il- lejl jew minħabba l- istrapazz tirrifletti nuqqasijiet terapewtiċi u/ jew effiċjenza insuffiċjenti, u l- bżonn biex il- kura tkun adatta u/ jew mibdula għandha tkun ikkunsidrata (ara sezzjoni 4. 8).
Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8 Undesirable effects).
Teħid man- nifs ta’ Ventavis jista ’ jwassal għal riskju ta ’ induzzjoni ta ’ bronkospażmu, speċjalment f’ pazjenti b’ attività eċċessiva tal- bronki (ara sezzjoni 4. 8 Effetti mhux mixtieqa).
Moreover, the benefit of Ventavis has not been established in patients with concomitant Chronic Obstructive Pulmonary Disease (COPD) and severe asthma.
Barra minn hekk, il- benefiċċju ta ’ Ventavis ma ġiex stabbilit f’ pazjenti li jbatu wkoll minn Marda Pulmonari Ostruttiva Kronika (COPD) u ażżma qawwija.
Patients with concomitant acute pulmonary infections, COPD and severe asthma should be carefully monitored.
Pazjenti li jbatu wkoll minn infezzjonijiet akuti pulmonari, COPD u ażżma severa għandhom ikunu mmonitorjati b’ attenzjoni.
In patients with low systemic blood pressure, care should be taken to avoid further hypotension.
F’ pazjenti bi pressjoni tad- demm fil- ġisem baxxa, attenzjoni għandha tingħata biex tkun evitata li l- pressjoni titbaxxa aktar.
Ventavis should not be initiated in patients with systolic arterial hypotension less than 85 mmHg.
Ventavis m’ għandux jinbeda f’ pazjenti bi pressjoni sistolika fl - arterji baxxa ta ’ inqas minn 85 mmHg.
Should signs of pulmonary oedema occur when inhaled iloprost is administered in patients with pulmonary hypertension, the possibility of associated pulmonary veno-occlusive disease should be considered.
Jekk sinjali ta ’ akkumulazzjoni ta’ ilma fil- pulmun jseħħu meta jingħata iloprost miġbud man- nifs lill- pazjenti bi pressjoni pulmonari għolja, il- possibbilità ta ’ mard okklużiv tal- vini pulmonari assoċjat għandu jkun ikkunsidrat.
The treatment should be stopped.
Il- kura għandha titwaqqaf.
In case of interruption of Ventavis therapy, the risk of rebound effect is not formally excluded.
F’ każ ta ’ twaqqif tal- kura b’ Ventavis, ir- riskju li l- pressjoni terġa ’ togħla mhux formalment eskluż.
Careful monitoring of the patient should be performed, when inhaled iloprost therapy is stopped and an alternative treatment should be considered in critically ill patients.
Ġħandu jkun hemm osservazzjoni tal- pazjent b’ attenzjoni, meta l- kura ta ’ iloprost miġbud man- nifs titwaqqaf u kura alternattiva għandha tiġi ikkunsidrata f’ pazjenti morda serjament.
Iloprost elimination is reduced in patients with hepatic dysfunction and in patients with renal failure requiring dialysis (see section 5.2).
It- tneħħija ta ’ iloprost hija mnaqqsa f’ pazjenti bi problemi fil- funzjoni tal- fwied u f’ pazjenti b’ kollass tal- funzjoni tal- kliewi li jeħtieġu d- dijalisi (ara sezzjoni 5. 2).
A cautious initial dose titration using dosing intervals of at least 3 hours is recommended (see section 4.2).
Huwa rakkomandat li d - doża tal- bidu tiġi ddożata b’ attenzjoni bl- użu ta ’ intervalli ta ’ bejn id- doża ta ’ mill- inqas 3 siegħat (ara sezzjoni 4. 2).
Prolonged oral treatment with iloprost clathrate in dogs up to one year was associated with slightly increased fasted serum glucose levels.
Kura orali fit- tul b’ iloprost clathrate fil- klieb sa sena, kien assoċjat ma ’ żjieda ħafifa fil- livelli ta ’ zokkor fis- serum waqt stat sajjem.
It cannot be excluded that this is also relevant to man on prolonged Ventavis therapy.
Ma jistax ikun eskluż li dan huwa wkoll rilevanti għal bniedem b’ kura fit- tul b’ Ventavis.
To minimise accidental exposure, it is recommended to use Ventavis with nebulisers with inhalation- triggered systems (HaloLite/ Prodose), and to keep the room well ventilated.
Biex l- espożizzjoni aċċidentali tkun l- inqas possibbli huwa rrakkomandat li Ventavis jintuża f’ nebulizzaturi b’ sistema li terħi biss il- mediċina mal- ġbid tan- nifs il- ġewwa għal ġol- pulmun (HaloLite/ Prodose), u biex il- kamra tinżamm ventilata tajjeb.
Ventavis nebuliser solution should not come into contact with skin and eyes; oral ingestion of Ventavis solution should be avoided.
Is- soluzzjoni għan- nebulizzatur Ventavis m’ għandhiex tiġi f’ kuntatt mal- ġilda u ma ’ l- għajnejn; għandu jkun evitat li s- soluzzjoni Ventavis tittieħed mill- ħalq.
During nebulisation sessions a facial mask must be avoided and only a mouthpiece should be used.
Waqt is- sessjonijiet ta ’ nebulizzazzjoni, maskra tal- wiċċ għandha tkun evitata u l- biċċa tal- ħalq biss għandha tintuża.
Iloprost may increase the effect of vasodilatators and antihypertensive agents.
Iloprost jista ’ jżid l- effett ta ’ mediċini li jwessgħu l- vini u l- arterji u ta ’ aġenti li jintużaw għall- kura ta ’ pressjoni għolja.