qanastek/EMEA-V3 huggingface dataset:
might trigger breathing difficulties. − If your blood pressure is too low (less than 85 mmHg) you should not start the therapy with Ventavis.
Teħid man- nifs ta ’ Ventavis jista ’ jikkawża diffikultajiet biex tieħu n- nifs. − Jekk il- pressjoni tad- demm tiegħek hija baxxa żżejjed (inqas minn 85 mmHg) m’ għandekx tibda l- kura b’ Ventavis.
You will need special medical observation in some cases:
F’ xi każijiet se jkollok bżonn osservazzjoni medika speċjali:
- In general, you will need to take special care to try and avoid fainting or other effects of low
- B’ mod ġenerali, int se jkollok bżonn li toqgħod attent ħafna sabiex tipprova tevita li
blood pressure, such as dizziness: • Stand up slowly when you get out of chairs or bed.
jħossok ħass ħażin jew li jkollok effetti oħra ta ’ pressjoni baxxa tad- demm, bħal sturdament: • Qum bil- wieqfa bil- mod meta tqum minn fuq xi siġġu jew mis- sodda.
You will help your body get used to the change in position and blood pressure • If you tend to faint as soon as you get out of bed, it may be helpful to take your first dose of the day while you’ re still lying down. • Avoid any exceptional straining, for example physical exertion; it might be useful to inhale Ventavis before. such physical exertion • Have someone on standby to watch you, if possible.
B’ hekk tgħin lil ġismek jidra l- bidla fil- pożizzjoni u l- pressjoni tad- demm • Jekk inti għandek tendenza li jħossok ħażin hekk kif tqum mis- sodda, jista ’ jkun ta ’ għajnuna li tieħu l- ewwel doża tal- jum meta tkun għadek mimdud. • Evita strapazz eċċezzjonali, per eżempju strapazz fiżiku; il- fatt li tiġbed Ventavis man - nifs qabel xi strapazz fiżiku jista ’ jgħinek • Ħu ħsieb li jkollok lil xi ħadd ħdejk għal li jista ’ jkun, jekk hu possibbli.
Warn them to call a doctor if you faint.
Avżah/ a biex iċempel lit- tabib jekk int iħossok ħażin.
The doctor may consider a change of treatment.
Il- tabib ser jagħtik parir dwar x’ għandek tagħmel u possibbilment jippreskrivilek kura. • Jekk l- episodji ta ’ ħass ħażin jmorru għall- agħar minħabba l- marda prinċipali, għid lit - tabib tiegħek.
- If you have liver problems, you may be prescribed a lower dose of Ventavis than for other
Il- tabib jista ’ jikkunsidra tibdil fil- kura − Jekk għandek problemi fil- fwied, int tista ’ tingħata doża aktar baxxa ta ’ Ventavis minn dik mogħtija lil pazjenti oħra − Jekk għandek problemi serji ħafna fil- kliewi, ara lit- tabib tiegħek. − Jekk il- kondizzjoni ġenerali tiegħek tmur għall- agħar, ara lit- tabib tiegħek
If you are under 18 years, please make your doctor aware of your age.
Jekk inti taħt l- età ta ’ 18- il sena, jekk jogħġbok għid lit- tabib tiegħek dwar l- età tiegħek.
Ventavis has not yet been tested in children and adolescents.
Ventavis għadu ma ġiex ittestjat fit- tfal u l- adolexxenti.
30 Taking other medicines
Meta tuża mediċini oħra
Ventavis and certain other medicines may influence each other in the way they work in your body.
Ventavis u ċertu mediċini oħra jistgħu jinfluwenzaw lil xulxin fil- mod ta ’ kif jaħdmu fil- ġisem tiegħek.
Be specially careful to mention any of these: • Medicines used to treat high blood pressure or heart disease • Medicines which inhibit blood clotting (this includes acetylsalicylic acid a substance present in many medicines that lower fever and relieve pain, as well as others) Your doctor or pharmacist has more information on medicines to be careful with or avoid when using Ventavis, so always tell them if you are taking other medicines.
Oqgħod attent b’ mod partikulari li ssemmi dawn li ġejjin: • Mediċini li jintużaw biex jikkuraw pressjoni għolja tad- demm jew mard tal- qalb • Mediċini li jinibixxu it- tagħqid tad- demm (dawn jinkludu acetylsalicylic acid, sustanza li tinsab f’ ħafna mediċini li jniżżlu d- deni u jtaffu uġigħ, kif ukoll oħrajn) It- tabib jew l- ispiżjar tiegħek għandhom iktar informazzjoni dwar mediċini li għandek toqgħod attent għalihom jew li trid tevita meta tkun qed tuża Ventavis, għalhekk dejjem għidilhom jekk qed tieħu mediċini oħra.
Pregnancy:
31 Tqala:
• If you are pregnant, or think you might be, tell your doctor straight away.
Jekk inti tqila, jew taħseb li tista tkun, għid lit- tabib tiegħek malajr kemm jista ’ jkun.
Ventavis must not be used by pregnant women (see section 2.
Ventavis m’ għandux jintuża minn nisa tqal (ara sezzjoni 2 Tużax Ventavis).
Do not use Ventavis). • If you could get pregnant, use reliable contraception from the time you start treatment and during treatment (ask your doctor).
Jekk inti tista ’ toħroġ tqila, uża kontraċezzjoni xierqa minn meta tibda il- kura u waqt il- kura (staqsi lit- tabib tiegħek).
Stop breast-feeding when you start Ventavis treatment.
Waqqaf it- treddigħ meta tibda l- kura b’ Ventavis.
Ventavis must not be given to women who are breast-feeding, since it is not known whether the active substance is passed on through breast milk.
Ventavis m’ għandux jingħata lil nisa li qed ireddgħu billi mhuwiex magħruf jekk is- sustanza attiva tgħaddix fil- ħalib tas- sider.
Newborns, infants, and pregnant women should not be subjected to Ventavis in the room air.
Trabi tat- twelid, tfal żgħar, u nisa tqal m’ għandhomx ikunu esposti għal Ventavis fl- arja fil - kamra.
These persons should not remain in a closed room where Ventavis is being administered to a patient.
Dawn il- persuni m’ għandhomx joqgħodu f’ kamra magħluqa fejn Ventavis ikun qed jingħata lil xi pazjent.
Ventavis brings down blood pressure and may cause dizziness or light-headedness in some people.
Ventavis iniżżel il- pressjoni tad- demm u jista ’ jikkawża sturdament jew mejt f’ xi nies.
Do not drive or operate any tools or machines if you feel these effects of low blood pressure.
Issuqx jew tħaddiem l- ebda tagħmir jew magni jekk tħoss dawn l- effetti ta ’ pressjoni baxxa tad- demm.
Important information about some of the ingredients of Ventavis:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ventavis:
This medicinal product contains small amounts (less than 100 mg per dose) of ethanol (alcohol).
Dan il- prodott mediċinali fih ammonti żgħar (inqas minn 100 mg kull doża) ta ’ ethanol (alkoħol).
HOW TO USE VENTAVIS
KIF GĦANDEK TUŻA VENTAVIS
How to use Ventavis:
Kif għandek tuża Ventavis:
Always take Ventavis exactly as your doctor has told you.
Dejjem għandek tieħu Ventavis skond il- parir tat- tabib.
Ventavis nebuliser solution is inhaled using the nebulisers your doctor prescribed (either the HaloLite, the Prodose, the Venta-Neb or the I-Neb AAD system).
Is- soluzzjoni ta ’ Ventavis għan - nebulizzatur tinġibed man- nifs bl- użu tan- nebulizzaturi li t- tabib tiegħek ippreskrivilek (jew is - sistema ta ’ HaloLite, Prodose jew dik ta ’ Venta- Neb).
The nebuliser turns Ventavis solution into a mist which you breathe in through your mouth.
In- nebulizzatur jibdel is- soluzzjoni ta ’ Ventavis fi ċpar li inti tiġbed man- nifs minn ġo ħalqek.
Follow carefully any extra instructions that come with the nebuliser.
Segwi bl- attenzjoni kwalunkwe struzzjonijiet addizzjonali li jiġu man- nebulizzatur.
Check with your doctor or pharmacist if you are unsure.
Iċċekkja mat- tabib jew l- ispiżjar tiegħek jekk ma tkunx ċert/ a.
Ventavis solution that you do not use in one inhalation session has to be thrown away.
Is- soluzzjoni ta ’ Ventavis li ma tużax f’ sessjoni waħda ta ’ ġbid man- nifs għandha tintrema.
31 How much to inhale:
Kemm tieħu man- nifs:
The dose of Ventavis that is right for you depends on your individual condition and will be worked out by your doctor.
Id- doża ta ’ Ventavis li hija xierqa għalik tiddependi mill- kundizzjoni individwali tiegħek u ser tinħadem mit- tabib tiegħek.
Most people will have 6 to 9 inhalation sessions spread throughout the day.
Il- maġġoranza ta ’ persuni ser ikollhom 6 sa 9 sessjonijiet ta ’ teħid man- nifs mifruxa tul il - ġurnata.
One inhalation session will usually last about 4 to 10 minutes depending on the prescribed dose.
Sessjoni ta ’ teħid man- nifs ser iddum normalment madwar 4 sa 10 minuti skond id- doża preskritta.
In case of liver problems, your doctor will introduce you to Ventavis gradually and possibly prescribe fewer daily inhalations.
F’ każ ta ’ problemi fil- fwied jew jekk għandek problemi fil- kliewi severi ħafna, it- tabib tiegħek ser jibdilek Ventavis gradwalement u possibilment jippreskrivi inqas sessjonijiet ta ’ teħid man- nifs kuljum.
If you have the impression that the effect of Ventavis is too strong or too weak, talk to your doctor or pharmacist.
Jekk għandek l- impressjoni li l- effett ta ’ Ventavis huwa qawwi jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
For HaloLite and ProDose systems:
32 Għas- sistemi HaloLite u ProDose:
Just before you start to inhale, break open the glass container containing 2 ml solution, which shows two coloured rings (white-pink), and transfer the complete contents into the nebuliser medication chamber.
Eżatt qabel tibda tiġbed man- nifs, iftaħ il- kontenitur tal- ħġieġ u ttrasferixxi il- kontenut kollu fil - kompartiment tal- medikazzjoni tan- nebulizzatur.
You should run the inhalation cycle twice if you require a high dose (5 micrograms) and once if you require a low dose (2.5 micrograms).
Għandek tagħmel iċ- ċiklu ta ’ ġbid tan- nifs għal ġol- pulmuni darbtejn jekk inti teħtieġ doża għolja (5 mikrogrammi) u darba jekk inti teħtieġ doża baxxa (2. 5 mikrogrammi).
Independent of the dose the filling volume is always the contents of one glass container.
Indipendenti mid- doża, il - volum tal- mili huwa dejjem il- kontenut ta ’ kontenitur wieħed tal- ħġieġ.
The inhalation time depends on your breathing pattern.
Il- ħin tal- ġbid tan- nifs jiddependi fuq kif inti tieħu n- nifs.
Dose of iloprost at mouthpiece
Doża ta ’ iloprost fil- biċċa tal- ħalq
Estimated Inhalation time
tal- Ġbid tan - Nifs
(frequency of 15 breaths per minute)
(frekwenza ta ’ 15- il nifs kull minuta)
4 to 5 min
4 sa 5 min
8 to 10 min
8 sa 10 min
For the Venta-Neb system:
Għas- sistema Venta- Neb:
Just before you start to inhale, break open the glass container and transfer the complete contents into the nebuliser medication chamber.
Eżatt qabel tibda tiġbed man- nifs, iftaħ il- kontenitur tal- ħġieġ u ttrasferixxi l- kontenut kollu fil - kompartiment tal- medikazzjoni tan- nebulizzatur.
Your doctor will adjust Venta-Neb to the program you need to receive the dose prescribed for you.
It- tabib tiegħek ser jaġġusta Venta- Neb għal programm li tkun teħtieġ biex tirċievi d- doża li tkun ġiet preskritta lilek.
You should use the green baffle plate to obtain the optimal droplet size for the administration of Ventavis.
Għandek tuża l- baffle plate aħdar biex tikseb l- aħjar daqs ta ’ qtar għall- għoti ta ’ Ventavis.
Dose of iloprost at mouthpiece
Doże ta ’ iloprost fil- biċċa tal- ħalq
Estimated Inhalation time
Ħin Stmat tal- Ġbid tan - Nifs
2.5 micrograms 5 micrograms
2. 5 mikrogrammi 5 mikrogrammi
For the I-Neb AAD system:
Għas- sistema I- Neb AAD:
Just before you start to inhale, break open the glass container containing 1 ml solution, which shows three coloured rings (pink-red-red), and transfer the complete contents into the nebuliser medication chamber.
Eżatt qabel tibda tiġbed man- nifs, iftaħ il- kontenitur tal- ħġieġ li fih 1ml ta ’ soluzzjoni, li juri tlett ċrieki kkuluriti (roża- aħmar – aħmar) u ttrasferixxi l- kontenut kollu fil- kompartiment tal- medikazzjoni tan- nebulizzatur.
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 Għad- doża ta ’ 5 mikrogrammi, il- kompartiment tal- mediċina (650 mikrolitri) bil- lukkett ta ’ kulur vjola jintuża flimkien mad- disk tal- kontroll il- vjola 33 Għandek taċċerta ruħek li tuża il- kompartiment tal- mediċina bil- lukkett l- aħmar għad- doża ta ’ 2. 5 mikrogrammi u l- kompartiment tal- mediċina bil- lukkett vjola għad- doża ta ’ 5 mikrogrammi
You should make also sure that the colour of the medication chamber latch fits with the colour of the control disc used in order to receive the prescribed dose.
Għandek taċċerta ruħek ukoll li l- kulur tal- lukkett tal- kompartiment tal- mediċina jaqbel mal- kulur tad - disk ta ’ kontroll li ntużat biex tieħu d- doża preskritta.
Dose of iloprost at mouthpiece 2.5 micrograms
Doża ta ’ iloprost mill- biċċa tal - ħalq 2. 5 mikrogrammi
Estimated
Stima
Inhalation time 3.2 min
tal- ħin ta ’ Ġbid man- nifs 3. 2 min
For further details please refer to the instruction manual of the nebuliser device or ask your doctor.
6. 5 min
You should not switch to another nebuliser without consulting your treating doctor.
Staqsi lit- tabib tiegħek biex ikollok xi ħadd li jista ’ jgħinek issir familjari sew ma ’ l- użu tan - nebulizzatur.
Do not let Ventavis solution come into contact with your skin or eyes.
Tħallix is- soluzzjoni ta ’ Ventavis tiġi f’ kuntatt mal- ġilda tiegħek jew m’ għajnejk.
If it does, rinse the skin or your eyes immediately with water.
Jekk dan iseħħ, laħlaħ il- ġilda tiegħek jew għajnejk minnufih bl- ilma.
Do not drink Ventavis solution.
Tixrobx is- soluzzjoni ta ’ Ventavis.
If drinking accidentally occurs, drink plenty of water and talk to a doctor.
Jekk xorb aċċidentali jseħħ, ixrob ħafna ilma u kellem tabib.
Drinking Ventavis could also lead to a temporary overdose – see “ If you take more Ventavis than you should”.
Ix- xorb ta ’ Ventavis jista ’ jwassal ukoll għal doża eċċessiva temporanja – ara “ Jekk tieħu aktar Ventavis milli suppost ”.
If you use more Ventavis than you should:
Jekk tuża Ventavis aktar milli suppost:
Using more Ventavis than you should may lead to a decrease in blood pressure with symptoms like dizziness or fainting.
Jekk tuża iktar Ventavis milli suppost jista ’ jwassal għal tnaqqis fil- pressjoni tad- demm b' sintomi bħal sturdament jew ħass ħażin.
You may also experience headache, reddening of the face (flushing), feeling sick (nausea), vomiting or diarrhoea.
Jista ’ jkollok ukoll uġigħ ta ’ ras, ħmura fil- wiċċ (fwawar), tħossok imdardar (nawsja), rimettar jew dijarea.
If this happens: • Stop the inhalation session • Talk to your doctor
Jekk dan jiġri: • Waqqaf is- sessjoni ta ’ ġbid tan- nifs għal ġol- pulmuni • Kellem lit- tabib tiegħek
See also section 2, Take special care with Ventavis, for advice on what you have to do if you have low blood pressure or fainting episodes.
Ara wkoll sezzjoni 2, Oqgħod attent ħafna b’ Ventavis, għal parir dwar x’ għandek tagħmel jekk ikollok episodji ta ’ pressjoni baxxa jew ħass ħażin.
If you forget to take a dose:
Jekk tinsa tieħu doża
You should not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Please ask your doctor what you should do.
Jekk jogħġbok staqsi lit - tabib tiegħek x’ għandek tagħmel.
If you stop taking Ventavis:
Jekk tieqaf tieħu Ventavis:
If you stop or wish to stop treatment, you should discuss this with your doctor first.
Jekk tieqaf, jew tixtieq li twaqqaf il- kura, għandek qabel tiddiskuti dan mat- tabib tiegħek.
Room ventilation:
Ventilazzjoni tal- kamra:
Be sure to ventilate or air the room in which you have taken your Ventavis treatment.
Kun ċert li tivventila jew iddaħħal l- arja fil- kamra fejn tkun ħadt il- kura b ’ Ventavis.
Other persons might accidentally be exposed to Ventavis through the room air.
Persuni oħrajn jistgħu aċċidentalment ikun esposti għal Ventavis mill- arja tal- kamra.
In particular, newborns, infants, and pregnant women should not be subjected to Ventavis.
B’ mod specjali, trabi tat - twelid, tfal żgħar, u nisa tqal m’ għandhomx ikunu esposti għal Ventavis.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsti lit- tabib jew lill- ispiżjar tiegħek.
33 4.
34 4.
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJU LI JISTA ’ JKOLLU
Like all medicines, Ventavis can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Ventavis jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Below we list possible side effects by how likely they are:
Hawn taħt hawn imniżżla l- effetti mhux mixtieqa possibbli skond kemm hemm probabbilta ’ li jseħħu.
Common: affects 1 to 10 users in 100.
Komuni ħafna: jaffettwaw aktar minn persuna waħda li qed tużah minn kull 10 Komuni: jaffettwaw 1 sa 10 persuni minn kull 100 li qed jużawh
• Very common side effects
• • Effetti komuni ħafna
- Widening of the blood vessels (vasodilatation).
- Twessigħ tal- vini jew l- arterji (vasodilatazzjoni).
Symptoms can be flushing or reddening of the face.
Is- sintomi jistgħu jkunu fwawar, jew ħmura tal -
- Increase in coughing
- Żjieda fis- sogħla
- Low blood pressure (hypotension).
- Pressjoni baxxa tad- demm (ipotensjoni).
Peripheral oedema is a very common symptom of the illness itself but can also occur during treatment with Ventavis.
Edima periferali hija sintomu komuni ħafna tal- marda nnifisha, iżda jista ’ jseħħ ukoll waqt kura b’ Ventavis.
• Common effects
• Effetti komuni
- Headaches.
- Uġigħ ta ’ ras
- Pain in jaw/ spasm of the jaw muscles (trismus)
- Uġigħ fix- xedaq/ spażmu tal- muskoli tax- xedaq (diffikultà biex tiftaħ il- ħalq)
- Dizziness, which is related to low blood pressure (hypotension).
- Sturdament relatat ma ’ pressjoni baxxa (ipotensjoni)
- Fainting (syncope)
Ħass ħażin (sinkope)
Fainting (syncope) is a common symptom of the illness itself but can also occur during treatment with Ventavis.
Ħass ħażin (sinkope) huwa sintomu komuni tal- marda nnifisha, iżda jista ’ jseħħ ukoll waqt kura b’ Ventavis.
See also section 2, Take special care with Ventavis, for advice on what you can do to try and avoid this.
Ara wkoll sezzjoni 2, Oqgħod attent ħafna b’ Ventavis, għall- parir dwar x’ tista ’ tagħmel biex tevita ’ li dan iseħħ.
• Other possible effects
Rimettar, tqalligħ, dijarea u qtugħ ta ’ nifs ġew irrappurtati f’ pazjenti li qed jużaw Ventavis.
In this case ask your doctor.
Diffikultajiet biex tieħu n- nifs u tħarħir ġew irrappurtati wara l- użu ta ’ Ventavis, speċjalment f’ pazjenti b’ infezzjoni fil- pulmun, ażżma severa jew marda oħra tal- pulmun.
Vomiting, nausea, diarrhoea and dyspnoea have been reported in patients using Ventavis.
• Effetti oħra possibbli
Breathing difficulties and wheezing have been reported after Ventavis use, particularly in patients with an infection of the lungs, severe asthma, or other lung disease.
Jekk inti qed tieħu wkoll mediċini biex traqqaq id- demm (mediċini kontra t- tagħqid tad- demm), x’ aktarx ikun hemm b’ mod komuni episodji ħfief ta ’ fsad ta ’ demm.
• Adverse events in healthy volunteers
• Avvenimenti avversi f’ voluntiera f’ saħħithom
Pain, discomfort in the breast (32.5%), pain when swallowing (pharyngolaryngeal pain, throat irritation (22.5%)) and nausea (7.5%) were adverse events that occurred in healthy volunteers in a special study, when they received fixed 2.5 microgram 6 times daily.
Uġigħ, skonfort fis- sider (32. 5%), uġigħ meta tibla ’ (uġigħ faringolarinġeali), irritazzjoni fil- griżmejn (22. 5%) u tħossok imdardar (nawsja 7. 5%) kienu avvenimenti avversi li seħħew f’ volontiera b’ saħħithom fi studju speċjali, meta irċevew ammont fiss ta ’ 2. 5 mikrogrammi 6 darbiet kuljum..
All these adverse events were non-serious and mild.
Dawn l- avvenimenti avversi kollha kienu kollha mhux serji u ħfief.
o If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
o Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, għid lit- tabib jew lill- ispiżjar tiegħek.
Keep out of the reach and sight of children.
KIF TAĦŻEN VENTAVIS
Do not use Ventavis after the expiry date which is stated on the pack.
Tużax Ventavis wara d- data ta ’ skadenza li tidher fuq il- pakett.
There are no special storage instructions.
M’ hemmx struzzjonijiet ta ’ ħażna speċjali.
34 Medicines should not be disposed of via wastewater or household waste.
35 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
1 ml solution contains 10 micrograms iloprost (as iloprost trometamol).
X' fih Ventavis • Is- sustanza attiva hi iloprost 1 ml tas- soluzzjoni fih 10 mikrogrammi ta ’ iloprost (bħala iloprost trometamol).
Each ampoule with 1 ml contains 10 micrograms iloprost.
Kull ampulla b' 1 ml fiha 10 mikrogrammi ta 'iloprost.
Each ampoule with 2 ml contains 20 micrograms iloprost.
Kull ampulla ta '2 ml fiha 20 mikrogramma ta' iloprost.
• The other ingredients are trometamol, ethanol 96%, sodium chloride, hydrochloric acid for pH adjustment, and water for injections.
• Is- sustanzi l- oħra huma trometamol, ethanol 96%, sodium chloride, hydrochloric acid għal aġġustament tal- pH, u ilma għall- injezzjonijiet.
Ventavis is provided in colourless ampoules (type I glass), containing either 1 ml or 2 ml nebuliser solution.
Ventavis hu ipprovdut f' ampulli bla kulur (ħġieġ ta 'tip I), li fihom jew 1 ml jew 2 ml soluzzjoni għan - nebulizzatur.
What Ventavis looks like and content of the pack:
Id- dehra ta 'Ventavis u d- daqs tal- pakkett:
Ventavis is a clear, colourless nebuliser solution for inhalation.
Ventavis hu soluzzjoni għan- nebulizzatur għall- ġbid man- nifs, ċara, bla kulur.
Ventavis is available in packs containing:
Ventavis hu disponibbli f' pakketti li fihom:
- 30, 90, 100, or 300 ampoules with 2 ml for the use with HaloLite, Prodose and Venta-Neb.
- 30, 90, 100, jew 300 ampulla b' 2 ml għall- użu ma 'HaloLite, Prodose u Venta- Neb.
The
L- ampulli li
ampoules containing 2 ml show two coloured rings (white – pink).
fihom 2 ml għandhom żewġ ċrieki bil- kulur (abjad – roża).
- or 30 or 168 ampoules with 1 ml for use with the I-Neb nebuliser.
- jew 30 jew 168 ampulla b' 1 ml għall- użu man- nebulizzatur I- Neb.
The ampoules containing 1 ml
L- ampulli li fihom 1 ml
show three coloured rings (pink – red- red).
għandhom tliet ċrieki bil- kulur (roża – aħmar - aħmar).
Bayer Schering Pharma AG, D-13342 Berlin, Germany
Bayer Schering PharmaAG, D- 13342 Berlin, Il- Ġermanja
Berlimed S. A., Poligono Industrial Santa Rosa s/ n, 28806 Alcalá de Henares, Madrid, Spain
Bayer Schering Pharma AG, D- 13342 Berlin, Il- Ġermanja jew Berlimed S. A., Poligono Industrial Santa Rosa s/ n, 28806 Alcalá de Henares, Madrid, Spanja Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Magyarország Bayer Hugária KFT Tel.: +36 1487-4100
Magyarország Bayer Hugária KFT Tel.: +36 - 1487- 4100
Alfred Gera and Sons Ltd.
Malta Česká republika Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05
Bayer s. r. o Tel: +35 621446205 Schering s. r. o.
Nederland Bayer B. V., Bayer Schering Pharma Tel: +31-(0)297-28 06 66
Tel: + 420 271 730 661 Nederland Danmark Bayer B. V., Bayer Schering Pharma Bayer A/ S Tel: +31 - (0) 297- 28 06 66 Tlf: +45- 45 235000
Norge Bayer AS Tlf: +47 24 11 18 00
36 Norge Deutschland Bayer AS Bayer Vital GmbH Tlf: +47 24 11 18 00 Tel: +49 - (0) 214- 3051348
Ελλάδα Bayer Ελλάς ΑΒΕΕ Τηλ: +30 210 618 75 00
Tel: +34- 93- 495 65 00
Portugal Bayer Portugal S. A.
Tel.: +48 22 572 35 00 Portugal Bayer Portugal S. A.
Romania SC Bayer SRL Tel.: +40 21 528 59 00
Romania France SC Bayer SRL Bayer Santé Tel.: +40 21 528 59 00 Tél.: +33 3 20 20 80 80
Italia Italfarmaco S. p. A.
Suomi/ Finland Italia Bayer Oy, Bayer Schering Pharma Italfarmaco S. p. A.
Tel: +39 02 644 31
Puh/ Tel: +358- 20- 78521 Tel: +39 02 644 31
Κύπρος NOVAGEM Limited Τηλ: + 357 22747747
Sverige Κύπρος Bayer AB NOVAGEM Limited Tel: +46 - (0) 8- 580 223 00 Τηλ: + 357 22747747
Latvija UAB Bayer Latvijas filiā le Tel: +37 1 67 84 55 63
Latvija UAB Bayer Latvijas filiāle Tel: +371 67 84 55 63
This medicine has been authorised under “ exceptional circumstances”.
Dan il- prodott mediċinali kien awtorizzat taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba ir- rarità ta ’ din il- marda kien impossibli li jinkiseb tagħrif komplut dwar din il - mediċina.
36 The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida dwar din il- mediċina u dan il- fuljett ser jiġi aġġornat skond il- bżonn.
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The following information is intended for medical or healthcare professionals only:
37 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Instructions for use and handling
Tagħrif għall- użu u mmaniġġjar
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 se jkun trasferit fil- kompartiment tal- medikazzjoni tan- nebulizzatur eżatt qabel l- użu.
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.
Dose of iloprost at mouthpiece
Doża ta ’ l- ijloprost fil- biċċa
Estimated Inhalation time
Stima tal- ħin ta ’ ġbid għal ġol -
(frequency of 15 breaths per minute)
pulmuni (frekwenza ta ’ 15- il nifs kull minuta)
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 għal ġol- pulmuni bi programm ta ’ doża ssettjata minn qabel ta ’ 2. 5 mikrogrammi bil- mili ta ’ ampulla waħda ta ’ 2 ml.
For details refer to the instruction manuals of the HaloLite and Prodose nebuliser.
Għad- dettali jekk jogħġbok irreferi għal manwali ta ’ l- istruzzjonijiet tan- nebulizzatur HaloLite u Prodose.
VentaNeb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis.
Flimkien ma ’ dan, Venta- Neb, nebulizzatur ultrasoniku li jista ’ jinġarr u li jaħdem bil- batteriji, intwera li hu adattat għall- għoti ta ’ Ventavis.
For each inhalation session, the content of one ampoule containing 2 ml of 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 tan- nifs għal ġol- pulmuni, il- kontenut ta ’ ampulla waħda ta ’ 2 ml ta ’ Ventavis ser ikun trasferit fil - kompartiment tal- medikazzjoni tan- nebulizzatur dritt qabel l- użu.
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.
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.
VentaNeb 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.
Estimated Inhalation time
iloprost fil- biċċa tal- ħalq
VentaNeb
Ħin stmat tal- Ġbid tan- Nifs
2.5 micrograms 5 micrograms
2. 5
The I-Neb AAD System is a portable, hand-held, vibrating mesh technology nebuliser system, This system generates droplets by ultrasound, which is forcing the solution through a mesh.
5 mikrogrammi
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.
37 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 and 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.
For each medication chamber there is a corresponding colour coded control disc:
Għal kull kompartiment tal- mediċina hemm disk tal- kontroll b’ kodiċi tal- kulur korrispondenti.
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 ’ 2. 5 mikrogrammi, il- kompartiment tal- mediċina (350 mikrolitri) bil- lukkett l- aħmar jintuża flimkien mad- disk tal- kontroll l- aħmar Għad- doża ta ’ 5 mikrogrammi, il- kompartiment tal- mediċina (650 mikrolitri) bil- lukkett ta ’ kulur vjola jintuża flimkien mad- disk tal- kontroll il- vjola
Estimated Inhalation time
Stima tal- ħin ta ’ Ġbid għal ġol - Pulmuni
3.2 min 6.5 min
mikrogrammi
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, patients stabilized on one nebuliser should not switch to another nebuliser without supervision by the treating physician.
I- Neb AAD
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.
5 mikrogrammi
VFEND 50 mg film-coated tablets
VFEND 50 mg pilloli miksijin b' rita
Each tablet contains 50 mg voriconazole.
Kull pillola fiha 50 mg ta 'voriconazole.
Excipient: lactose monohydrate 63.42 mg.
Sustanza mhux attiva: lactose monohydrate 63. 42 mg Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
White, round tablet, debossed “ Pfizer” on one side and “ VOR50” on the reverse.
Pillola bajda, tonda, bi “ Pfizer ” imnaqqax fuq naħa u “ VOR50 ” fuq in- naħa l- oħra.
Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated as follows:
Voriconazole huwa aġent antifungali triazole bi spettru wiesa 'li huwa indikat kif ġej:
Treatment of invasive aspergillosis.
Kura ta 'asperġillosi invażiva.
Treatment of candidemia in non-neutropenic patients.
Kura ta 'candidemia f' pazjenti mhux newtropeniċi.
Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Kura ta 'infezzjonijiet invażivi serji Candida reżistenti għal fluconazole (fosthom C. krusei).
Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Kura ta 'infezzjonijiet fungali serji kkawżati minn Scedosporium spp. u Fusarium spp.
VFEND should be administered primarily to patients with progressive, possibly life-threatening infections.
VFEND għandu jingħata primarjament lil pazjenti b' infezzjonijiet progressivi li jistgħu jkunu ta 'periklu għall- ħajja.
VFEND film-coated tablets are to be taken at least one hour before, or one hour following, a meal.
VFEND pilloli miksijin b' rita għandhom jittieħdu mill- anqas siegħa qabel, jew siegħa wara, ikla.
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4).
Disturbi elettroliti bħal ipokalimja, hypomagnesaemia u ipokalċimja għandhom jiġu mmonitorjati u korretti, jekk ikun meħtieġ, qabel ma tinbeda u waqt terapija b' voriconazole (ara sezzjoni 4. 4).
VFEND is also available as 200 mg film-coated tablets, 200 mg powder for solution for infusion and 40 mg/ ml powder for oral suspension.
VFEND huwa disponibbli wkoll bħala pilloli miksijin b' rita ta '200 mg, trab ta' 200 mg għal soluzzjoni għal infużjoni u trab ta '40 mg/ ml għal suspensjoni orali.
Use in adults Therapy must be initiated with the specified loading dose regimen of either intravenous or oral VFEND to achieve plasma concentrations on Day 1 that are close to steady state.
Użu f' persuni adulti It- terapija trid tinbeda bir- reġim speċifikat tal- loading dose ta 'VFEND ġol- vini jew orali sabiex jinkisbu konċentrazzjonijiet tal- plasma fl- 1 Jum li jkunu qrib ta' stat stabbli.
On the basis of the high oral bioavailability (96%; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Fuq il- bażi tal - bijodisponibilità orali għolja (96%; ara sezzjoni 5. 2), il- qalba bejn amministrazzjoni fil- vini u orali hija f' waqtha meta klinikament indikata.
2 Detailed information on dosage recommendations is provided in the following table:
2 Tagħrif dettaljat dwar ir- rakkomandazzjonijiet tad- dożaġġ huwa pprovdut fit- tabella segwenti:
Intravenous
Fil- vini
Patients 40 kg and above
Pazjenti li jiżnu 40 kg u Pazjenti li jiżnu anqas
Oral Patients less than 40 kg
minn 40 kg
Loading Dose
Reġim tal- Loading
6 mg/ kg every 12 hours
6 mg/ kg kull 12- il
400 mg every 12 hours
400 mg kull 12- il
200 mg every 12 hours
200 mg kull 12- il
Regimen (first 24 hours)
Dose siegħa (għall- ewwel 24 siegħa (għall- ewwel 24 siegħa (għall- ewwel 24 (l- ewwel 24
(for the first 24 hours)
siegħa) siegħa) siegħa)
(for the first 24 hours)
siegħa)
(for the first 24 hours)
Doża ta 'Manteniment (wara l- ewwel 24 siegħa)
4 mg/ kg twice daily
4 mg/ kg darbtejn kuljum
200 mg twice daily
200 mg darbtejn kuljum
100 mg twice daily
100
Dosage adjustment If patient response is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration.
Aġġustament tad- doża Jekk ir- rispons tal- pazjent ma jkunx adegwat, id- doża ta 'manteniment tista' tiżdied għal 300 mg darbtejn kuljum fil- każ ta 'amministrazzjoni orali.
For patients less than 40 kg the oral dose may be increased to 150 mg twice daily.
Fil- każ ta 'pazjenti li jiżnu anqas minn 40 kg id - doża orali tista' tiżdied għal 150 mg darbtejn kuljum.
If patients are unable to tolerate treatment at these higher doses reduce the oral dose by 50 mg steps to the 200 mg twice daily (or 100 mg twice daily for patients less than 40 kg) maintenance dose.
Jekk il- pazjenti ma jkunux jistgħu jittolleraw kura f' dawn id- dożi ogħla, id- doża orali għandha tiġi mnaqqsa b' 50 mg kull darba għad- doża ta 'manteniment ta' 200 mg darbtejn kuljum (jew 100 mg darbtejn kuljum fil- każ ta 'pazjenti li jiżnu anqas minn 40 kg).
Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Phenytoin jista 'jingħata flimkien ma' voriconazole jekk id- doża ta 'manteniment ta' voriconazole tiżdied minn 200 mg għal 400 mg b' mod orali, darbtejn kuljum (100 mg għal 200 mg b' mod orali, darbtejn kuljum fil- każ ta 'pazjenti li jiżnu anqas minn 40 kg), ara sezzjonijiet 4. 4 u 4. 5.
Rifabutin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 350 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Rifabutin jista 'jingħata flimkien ma' voriconazole jekk id- doża ta 'manteniment ta' voriconazole tiżdied minn 200 mg għal 350 mg b' mod orali, darbtejn kuljum (100 mg għal 200 mg b' mod orali, darbtejn kuljum fil- każ ta 'pazjenti li jiżnu anqas minn 40 kg), ara sezzjonijiet 4. 4 u 4. 5.
Efavirenz may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50%, i. e. to 300 mg once daily.
Efavirenz jista jiġi mogħti flimkien ma voriconazole jekk id- doża ta ’ manteniment ta ’ voriconazole hija miżjuda għal 400 mg kull 12- il siegħa, u d- doża ta ’ efavirenz hija mnaqqsa bil- 50%, i. e. għal 300 mg darba kuljum.
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5).
Meta t- trattament b’ voriconazole huwa mwaqqaf, id- dużaġġ tal- bidu ta ’ efavirenz għandu jkun mibdul għal li kien (ara sezzjojijiet 4. 4 u 4. 5).
Treatment duration depends upon patients’ clinical and mycological response.
It- tul tal- kura jiddependi fuq ir- rispons kliniku u mikoloġiku tal- pazjenti.
Use in the elderly No dose adjustment is necessary for elderly patients (see section 5.2).
Użu f' persuni anzjani Mhux meħtieġ aġġustament tad- doża għal pazjenti anzjani (ara sezzjoni 5. 2).
Use in patients with renal impairment The pharmacokinetics of orally administered voriconazole are not affected by renal impairment.
Użu f' pazjenti b' indeboliment tal- kliewi Il- farmakokinetika ta 'voriconazole mogħti b' mod orali mhix affettwata minn indeboliment tal- kliewi.
Therefore, no adjustment is necessary for oral dosing for patients with mild to severe renal impairment (see section 5.2).
Għalhekk, mhux meħtieġ aġġustament tad- dożaġġ orali fil- każ ta 'pazjenti b' indeboliment ħafif għal sever tal- kliewi (ara sezzjoni 5. 2).
Voriconazole is haemodialysed with a clearance of 121 ml/ min.
Voriconazole jiġi ħemodijalizzat bi tneħħija ta '121 ml/ min.
A four hour haemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment.
Sessjoni ta 'ħemodijaliżi ta' erba 'sigħat ma tneħħix ammont suffiċjenti ta' voriconazole biex teħtieġ aġġustament tad- doża.
Use in patients with hepatic impairment No dose adjustment is necessary in patients with acute hepatic injury, manifested by elevated liver function tests (ALAT, ASAT) (but continued monitoring of liver function tests for further elevations is recommended).
Użu f' pazjenti b' indeboliment tal- fwied Mhux meħtieġ aġġustament tad- doża f' pazjenti b' ferita epatika akuta, murija b' testijiet tal- funzjoni elevata tal- fwied (ALAT, ASAT) (iżda monitoraġġ kontinwu tat- testijiet tal- funzjoni tal- fwied huwa rakkomandat).
3 It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving VFEND (see section 5.2).
3 Huwa rakkomandat li jintużaw ir- reġimi standard tal- loading dose iżda li d- doża ta 'manteniment titnaqqas bin- nofs f' pazjenti b' cirrożi epatika ħafifa għal moderata (Child- Pugh A u B) li jkunu qegħdin jirċievu VFEND (ara sezzjoni 5. 2).
VFEND has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
VFEND ma ġiex studjat f' pazjenti b' ċirrożi epatika kronika severa (Child- Pugh C).
VFEND has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and must only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk.
VFEND ġie assoċjat ma 'elevazzjonijiet f' testijiet tal- funzjoni tal- fwied u sinjali kliniċi ta' ħsara fil - fwied, bħas- suffejra, u għandu jintuża biss f' pazjenti b' indeboliment sever tal- fwied jekk il- vantaġġ ikun akbar mir- riskju potenzjali.
Patients with hepatic impairment must be carefully monitored for drug toxicity (see also section 4.8).
Il- pazjenti b' indeboliment tal- fwied iridu jiġu mmonitorjati sewwa għat- tossiċità mill- mediċina (ara wkoll sezzjoni 4. 8).
Use in children VFEND is not recommended for use in children below 2 years due to insufficient data on safety and efficacy (see also sections 4.8 and 5.1).
VFEND mhux mhux irrakkomandat għall- użu fit- tfal taħt is- sentejn peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara wkoll sezzjoni 4. 8 u 5. 1).
The recommended maintenance dosing regimen in paediatric patients 2 to < 12 years is as follows:
Ir- reġim rakkomandat tad- dożaġġ ta 'manteniment f' pazjenti pedjatriċi ta' 2 sa < 12- il sena huwa kif ġej:
Intravenous*
Reġim tal- Loading Dose
Oral**
Fil- vini *
Loading Dose Regimen
Orali **
No oral or intravenous loading dose is recommended
Mhix rakkomandata loading dose
Maintenance Dose
orali jew fil- vini.
7 mg/ kg twice daily
7 mg/ kg darbtejn kuljum
*Based on a population pharmacokinetic analysis in 82 immunocompromised patients aged 2 to < 12 years **Based on a population pharmacokinetic analysis in 47 immunocompromised patients aged 2 to < 12 years
* Imsejjes fuq analiżi farmakokinetika tal- popolazzjoni fi 82 pazjent immunokompromess ta 'bejn 2 u < 12- il sena ** Imsejjes fuq analiżi farmakokinetika tal- popolazzjoni f' 47 pazjent immunokompromess ta' bejn 2 u < 12- il sena
Use in paediatric patients aged 2 to < 12 years with hepatic or renal insufficiency has not been studied (see section 4.8 and section 5.2).
L- użu f' pazjenti pedjatriċi li għandhom 2 sa < 12- il sena b' insuffiċjenza epatika jew renali ma ġiex studjat (ara sezzjoni 4. 8 u sezzjoni 5. 2).
These paediatric dose recommendations are based on studies in which VFEND was administered as the powder for oral suspension.
Dawn ir- rakkomandazzjonijiet dwar id- doża pedjatrika huma msejsa fuq studji li fihom VFEND ingħata bħala t- trab għal suspensjoni orali.
Bioequivalence between the powder for oral suspension and tablets has not been investigated in a paediatric population.
Il- bijoekwivalenza bejn it- trab għal suspensjoni orali u l - pilloli ma ġietx studjata f' popolazzjoni pedjatrika.
Considering the assumed limited gastro-enteric transit time in paediatrics, the absorption of tablets may be different in paediatric compared to adult patients.
Meta tqis il- ħin ta 'passaġġ gastroenteriku preżumibbilment limitat fit- tfal, l- assorbiment tal- pilloli jista' jkun differenti f' pazjenti pedjatriċi meta mqabbel ma 'pazjenti adulti.
It is therefore recommended to use the oral suspension formulation in children aged 2- < 12.
Għalhekk huwa rakkomandat li tintuża l- formulazzjoni tas- suspensjoni orali fi tfal ta '2 sa < 12- il sena.
Adolescents (12 to 16 years of age): should be dosed as adults.
L- adoloxxenti (12 sa 16- il sena): għandhom jingħataw dożi bħall- adulti.
Hypersensitivity to the active substance or to any of the excipients
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanza mhux attiva.
Coadministration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine with VFEND is contraindicated since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes (see section 4.5).
L- amministrazzjoni tas- sostratti ta 'CYP3A4, terfenadine, astemizole, cisapride, pimozide jew quinidine flimkien ma' VFEND hija kontra- indikata billi konċentrazzjonijiet akbar ta 'dawn il- prodotti mediċinali fil- plasma jistgħu jwasslu għal titwil tal- QTc u okkorrenzi rari ta' torsades de pointes (ara sezzjoni 4. 5).
Coadministration of VFEND with rifampicin, carbamazepine and phenobarbital is contraindicated since these medicinal products are likely to decrease plasma voriconazole concentrations significantly (see section 4.5).
4 L- amministrazzjoni ta 'VFEND ma' rifampicin, carbamazepine u phenobarbital hija kontra- indikata billi dawn il- prodotti mediċinali huma probabbli li jnaqqsu l- konċentrazzjonijiet ta 'voriconazole fil - plasma b' mod sinifikanti.
Coadministration of VFEND with high dose ritonavir (400 mg and above twice daily) is contraindicated because ritonavir significantly decreases plasma voriconazole concentrations in healthy subjects at this dose.
L- amministrazzjoni ta 'VFEND ma' doża għolja ta 'ritonavir (400 mg u aktar darbtejn kuljum) hija kontra- indikata billi ritonavir inaqqas b' mod sinifikanti l- konċentrazzjonijiet ta' voriconazole fil - plasma f' suġġetti b' saħħithom f' din id- doża.
(see section 4.5, for lower doses see section 4.4).
(ara sezzjoni 4. 5, għal dożi aktar baxxi ara sezzjoni 4. 4).
4 Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, is contraindicated since increased plasma concentrations of these medicinal products can lead to ergotism (see section 4.5).
L- amministrazzjoni f' daqqa ta 'alkalojdi ta' l- ergotina (ergotamine, dihydroergotamine), li huma sostratti ta 'CYP3A4, hija kontra- indikata billi konċentrazzjonijiet akbar ta' dawn il- prodotti mediċinali fil- plasma jistgħu jwasslu għal ergotiżmu (ara sezzjoni 4. 5).
Coadministration of voriconazole and sirolimus is contraindicated, since voriconazole is likely to increase plasma concentrations of sirolimus significantly (see section 4.5).
L- amministrazzjoni ta 'voriconazole ma' sirolimus hija kontra- indikata, billi voriconazole huwa probabbli li jżid il- konċentrazzjonijiet fil- plasma ta 'sirolimus b' mod sinifikanti (ara sezzjoni 4. 5).
The concomitant use of voriconazole with St John’ s Wort is contraindicated (see section 4.5).
John’ s wort (fexfiex) huwa kontraindikat.
Caution should be used in prescribing VFEND to patients with hypersensitivity to other azoles (see also section 4.8).
Għandha tintuża kawtela meta VFEND jiġi ordnat lil pazjenti b' sensittività eċċessiva għal sustanzi antifungali oħra (ara wkoll sezzjoni 4. 8).
Some azoles, including voriconazole have been associated with QT interval prolongation.
Ċerti sustanzi antifungali, fosthom voriconazole ġew assoċjati ma 'titwil ta' l- intervall QT.
There have been rare cases of torsades de pointes in patients taking voriconazole who had risk factors, such as history of cardiotoxic chemotherapy, cardiomyopathy, hypokalaemia and concomitant medications that may have been contributory.
Kien hemm każijiet rari ta 'torsades de pointes f' pazjenti jieħdu voriconazole li kellhom fatturi ta' riskju, bħal storja ta 'kemjoterapija kardjotossika, kardjomijopatija, ipokalimja u medikazzjonijiet konkomitanti li setgħu kkontribwew.
Voriconazole should be administered with caution to patients with potentially proarrhythmic conditions, such as
Voriconazole għandu jingħata b' kawtela lil pazjenti li għandhom kondizzjonijiet potenzjalment proarritmiċi, bħal
 Congenital or acquired QT-prolongation  Cardiomyopathy, in particular when heart failure is present  Sinus bradycardia  Existing symptomatic arrhythmias  Concomitant medication that is known to prolong QT interval Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.2).
Disturbi elettroliti bħal ipokalimja, hypomagnesaemia u ipokalċimja għandhom jiġu mmonitorjati u korretti, jekk ikun meħtieġ, qabel ma tinbeda u waqt terapija b' voriconazole (ara sezzjoni 4. 2).
A study has been conducted in healthy volunteers which examined the effect on QT interval of single doses of voriconazole up to 4 times the usual daily dose.
Sar studju fost voluntiera b' saħħithom li eżamina l- effett fuq l- intervall QT ta 'dożi waħdiena ta' voriconazole sa 4 darbiet aktar mid- doża normali ta 'kuljum.
No subject experienced an interval exceeding the potentially clinically relevant threshold of 500 msec (see section 5.1).
Ebda suġġett ma esperjenza intervall li jaqbeż il- limitu kliniku potenzjalment rilevanti ta '500 msec (ara sezzjoni 5. 1).
In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with VFEND (including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities).
Fi studji kliniċi, kien hemm każijiet mhux komuni ta 'reazzjonijiet epatiċi waqt kura b' VFEND (inkluż epatite klinika, kolestażi u insuffiċjenza epatika f' daqqa, inkluż imwiet).
Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy). Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Reazzjonijiet epatiċi għaddiena, fosthom epatite u suffejra, seħħew fost pazjenti b' ebda fatturi oħra ta 'riskju identifikabbli.