qanastek/EMEA-V3 huggingface dataset:
15 who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Sustanzi għall- kura tal- problema ta ’ l- erezzjoni tal- pene għandhom jintuzaw b' aktar attenzjoni f' pazjenti b' deformazzjoni anatomika tal- pene (bħal angulazzjoni, fibrożi fil- korpus kavernożum jew il- marda ta 'Peyronie), jew f’ pazjenti li jsofru minn mard li minħabba fih hemm probabilità akbar li jkollhom prijapiżmu (bħal anemija sickle cell, majeloma multipla jew lewkimja).
In humans, vardenafil had no effect on bleeding time alone or in combination with acetylsalicyclic acid (see section 4.5).
16 m’ għandu l- ebda effett fuq il- ħin ta ’ kemm idum ħiereġ id- demm (fsada) la waħdu, u lanqas meta mħallat ma ’ acetylsalicylic acid (ara sezzjoni 4. 5).
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP 3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
17 Għalkemm ma sarux studji speċifiċi dwar l- interazzjoni għall- mediċini kollha, analiżi farmakokinetika tal- popolazzjoni ma wriet l- ebda effett fuq il- farmakokinetika ta 'vardenafil meta ngħata flimkien ma ’ dawn il- mediċini: acetylsalicylic acid, inibituri ACE, beta- blokers, inibituri ħfief ta' CYP 3A4, dijuretiċi, u prodotti mediċinali għall- kura tad- dijabete (sulfonylureas u metformin).
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
18 Vardenafil (10 mg) ma tawwalx il- ħin ta ’ fsada ikkawżata minn acetylsalicylic acid (2 x 81 mg).
Ear and labyrinth Disorders
(≥1/ 100)
Sudden deafness**
< 1% / 100) *
Cardiac Disorders incl. related Investigations
tittieħed < 0. 1/ 1, 000%) * stima mid - data disponibbli) Disturbi Kardijaċi inkluż Investigazzjonijiet Relatati
Vascular Disorders incl. related Investigations
Disturbi Vaskulari inkluz Investigazzjonijiet Relatati
Flushing
Fawra
Gastrointestinal Disorders incl. related Investigations Skin and Subcutaneous Tissue Disorders
Disturbi Gastro - intestinali inkluż Investigazzjonijiet Relatati
Abnormal liver function tests GGTP increased Photosensitivity reaction Face oedema Rash
Testijiet tal - funzjoni tal - fwied mhux normali Żjieda fil- GGTP
Muscle Rigidity Priapism Erections increased (prolonged or painful erections)
Disturbi fis- sistema Riproduttiva u fis - Sider
*For adverse reactions reported in < 1% of patients, only those which warrant special attention, because of their possible association with serious disease states or of otherwise clinical relevance are listed.
Prijapiżmu Erezzjonijiet miżjuda (Erezzjonijiet li jdumu jew bl - uġigħ)
20 **Sudden deafness or loss of hearing has been reported in a small number of postmarketing and clinical trial cases with the use of all PDE5 inhibitors, including vardenafil.
* Minn dawk l- effetti mhux mixtieqa li deheru f '< 1% tal- pazjenti, ġew mnizzla biss dawk li jeħtieġu attenzjoni speċjali, minħabba li jistgħu jkunu assoċjati ma ’ mard serju jew ta ’ relevanza klinika. ** Ġie rrappurtat tnaqqis jew telf tas- smigħ f’ daqqa waħda f’ numru żgħir ta ’ każijiet fi provi ta ’ wara t- tqegħid fis- suq u fi provi kliniċi bl- użu ta ’ inibituri ta ’ PDE5, inkluż vardenafil.
21 Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects.
Vardenafil ibaxxi l- pressjoni b' mod ħafif u temporanju, li fil- biċċa l- kbira tal- każijiet, ma jikkawżawx effetti kliniċi.
Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
21 dożi ripetuti sa 40 mg ta ’ vardenafil mogħtija mill- ħalq, m’ għamlu l- ebda bidla klinikament relevanti fl- ECG ta ’ rġiel voluntiera b' saħħithom.
22 In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
22 Waqt prova klinika f’ pazjenti b’ dijabete mellitus, dożi ta ’ 10 mg u 20 mg ta ’ vardenafil wasslu għal titjib sinifikattiv fil- punteġġ tal- funzjoni erettili, fil- ħila biex tintlaħaq u tinżamm erezzjoni tal- pene għal tul ta ’ ħin biżżejjed biex jirnexxi l- att sesswali u rigidita ’ tal- pene, meta mqabbla mal- plaċebo.
Parts of M1 are in the form of the glucuronide in systemic circulation.
Fil- bnedmin, il- metabolit prinċipali li jiċċirkola fid- demm (M1) jifforma minn desethylation ta ’ vardenafil u jkompli jiġi metabolizzat, b’ half life ta ’ eliminazzjoni mill- plażma ta ’ madwar 4 sigħat.
23 Elimination
23 Partijiet minn M1 jinsabu bħala glucuronide fiċ- ċirkolazzjoni sistemika.
Film coat: macrogol 400 hypromellose titanium dioxide (E171) ferric oxide yellow (E172) ferric oxide red (E172)
24 Kisja b’ rita: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide isfar (E172), ferric oxide aħmar (E172)
4 March 2003
4 ta ’ Marzu 2003
Date of last renewal::
Data ta ’ l- aħħar tiġdid:
Vivanza 20 mg film-coated tablets
Vivanza 20 mg, Pilloli miksija b’ rita.
Orange round tablets marked with a ‘ v’ on one side and “ 20” on the other side.
Pillola tonda, oranġjo b ’’ v ’ fuq naħa u '20' fuq in- naħa l- oħra.
Treatment of erectile dysfunction in adult men.
Kura għal problema ta ’ l- erezzjoni tal- pene, fl- irġiel adulti.
Use in patients with hepatic impairment
Użu f' pazjenti b’ indeboliment fil- funzjoni tal- fwied.
26 Use in patients with renal impairment
26 Użu f' pazjenti b’ indeboliment fil- funzjoni tal- kliewi.
Agents for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’ s disease), or in patients
27 ventrikulu tax- xellug, eż., stenożi ta ’ l- aorta, stenożi subaortika ipertrofika idjopatika, jistgħu jkunu sensittivi għall- azzjoni ta ’ vażodilataturi inklużi impedituri ta ’ phosphodiesterase tat- Tip 5.
In humans, vardenafil had no effect on bleeding time alone or in combination with acetylsalicyclic acid (see section 4.5).
28 m’ għandu l- ebda effett fuq il- ħin ta ’ kemm idum ħiereġ id- demm (fsada) la waħdu, u lanqas meta mħallat ma ’ acetylsalicylic acid (ara sezzjoni 4. 5).
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP 3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
29 Għalkemm ma sarux studji speċifiċi dwar l- interazzjoni għall- mediċini kollha, analiżi farmakokinetika tal- popolazzjoni ma wriet l- ebda effett fuq il- farmakokinetika ta 'vardenafil meta ngħata flimkien ma ’ dawn il- mediċini: acetylsalicylic acid, inibituri ACE, beta- blokers, inibituri ħfief ta' CYP 3A4, dijuretiċi, u prodotti mediċinali għall- kura tad- dijabete (sulfonylureas u metformin).
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
30 Vardenafil (10 mg) ma tawwalx il- ħin ta ’ fsada ikkawżata minn acetylsalicylic acid (2 x 81 mg).
31 System Organ
Sistema tal -
Headache Dizziness
Uġigħ ta 'ras
Abnormal liver function tests GGTP increased Photosensitivit y reaction Face oedema Rash
Testijiet tal - funzjoni tal - fwied mhux normali Żjieda fil- GGTP
Blood creatine Muscle Rigidity phosphokinase increased Myalgia Back Pain Priapism Erections increased (prolonged or painful erections)
Żjieda fil - creatine phosphokinase tad- demm Mijalġja Uġigħ fid- dahar
32 **Sudden deafness or loss of hearing has been reported in a small number of postmarketing and clinical trial cases with the use of all PDE5 inhibitors, including vardenafil.
* Minn dawk l- effetti mhux mixtieqa li deheru f '< 1% tal- pazjenti, ġew mnizzla biss dawk li jeħtieġu attenzjoni speċjali, minħabba li jistgħu jkunu assoċjati ma ’ mard serju jew ta ’ relevanza klinika. ** Ġie rrappurtat tnaqqis jew telf tas- smigħ f’ daqqa waħda f’ numru żgħir ta ’ każijiet fi provi ta ’ wara t- tqegħid fis- suq u fi provi kliniċi bl- użu ta ’ inibituri ta ’ PDE5, inkluż vardenafil.
33 Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects.
Vardenafil ibaxxi l- pressjoni b' mod ħafif u temporanju, li fil- biċċa l- kbira tal- każijiet, ma jikkawżawx effetti kliniċi.
Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
33 dożi ripetuti sa 40 mg ta ’ vardenafil mogħtija mill- ħalq, m’ għamlu l- ebda bidla klinikament relevanti fl- ECG ta ’ rġiel voluntiera b' saħħithom.
34 In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
34 Waqt prova klinika f’ pazjenti b’ dijabete mellitus, dożi ta ’ 10 mg u 20 mg ta ’ vardenafil wasslu għal titjib sinifikattiv fil- punteġġ tal- funzjoni erettili, fil- ħila biex tintlaħaq u tinżamm erezzjoni tal- pene għal tul ta ’ ħin biżżejjed biex jirnexxi l- att sesswali u rigidita ’ tal- pene, meta mqabbla mal- plaċebo.
35 Elimination
35 Partijiet minn M1 jinsabu bħala glucuronide fiċ- ċirkolazzjoni sistemika.
Film coat: macrogol 400 hypromellose titanium dioxide (E171) ferric oxide yellow (E172) ferric oxide red (E172)
36 Kisja b’ rita: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide isfar (E172), ferric oxide aħmar (E172)
36 6.2 Incompatibilities
2 Inkompatibilitajiet
This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandhiec bżonn ta ’ ħażna speċjali.
OUTER CARTON TEXT
KLIEM FUQ IL KARTUNA TA ’ BARRA
Vivanza 5 mg film-coated tablets vardenafil
Vivanza 5 mg, Pilloli miksija b’ rita Vardenafil
EU/ 1/ 03/ 249/ 001 2 Tablets EU/ 1/ 03/ 249/ 002 4 Tablets EU/ 1/ 03/ 249/ 003 8 Tablets EU/ 1/ 03/ 249/ 004 12 Tablets
EU/ 1/ 03/ 249/ 001 2 Pilloli EU/ 1/ 03/ 249/ 002 4 Pilloli EU/ 1/ 03/ 249/ 003 8 Pilloli EU/ 1/ 03/ 249/ 004 12- il Pillola
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Vivanza 5 mg film-coated tablets vardenafil
Vivanza 5 mg, pilloli miksija b’ rita vardenafil
Vivanza 10 mg film-coated tablets vardenafil
Vivanza 10 mg, Pilloli miksija b’ rita Vardenafil
EU/ 1/ 03/ 249/ 005 2 Tablets EU/ 1/ 03/ 249/ 006 4 Tablets EU/ 1/ 03/ 249/ 007 8 Tablets EU/ 1/ 03/ 249/ 008 12 Tablets
EU/ 1/ 03/ 249/ 005 2 Pilloli EU/ 1/ 03/ 249/ 006 4 Pilloli EU/ 1/ 03/ 249/ 007 8 Pilloli EU/ 1/ 03/ 249/ 008 12- il Pillola
Vivanza 10 mg film-coated tablets vardenafil
Vivanza 10 mg, pilloli miksija b’ rita Vardenafil
Vivanza 20 mg film-coated tablets vardenafil
Vivanza 20 mg, Pilloli miksija b’ rita vardenafil
SPECIAL STORAGE CONDITIONS
M’ hemmx bżonn ta ’ ħażna speċjali
EU/ 1/ 03/ 249/ 009 2 Tablets EU/ 1/ 03/ 249/ 010 4 Tablets EU/ 1/ 03/ 249/ 011 8 Tablets EU/ 1/ 03/ 249/ 012 12 Tablets
EU/ 1/ 03/ 249/ 009 2 Pilloli EU/ 1/ 03/ 249/ 010 4 Pilloli EU/ 1/ 03/ 249/ 011 8 Pilloli EU/ 1/ 03/ 249/ 012 12- il Pillola
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Vivanza 20 mg film-coated tablets vardenafil
Vivanza 20 mg, pilloli miksija b’ rita Vardenafil
Vivanza 5 mg film-coated tablets Vardenafil
Vivanza 5 mg pilloli miksija b’ rita Vardenafil
What Vivanza is and what it is used for 2.
X’ inhu Vivanza u għalxiex jintuża 2.
Before you take Vivanza 3.
Qabel ma tieħu Vivanza 3.
How to take Vivanza 4.
Kif għandek tieħu Vivanza 4.
Possible side effects 5 How to store Vivanza 6 Further information
Kif taħżen Vivanza 6.
WHAT VIVANZA IS AND WHAT IT IS USED FOR
X’ INHU VIVANZA U GĦALXIEX JINTUŻA
Vivanza belongs to a group of medicines which are used to treat difficulties in getting or keeping an erection (erectile dysfunction).
Vivanza jagħmel parti minn grupp ta ’ mediċini użati fil- kura ta ’ diffikultajiet biex tintlaħaq jew biex tinżamm erezzjoni (disfunzjoni erettili)..
About erection difficulties At least one in ten men has trouble getting or keeping an erection at some time.
Dwar diffikultajiet erettili Fl- irġiel, ta ’ l- inqas wieħed minn kull għaxra jkollhom diffikultà biex jilħqu jew iżommu erezzjoni xi darba jew oħra tul ħajjithom.
Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.
Tkun xi tkun il- kawża, minħabba tibdiliet fil- muskoli, vini u arterji ma jkunux hemm biżżejjed demm li jibqa ’ fil- pene, u b’ hekk tkun diffiċli biex il- pene jibbies u jinżamm iebes.
How Vivanza works Vivanza will only work when you are sexually stimulated.
Kif taħdem Vivanza Vivanza jaħdem biss meta int tkun sesswalment stimulat.
It reduces the action of the natural chemical in your body which makes erections go away.
Huwa jnaqqas l- azzjoni tal- kimika naturali fil- ġisem tiegħek li jġiegħel l- erezzjonijiet imorru.
VIVANZA allows an erection to last long enough for you to satisfactorily complete sexual activity.
VIVANZA jħalli erezzjoni ddum biżżejjed biex int ittemm b’ mod sodisfaċenti l- attività sesswali.
BEFORE YOU TAKE VIVANZA
QABEL MA TIEĦU VIVANZA
Do not take Vivanza
Tieħux Vivanza
See
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal vardenafil jew sustanzi oħra ta ’
the ingredients in section 6.
Ara l- ingredjenti f’ sezzjoni 6.
Taking these medicines with Vivanza could seriously affect your blood pressure.
Jekk tieħu dawn il- mediċini flimkien ma ’ Vivanza, jista ’ jkun hemm effett serju fuq il- pressjoni tiegħek.
- If you have a severe heart or liver problem
moffa
- If you are having kidney dialysis
- Jekk għandek problemi severi fil- qalb jew fil- fwied
- If you have recently had a stroke or heart attack
- Jekk qed tagħmel dijalisi tal- kliewi
- If you have or have had low blood pressure
- Jekk kellek attakk tal- qalb jew puplesija reċenti
- If you have ever had a condition involving loss of vision due to damage to the optic nerve from
- Jekk għandek jew kien ikollok pressjoni baxxa
These include sickle cell disease, multiple myeloma and leukaemia If you have stomach ulcers (also called gastric or peptic ulcers) If you have a bleeding disorder (such as haemophilia) If you are using any other treatments for erection difficulties If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor immediately.
(Dawn jissejħu wkoll ulceri gastriċi jew peptiċi) • Jekk għandek xi marda ta ’ fsada (bħall- emofilja) • Jekk qed tuża xi kura oħra għal diffikultajiet fl- erezzjoni. • Jekk qatt kellek nuqqas f’ daqqa jew telf tal- vista, tibqax tieħu Vivanza u kellem lit- tabib tiegħek minnufih.
Vivanza is for men of 18 years and over It is not intended for use by women, children or men under 18.
Vivanza hija għall- irġiel ta '18- il sena u fuqhom Vivanza mhux indikata għall- użu fin- nisa, tfal jew irġiel taħt 18- il sena.
Vivanza will usually be fine with most medicines.
Ġeneralment Vivanza taqbel mal- biċċa l- kbira tal- mediċini.
Taking these medicines with Vivanza could seriously affect your blood pressure.
Jekk tieħu dawn il- mediċini ma ’ Vivanza, jista ’ jkun hemm effetti serji fuq il- pressjoni tiegħek.
Talk to a doctor without taking Vivanza Medicine for the treatment of arrythmias, such as quinidine, procainamide, amiodarone or sotalol Ritonavir or indinavir, medicines for HIV.
Kellem tabib mingħajr ma tieħu Vivanza. • Mediċina għall- kura ta ’ l- arritmija, bħal quinidine, procainamide, amiodarone jew sotalol • Ritonavir jew indinavir, mediċini għall- HIV.
Talk to a doctor without taking Vivanza Ketoconazole or itraconazole, anti-fungal medicines Erythromycin or clarithromycin, macrolide antibiotics Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia)
Kellem tabib mingħajr ma tieħu Vivanza • Ketoconazole jew itraconazole, mediċini kontra l- moffa • Erythromycin jew clarithromycin, antibiotiċi macrolide • Alfa- blockers, tip ta 'mediċina li tintuża biex tikkura pressjoni għolja jew tkabbir tal- prostata (bħal iperplasija beninna tal- prostata).
Taking Vivanza with food and drink You can take Vivanza with or without food – but preferably not after a heavy or high-fat meal as this may delay the effect.
Meta tieħu Vivanza ma ’ l- ikel u max- xorb • Tista ’ tieħu Vivanza ma 'l- ikel jew mingħajr ikel – iżda preferibbilment mhux wara ikla tqila jew b’ ħafna xaħmijiet għax dan jista ’ jittardja l- effett. • Tixrobx meraq tal- grejpfrut meta tieħu Vivanza.
Don’ t drink grapefruit juice when you use Vivanza.
Dan jista ’ jtellef l- effett li jkollha s- soltu l - medicina.
It can interfere with the usual effect of the medicine.
Xorb alkoħoliku jista ’ jżid id- diffikultajiet fl- erezzjoni.
Pregnancy and breast-feeding Vivanza is not for use by women.
Tqala u treddigħ Vivanza mhux għall- użu minn nisa.
Driving and using machines Vivanza might make some people feel dizzy or affect their vision.
Sewqan u tħaddim ta ’ magni Vivanza jista ’ jġiegħel lil xi nies iħossuhom sturduti jew jaffettwa l- vista tagħhom.
If you feel dizzy, or if your vision is affected after taking Vivanza don’ t drive or operate any tools or machines.
Jekk wara li tieħu Vivanza tħossok sturdut jew il- vista tiegħek tiġi affetwata, m' għandekx issuq, tagħmel użu minn għodda jew tħaddem magni.
HOW TO TAKE VIVANZA
KIF GĦANDEK TIEĦU VIVANZA
Always take Vivanza exactly as your doctor has told you.
Dejjem għandek tieħu Vivanza skond il- parir tat- tabib.
Take a Vivanza tablet about 25 to 60 minutes before sexual activity.
Ħu pillola Vivanza madwar 25 sa 60 minuta qabel attività sesswali.
With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Vivanza.
Bi stimulazzjoni sesswali jista ’ jkollok erezzjoni minn 25 minuta sa 4 jew 5 sigħat wara li tieħu l- pillola Vivanza. • Ibla ’ pillola waħda ma 'tazza ilma
Swallow one tablet with a glass of water Don’ t use Vivanza more than once a day.
Tieħux Vivanza aktar minn darba kuljum.
53 Tell the doctor if you think Vivanza is too strong or too weak.
Jekk tħoss li l- effett ta ’ Vivanza huwa qawwi jew dgħajjef wisq, kellem lit- tabib.
He or she may suggest a different dose, depending on how well it works for you.
Dan jista ’ jissuġġerilek doża differenti, skond kemm Vivanza taħdem tajjeb fuqek.
If you take more Vivanza than you should Men who take too much Vivanza may experience more side effects or may get severe back pain.
Jekk tieħu Vivanza aktar milli suppost Irġiel li jieħdu aktar Vivanza milli suppost jista ’ jkollhom aktar effetti mhux mixtieqa jew ikollhom uġigħ qawwi fid- dahar.
If you take more Vivanza than you should, tell your doctor.
Jekk tieħu aktar Vivanza milli suppost, għid lit- tabib tiegħek.
Like all medicines, Vivanza can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra Vivanza jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE VIVANZA
KIF TAĦŻEN VIVANZA
Do not use Vivanza after the expiry date which is stated on the carton.
Tużax Vivanza wara d- data ta 'skadenza li tidher fuq il- kartuna.
What Vivanza contains
X’ fih Vivanza
What Vivanza looks like and contents of the pack Vivanza 5 mg film-coated tablets are orange with the BAYER cross on one side and the strength (5) on the other side.
Id- Dehra ta ’ Vivanza u l- kontenuti tal- pakkett Vivanza 5 mg pilloli miksija b’ rita huma oranġjo immarkata b ’ ‘ v ’ fuq naħa waħda u (5) fuq l- oħra.
The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets.
Il - pilloli huma pprovduti f’ pakketti b’ folji li fihom 2, 4, 8 jew 12- il pillola.
Bayer AG, D-51368 Leverkusen, Germany.
Bayer AG, D- 51368 Leverkusen, Il - Ġermanja.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
55 Għall kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ελλάδα ALAPIS PHARMA ΑΒΕΕ Tηλ.: +30 2130 175000
Tηλ.: +30 2130 175000
56 PACKAGE LEAFLET:
57 FULJETT TA ’ TAGĦRIF:
Vivanza 10 mg film-coated tablets Vardenafil
Vivanza 10 mg pilloli miksija b’ rita Vardenafil
How to store Vivanza 6.
Kif taħżen Vivanza 6.
Vivanza belongs to a group of medicines which are used to treat difficulties in getting or keeping an erection (erectile dysfunction).
Vivanza jagħmel parti minn grupp ta ’ mediċini użati fil- kura ta ’ diffikultajiet biex tintlaħaq jew biex tinżamm erezzjoni (disfunzjoni erettili).
57 Take special care with Vivanza If you have heart trouble.
Oqgħod attent ħafna b’ Vivanza • Jekk għandek problemi f' qalbek.
58 Tell the doctor if you think Vivanza is too strong or too weak.
Jekk tħoss li l- effett ta ’ Vivanza huwa qawwi jew dgħajjef wisq, kellem lit- tabib.
What Vivanza looks like and contents of the pack Vivanza 10 mg film-coated tablets are orange with the BAYER cross on one side and the strength (10) on the other side.
Id- Dehra ta ’ Vivanza u l- kontenuti tal- pakkett Vivanza 10 mg pilloli miksija b’ rita huma oranġjo immarkata b ’ ‘ v ’ fuq l- oħra.
The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets.
Il- pilloli huma pprovduti f’ pakketti tal- folja b’ folji 2, 4, 8 jew 12- il pillola.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
61 Għall kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Vivanza 20 mg film-coated tablets Vardenafil
Vivanza 20 mg pilloli miksija b’ rita Vardenafil
62 Take special care with Vivanza If you have heart trouble.
Oqgħod attent ħafna b’ Vivanza • Jekk għandek problemi f' qalbek.
Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription Vivanza will usually be fine with most medicines.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
But some may cause problems, especially these:
Ġeneralment Vivanza taqbel mal- biċċa l- kbira tal- mediċini.
Swallow one tablet with a glass of water
Bi stimulazzjoni sesswali jista ’ jkollok erezzjoni minn 25 minuta sa 4 jew 5 sigħat wara li tieħu l- pillola Vivanza. • Ibla ’ pillola waħda ma 'tazza ilma
Don’ t use Vivanza more than once a day.
Tieħux Vivanza aktar minn darba kuljum.
63 Tell the doctor if you think Vivanza is too strong or too weak.
Jekk tħoss li l- effett ta ’ Vivanza huwa qawwi jew dgħajjef wisq, kellem lit- tabib.
Each tablet contains 20 mg of vardenafil (as hydrochloride
Kull pillola fiha 20 mg vardenafil (bħala hydrochloride
What Vivanza looks like and contents of the pack Vivanza 20 mg film-coated tablets are orange with the BAYER cross on one side and the strength (20) on the other side.
Id- Dehra ta ’ Vivanza u l- kontenuti tal- pakkett Vivanza 20 mg pilloli miksija b’ rita huma oranġjo immarkata b ’ ‘ v ’ fuq l- oħra.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
67 Għall kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHA TIĠI IMPLIMENTATA MILL- ISTATI MEMBRI KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHA TIĠI IMPLIMENTATA MILL- ISTATI MEMBRI
The Member States shall ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri għandhom jassiguraw li l- kundizzjonijiet jew restrizzjonijiet kollha dwar l- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritt hawn taħt ikunu implimentati.
The Member States shall agree details of the implementation of the post-marketing surveillance study in each member state with the MAH and ensure that it is put in place prior to marketing of the product.
L- Istati Membri għandhom jaqblu fuq dettalji ta ’ l- implimentazzjoni ta ’ sorveljanza wara t - tqegħid fis- suq ma ’ l- MAH f’ kull stat membru u jassiguraw li tkun stabbilita qabel il- prodott ikun fis- suq.
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that prior to prescribing (and at the discretion of the Member State, dispensing) all health care professionals who intend to prescribe (and where appropriate, dispense) Volibris have been provided with the following:
L- Istati Membri għandhom jaqblu fuq id- dettalji ta’ sistema ta ’ distribuzzjoni kontrollata ma ’ l- MAH skond ir- regolamenti nazzjonali u sistemi ta ’ kura tas- saħħa u jassiguraw li tkun implimentata fuq livell nazzjonali biex qabel ma jippreskrivuha (u fuq id- diskrezzjoni ta ’ l - Istat Membru, jagħtu l- mediċina) il- professjonisti kollha fil- qasam tas- saħħa li jkollhom l - intenzjoni li jippreskrievu (u fejn ikun xieraq, jagħtu l- mediċina) Volibris jkollhom dan li ġej:
Product information (Summary of Product Characteristics (SPC) and Package Leaflet) Healthcare professional information regarding Volibris Pre-prescription checklist for physicians Information about the post marketing surveillance study Information booklets for patients Information booklets for male partners of female patients with childbearing potential Patient reminder cards Pregnancy reporting forms Adverse drug reaction reporting forms
Informazzjoni fuq Volibris għall- professjonisti fil- qasam tas- saħħa Lista biex it- tabib jiċċekkja qabel jippreskrivi Informazzjoni dwar l- studju ta ’ sorveljanza wara t- tqegħid fis- suq Kotba żgħar ta ’ informazzjoni għall- pazjenti Kotba żgħar ta ’ informazzjoni għas- sieħba rġiel ta ’ pazjenti nisa li jista ’ jkollhom it- tfal Cards biex ifakkru lil pazjent Formoli biex tirraporta waqt it- tqala Formoli biex tirraporta effetti avversi ta ’ mediċina
The Member States shall ensure that the following key elements are included in the appropriate material and that the material is not promotional.
L- Istati Membri għandhom jassiguraw li dawn l- elementi kruċjali li ġejjin ikunu nklużi f’ materjal addattat u li dan il- materjal ma jkunx promozzjonali
Health care Professional information The healthcare professional information regarding Volibris should contain the following key elements:
Informazzjoni lil Professjonisti fil- qasam tas- saħħa L- informazzjoni fuq Volibris għall- professjonisti fil- qasam tas- saħħa għandu jkollha dawn l- elementi kruċjali li ġejjin:
Obligations of health care professionals in relation to the prescribing of Volibris: o That patients should be capable of complying with the requirements for the safe use of Volibris. o The need to provide comprehensive advice and counselling to patients. o The need to provide patients with the appropriate information booklet(s) and patient reminder card. o Should consider monthly prescription of 30 day supply to ensure that patients and key test results are reviewed prior to further prescription. o That the safety database of Volibris is limited and physicians are encouraged to enrol patients in a post marketing surveillance study. o To report suspected adverse reactions and pregnancy.
L- obbligazzjonijiet tal- professjonisti fil- qasam tas- saħħa fejn għandu x’ jaqsam il- preskrizzjoni ta ’ Volibris: o Li l- pazjenti għandhom ikunu kapaċi li jħarsu il- ħtiġijiet għall- użu mingħajr periklu ta ’ Volibris: o Il- bżonn li jkun provdut tagħrif u parir komprensiv lil pazjent o Il- bżonn li l- pazjenti ikunu provduti bi ktieb/ kotba żgħar ta ’ nformazzjoni adatti u l - card biex tfakkar lil- pazjent. o Li għanda tkun ikkonsidrata riċetta ta ’ xahar għal provediment ta ’ 30 ġurnata biex ikun assigurat li l- pazjenti u r- riżultati ta ’ testijiet importanti ikunu ċċekkjati qabel riċetti oħra jingħataw. o Li d- database ta ’ sigurta ’ ta ’ Volibris huwa limitat u li jiġu nkuraġġuti t- tobba biex idaħħlu aktar pazjenti fi studju ta ’ sorveljanza wara t- tqegħid fis- suq o Biex jirrapurtaw effetti avversi suspetti u tqala.
That Volibris is teratogenic o Volibris is contraindicated in pregnancy and in women of child bearing potential who are not using reliable contraception. o That women receiving Volibris should be advised of the risk of foetal harm. o Guidance for identifying women of child bearing potential and the actions the physician should take if unsure.
Li Volibris huwa teratoġeniku o Volibris huwa kontraindikat fit- tqala u f’ nisa li jista 'jkollhom it- tfal u li ma humiex qegħdin jużaw kontraċezzjoni ta' min joqgħod fuqha. o Li nisa li jkunu qegħdin jieħdu Volibris għandhom ikunu mwissija fuq ir- riskju ta ’ ħsara lil- fetu.
2/4 F or women with childbearing potential
2/ 4 Gwida biex ikunu identifikati nisa li jista ’ jkollhom it- tfal u l- azzjonijiet li għandu o jieħu t- tabib jekk ma jkunx ċert.
Exclusi on of pregnancy prior to treatment initiation and monthly pregnancy testing during treatment.
Għal nisa li jista ’ jkollhom it- tfal Għandha tiġi eskluża t- tqala qabel ma tinbeda l- kura u għandhom isiru testijiet tat - o tqala kull xahar waqt il- kura.
The need t o advise women (even if a woman has amenorrhoea) on the use of reliable contraception during treatment and for one month following permanent discontinuation of treatment.
Il- bżonn li jingħata parir lin- nisa (ukoll jekk mara ikollha amenorrea) fuq l- użu ta ’ o kontraċezzjoni ta ’ min joqgħod fuqha waqt il- kura u għal xahar wara li t- trattament jieqaf għal kollox.
Definiti on of reliable contraception and the need to seek expert advice if unsure what is suitable for an individual patient.
Definizzjoni ta ’ kontraċezzjoni ta ’ min joqgħod fuqha u l- bżonn li jitfittex parir espert o fejn ma jkunx hemm ċertezza ta ’ x’ inhu adatt għal pazjent individwali.
That if a w omen of childbearing potential needs to change or stop her method of contraception she should inform: − The physician prescribing her contraception that she is taking Volibris − The physician prescribing Volibris that she has changed or stopped her method of contraception.
Li jekk mara li jista ’ jkollha t- tfal ikollha bżonn tibdel jew twaqqaf il- metodu ta ’ o kontraċezzjoni tagħha hi għandha tinforma: − It- tabib li jippreskrivi l- kontraċezzjoni li qed tieħu Volibris − It- tabib li jippreskrivi Volibris li hi bidlet jew waqfet il- metodu ta ’ kontraċezzjoni tagħha Li l- pazjenta għandha tikkuntatja lit- tabib tagħha immedjatament jekk tissusspetta li o ħarġet tqila u għandu jinbeda trattament ieħor jekk tkun konfermata t- tqala.
That the patient sh ould contact her doctor immediately if pregnancy is suspected and that alternative therapy should be initiated if pregnancy confirmed.
Il- bżonn li jirreferu pazjenti li joħorġu tqal għand tabib speċjaliżżat jew b’ esperjenza o fit- teratoloġija u d- dijanjożi tagħha għal evalwazzjoni u parir.
To report all cases of pregnancy occurring during therapy.
Biex jirrapurtaw il- każi kollha ta ’ tqala li jseħħu waqt il- kura. o
• That Volibris is potentially hepatotoxic o Contraindication in patients with severe hepatic impairment (with or without cirrhosis) and in patients with baseline values of hepatic aminotransferases (AST and/or ALT) > 3X ULN. o Hepatic aminotransferases (ALT and/or AST) should be evaluated prior to initiation of ambrisentan. o During therapy, monthly monitoring of ALT and AST is recommended. o Discontinuation of ambrisentan therapy if patients develop sustained, unexplained clinically significant ALT and/or AST elevation or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice). o In subjects without clinical symptoms of hepatic injury or jaundice, reinitiation of ambrisentan may be considered following resolution of hepatic enzyme abnormalities.
• Li Volibris huwa potenzjalment tossiku għall- fwied o Mhux indikat f’ pazjenti b' indeboliment sever tal- fwied (bi jew mingħajr ċirrożi) u f’ pazjenti li għandhom il- valuri l- linja bażi ta’ aminotransferases tal- fwied (AST u/ jew ALT) > 3xULN. o Għalhekk għandhom jiġu evalwati l- aminotransferases tal- fwied (ALT u/ jew AST) qabel jinbeda ambrisentan. o Waqt il- kura, huwa rrakkomandat osservazzjoni kull xahar ta 'ALT u AST waqt il - kura. o Titwaqqaf il- kura b' ambrisentan jekk il- pazjenti jiżviluppaw żieda sostenuta, mhux spjegabbli u klinikament sinifikanti ta' ALT u/ jew AST, jew jekk żieda f' ALT u/ jew AST hija akkumpanjata b' sinjali jew sintomi ta 'ħsara fil- fwied (e. ż. suffejra). o F' pazjenti mingħajr sintomi kliniċi ta' ħsara fil- fwied jew suffejra, tista tiġi kkunsidrata il- possibilita 'li jerġa jinbeda ambrisentan wara li l- abnormalitajiet fl - enżimi tal- fwied jitranġaw.
The advice of a hepatologist is recommended.
Huwa rakkomandat il- parir ta 'epatologu.
• That treatment with Volibris often causes a decrease in haemoglobin and haematocrit o Initiation of Volibris is not recommended for patients with clinically significant anaemia. o Patients taking Volibris should have their haemoglobin and/or haematocrit levels measured regularly. o If tests show a clinically significant decrease in haemoglobin or haematocrit, and other causes have been excluded, consider reducing the dose of Volibris, or stopping treatment.
• Il- kura b’ Volibris ħafna drabi tikkawża nuqqas fl- emoglobina u l- ematokrit o M' huwiex rakkomandat bidu ta 'kura b' Volibris f' pazjenti b' anemija klinikament sinifikanti. o Pazjenti li qed jieħdu Volibris għandhom jkollhom il- livelli ta ’ emoglobina u/ jew l - ematokrit iċċekkjati regolarment. o Għandu jiġi kkunsidrat tnaqqis fid- doża ta ’ Volibris jew twaqqif tal- kura jekk testijiet juru tnaqqis klinikament sinifikanti fl- emoglobina jew l- ematokrit u kawżi oħra ikunu ġew esklużi.
• That treatment with Volibris causes peripheral oedema and fluid retention o If a patient develops clinically significant peripheral oedema, with or without associated weight gain, carry out further evaluation to determine the cause and if appropriate consider discontinuation of Volibris.
• Il- kura b’ Volibris tagħmel edema periferali u ritenzjoni ta ’ fluwidu o Jekk pazjent jiżviluppa edema periferali klinikament sinifikanti bi jew mingħajr żieda assoċjata fil- piż, għamel aktar evalwazzjoni biex issib il- kawża u jekk ikun hemm bżonn ikkunsidra li twaqqaf Volibris.
• That chronic administration of Volibris in animals has been linked to testicular tubular atrophy and impaired fertility.
• L- għoti kroniku ta ’ Volibris fl- annimali ġie assoċjat ma ’ atrofija tat- tubi tat- testikoli u nuqqas ta ’ fertilita ’.
The effect of Volibris on human testicular function and male fertility is not known.
Mhux magħruf l- effett ta 'Volibris fuq il- funzjoni tat- testikola umana u l- fertilita' ta 'l- uman maskil.
• That Volibris should be initiated with caution in patients with severe renal impairment.
3/ 4 • Li Volibris għandu jinbeda b’ kawtela f’ pazjenti b’ indebboliment serju tal- kliewi.
• That hypersensitivity reactions, although uncommon, have been reported with Volibris.
Il- lista li juża t- tabib biex jiċċekkja qabel jagħmel ir- riċetta turi aktar
3/4 Physician checklist The physician pre-prescription checklist will highlight the contraindications to the use of ambrisentan and important pre-prescription assessments including: • Liver function tests. • Determination of child bearing potential in female patients. • Pregnancy test if female patient with childbearing potential. • That women of child bearing potential are on reliable contraception.
kontraindikazzjonijiet għal użu ta ’ ambrisentan u affarijiet importanti li għandhom ikunu iċċekkjati qabel ir- riċetta tingħata li jinkludu: • Testijiet tal- funzjoni tal- fwied. • Isir jaf jekk pazjenti nisa jistax ikollhom tfal. • Test tat- tqala jekk pazjenta mara jista ’ jkollha t- tfal. • Li nisa li jista 'jkollhom it- tfal qegħdin jużaw kontraċezzjoni ta' min joqgħod fuqha.
Patient information The information for patients should include the following information: • That Volibris may cause serious birth defects in unborn babies conceived before, during, or within a month after stopping treatment. • That Volibris cannot be initiated if patient is pregnant. • Women with childbearing potential must have a pregnancy test immediately prior to the first prescription and at monthly intervals whilst taking Volibris. • The need to ensure that women of child bearing potential are using reliable contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued. • That if a women of childbearing potential needs to change or stop her method of contraception she should inform: o The physician prescribing her contraception that she is taking Volibris o The physician prescribing Volibris that she has changed or stopped her method of contraception • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant. • The need for the patient to discuss with her doctor if she is planning to become pregnant. • That Volibris may cause liver injury. • That because of the potential for liver injury and anaemia, patients should have regular blood tests and also tell their doctor if experiencing any symptoms of liver injury. • That the patient should not give Volibris to any other person. • That the patient should tell their doctor about any adverse event.
Informazzjoni għall- pazjent L- informazzjoni għall- pazjenti għandha tinkludi l- informazzjoni li ġejja: • Li Volibris jista 'jagħmel ħsara serja lil- trabi mhux imwielda li l- konċepiment tagħhom ikun sar qabel, waqt jew fi żmien xahar wara li t- trattament ikun waqaf. • Li ma jistax jinbeda Volibris jekk pazjenta tkun tqila. • Nisa li jista ’ jkollhom it- tfal għandu jkollhom test tat- tqala mill- ewwel qabel l- ewwel riċetta u kull xahar waqt li jkunu qed jieħdu Volibris. • Il- bżonn li jkun żgurat li nisa li jista' jkollhom tfal qed jużaw ta 'kontraċettiv ta' min joqgħod fuqu u l- pazjenti għandhom jinfurmaw lit- tabib tagħhom dwar xi possibilita ’ ta ’ tqala qabel toħroġ kull riċetta ġdida. • Li jekk mara li jista ’ jkollha t- tfal ikollha bżonn tibdel jew twaqqaf il- metodu ta ’ kontraċezzjoni tagħha hi għandha tinforma: o It- tabib li jippreskrivila il- kontraċezzjoni li qed tieħu Volibris o It- tabib li jippreskrivi Volibris li hi bidlet jew waqfet il- metodu ta ’ kontraċezzjoni tagħha • Il- bżonn ta ’ pazjenti nisa biex jikkuntatjaw lit- tabib kuranti tagħhom immedjatament jekk jissusspettaw li jistgħu ikunu tqal. • Il- bżonn li pazjenta tiddiskuti mat- tabib tagħha jekk qed tippjana li toħroġ tqila. • Li Volibris jista ’ jagħmel ħsara fil- fwied. • Li minħabba il- possibilita ’ ta ’ ħsara fil- fwied u anemija, il- pazjenti għandu jkollhom testijiet regolari tad- demm u jgħidu lit- tabib tagħhom ukoll jekk jesperjenzaw xi sintomi ta ’ ħsara tal - fwied. • Li l- pazjent m’ għandux jagħti Volibris lil xi persuna oħra. • Li l- pazjent għandu jgħid lit- tabib tiegħu fuq xi event avvers.
Booklet for male partners of women with childbearing potential The information for male partners of women with childbearing potential should include the following information: • That Volibris may cause serious birth defects in unborn babies conceived before, during, or within a month after stopping treatment. • The need to ensure that women of child bearing potential are using reliable contraception. • That Volibris cannot be taken if a woman is or might become pregnant.
Kotba żgħar ta ’ nformazzjoni għas- sieħba ta ’ pazjenti nisa li jista ’ jkollhom it- tfal L- informazzjoni għas- sieħba ta ’ pazjenti li jista ’ jkollhom it- tfal għandha tinkludi l- informazzjoni li ġejja: • Li Volibris jista 'jagħmel ħsara serja lil- trabi mhux imwielda li l- konċepiment tagħhom ikun sar qabel waqt jew fi żmien xahar wara li t- trattament ikun waqaf. • Il- bżonn li tassigura li nisa li jista' jkollhom it- tfal qegħdin jużaw kontraċezzjoni ta 'min joqgħod fuqha. • Li ma jistax jittieħed Volibris jekk pazjenta tkun jew tista ’ toħroġ tqila.
Patient reminder card • This should include key messages regarding the need for regular blood and pregnancy tests and provide spaces for the dates of appointments and the results of tests.
Cards biex ifakkru lil pazjent • Din għandu jkollha messaġġi kruċjali fuq il- bżonn ta ’ testijiet regolari tad- demm u tat- tqala u jkollha postijiet għad- dati ta ’ l- appuntamenti u r- riżultati tat- testijiet.
What is Volibris?
X' inhu Volibris?
Volibris is a medicine containing the active substance ambrisentan.
Volibris huwa mediċina li fiha s- sustanza attiva ambrisentan.
It is available as tablets (pale pink, square:
Jiġi bħala pilloli (roża ċari, kwadri:
5 mg; deep pink, oval:
5 mg; roża skuri, ovali:
What is Volibris used for?
Għal xiex jintuża Volibris?
Volibris is used for the treatment of patients with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Volibris jintuża għat- trattament ta 'pazjenti li jbatu minn ipertensjoni arterjali pulmonari (PAH) biex itejjeb il- kapaċità għall- eżerċizzju (jiġifieri l- possibbiltà li jsir eżerċizzju fiżiku).
PAH is abnormally high blood pressure in the arteries of the lungs.
Il- PAH hija pressjoni għolja tad- demm fl- arterji tal- pulmuni.
Volibris is used in patients with class II or III disease.
Volibris jintuża f' pazjenti b' mard ta 'klassi II jew III.
The ‘ class ’ reflects the seriousness of the disease: ‘ class II ’ involves slight limitation of physical activity and ‘ class III’ involves marked limitation of physical activity.
Il - 'klassi' tirrifletti l- gravità ta- marda: 'klassi II' tinvolvi ftit limitazzjoni ta 'attività fiżika u' klassi III 'tinvolvi limitazzjoni qawwija ta' l- attività fiżika.
The effectiveness of Volibris has been shown in PAH with no identified cause and in PAH caused by connective tissue disease.
L- effikaċja ta 'Volibris fil- PAH intweriet mingħajr ma ġiet identifikata kawża u f' PAH ikkawżata minn mard tat- tessut konnettiv.
Because the number of patients with PAH is low, the disease is considered ‘ rare’, and Volibris was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 11 April 2005.
Minħabba li n- numru ta 'pazjenti li jbatu mill- PAH huwa wieħed baxx, il- marda hija kkunsidrata' rari ', u fil- 11 April 2005, Volibris kien iddiżinjat bħala' mediċina orfni '(mediċina li tintuża f' mard rari).
How is Volibris used?
Kif jintuża Volibris?
Treatment with Volibris must be initiated by a doctor who has experience in the treatment of PAH.
It- trattament b' Volibris jeħtieġ li jinbeda minn tabib b' esperjenza fit- trattament tal- PAH.
The standard dose of Volibris is 5 mg once a day.
Id- doża standard ta 'Volibris hija 5 mg darba kuljum.
The tablets should be swallowed whole, with or without food.
Il- pilloli għandhom jinbelgħu sħaħ, ma 'l- ikel jew fuq stonku vojt.
A 10 mg dose may have a greater effect in patients with class III disease but this is associated with an increased risk of fluid retention and swelling.
Doża ta '10 mg jista' jkollha iżjed effett f' pazjenti b' mard tal- klassi III iżda din hija assoċjata ma 'żieda fir- riskju ta' żamma ta 'fluwidi u nefħa.
Patients with PAH caused by connective tissue disease may also need to take 10 mg to get the best benefit from Volibris.
Il- pazjenti bil- PAH ikkaġunata minn mard tat- tessut konnettiv jaf ukoll ikollhom bżonn jieħdu 10 mg biex jiksbu l- aqwa benefiċċju minn Volibris.
The dose should only be increased if the 5 mg dose is well tolerated.
Id- doża għandha tiżdied biss jekk id- doża ta '5 mg tkun ittollerata sewwa.
Volibris is not recommended for use in patients below 18 years of age because of a lack of information on safety and effectiveness in this group.
Volibris mhuwiex rakkomandat f' pazjenti taħt it- 18- il sena minħabba nuqqas ta 'tagħrif fuq is- sigurtà u l- effikaċja f' dan il- grupp.
In patients who have severe problems with their kidneys, treatment with Volibris should be started with caution, and a dose increase should be carried out with particular care.
F' pazjenti li għandhom problemi gravi bil- kliewi tagħhom, it- trattament b 'Volibris għandu jinbeda b' kawtela, u ż- żieda fid- doża għandha ssir b' attenzjoni partikolari.
Volibris should not be used in patients who have severe liver problems as it has not been studied in this group.
Volibris ma għandux jintuża f' pazjenti li għandhom problemi gravi tal- fwied minħabba li ma ġiex studjat f' dan il- grupp.
How does Volibris work?
Kif jaħdem Volibris?
PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Il- PAH hija marda li ddgħajjef fejn hemm tidjieq gravi tal- vażi tad- demm tal- pulmuni.
It causes high blood pressure in the vessels taking blood from the heart to the lungs.
Din il- pressjoni tnaqqas l- ammont ta 'ossiġenu li jista' jidħol fid- demm fil- pulmuni, li jagħmel attività fiżika aktar diffiċli.
The active substance in Volibris, ambrisentan, blocks the receptors for a hormone called endothelin, which causes blood vessels to constrict.
Is- sustanza attiva f' Volibris, ambrisentan, timblokka r- riċetturi għal ormon imsejjaħ endothelin, li jikkawża t- tidjieq tal- vażi tad- demm.
By blocking the effect of endothelin, Volibris allows the vessels to dilate (expand), helping to lower the blood pressure and improving symptoms.
Billi jimblokka l- effett ta 'endothelin, Volibris iħalli l- vażi jinfetħu (jespandu), u jgħin biex ibaxxi l- pressjoni tad- demm u jtejjeb is- sintomi.
How has Volibris been studied?
Kif ġie studjat Volibris?
The effects of Volibris were first tested in experimental models before being studied in humans.
L- effetti ta 'Volibris ġew ittestjati l- ewwel f' mudelli sperimentali qabel ma ġew studjati fuq il - bnedmin.
The effectiveness of Volibris was studied in two main studies involving a total of 394 patients with PAH, most of whom had class II or III disease (slight or marked limitation of physical activity).
L- effikaċja ta 'Volibris ġiet studjata f' żewġ studji ewlenin li involvew total ta' 394 pazjent li jbatu mill - PAH, li l- parti l- kbira tagħhom kellhom il- marda tal- klassi II jew III (limitazzjoni ħafifa jew sinifikanti ta 'l- attività fiżika).
The studies compared various doses of Volibris (2.5, 5 and 10 mg) with placebo (a dummy treatment).
L- istudji qabblu diversi dożi ta 'Volibris (2. 5, 5 u 10 mg) mal- plaċebo (trattament finta).
The main measure of effectiveness was the change in the distance the patients could walk in six minutes after 12 weeks of treatment.
Il- kejl ewlieni ta 'l- effikaċja kien il- bidla fid- distanza li setgħu jimxu l- pazjenti f' sitt minuti wara trattament ta' 12- il ġimgħa.
This is a way of measuring the change in exercise capacity.
Dan huwa mod kif titkejjel il- bidla fil- kapaċità għall - eżerċizzju.
What benefit has Volibris shown during the studies?
X' benefiċċju wera Volibris waqt l- istudji?
Volibris was more effective than placebo at improving exercise capacity in patients with class II or III disease.
Volibris kien aktar effikaċi mill- plaċebo fit- titjib tal- kapaċità għall- eżerċizzju f' pazjenti b' mard tal - klassi II jew III.