qanastek/EMEA-V3 huggingface dataset:
Rapid administration of 2.0 mg/ kg of verteporfin at a rate of 7 ml/ minute to anaesthetised pigs resulted in haemodynamic effects and sometimes rapid death, occurring within 2 minutes of drug administration.
L- għotja mgħaġġla ta ’ 2. 0 mg/ kg ta ’ verteporfin b’ rata ta ’ 7 ml/ minuta fi ħnieżer illuppjati rriżulta f’ effetti emodinamiċi u xi kultant mewt f’ daqqa, fi żmien 2 minuti minn x’ ħin ingħatat il- mediċina.
Similar effects were observed in sedated pigs.
Effetti simili ġew osservati fi ħnieżer mogħtija l- kalmanti.
Pre-dosing with diphenhydramine diminished these effects, suggesting that histamine may play a role in this process.
Meta ngħata diphenhydramine minn qabel dawn l- effetti naqsu li jissuġġerixxi li histamine jista ’ jieħu sehem f’ dan il- proċess.
Non-anaesthetised non-sedated animals were not affected by these dosing parameters.
Bhejjem mhux illuppjati jew mingħajr kalmanti ma ġewx affettwati minn dawn il- parametri ta ’ dożaġġ.
No changes were recorded in either conscious or anaesthetised dogs receiving 20 mg/ kg verteporfin at an infusion rate of 5 ml/ minute.
L- ebda bidliet ma ġew irrappurtati fi klieb konxji jew fi klieb taħt loppju li kienu qed jirċievu 20 mg/ kg verteporfin b’ rata ta ’ infużjoni ta ’ 5 ml/ minuta.
The effects may result from complement activation.
L- effetti setgħu kienu riżultat ta ’ attivazzjoni komplementari.
Verteporfin at more than 5 times the expected maximum plasma concentration in treated patients, caused a low level of complement activation in human blood in vitro.
Verteporfin f’ konċentrazzjonijiet ta ’ aktar minn 5 darbiet akbar mill- konċentrazzjoni massima tal - plażma mistennija, ikkawża livell baxx ta ’ attivazzjoni komplementari f’ demm tal- bniedem in vitro.
Levels of ocular toxicity in normal rabbits and monkeys, particularly on the retina/ choroid, correlated with drug dose, light dose, and time of light treatment.
Livelli ta ’ tossiċità okulari fi fniek u xadini normali, partikolarment fuq ir- retina/ korojd, ikkorrelatw mad- doża ta ’ mediċina, id- doża ta ’ dawl, u l- ħin ta ’ kura bid- dawl.
A retinal toxicity study in normal dogs with intravenous verteporfin and ambient light on the eye showed no treatment-related ocular toxicity.
Studju ta ’ tossiċità fir- retina fuq klieb normali b’ verteporfin minn ġol- vini u b’ dawl normali fl- għajn ma wera l- ebda tossiċità okulari marbuta mal- kura.
In an embryotoxicity study rat foetuses of dams given greater than approximately 67 times the recommended human dose (based on AUC) had increasing incidences of anophthalmia/ microphthalmia, wavy ribs and foetal alterations.
Fi studju dwar it- tossiċità fuq l- embriju, feti ta ’ firien minn ommijiet mogħtija doża li kienet aktar minn madwar 67 darba d- doża rikmandata għall- bniedem, kellhom inċidenzi akbar ta ’ anoftalmija / mikroftalmija, kustilji mbewqa u alterazzjonijiet tal- fetu.
No teratogenicity was observed in foetuses from rabbits given 67 times the recommended human dose.
L- ebda teratoġeniċità ma ġiet osservata f’ feti ta ’ fniek mogħtija doża 67 darba aktar mid- doża rrikmandata għall- bniedem.
Verteporfin was not genotoxic in the absence or presence of light in the usual battery of genotoxic test.
Verteporfin ma kienx ġenotossiku fin- nuqqas jew preżenza ta ’ dawl fil- batterija tas- soltu ta ’ test ġenotossiku.
Immunomodulatory effects have been observed in mice.
Ġew osservati effetti immunomodulatorji fil- ġrieden.
Whole body light activation within 3 hours of verteporfin administration beneficially modified the course of several immunologically mediated pathological conditions and diminished normal-skin immune responses without causing skin reactivity or generalised non-specific immune suppression.
Attivazzjoni ta ’ dawl fuq il- ġisem kollu fi żmien 3 sigħat li ngħata verteporfin immodifika b’ mod ta ’ benefiċċju l- kors ta ’ bosta kondizzjonijiet patoloġiċi medjati immunoloġikament u naqqas reazzjonijiet immunitarji ta ’ ġilda normali bla ma kkaġuna reattività tal- ġilda jew soppressjoni immunitarja ġenerali mhux speċifika.
Lactose monohydrate Egg phosphatidylglycerol Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)
Lactose monohydrate Phosphatidylglycerol tal- bajd Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)
Visudyne precipitates in saline solutions.
Visudyne jippreċipita f’ soluzzjoni tal- melħ.
Do not use normal saline or other parenteral solutions.
Tużax soluzzjoni tal- melħ normali jew taħlitiet oħra parenterali.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Fin- nuqqas ta ’ studji ta ’ kompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti medċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
Shelf-life in the sealed vial:
Żmien kemm idum tajjeb fil- kunjett issiġillat:
4 years Shelf-life after reconstitution and dilution:
4 snin Żmien kemm idum tajjeb wara rikostituzzjoni u dilwizzjoni:
Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
L- istabilità kimika u fiżika waqt l- użu intweriet għal 4 sigħat f’ 25°C.
If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and would normally not last longer than 4 hours below 25°C protected from light.
6. 4 Prekawzjonijiet speċjali għall- ħażna
After reconstitution and dilution: see section 6.3.
Wara r- rikostituzzjoni u dilwizzjoni: ara sezzjoni 6. 3.
Powder in glass vial (type I), sealed with butyl stopper and aluminium cap.
Trab f’ kunjett tal- ħġieġ, issiġillat b’ tapp tal- butyl u għatu ta ’ l- aluminium.
Reconstituted Visudyne is an opaque dark green solution.
Irrikostitwixxi Visudyne f’ 7. 0 ml ta ’ ilma għall- injezzjonijiet biex tagħmel 7. 5 ml ta ’ soluzzjoni ta ’ 2. 0 mg/ ml.
It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration.
Visudyne rikostitwit huwa soluzzjoni ħadra skura opaka. Huwa rakkomandat li Visudyne ikun mifli għal xi frak jew telf ta ’ kulur qabel jingħata.
For a dose of 6 mg/ m2 body surface (see section 4.2) dilute the required amount of Visudyne solution in 5% Glucose for Injection to a final volume of 30 ml.
Għal doża ta ’ 6 mg/ m2 tas- superfiċje tal- ġisem (ara sezzjoni 4. 2) iddilwixxi l- ammont meħtieġ ta ’ soluzzjoni Visudyne f’ 5% Glucose għall- injezzjoni għall- volum finali ta ’ 30 ml.
Do not use saline solution (see section 6.2).
Tużax soluzzjoni tal- melħ (ara sezzjoni 6. 2).
Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μ m is recommended.
Użu ta ’ filtru standard tal - linja ta ’ infużjoni b’ membrani idrofiliċi (bħal polyethersulfone) b’ pori ta ’ daqs mhux anqas minn 1. 2 μm huwa rrikmandat.
The vial and any unused portion of reconstituted solution should be discarded after single use.
Il- kunjett u kwalunkwe parti tas- soluzzjoni rikostitwita li ma tintużax għandha tintrema wara li tintuża darba.
If material is spilled, it should be contained and wiped up with a damp cloth.
Jekk jinxtered il- materjal, għandu jinġabar u jintmesaħ b’ ċarruta niedja.
Eye and skin contact should be avoided.
Kuntatt ma ’ l- għajnejn u l - ġilda għandu jiġi evitat.
Use of rubber gloves and eye protection is recommended.
Huwa rrikmandat l- użu ta ’ ingwanti tal- lasktu u protezzjoni ta ’ l- għajnejn.
All materials should be disposed of properly.
Għandek tarmi il- materjali kollha kif jixraq.
27 July 2000 Date of first renewal:
27 Lulju 2000 Data ta ’ l- ewwel tiġdid:
27 July 2005
27 Lulju 2005
Name and address of manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
26, rue de la Chapelle F-68333 Huningue Cedex France
26, rue de la Chapelle F- 68333 Huningue Cedex Franza
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 dated 30 June 2008 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Il- MAH għandu jaċċerta ruħu li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 1. 0 iddatat 30 Ġunju 2008 ppreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun f’ lokha u taħdem qabel u waqt li l- prodott ikun fis- suq.
Visudyne 15 mg powder for solution for infusion Verteporfin
Visudyne 15 mg trab għal soluzzjoni għall- infużjoni Verteporfin
Lactose monohydrate, dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321).
Lactose, dimyristoyl phosphatidylcholine, phosphatidylglycerol tal- bajd, ascorbyl palmitate, butylated hydroxytoluene (E321).
Box containing 1 vial of powder.
Kaxxa b’ kunjett 1 ta ’ trab.
Do not dissolve in saline.
Tħollux fl- ilma bil- melħ.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) SPEĊJALI OHRA, JEKK MEĦTIEĠA
Shelf-life after reconstitution and dilution: see package leaflet.
Żmien kemm idum tajjeb wara li jitħallat u jiġi dilwit: ara l- fuljett ta ’ tagħrif.
Visudyne 15 mg powder for solution for infusion Verteporfin Intravenous use
Visudyne 15 mg trab għal soluzzjoni għall- infużjoni Verteporfin Użu għal ġol- vini
Each vial contains 15 mg of verteporfin
Kull kunjett fih 15 mg ta ’ verteporfin
Visudyne 15 mg powder for solution for infusion verteporfin
Visudyne 15 mg trab għal soluzzjoni għall- infużjoni verteporfin
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, lill- ispiżjar jew lill- infermier tiegħek.
please tell your doctor or nurse.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew l- infermier tiegħek.
What Visudyne is and what it is used for 2.
X’ inhu Visudyne u għalxiex jintuża 2.
Before you are given Visudyne 3.
Qabel ma tingħata Visudyne 3.
How Visudyne is used 4.
Kif għandek tuża Visudyne 4.
How to store Visudyne 6.
Kif taħżen Visudyne 6.
WHAT VISUDYNE IS AND WHAT IT IS USED FOR
X’ INHU VISUDYNE U GĦALXIEX JINTUŻA
Visudyne is a light-activated medicinal product used in photodynamic therapy.
Visudyne huwa prodott mediċinali li jiġi attivat bid- dawl li jintuża f’ terapija fotodinamika.
It is used for the treatment of the wet form of age-related macular degeneration (AMD) and pathological myopia (PM).
Hu jintuża għall- kura ta ’ diġenerazzjoni makulari marbuta ma ’ l- età (AMD) - wet form u mijopija patoloġika (PM).
These diseases lead to vision loss due to damage of the retina caused by ingrowth of blood vessels, called choroidal neovascularisation (CNV).
Dan il- mard iwassal għal telf ta ’ vista minnħabba ħsara fir- retina kkawżata minn vini tad- demm li jikbru ’ l ġewwa, imsejħa neovaskularizzazzjoni korojdali (CNV).
There are two types of CNV, known as classic CNV and occult CNV, which can be identified by fluorescein angiography.
Hemm żewġ tipi ta ’ CNV, magħrufa bħala CNV klassika u CNV okkulta, li jistgħu jiġu identifikati permezz ta ’ anġjografija fluworexxenti.
Visudyne is used for the treatment of predominantly classic CNV in AMD patients, and of all types of CNV in pathological myopia patients.
Visudyne jintuża għal kura ta ’ CNV prinċipalment klassika f’ pazjenti b’ AMD, u ta ’ kull tip ta ’ CNV f’ pazjenti b’ mijopija patoloġika.
BEFORE YOU ARE GIVEN VISUDYNE
QABEL MA TINGĦATA VISUDYNE
You should not be given Visudyne:
M’ għandekx tingħata Visudyne:
- if you are allergic (hypersensitive) to verteporfin or any of the other ingredients of Visudyne.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal verteporfin jew sustanzi oħra ta ’
- if you have porphyria.
- jekk għandek porfirja.
- if you have a severe liver impairment.
- jekk għandek indeboliment qawwi tal- fwied.
Take special care with Visudyne:
Oqgħod attent ħafna b’ Visudyne:
- Tell your doctor if you have any illnesses or are receiving any medication.
- Itlob il- parir tat- tabib tiegħek jekk għandek xi mard jew qed tirċievi xi medikazzjoni.
Your doctor needs to
Jeħtieġ li
take this into account when he/ she is treating you.
t- tabib tiegħek iqis dan meta jkun/ tkun qed j/ tikkurak.
- If you experience any problems during the treatment, please tell your doctor or nurse.
- Jekk waqt il- kura jkollok xi problemi, jekk jogħġbok għid lit- tabib jew infermier tiegħek.
- If, during the infusion, Visudyne goes outside the vein, and especially if the affected area is
- Jekk waqt l- infużjoni, Visudyne imur barra l- vina, u speċjalment jekk l- erja effettwata tkun
exposed to light, this can cause pain, swelling, blistering and a change in skin colour in the area of the leakage.
esposta għad- dawl, dan jista ’ jikkawża uġigħ, nefħa u bidla fil- lewn tal- ġilda fil- parti fejn kien hemm it- tnixxija.
If this happens, the infusion needs to be stopped and the skin treated with cold compresses and thoroughly protected from light until the skin colour returns to normal.
Jekk jiġri dan, l- infużjoni trid titwaqqaf u l- ġilda għandha tiġi kkurata b’ pakkett kiesaħ u għandha tkun protetta sew mid- dawl sakemm il- lewn tal- ġilda jerġa ’ lura għan- normal.
You may need to take a painkiller.
Jista ’ jkollok bżonn tieħu pillola għall- uġigħ.
- You will be sensitive to bright light for 48 hours after the infusion.
- Se tkun sensittiv għal dawl qawwi għal 48 siegħa wara l- infużjoni.
During that time, avoid
Matul dan il- ħin, trid tevita
exposure to direct sunlight, bright indoor lights such as in tanning salons, bright halogen lighting, high power lighting as used by surgeons or dentists, or light from light-emitting medical devices such as pulse oximeters.
espożizzjoni diretta għad- dawl tax- xemx jew dwal qawwija ta ’ ġewwa bħal f’ tanning salons, dawl aloġenu qawwi, jew dawl qawwi bħal ma jużaw il- kirurgi jew id- dentisti, jew dawl minn apparat mediku li jarmi d- dawl bħal ossimetri pulsanti.
If you have to go outdoors during daylight in the first
Jekk ikollok toħroġ barra fid- dawl tax -
20 48 hours after treatment, you must protect your skin and eyes by wearing protective clothing and dark sunglasses.
20 xemx fl- ewwel 48 siegħa wara l- kura, trid tipproteġi l- ġilda tiegħek u għajnejk billi tilbes ħwejjeġ protettiv u nuċċali tax- xemx skur.
Sunscreens offer no protection.
Il- kremi kontra x- xemx ma joffru l- ebda protezzjoni.
Normal indoor lighting is safe.
Dawl normali ta ’ ġewwa mhux ta ’ periklu.
Do not stay in the dark because exposure to normal indoor lighting will help your body to eliminate Visudyne more quickly.
Toqgħodx fid- dlam għax id- dawl normali ta ’ ġewwa jgħin lill- ġismek biex jeħles minn Visudyne aktar malajr.
- If you experience any eye problems after the treatment, please inform your doctor.
- Jekk tħoss xi problemi f’ għajnejk wara l- kura, jekk jogħġbok avża lit- tabib tiegħek.
Pregnancy and breast-feeding There is no experience with Visudyne in pregnant women.
Tqala u Treddigħ Ma hemmx esperjenza b’ Visudyne f’ nisa waqt it- tqala.
If you are pregnant or planning to become pregnant or are breast-feeding, you should only be given Visudyne if your doctor considers it absolutely essential.
Jekk int ħriġt tqila jew qed tippjana biex toħroġ tqila jew qed tredda ’, għandek tingħata Visudyne biss jekk it- tabib tiegħek jikkonsidrha essenzjali b’ mod assolut.
Driving and using machines After Visudyne treatment you may have some vision problems.
Wara kura b’ Visudyne jista ’ jkollok xi problemi fil- vista.
If this happens to you, do not drive or operate any tools or machines until your vision improves.
Jekk jiġrilek hekk, m’ għandekx issuq jew tuża magni sakemm il- vista tmurlek għall- aħjar.
Important information about some of the ingredients of Visudyne Visudyne contains small amounts of butylated hydroxytoluene (E321).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Visudyne Visudyne fih ammonti żgħar ta ’ butylated hydroxytoluene (E321).
This ingredient is irritant to eyes, skin and mucous membranes.
Din is- sustanza hija irritanti għall - għajnejn, għal ġilda u għal membrani mukużi.
If you come into direct contact with Visudyne, wash it off extensively with water.
Jekk ikollok kuntatt dirett ma ’ Visudyne, għandek tneħħiħ billi taħslu bl- ilma b’ mod estensiv.
HOW VISUDYNE IS USED
KIF GĦANDEK TUŻA VISUDYNE
Your doctor or the pharmacist will prepare the Visudyne infusion solution.
It- tabib jew l- ispiżjar tiegħek jipprepara s- soluzzjoni għall- infużjoni ta ’ Visudyne.
It will be administered by your doctor or nurse.
Ser jingħatalek mit - tabib jew infermier tiegħek.
At the end of the infusion, your doctor will put a special contact lens onto your eye and treat your eye using a special laser.
Fi tmiem ta ’ l- infużjoni, it- tabib tiegħek se jpoġġi f’ għajnejk lenti tal - kuntatt speċjali u jikkuralek għajnejk bl- użu ta ’ lejżer speċjali.
It takes 83 seconds to deliver the laser dose of 50 J/ cm2 required to activate Visudyne.
Id- doża ta ’ lejżer ta ’ 50 J/ cm2 meħtieġa biex tattiva Visudyne tintlaħaq fi 83 sekonda.
During this time, you will have to follow your doctor’ s instructions and keep your eyes still.
Matul dan il- ħin, se jkollok issegwi l- istruzzjonijiet tat- tabib tiegħek u ma ċċaqlaqx għajnejk.
If necessary, Visudyne therapy can be repeated every 3 months.
Jekk ikun hemm bżonn, it- terapija b’ Visudyne tista ’ tiġi ripetuta kull 3 xhur.
If you are given more Visudyne than you should be Overdose of Visudyne may prolong the time during which you are photosensitive and you may need to follow the protection instructions given in section 2 for longer than 48 hours.
Jekk tingħata Visudyne aktar milli suppost Doża eċċessiva ta ’ Visudyne tista ’ ttawwallek il- ħin li waqtu ddum fotosensittiv u jista ’ jkollok bżonn issegwu l- istruzzjonijiet ta ’ protezzjoni mogħtija f’ sezzjoni 2 għal aktar minn 48 siegħa.
Your doctor will advise you.
It- tabib tiegħek se jagħtik parir.
Like all medicines, Visudyne can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Visudyne jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
At the recommended dose, a small number of patients experienced one or more of the following undesirable effects.
Fid- doża rrikmandata, numru żgħir ta ’ pazjenti kellhom wieħed jew aktar mill- effetti nhux mixtieqa li ġejjin.
Most of these effects were minor and lasted only for a short while.
Bosta minn dawn l- effetti kienu minuri u damu biss ħin qasir.
In the treated eye, abnormal or decreased vision, a change in the field of vision, bleeding of the retina or into the vitreous humour, displacement of the retina, and lack of blood circulation to the retina or choroid were reported by a few patients.
Fl- għajn ikkurata, ftit pazjenti rrapurtaw vista mhux normali jew imnaqqsa, bidla fil- kamp viżiv, fsada tar- retina jew għal ġol- vitreous humour, ċaqlieq tar- retina, u nuqqas ta ’ ċirkolazzjoni tad- demm lejn ir - retina jew il- korojd.
In addition, some patients reported one or more of the following: nausea, sunburn, tiredness, infusion- related back and chest pain which may radiate to other areas, including but not limited to, the pelvis, shoulders or rib cage, increased cholesterol, pain, increased blood pressure, decreased sensation, fever.
Barra minn hekk, xi pazjenti rrapurtaw wieħed jew aktar minn dawn: dardir, ħruq tax- xemx, għeja, uġigħ marbut ma ’ l- infużjoni li tfaċċja, prinċipalment bħala uġigħ fid- dahar, imma li jista ’ ukoll jimxi għal partijiet oħra bħall- pelvi, iċ- ċintura ta ’ l- ispallejn jew il- kustilji, żjieda fil- kolesterol, uġigħ, żjieda fil- pressjoni tad- demm, nuqqas ta ’ sensazzjoni, deni.
Vasovagal reactions (light-headedness and fainting) and allergic reactions, which on rare occasions
Ġew irrappurtati reazzjonijiet vażovagali (diżorjentazzjoni u ħass ħażin) u reazzjonijiet ta ’ allerġija, li f’ okkażjonijiet rari jistgħu jkunu
21 can be severe, have been reported.
21 qawwija.
General symptoms can include headache, malaise, fainting, sweating, dizziness, rash, hives, itching, breathlessness, flushing, or changes in blood pressure and heart rate.
Sintomi ġenerali jistgħu jinkludu uġigħ ta ’ ras, ħass ħażinijiet, telf mis- sensi, għaraq, sturdament, raxx, ħorriqija, ħakk, qtugħ ta ’ nifs, issir ruxxan, jew bidliet fil- pressjoni tad- demm u fir - rata tat- taħbit tal- qalb.
As with other types of injections, some patients experienced pain, swelling, inflammation, blistering, leakage into the area surrounding the vein, bleeding at the injection site, change in skin colour and hypersensitivity.
Bħal fil- każ ta ’ tipi oħra ta ’ injezzjonijiet, xi pazjenti ħassew uġigħ, nefħa, infjammazzjoni, bżieżaq, tnixxija għall- parti madwar il- vina, fsada mis- sit ta ’ mnejn tingħata l- injezzjoni, tibdil fil- kulur tal - ġilda u sensittività eċċessiva.
If this happens to you, there will be increased sensitivity to light in that part of the skin until the green discoloration disappears.
Jekk jiġrilek hekk, ikun hemm aktar sensittività għad- dawl f’ dik il- parti tal- ġilda sakemm jitlaq il- lewn ħadrani.
Heart attack has been reported, particularly in patients with a history of heart disease, sometimes within 48 hours after treatment with Visudyne.
Attakk tal- qalb kien irrappurtat, l- aktar f’ pazjenti li kellhom problemi kardjovaskulari fil- passat, kultant fi żmien 48 siegħa wara trattament b’ Visudyne.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew infermier tiegħek.
STORING VISUDYNE
KIF TAĦŻEN VISUDYNE
Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Intweriet stabbilità kimika u fiżika għal 4 sigħat f’ 25°C.
If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and would normally not last longer than 4 hours below 25°C protected from light.
Jekk ma jintużax minnufih, iż- żmien u kundizzjoni ta ’ ħażna qabel jintuża huma r - responsabbiltà ta ’ min jużah u normalment ma ’ jaqbżux l- 4 sigħat taħt 25°C milquh mid- dawl.
Do not use Visudyne after the expiry date which is stated on the carton and vial.
Tużax Visudyne wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- kunjett.
What Visudyne contains
X’ fih Visudyne
- The active substance is verteporfin.
- Is- sustanza attiva hija verteporfin
- The other ingredients are dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl
- Is- sustanzi l- oħra huma dimyristoyl phosphatidylcholine, phosphatidylglycerol tal- bajd,
palmitate, butylated hydroxytoluene (E321) and lactose monohydrate.
ascorbyl palmitate, butylated hydroxytoluene (E321) u lactose monohydrate.
What Visudyne looks like and contents of the pack Visudyne is supplied as a dark green to black powder in a clear glass vial.
Id- Dehra ta ’ Visudyne u l- kontenuti tal- pakkett Visudyne jiġi bħala trab aħdar għal iswed f’ kunjett tal- ħġieġ trasparenti.
The powder is reconstituted in water prior to use to form an opaque dark green solution.
It- trab jiġi rikostitwit ma ’ l - ilma qabel jintuża sabiex jifforma soluzzjoni opaka ħadra skura.
Visudyne is available in packs containing 1 vial of powder.
Visudyne jiġi f’ pakketti li jkun fihom kunjett 1 ta ’ trab.
22 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
24 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
24 TAGĦRIF GĦALL- PROFESSJONISTI FIL- KURA TAS- SAĦĦA
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku jew tal- kura tas- saħħa:
Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ ml solution.
Irrikostitwixxi Visudyne f’ 7. 0 ml ilma għall- injezzjonijiet sabiex tagħmel 7. 5 ml ta ’ soluzzjoni ta ’ 2. 0 mg/ ml.
Reconstituted Visudyne is an opaque dark green solution.
Visudyne rikostitwit huwa soluzzjoni ħadra skura opaka.
It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration.
Huwa rakkomandat li Visudyne rikostitwit jiġi mifli għal frak jew telf ta ’ kulur qabel jingħata.
For a dose of 6 mg/ m2 body surface (the dosage recommended for the treatment) dilute the required amount of Visudyne solution in 5% glucose for injection to a final volume of 30 ml.
Għal doża ta ’ 6 mg/ m2 superfiċje tal - ġisem (id- dużaġġ rakkomandat għall- kura) idilwixxi l- ammont tas- soluzzjoni Visudyne meħtieġ f’ 5% soluzzjoni tal- glucose għall- injezzjonijiet għal volum finali ta ’ 30 ml.
Do not use saline solution.
Tużax ilma bil- melħ.
Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μ m is recommended.
L- użu ta ’ filtru ta ’ pajp ta ’ l- infużjoni standard b’ membrani idrofiliċi (bħal polyethersulfone) b’ daqs ta ’ pori ta ’ mhux anqas minn 1. 2 µm huwa rakkomandat.
For storage conditions, please see section 5 of this leaflet.
Għall- kundizzjonijiet tal- ħażna, jekk jogħġbok ara sezzjoni 5 ta ’ dan il- fuljett.
If material is spilled, it should be contained and wiped up with a damp cloth.
Jekk il- materjal jinxtered, għandu jiġi milquh u jintmesaħ b’ biċċa niedja.
Eye and skin contact should be avoided.
Kuntatt mal- ġilda u ma ’ l - għajnejn għandu jkun evitat.
Use of rubber gloves and eye protection is recommended.
L- użu ta ’ ingwanti tal- lasktu u protezzjoni għall- għajnejn huma rakkomandati.
All materials should be disposed of properly.
Il- materjali kollha għandhom jintremew kif jixraq.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Vivanza?
X' inhi Vivanza?
Vivanza is a medicine that contains the active substance vardenafil.
Vivanza hija mediċina li fiha s- sustanza attiva vardenafil.
It is available as round, orange tablets (5, 10, or 20 mg).
Tiġi bħala pilloli tondi, oranġjo (ta '5, 10 u 20 mg).
What is Vivanza used for?
Għalxiex tintuża Vivanza?
Vivanza is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Vivanza tintuża fit- trattament ta 'rġiel adulti f' disfunzjoni erettili (imsejħa wkoll impotenza), li tikkonsisti fl- inkapaċità li jilħqu jew iżommu pene iebes (erezzjoni) għal attività sesswali sodisfaċenti.
For Vivanza to be effective, sexual stimulation is required.
Biex Vivanza jkollha effett, teħtieġ stimulazzjoni sesswali.
How is Vivanza used?
Kif tintuża Vivanza?
The recommended dose of Vivanza is 10 mg, taken with or without food, about 25 to 60 minutes before sexual activity.
Id- doża rakkomandata ta 'Vivanza hi ta' 10 mg, meħuda weħedha jew ma 'l- ikel, bejn 25 sa 60 minuta qabel l- attività sesswali.
If Vivanza is taken with a high fat meal, the onset of activity may be delayed.
Jekk Vivanza tittieħed ma 'ikla xaħmija ħafna, il- bidu ta' l- attività sesswali jista 'jitbiegħed.
The dose may be increased to a maximum of 20 mg or decreased to 5 mg depending on the effectiveness and side effects.
Id- doża tista 'tiżdied sa massimu ta' 20 mg jew titnaqqas sa 5 mg skond kemm tkun taħdem u l- effetti sekondarji.
The maximum recommended dosing frequency is one tablet per day.
Il- doża massima rakkomandata hi ta 'pillola waħda kuljum.
How does Vivanza work?
Kif taħdem Vivanza?
The active ingredient of Vivanza, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Is- sustanza attiva f' Vivanza, vardenafil, tagħmel parti minn grupp ta 'mediċini magħruf bħala inibituri tal- fosfodjesterażi (phosphodiesterase) tat- tip 5 (PDE5).
It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic GMP (cGMP).
Taħdem billi timblokka l- enzim fosfodjesterażi, li normalment ikisser sustanza magħrufa bħala GMP ċikliku (cGMP).
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the inflow of blood in the corpora that produces the erection.
Waqt l - istimulazzjoni sesswali normali, is- cGMP jiġi prodott fil- pene, u jikkawża lill- muskolu fit- tessut artab tal- pene (il- corpora cavernosa) jirrilassa, u jippermetti l- fluss tad- demm fil- corpora, u b' hekk jipproduċi l- erezzjoni.
By blocking the break down of cGMP, Vivanza restores erectile function.
Billi jimblokka t- tkissir tas- cGMP, Vivanza treġġa 'l- funzjoni ta' l- erezzjoni għan- normal.
Sexual stimulation is still needed to produce an erection.
Xorta jibqa 'l- bżonn ta' stimulazzjoni sesswali biex tiġi prodotta l- erezzjoni.
How has Vivanza been studied?
Kif ġiet studjata Vivanza?
Vivanza has been studied in four main studies including 2,431 patients aged 20 to 83 years, where it was compared with placebo (a dummy treatment).
Vivanza ġiet studjata f' erba 'studji ewlenin bis- sehem ta' 2, 431 pazjent ta 'bejn 20 u 83 sena, fejn tqabblet mal- plaċebo (trattament finta).
One study was carried out in diabetic men and another in post-prostatectomy patients (men who have had their prostate gland removed).
Studju minnhom sar fi rġiel dijabetiċi u ieħor f' pazjenti li tkun saritilhom prostatektomija (tneħħitilhom il- prostata).
The main measure of effectiveness was the ability to get and maintain an erection.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kienet il - kapaċità li jilħqu u jżommu erezzjoni.
What benefit has Vivanza shown during the studies?
Liema benefiċċju wriet Vivanza waqt l- istudji li ġew mwettqa?
Vivanza was significantly more effective than placebo for all measures in all studies.
Vivanza kienet ferm iktar effikaċi mill- plaċebo fil- kejl kollu fl- istudji kollha.
What is the risk associated with Vivanza?
X' inhu r- riskju assoċjat ma 'Vivanza?
The most common side effects with Vivanza (seen in more than 1 patient in 10) are headache and flushing.
L- iktar effetti sekondarji komuni b' Vivanza (li deher f' iktar minn pazjent 1 minn kull 10) huma l- uġigħ ta 'ras u l- ħmura fil- wiċċ.
For the full list of all side effects reported with Vivanza, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati b' Vivanza, ara l- Fuljett ta' Tagħrif.
Vivanza should not be used in people who may be hypersensitive (allergic) to vardenafil or any of the other ingredients, and where sexual activity is inadvisable (e. g. men with severe heart disease such as unstable angina or severe heart failure).
Vivanza ma għandhiex tintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal vardenafil jew għal xi sustanza oħra tiegħu, u minn persuni li ma jkunux rakkomandati li jieħdu sehem f' attività sesswali (eż. rġiel b' mard tal- qalb sever bħall- anġina instabbli jew falliment tal- qalb sever).
It should also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Lanqas ma għandha tintuża minn pazjenti li xi darba kellhom telf tal- vista minħabba problema fil- fluss tad- demm lejn in- nervitura fl- għajn (newropatija ottika iskemika anterjuri mhux arteritika jew NAION).
Vivanza should not be taken with nitrates (medicines used to treat angina).
Vivanza ma għandhiex tittieħed man- nitrati (mediċini użati fit- trattament ta 'l- anġina).
Because Vivanza has not been studied in patients with severe liver or kidney disease, patients who have problems with their blood pressure, or who have had a stroke or a heart attack within the last six months, they should not use it.
Billi Vivanza ma ġietx studjata f' pazjenti b' mard sever tal- fwied jew tal- kliewi, pazjenti li jkollhom problemi bil- pressjoni tad- demm, jew li tkun tathom puplesija jew attakk tal- qalb fl- aħħar sitt xhur, dawn il- pazjenti ma għandhomx jużawha.
Vivanza should not be taken with some medicines, such as ketoconazole and itraconazole (to treat fungal infections) in men over 75 years, or ritonavir or indinavir (to treat HIV infection).
Vivanza ma għandhiex tintuża ma 'xi mediċini, bħal ketoconazole u itraconazole (biex jittrattaw infezzjonijiet minn fungi) fi rġiel ta' 'l fuq minn 75 sena, jew ritonavir jew indinavir (biex jittrattaw infezzjoni ta' l- HIV.
Why has Vivanza been approved?
Għaliex ġiet approvata Vivanza?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vivanza’ s benefits are greater than its risks for the treatment of men with erectile dysfunction.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Uman (CHMP) iddeċieda li l- benefiċċji ta 'Vivanza fit - trattament ta' rġiel b' disfunzjoni erettili huma ikbar mir- riskji tiegħu.
The Committee recommended that Vivanza be given marketing authorisation.
Il- Kumitat irrakkomanda li Vivanza tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Vivanza:
Informazzjoni oħra dwar Vivanza:
The European Commission granted a marketing authorisation valid throughout the European Union for Vivanza to Bayer AG on 4 March 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Vivanza lil Bayer AG fl - 4 ta' Marzu 2003.
The marketing authorisation was renewed on 4 March 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 4 ta 'Marzu 2008.
The full EPAR for Vivanza is available here.
L- EPAR sħiħ dwar Vivanza jinstab hawn.
Vivanza 5 mg film-coated tablets
Vivanza 5 mg, Pilloli miksija b’ rita.
Each tablet contains 5 mg of vardenafil (as hydrochloride trihydrate).
Kull pillola fiha 5 mg ta ’ vardenafil (bħala hydrochloride trihydrate).
Orange round tablets marked with ’ v’ on one side and “ 5” on the other side.
Pillola tonda, oranġjo immarkata b ’’ v ’ fuq naħa waħda u '5' fuq in- naħa l- oħra.
In order for Vivanza to be effective, sexual stimulation is required.
Biex Vivanza ikun effettiv, hija meħtieġa stimulazzjoni sesswali.
Vivanza is not indicated for use by women.
Vivanza mhux indikat għal użu minn nisa.
Vivanza can be taken with or without food.
Vivanza jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
The onset of activity may be delayed if taken with a high fat meal (see section 5.2).
Jekk jittieħed ma ’ ikla li jkun fiha ħafna xaħmijiet, l- effett jista ’ jdum aktar biex jidher (ara sezzjoni 5. 2).
Use in elderly men
Użu f’ irġiel anzjani
Vivanza is not indicated for individuals below 18 years of age.
Vivanza mhux indikat għall- persuni taħt l- età ta ’ 18- il sena.
There is no relevant indication for use of Vivanza in children.
Ma hemm l- ebda indikazzjoni rilevanti għall- użu ta ’ Vivanza fit- tfal.
2 Use in patients with renal impairment
2 Użu f' pazjenti b’ indeboliment renali.
Vivanza is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Vivanza huwa kontra- indikat f’ pazjenti li għandhom telf tal- vista f’ għajn waħda minħabba newropatija ottika anterjuri iskemika mhux arteritika (NAION), kemm jekk dan l- episodju kien konness ma ’ espożizzjoni minn qabel għal inibitur ta ’ PDE5 kif ukoll jekk le (ara sezzjoni 4. 4).
- recent history of stroke or myocardial infarction (within the last 6 months),
- puplesija jew infart mijokardijaku reċenti (fl- aħħar 6 xhur), anġina mhix stabbli,
- unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.
- fejn hu magħruf li jkun hemm mard ereditarju ta ’ deġenerazzjoni tar- retina bħal retinite
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity (see section 4.3).
Qabel tinbeda xi tip ta ’ kura għal problema ta ’ l- erezzjoni tal- pene, it- tobba għandhom iqisu il - kundizzjoni kardjovaskulari tal- pazjenti tagħhom peress li hemm ċertu riskju fuq il- qalb marbut ma ’ l - attività sesswali (ara sezzjoni 4. 3).
Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Vardenafil għandu effetti vażodilatatorji, u jirriżulta fi tnaqqis ħafif u temporanju fil- pressjoni tad- demm (ara sezzjoni 5. 1).
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
3 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.
Vardenafil may be administered at any time with tamsulosin.
Vardenafil jista ’ jingħata fi kwalunkwe ħin ma ’ tamsulosin.
Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
Żjieda ftit, ftit fid- doża ta ’ alfa- blockers tista ’ tiġi assoċjata ma ’ tnaqqis akbar fil - pressjoni tad- demm f’ pazjenti li qed jieħdu vardenafil.
Vardenafil dose adjustment might be necessary if modrate CYP 3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see sections 4.5 and 4.2).
Jista ’ jkun hemm bżonn tibdil fid- doża ta ’ vardenafil meta jingħata flimkien ma ’ inibituri moderati ta ’ CYP 3A4 bħal ma huma erythromycin u clarithromycin (ara sezzjoni 4. 5 u sezzjoni 4. 2).
And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either drug alone.
U doża waħda mill- ħalq ta ’ 10 mg vardenafil mogħtija flimkien mal - effett ta ’ kull 400 mg gatifloxacin, mediċina b ’ effett QT komparabbli, wriet effett QTc addizzjonali ta ’ 4 msec meta mqabbel ma ’ waħda minn dawn il- mediċini individwalment.
The clinical impact of these QT changes is unknown (see section 5.1).
L- impatt kliniku ta ’ dan it- tibdil fil- QT mhux magħruf (ara sezzjoni 5. 1).
Medicinal products that may prolong QTc interval, including vardenafil, are best avoided in patients with relevant risk factors, for example, hypokalaemia; congenital QT prolongation; concomitant administration of antiarrhythmic medicinal products in Class 1ª (e. g. quinidine, procainamide), or Class III (e. g. amiodarone, sotalol).
Prodotti mediċinali li jistgħu jtawwlu l- intervallQTc, inkluż vardenafil, aħjar jiġu evitati f’ pazjenti b’ fatturi ta ’ riskju relevanti, per eżempju, ipokalimja; żjieda konġenitali tal- QT; l- għoti flimkien ta ’ prodotti mediċinali kontra l- arritmija fi Klassi 1ª (eż. quinidine, procainamide), jew fi Klassi III (eż. amiodarone, sotalol).
Visual defects and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in connection with the intake of Vivanza and other PDE5 inhibitors.
Difetti fil- vista u każijiet ta ’ newropatija ottika iskemika mhux arterika (NAION) ġew irrappurtati f’ konnessjoni ma ’ l- użu ta ’ Vivanza u inibituri ta ’ PDE5 oħra.
The patient should be advised that in the case of sudden visual defect, he should stop taking Vivanza and consult immediately a physician (see section 4.3).
Il- pazjent għandu jiġi mgħarraf li f’ każ ta ’ difett fil- vista li jseħħ f’ daqqa waħda, hu għandu jieqaf jieħu Vivanza u jkellem lit- tabib minnufih (ara sezzjoni 4. 3).
The interaction is a consequence of blocking hepatic metabolism of Vivanza by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9.
L- interazzjoni hija konsegwenza ta ’ l- impediment tal- metaboliżmu ta ’ Vivanza fil- fwied minn ritanovir, impeditur ta ’ CYP3A4 qawwi ħafna, li jimpedixxi wkoll CYP2C9.
Ritonavir significantly prolonged the half-life of Vivanza to 25.7 hours (see section 4.3).
Ritanovir itawwal b’ mod sinifikanti il- half- life ta ’ Vivanza għal 25. 7 siegħa (ara sezzjoni 4. 3).
Vivanza may be administered at any time with tamsulosin.
Vivanza jista ’ jingħata f’ kwalunkwe ħin ma ’ tamsulosin.
Vivanza is not indicated for use by women.
Vivanza mhux indikat għall- użu minn nisa.
As dizziness and abnormal vision have been reported in clinical trials with vardenafil, patients should be aware of how they react to Vivanza, before driving or operating machinery.
Fi provi kliniċi dwar vardenafil kienu rrappurtati sturdament u problemi fil- vista, għalhekk il- pazjenti għandhom jaraw x’ reazzjoni jkollhom għal Vivanza qabel isuqu jew iħaddmu xi magni.
Over 9,500 patients have received Vivanza in clinical trials.
Fi provi kliniċi li saru, ’ l fuq minn 9500 pazjent ingħataw Vivanza.
Very Common (≥ 1/ 10)
Komuni Komuni
Common (≥ 1/ 100 and < 1/ 10)
Mhux Komuni
Uncommon (≥ 1/ 1,000 and < 1/ 100)*
Rari
Rare (≥ 1/ 10,000 and < 1/ 1,000)*
Mhux
Immune System Disorders
Klassifika tal -
Hypersensitivity
Ħafna
Psychiatric Disorders
(≥1% / 100 u
Anxiety
(≥0. 1/ 1, 000% u
Nervous System Disorders
(≥10. 0/ 10, 0001
Headache
Magħruf (ma
Dizziness
Organi
Somnolence
(≥1/ 100)
Related Investigations
< 1/ 10%)
Intraocular pressure increased
< 1% / 100) *
Non-arteritic-anterior ischemic optic neuropathy Visual defects
% u
Sudden deafness**
tistax
Cardiac Disorders incl. related Investigations
tittieħed < 0. 1/ 1, 000%) * stima mid - data disponibbli) Disturbi fis - Sistema Immuni Disturbi Psikjatriċi
Tachycardia Palpitations
Sensittività eċċessiva Ansjetà
Angina Pectoris Myocardial ischemia
Disturbi fis - Sistema Nervuża
Myocardial Infarction
Uġigħ ta 'ras
Vascular Disorders incl. related Investigations
Sturdament
Flushing
Ngħas
Hypertension Hypotension Orthostatic Hypotension
Sinkope Aċċessjoni Amnesija globali temporanja
Respiratory, Thoracic and Mediastinal Disorders
Disturbi fl - Għajnejn inkluż Investigazzjonijiet Relatati
Nasal Congestion
Produzzjoni tad - dmugħ tiżdied Problemi fil - vista (inkluż vista għad- dawl aktar qawwija) Chromatopsia Konġuntivite Vista mċajpra
Dyspnoea Epistaxis
Żjieda tal - Pressjoni ta ’ ġol- għajn
Gastrointestinal Disorders incl. related Investigations
newropatija ottika anterjuri iskemika mhux arterika (NAION) Difetti fil- vista
Dyspepsia Nausea
Disturbi fil - widnejn u fis - sistema labirintika
Abnormal liver function tests GGTP increased
Telf tas- smigħ f’ daqqa waħda
Uncommon (≥ 1/ 1,000 and < 1/ 100)*
Takikardja Palpitazzjonijiet
Rare (≥ 1/ 10,000 and < 1/ 1,000)*
Anġina Pectoris Iskemja mijokardijaka
Skin and Subcutaneous Tissue Disorders
Qtugħ ta ’ nifs Epistassi
Photosensitivit y reaction Face oedema Rash
Testijiet tal - funzjoni tal - fwied mhux normali Żjieda fil- GGTP
Musculoskeletal and Connective Tissue Disorders incl.
Disturbi fil- Ġilda u Tessuti ta ’ taħt il - ġilda
Related Investigations Reproductive System and Breast Disorders
Reazzjoni ta ’ sensittività għad- dawl Edima fil- wiċċ Raxx
Muscle Rigidity Priapism Erections increased (prolonged or painful erections)
Prijapiżmu Erezzjonijiet miżjuda (Erezzjonijiet li jdumu jew bl - uġigħ)
Serious cardiovascular events, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post marketing in temporal association with another medicinal product in this class.
Disturbi vaskulari: każijiet ta ’ mard kardjovaskulari serju li kienu jinkludu emorraġija ċerebrovaskulari, mewta f' daqqa ikkawżata minn problemi fil- qalb, attakk iskemiku temporanju, anġina mhux stabbli u arritmija
8 Penile erection is a haemodynamic process.
L- erezzjoni tal- pene hija proċess emodinamiku.
It activates the enzyme guanylate cyclase, resulting in an increased level of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum.
Dan jattiva l- enżima guanylate cyclase u jirriżulta f’ żjieda fil- livell ta 'cyclic guanosine monophosphate (cGMP) fil- korpus cavernosum.
Effects on the QT interval were measured one hour post dose (average Tmax for vardenafil).
Effetti fuq l- intervall QT ġew imkejla siegħa wara li ngħatat id- doża (Tmax medja ta ’ vardenafil).
The primary objective of this study was to rule out a greater than 10 msec effect (i. e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/ RR1/ 3) from baseline at the 1 hour post-dose time point.
Il- mira prinċipali ta ’ dan l- istudju kienet biex jiġi aċċertat li m’ hemmx effett akbar minn 10 msec fuq l- intervall QTc (i. e. biex jintwera nuqqas ta ’ dan l- effett) ta ’ doża waħda ta ’ 80 mg ta ’ vardenafil mogħtija mill- ħalq, meta mqabbla mal- plaċebo, kif imkejjel mill- bidla fil- formola ta ’ korrezzjoni ta ’ Fridericia (QTcF=QT/ RR1/ 3) mill- linja bażi siegħa wara li ngħatat id- doża.
6-9) and 10 msec (90% CI:
6- 9) u ta ’ 10 msec (90% CI:
4-7) at 10 and 80 mg doses compared to placebo, at one hour postdose.
4- 7) b’ dożi ta ’ 10 mg u 80 mg meta mqabbla mal- plaċebo, wara siegħa li ngħatat id- doża.
When using the individual correction formulae, none of the values were out of the limit.
Meta ġiet użata il- formola għall - korrezzjoni individwali, l- ebda wieħed mill- valuri ma kien barra mill- limitu ta ’ l- istudju.
Over 1630 patients have been treated with Vivanza for six months or longer.
Fi provi kliniċi, vardenafil, ingħata lil aktar minn 3750 raġel bi problemi fl- erezzjoni tal- pene (ED), b’ etajiet li varjaw bejn 18 u 89 sena, li ħafna minnhom kellhom aktar minn marda waħda fl- istess waqt. ’ L fuq minn 1630 pażjent kienu kkurati b’ Vivanza għal sitt xhur jew aktar.
The
Il- gruppi ta 'pazjenti li ġejjin kienu rappreżentati: anzjani (22%), pazjenti bi pressjoni għolja (35%), pazjenti li għandhom dijabete mellitus (29%), mard iskemiku tal- qalb u mard kardjovaskulari ieħor (7%), mard kroniku tal- pulmun (5%), iperlipidimja (22%), depressjoni (5%), tneħħija radikali tal - prostata (9%).
9 following groups were not well represented in clinical trials: elderly (> 75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3).
4%), u pazjenti b' ċerti tipi ta ’ mard kardjovaskulari (ara sezzjoni 4. 3).
In a clinical trial in post-prostatectomy patients, 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.
Waqt prova klinika f’ pazjenti wara li tneħħitilhom il- prostata, dożi ta ’ 10 mg u 20 mg ta ’ vardenafil tejbu b’ mod sinifikanti il- punteġġ tal- funzjoni erettili, l- 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.
The mean absolute oral bioavailability is 15%.
Il- bijodisponibiltà medja assoluta hija 15%.
Vardenafil AUC is
L- AUC ta ’ vardenafil ma tinbidilx.
11 5.3 Preclinical safety data
3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
4March 2003
4 ta ’ Marzu 2003
4March 2008
4 ta ’ Marzu 2008
Vivanza 10 mg film-coated tablets
Vivanza 10 mg, Pilloli miksija b’ rita.
Orange round tablets marked with a ‘ v’ on one side and “ 10” on the other side.
Pillola tonda, oranġjo immarkata b ’’ v ’ fuq naħa waħda u '10' fuq in- naħa l- oħra.
- - -
- marda tal- kliewi ta ’ l- aħħar stadju li teħtieġ dijalisi,
severe hepatic impairment (Child-Pugh C), end stage renal disease requiring dialysis, hypotension (blood pressure < 90/ 50 mmHg),
- pressjoni baxxa (pressjoni tad- demm < 90/ 50mmHg),
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
15 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.