qanastek/EMEA-V3 huggingface dataset:
Daily intravenous administration of cidofovir during the period of organogenesis led to reduced fetal body weights when administered to pregnant rats at 1.5 mg/ kg/ day and to pregnant rabbits at 1.0 mg/ kg/ day.
Meta cidofovir ingħata kuljum, ġol- vina, lill- firien tqal f’ doża ta ’ 1. 5 mg/ kg/ jum u lill- fniek tqal f’ doża ta ’ 1. 0mg/ kg/ jum, tul iż- żmien li fih kienu qed jissawwru l- organi, dan irriżulta fi tnaqqis fil- piż tal- fetu.
The no- observable-effect dosages for embryotoxicity was 0.5 mg/ kg/ day in rats and 0.25 mg/ kg/ day in rabbits.
Id- dożi li bihom ma ġiex osservat effett tossiku fuq l- embriju kienu ta ’ 0. 5 mg/ kg/ jum fil- firien, u 0. 25 mg/ kg/ jum fil- fniek.
Sodium Hydroxide Hydrochloric Acid Water for Injection
Sodium hydroxide Hydrochloric acid Ilma għall- injezzjonijiet
9 6.2 Incompatibilities
6. 2 Inkompatibiltajiet
This medicinal product must not be mixed with other medicinal products or diluents except those mentioned in section 6.6.
Dan il- prodott mediċinali ma għandux ikun mħallat ma prodotti mediċinali oħra ħlief dawk imsemmija f’ sezzjoni 6. 6.
From a microbiological point of view, the product must be used immediately.
Minn punt ta ’ vista mikrobijoloġiku, il- prodott għandu jintuża immedjatament
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 – 8ºC when dilution is performed under controlled and validated aseptic conditions.
Stabbilta ’ kimika u fiżika waqt l- użu ġiet murija li hi l- iktar sa 24 siegħa f’ temperatura ta ’ 2 – 8 ºC, meta ikun dilwit taħt kundizzjonijiet asettiċi kontrollati u validati.
Storage beyond 24 hours or freezing is not recommended.
Ħżin għal iktar minn 24 siegħa jew iffriżar mhumiex rakkomandati.
Refrigerated solutions should be allowed to warm to room temperature prior to use.
Soluzzjonijiet imkessħin għandhom jitħallew jisħnu sat- temperatura tal- kamra qabel jintużaw.
Do not refrigerate or freeze.
Taħżinx fil- friġġ jew fil- friża.
For storage conditions of the diluted medicinal product see section 6.3
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali dilwit ara sezzjoni 6. 3.
5 ml clear glass vials with a 5 ml nominal fill volume.
Kunjetti ta ’ 5 ml magħmulin minn ħġieġ trasparenti li jintużaw darba biss, u li jintlew b’ volum nominali ta ’ 5ml.
The container/ closure components include:
Il- kontenitur u s- sistema ta ’ kif jingħalaq jinkludu:
Type I clear borosilicate glass vials, Teflon faced grey butyl plug stoppers, and aluminium crimp seals with a flip off plastic tab.
Kunjett tal- ħġieġ trasparenti tat - tip Nru I magħmula minn borosilicate, tappijiet griżi tal- butyl miksija bit- Teflon, u siġill mitni bil - pressa, ta ’ l- aluminju, b’ tapp tal- plastik li tiftħu b’ saba ’.
Each pack contains one 5 ml vial.
Kull pakkett fih kunjett wieħed ta ’ 5 ml.
VISTIDE is supplied in single-use vials.
VISTIDE jiġi ġo kunjetti li jintużaw darba biss.
Partially used vials should be discarded.
Kunjetti li ntużaw parzjalment għandhom jintremew
6.6 Special precautions for disposal and other handling of the product
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor u għal immaniġġar ieħor tal- prodott
Method of preparation and administration VISTIDE vials should be visually inspected for particulate matter and discolouration prior to administration.
Il- metodu li bih jiġi ppreparat u kif jingħata Il- kunjetti ta ’ VISTIDE għandhom jiġu miflija għal xi frak kif ukoll għal xi tibdil fil- kulur, qabel ma tingħata l- mediċina.
With a syringe, transfer under aseptic conditions the appropriate dose of VISTIDE from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution, and mix thoroughly.
B’ siringa taħt kundizzjonijiet asettiċi, itrasferixxi d- doża adattata ta ’ VISTIDE minn ġol- kunjett għal ġo borża ta ’ l- infużjoni b’ 100 ml ta ’ taħlita tas- salina 0. 9% (normali), u mbagħad ħallat sew.
The entire volume should be infused intravenously into the patient at a constant rate over a period of 1 hour by use of a standard infusion pump.
Il- volum li jirriżulta għandu jingħata kollu lil- pazjent, fil- vina, u b’ rata kostanti fuq medda ta ’ siegħa billi tintuża pompa stàndard ta ’ l- infużjonijiet.
VISTIDE should be administered by health care professionals adequately experienced in the care of AIDS patients.
VISTIDE għandu jingħata biss minn nies professjonali li għandhom esperjenza biżżejjed fil- kura ta ’ pazjenti bl- AIDS.
The chemical and physical stability of VISTIDE admixed with saline has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) or ethylene/ propylene copolymer, and in PVC based vented I. V. administration sets.
10 L- istabilità kemm kimika kif ukoll fiżika ta ’ VISTIDE meta dan kien imħallat mas- salina kienet intweriet fi fliexken tal- ħġieġ, f’ boroż ta ’ l- infużjonijiet magħmula minn polvinyl chloride (PVC), jew ethylene/ propylene co- polymer, u anki f’ settijiet ta ’ l- infużjoni ġol- vina b’ vent, magħmulin bil- bażi tal- PVC.
Other types of I. V. set tubing and infusion bags have not been studied.
Tipi oħrajn ta ’ tubi u boroż ta ’ l- infużjonijiet ma ġewx studjati.
Compatibility with Ringer’ s Solution, Lactated Ringer’ s Solution or bacteriostatic infusion fluids has not been evaluated.
Il- kompatibilità mas- soluzzjoni tat- tip Ringer, u mas- soluzzjoni tat- tip Lactated Ringer jew ma ’ sustanzi fluwidi u batterjostatiċi għall- infużjonijiet, ma ġietx valutata.
Handling and disposal Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of VISTIDE.
Immaniġġjar u rimi Huwa irrakkomandat li jittieħdu prekawzjonijiet adegwati, inkluż l- użu ta ’ apparat tas- sigurtà li jkun adattat, waqt il- preparazzjoni u waqt li jkun qed jingħata u anki waqt ir- rimi ta ’ VISTIDE.
The preparation of VISTIDE reconstituted solution should be done in a laminar flow biological safety cabinet.
Is - soluzzjoni rikostitwita ta ’ VISTIDE għandha tiġi ppreparata f’ cabinet tas- sigurtà bijoloġika tat- tip laminar flow.
Personnel preparing the reconstituted solution should wear surgical gloves, safety glasses and a closed front surgical-type gown with knit cuffs.
Min jipprepara s- soluzzjoni għandu jilbes ingwanti tal- kirurġija, nuċċali tas- sigurtà, u lbies twil b’ quddiem magħluq u bit- tarf tal- komma jagħlaq sew, bħal dak li jintuża mill- kirurgi waqt l - operazzjonijiet.
If VISTIDE contacts the skin, wash membranes and flush thoroughly with water.
Jekk VISTIDE jmiss mal- ġilda, aħsel il- membrani u laħlaħ sew bl- ilma.
Excess VISTIDE and all other materials used in the admixture preparation and administration
VISTIDE li jibqa żejjed u kull materjal ieħor li jkun intuża kemm fil- preparazzjoni tas- soluzzjoni kif ukoll sabiex din tingħata għandhom jitqegħdu f’ kontenitur li minnu ma jkunux jistgħu inixxu u li ma jittaqqabx, biex imbagħad jintremew.
Obtaining probenecid Probenecid is not supplied with VISTIDE and should be obtained via the Marketing Authorisation Holder of probenecid.
Kif takkwista probenecid Probenecid ma jkunx fornut flimkien ma ’ VISTIDE u wieħed għandu jakkwistah mingħand id - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
However, in case of difficulty in obtaining probenecid the local representative of the Marketing Authorisation Holder of VISTIDE should be contacted for information (See also sections 4.2 and 4.4).
F’ każ li wieħed isib xi diffikultà biex jakkwista probenecid, li għandu jagħmel hu li jikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq ta ’ VISTIDE sabiex jiġbor aktar tagħrif (ara wkoll sezzjonijiet 4. 2 u 4. 4).
DATE OF RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
Date of first authorisation Date of last renewal.
Data ta ’ l- ewwel awtorizzazzjoni Data ta ’ l- aħħar tiġdid
23 April 1997 08 June 2007
23 ta ’ April 1997 08 ta ’ Ġunju 2007
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA.
Carton
Kartuna ta ’ barra
VISTIDE 75 mg/ ml concentrate for solution for infusion Cidofovir
VISTIDE 75 mg/ ml konċentrat għat- taħlita likwida għall- infużjoni Cidofovir
Cidofovir Each ml contains 75 mg cidofovir anhydrous.
Cidifovir Kull ml fih 75 mg cidofovir anhydrous.
Each vial contains 375 mg/ 5ml cidofovir anhydrous.
Kull kunjett fih 375 mg/ 5ml cidofovir anhydrous.
For intravenous infusion only.
Għall- użu bħala infużjoni fil- vina biss.
Dilute before use.
Għandu jiġi dilwit qabel l- użu.
Do not store above 30°C.
JIS [XX/ SSSS]
VISTIDE 75 mg/ ml concentrate for solution for infusion Cidofovir For intravenous infusion only.
VISTIDE 75 mg/ ml konċentrat għat- taħlita likwida għall- infużjoni Cidofovir Għal infużjoni għal ġol- vini biss.
Should not be administered by intraocular injection.
Ma għandux jingħata permezz ta ’ injezzjoni fl- għajn
Batch:
Lott [numru]
Do not refrigerate or freeze.
Tagħmlux fi friġġ jew friża.
VISTIDE 75 mg/ ml concentrate for solution for infusion Cidofovir
Cidofovir
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li
please tell your doctor or pharmacist
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek
What VISTIDE is and what it is used for 2.
X’ inhu VISTIDE u għalxiex jintuża 2.
Before you use VISTIDE 3.
Qabel ma ’ tuża VISTIDE 3.
How to use VISTIDE 4.
Kif għandek tuża VISTIDE 4.
How to store VISTIDE 6.
Kif taħżen VISTIDE 6.
What VISTIDE is and what it is used for
X’ INHU VISTIDE U GĦALXIEX JINTUŻA
VISTIDE is an antiviral medicine which blocks the replication of cytomegalovirus (CMV) by interfering with viral DNA production.
VISTIDE huwa mediċina għal kontra l- virus li jwaqqaf il- proċess li bih is- cytomegalovirus (CMV) isawwar kopja tiegħu innifsu u dan billi jfixkel il- produzzjoni tad- DNA tal- virus.
VISTIDE is indicated in the treatment of CMV retinitis in patients with Acquired Immunodeficiency Syndrome (AIDS).
VISTIDE huwa indikat għat- trattament ta ’ retinite li tkun ikkawżata mis- CMV f’ pazjenti li jsofru bis - sindrome ta ’ immunodefiċjenza akwiżita (AIDS).
VISTIDE will not cure your CMV retinitis but may improve your condition by delaying progression of the disease.
VISTIDE ma jfejjqekx mir- retinite ikkawżata mis - CMV imma għandu mnejn itejjeb il- kundizzjoni tiegħek billi jnaqqas ir- rata li biha tavvanza din il - marda.
VISTIDE is for intravenous (into a vein) infusion and is not for intraocular injection (direct injection into the eye).
VISTIDE qiegħed għall- użu bħala infużjoni fil- vina biss, u m’ għandux jingħata bħala injezzjoni fl - għajn.
What is CMV retinitis?
X’ inhi r- retinite kkawżata mis- CMV?
CMV retinitis is an eye infection caused by a virus named cytomegalovirus (CMV).
Din hija infezzjoni fl- għajn ikkawżata minn virus msejjaħ cytomegalovirus (CMV).
CMV attacks the retina of the eye and may cause loss of vision, and eventually lead to blindness.
Is- CMV jattakka r- retina tal- għajn u jista ’ jwassal għal tnaqqis fil- vista u saħansitra eventwalment anki jagħma lill - pazjent.
Patients with acquired immunodeficiency syndrome (AIDS) are at high risk of developing CMV retinitis or other forms of CMV disease such as colitis.
Pazjenti bl- AIDS huma f’ riskju għoli li jiżviluppaw retinite minħabba fis- CMV jew inkella xi forma oħra ta ’ mard minħabba fis- CMV bħal per eżempju kolite.
Treatment for CMV retinitis is necessary to reduce the potential for blindness.
It- trattament tar- retinite ikkawżata mis - CMV huwa neċessarju sabiex titnaqqas il- possibiltà li wieħed jitlef id- dawl.
Before you use VISTIDE
QABEL MA TUŻA VISTIDE
Do not use VISTIDE if you • Are hypersensitive (allergic) to cidofovir or any of the other ingredients of VISTIDE. • Have pre-existing kidney disease. • Or if you cannot take the medicine probenecid because of a serious allergy to probenecid or other sulfa-containing medications (e. g. sulfamethoxazole). • VISTIDE must not be administered by intraocular injection.
Tużax VISTIDE • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal cidofovir jew sustanzi oħra ta ’ VISTIDE. • jekk inti għandek mard tal- kliewi li kien għandek qabel. • jekk inti ma tistax tieħu l- mediċina probenecid minħabba f’ allerġija serja għal probenecid jew għal xi medikazzjoni oħra li jkun fiha s- sulfa - (eż., sulfamethoxazole). • VISTIDE m’ għandux jkun mgħoti b’ injezzjoni fl- għajnejn
20 Take special care with VISTIDE:
20 Oqgħod attent ħafna b’ VISTIDE:
Kidney damage is the major side effect of VISTIDE treatment.
Il- ħsara fil- kliewi hija l- aktar effett sekondarju importanti li jseħħ minħabba t- trattament b’ VISTIDE.
To minimise the potential for damage to the kidneys, you will receive intravenous fluids (normal saline) and probenecid tablets with each dose of VISTIDE.
Biex titnaqqas il- possibiltà ta ’ ħsara fil- kliewi, int għandek tingħata fluwidi fil- vina (salina normali) u pilloli ta ’ probenecid ma ’ kull doża ta ’ VISTIDE.
Your doctor may also instruct you to drink plenty of fluids.
It- tabib għandu mnejn igħidlek ukoll biex tixrob ħafna.
Your doctor will monitor your kidney function prior to each dose of VISTIDE.
It- tabib għandu wkoll jeżaminalek il- funzjoni tal- kliewi qabel kull doża ta ’ VISTIDE.
Your treatment with VISTIDE may be discontinued by your doctor if changes in kidney function occur.
It - trattament tiegħek b’ VISTIDE għandu mnejn jitwaqqaflek mit- tabib jekk ikun hemm xi bdil fil - funzjoni tal- kliewi.
You may continue taking antiretrovirals (anti-HIV medications) and medication to prevent AIDS- related opportunistic infections.
Inti tista ’ tibqa tieħu mediċini għal kontra r- retroviruses (medikazzjonijiet għal kontra l- HIV) u anki medikazzjonijiet biex tilqa għal kontra infezzjonijiet opportunisti li s- soltu huma relatati ma ’ l- AIDS.
However, because the side effects of VISTIDE include kidney damage, it will be necessary to stop taking all other medications that may also cause kidney damage.
Madankollu, billi l- effetti mhux mixtieqa ta ’ VISTIDE jinkludu ħsara għall- kliewi, jkun meħtieġ li twaqqaf kull mediċina oħra li tista ’ wkoll tagħmel ħsara fil- kliewi.
You should tell your doctor if you are receiving other medications which are known to potentially damage the kidney, such as tenofovir, aminoglycosides, amphotericin B, foscarnet, intravenous pentamidine, adefovir and vancomycin.
Għandek tavża lit- tabib jekk int tkun qed tieħu mediċini oħrajn li huwa magħruf li jistgħu jagħmlu xi ħsara fil- kliewi, bħalma huma tenofovir, l- aminoglycosides, amphotericin B, foscarnet, pentamidine fil- vina, adefovir u vancomycin.
These medicines must be stopped AT LEAST 7 days before taking VISTIDE.
Dawn il- mediċini għandhom jitwaqqfu MILL- ANQAS 7 ijiem qabel ma tieħu VISTIDE.
Vistide is not used for the treatment of HIV infection.
Vistide ma jintużax għat- trattament ta ’ infezzjoni HIV.
Tell your doctor if you have diabetes mellitus.
Avża lit- tabib jekk għandek id- dijabete mellitus.
VISTIDE should be used with caution in diabetic patients due to the potential increased risk of developing ocular hypotony (low pressure in the eye).
VISTIDE għandu jintuża b’ kawtela f’ pazjenti li jbatu bid- dijabete minħabba li dawn il- pazjenti jkunu f’ riskju akbar li jiżviluppaw tnaqqis fil- pressjoni ta ’ ġol- għajn.
VISTIDE may cause transient side effects such as fatigue or weakness.
VISTIDE jista ’ jikkawża effetti oħra transitorji bħal għeja kbira u dgħufija.
If you drive or operate machinery, discuss this with your doctor to get their recommendation about discontinuing these activities based upon the condition of your disease and your tolerance of the medication.
Jekk ser issuq jew ser tħaddem xi magni, tkellimha mat- tabib biex tara x’ parir jagħtik dwar jekk għandekx twaqqaf dawn l- attivitajiet, liema parir ser ikun jiddependi mill- kundizzjoni tal- marda tiegħek, u minn kemm tiflaħ għal- medikazzjoni.
During treatment with VISTIDE you should receive regular follow-up ophthalmologic examinations for possible occurrence of eye irritation, inflammation or swelling.
Matul it- trattament b’ VISTIDE għandek tmur regolarment sabiex ikollok eżami okulari għall - possibilta ’ ta ’ irritazzjoni fl- għajnejn, infjammazzjoni jew nefħa.
Any pain, redness or itching of the eye or changes in your vision should be promptly reported to your doctor.
Kull uġiegħ, ħmura jew ħakk fl - għajnejn jew bdil fil- viżjoni għandha tkun irrappurtata mill- ewwel lit- tabib tiegħek.
VISTIDE caused reduced testes weight and hypospermia (low sperm count) in animals.
Fl- annimali, VISTIDE irriżulta fi tnaqqis fil- piż tat- testikoli u ipospermja (tnaqqis fl- għadd ta ’ l - isperma).
Although not observed in human studies of VISTIDE, such changes may occur in humans and cause infertility.
Għalkemm ma ġiex osservat fi studji b ’ VISTIDE fil- bniedem, xorta waħda hemm il - possibiltà li jiġri hekk fil- bniedem u dan jista ’ jwassal għall- infertilità.
You should not be given VISTIDE if you are pregnant.
M’ għandekx tingħata VISTIDE jekk inti tkun tqila.
If you become pregnant while taking this medication, you must inform your doctor immediately.
Jekk tinqabad tqila waqt li tkun qed tieħu din il - medikazzjoni, għandek tinforma lit- tabib minnufih.
VISTIDE has been shown to cause damage in unborn animals and should not be used during pregnancy unless the potential benefits justify the risks to the foetus.
Intwera li VISTIDE jagħmel ħsara f’ annimali li jkunu għadhom mhux imwielda u allura m’ għandux jintuża waqt it- tqala, sakemm il- vantaġġi li jista ’ jkun hemm ma jiġġustifikawx ir- riskji għall- fetu.
Women of childbearing potential should use birth control methods during and for 1 month following treatment with VISTIDE.
Nisa li jkunu għadhom ta ’ età li jista ’ jkollhom it- tfal għandhom jużaw kontraċettivi kemm waqt kif ukoll sa xahar wara t- trattament b’ VISTIDE.
You should not be given VISTIDE if you are breast feeding.
M’ għandekx tingħata VISTIDE jekk tkun qed tredda ’.
It is not known whether VISTIDE is excreted in human milk.
Mhux magħruf jekk VISTIDE joħroġx mal - ħalib tas- sider, fil- bniedem.
Because many medicines are excreted in human milk, nursing mothers should discontinue VISTIDE or stop nursing if they continue to receive VISTIDE.
Peress li ħafna mediċini fil- fatt joħorġu fil- ħalib tas- sider, fil- bniedem, nisa li jkunu jreddaw għandhom jew iwaqqfu VISTIDE, jew inkella jieqfu jreddgħu jekk ser jibqgħu jieħdu VISTIDE.
In general, women infected with HIV should not breast-feed their infants in order to avoid transmission of HIV to their newborn infant through the milk.
B’ mod ġenerali, nisa infettati bl- HIV ma għandhomx ireddgħu lit- tfal tagħhom sabiex ma jittrasmettux l- HIV lit- trabi tagħhom li jkunu għadhom kemm twieldu permezz tal- ħalib tagħhom.
VISTIDE has not been studied in children.
VISTIDE ma ġiex studjat fit- tfal.
Therefore, this medication should not be used in children.
Għalhekk, din il- mediċina ma għandhiex tintuża fuq it- tfal.
Using VISTIDE with food and drink:
21 Meta tuża VISTIDE ma ’ l- ikel u max- xorb:
Food should be taken prior to administration of VISTIDE.
VISTIDE għandu jingħata wara li tkun kilt xi ħaġa.
21 Important information about some of the ingredients of VISTIDE
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ VISTIDE
VISTIDE contains sodium.
VISTIDE fiħ is- sodju.
This should be taken into consideration by patients on a controlled sodium diet.
Dan għandu jkun ikkunsidrat minn pazjenti li qed isegwu dieta nieqsa fil- melħ.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed as these may interact with cidofovir or probenecid.
Jekk jogħġbok għarraf lit- tabib jew l- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki jekk mhux bir- riċetta tat- tabib, għax dawn jistgħu jeffettwaw ma ’ cidofovir jew probenecid.
Probenecid may interact with other medicines commonly used in the treatment of AIDS and AIDS- related illnesses, such as zidovudine (AZT).
Probenecid jista ’ jinteraġixxi ma ’ mediċini oħra li ta ’ spiss jintużaw fit- trattament tal- AIDS u mard ieħor li għandu x’ jaqsam ma ’ l- AIDS, bħal zidovudine (AZT).
If you are taking zidovudine, you should discuss with your doctor the option to either temporarily discontinue zidovudine or decrease the dose of zidovudine by 50% on days when VISTIDE and probenecid are administered.
Jekk tkun qed tieħu zidovudine, għandek tiddiskuti mat- tabib jekk ikunx aħjar li twaqqaf zidovudine għal ftit jew inkella tnaqqas id - doża ta ’ zidovudine b’ 50% f’ dawk il- ġranet li fihom tingħata VISTIDE u probenecid.
How to use VISTIDE
KIF GĦANDEK TUŻA VISTIDE
VISTIDE is administered by intravenous infusion and must not be administered by intraocular injection.
VISTIDE jingħata permezz ta ’ infużjoni fil- vina u m’ għandux jingħata bħala injezzjoni ġol- għajn.
VISTIDE must be administered by a health care professional.
VISTIDE għandu jingħata minn professjonista fil- qasam tas- saħħa.
To minimise the potential for kidney damage, probenecid tablets and intravenous saline solution must be administered with each VISTIDE infusion.
Biex titnaqqas il- possibiltà li ssir ħsara fil- kliewi, pilloli ta ’ probenecid u soluzzjoni tas- salina fil- vina għandhom jingħataw ma ’ kull infużjoni ta ’ VISTIDE.
The recommended dosage, frequency of use, or rate of infusion must not be exceeded.
Id- doża kif irrakkomandata, il- frekwenza ta ’ l - użu u r- rata ta ’ l- infużjoni m’ għandhomx jinqabżu.
VISTIDE must be diluted in 100 millilitres 0.9% (normal) saline prior to administration.
VISTIDE għandu jiġi dilwit ġo 100 millilitru ta ’ salina (normali) 0. 9% qabel ma jingħata.
Dosage in Adults
Id- doża fil- kbar
Induction Treatment.
Trattament li tibda bih.
The recommended dose of VISTIDE in patients with normal kidney function is 5 mg/ kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks.
Id- doża ta ’ VISTIDE li hija rrakkomandata f’ pazjenti li għandhom funzjoni tal- kliewi li hija normali hija ta ’ 5 mg/ kg tal- piż tal- ġisem (mogħtija bħala infużjoni fil- vina b’ rata kostanti fuq medda ta ’ siegħa) li tingħata darba fil- ġimgħa għal ġimgħatejn wara xulxin.
Maintenance Treatment.
Trattament ta ’ manteniment.
Beginning two weeks after completion of induction treatment, the recommended maintenance dose of VISTIDE in patients with normal kidney function is 5 mg/ kg body weight (given as an intravenous infusion at a constant rate over 1 hr) administered once every two weeks.
Dan jinbeda ’ ġimgħatejn wara li jitlesta t- trattament tal- bidu, u d- doża ta ’ VISTIDE li hija rrakkomandata biex tmantni biha f’ pazjenti b’ funzjoni tal- kliewi normali hija ta ’ 5 mg/ kg tal- piż tal- ġisem (mogħtija bħala infużjoni fil- vina b’ rata kostanti fuq medda ta ’ siegħa) li tingħata darba kull ġimgħatejn.
Dose Adjustment.
Regolar tad- doża.
If you have decreased kidney function, VISTIDE may not be appropriate therapy for you.
Jekk għandek xi tnnaqqis fil- fuzjoni tal- kliewi, jista ’ jagħti l- każ li VISTIDE ma jgħoddx għalik.
Samples of your urine and/ or blood will be obtained prior to each infusion of VISTIDE and used for testing kidney function.
Kampjuni ta ’ l- awrina u/ jew tad- demm jittieħdulek qabel kull infużjoni ta ’ VISTIDE u jintużaw biex tiġi eżaminata l- funzjoni tal- kliewi.
For patients with evidence of decreased kidney function, your VISTIDE dose may be interrupted or discontinued depending on your individual case.
F’ dawk il- pazjenti fejn ikun jidher li hemm tnaqqis fil- funzjoni tal- kliewi, d- doża ta ’ VISTIDE għandha mnejn titwaqqaf jew għal ftit, inkella għal kollox, kull każ għalih.
If you have accidentally been administered a dose of VISTIDE greater than prescribed for you, tell your doctor immediately.
Jekk aċċidentalment ġejt mogħti doża ta ’ VISTIDE li tkun akbar minn dik li tkun ordnata lilek, avża lit- tabib minnufih.
Can VISTIDE be mixed with other medications prior to use?
VISTIDE jista ’ jiġi mħallat ma ’ medikazzjonijiet oħrajn qabel ma jintuża?
No other medications or supplements should be added to the VISTIDE infusion bag.
L- ebda medikazzjoni jew supplimenti oħrajn m’ għandhom jiġu miżjuda ġol- borża ta ’ l- infużjoni li jkun fiha VISTIDE.
How will VISTIDE be prepared and given?
Kif se jiġi ppreparat VISTIDE u kif jingħata?
VISTIDE vials should be inspected visually prior to use.
Il- fjali ta ’ VISTIDE għanhom jiġu miflija qabel ma jintużaw.
If visible particles or discoloration are observed, the vial should not be used.
Jekk ikun jidher li hemm xi frak jew xi tibdil fil- kulur, il- fjala m’ għandiex tintuża.
The health care professional (e. g., physician/ nurse) will transfer the appropriate dose of VISTIDE from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution.
22 Il- professjonista fil- qasam tas- saħħa (ez., tabib / infermier) imbagħad jitrasferixxi d- doża adattata ta ’ VISTIDE mill- fjala għal ġol- borża ta ’ l- infużjoni li jkun fiha 100ml ta ’ soluzzjoni ta ’ salina (normali) 0. 9%.
The entire volume of the bag will be infused intravenously into you at a constant rate over a period of 1 hour by use of a standard infusion pump.
Il- volum kollu kemm hu tal- borża imbagħad jiġi infuż ġol- vini tiegħek b’ rata li hija kostanti fuq medda ta ’ siegħa permezz ta ’ pompa ta ’ l- infużjoni standard.
22 The chemical stability of VISTIDE mixed in saline solution has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) composition or ethylene/ propylene copolymer, and in PVC based vented I. V. administration sets.
L- istabilità kimika ta ’ VISTIDE meta dan kien imħallat mas- salina kienet intweriet fi fliexken tal - ħġieġ, f’ boroż ta ’ l- infużjonijiet magħmula minn polvinyl chloride (PVC), jew ethylene/ propylene co - polymer, u anki f’ settijiet ta ’ l- infużjoni ġol- vina b’ vent, magħmulin bil- bażi tal- PVC.
Compatibility of VISTIDE with Ringer’ s Solution, Lactated Ringer’ s Solution or bacteriostatic infusion fluids has not been evaluated.
Il- kompatibilità mas- soluzzjoni tat- tip Ringer, u mas- soluzzjoni tat- tip Lactated Ringer jew ma ’ sustanzi fluwidi u batterjostatiċi għall- infużjonijiet, ma ġietx valutata.
From a microbiological point of view, the product must be used immediately.
Minn punt ta ’ vista mikrobijoloġiku, il- prodott għandu jintuża immedjatament.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 – 8 ºC when dilution is performed under controlled and validated aseptic conditions.
Stabbilta ’ kimika u fiżika waqt l- użu ġiet murija li hi l- iktar sa 24 siegħa f’ temperatura ta ’ 2 – 8 ºC, meta ikun dilwit taħt kundizzjonijiet asettiċi kontrollati u validati.
Refrigerated infusion bags should be allowed to warm to room temperature prior to use.
Soluzzjonijiet imkessħin għandhom jitħallew jisħnu sat- temperatura tal- kamra qabel jintużaw.
VISTIDE is supplied in single-use vials.
VISTIDE issibu fi fjali li jintużaw darba biss.
Partially used vials must be discarded.
Fjali nofshom użati għandhom jintremew.
VISTIDE should be administered by health care professionals adequately experienced in the care of AIDS patients.
VISTIDE għandu jingħata minn professjonisti fil- qasam tas- saħħa li għandhom biżżejjed esperjenza fil- kura ta ’ pazjenti bl- AIDS.
Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of VISTIDE.
Huwa rrakkomandat li jittieħdu prekawzjonijiet xierqa inkluż l- użu ta ’ apparat tas- sigurtà adattat kemm għall- preparazzjoni, kif ukoll għall- amministrazzjoni u anki għar - rimi ta ’ VISTIDE.
The preparation of VISTIDE diluted solution should be done in a laminar flow biological safety cabinet.
Il- preparazzjoni tas- soluzzjoni dilwita ta ’ VISTIDE għanha ssir ġo cabinet tas - sigurtà bijoloġiku tat- tip laminar flow.
Personnel preparing the solution should wear surgical gloves, safety glasses and a closed front surgical-type gown with knit cuffs.
Dawk li jippreparaw is- soluzzjoni għandhom jilbsu ngwanti tal - kirurġija, nuċċali tas- sigurtà, u lbies twil b’ quddiem magħluq u bit- tarf tal- komma jagħlaq sew, bħal dak li jintuża mill- kirurgi waqt l- operazzjonijet.
Why is the medication probenecid given with VISTIDE?
Għaliex tingħata l- medikazzjoni probenecid ma ’ VISTIDE?
Probenecid tablets are given to minimise the potential for kidney damage.
Il- pilloli probenecid jingħataw sabiex dejjem titnaqqas aktar il- possibiltà ta ’ ħsara fil kliewi.
You must receive a course of probenecid tablets administered orally with each VISTIDE dose.
Int għandek tingħata kors ta ’ pilloli probenecid, mill- ħalq, ma ’ kull doża ta ’ VISTIDE.
Probenecid is only taken on the same day that VISTIDE is administered.
Żewġ grammi għandhom jingħataw 3 sigħat qabel id- doża ta ’ VISTIDE, u gramma waħda terġa ’ tingħata sagħtejn u mbagħad 8 sigħat (għal total ta ’ 4 grammi) wara li titlesta l- infużjoni ta ’ VISTIDE li tkun ingħatat fuq medda ta ’ siegħa.
See section 6 for further information on obtaining probenecid.
Ara sezzjoni 6 Aktar tagħrif, għall- informazzjoni dwar kif takkwista probenecid.
Why is normal saline solution given with VISTIDE?
Għaliex tingħata soluzzjoni ta ’ salina normali ma ’ VISTIDE?
Normal saline is given to minimise the potential for kidney damage.
Is- salina normali tingħata biex tnaqqas il- possibiltà ta ’ ħsara fil- kliewi.
You should receive a total of one litre of 0.9% (normal) saline solution intravenously with each infusion of VISTIDE.
Inti għandek tingħata total ta ’ litru ta ’ soluzzjoni ta ’ salina (normali) 0. 9% fil- vina ma ’ kull infużżjoni ta ’ VISTIDE.
The saline solution should be infused over a 1 hour period immediately before the VISTIDE infusion.
Is- soluzzjoni likwida tas- salina għandha tiġi nfuża fuq perijodu ta ’ siegħa immedjatament qabel l- infużjoni ta ’ VISTIDE.
If you can tolerate the additional fluid load, your doctor may administer a second litre of fluid.
Jekk tkun tiflaħ għal ammont akbar ta ’ fluwidu, it- tabib għandu mnejn jagħtik litru ieħor ta ’ fluwidu.
If administered, the second litre of saline should be initiated either at the start of the VISTIDE infusion or immediately afterwards, and infused over a 1 to 3 hour period.
Jekk dan it- tieni litru ta ’ salina jingħata, għandu jinbeda ’ jew mal- bidu ta ’ l- infużjoni ta ’ VISTIDE, jew immedjatament wara u għandu jiġi nfuż fuq 1- 3 sigħat.
Your doctor may also instruct you to drink plenty of fluids.
It- tabib għandu mnejn jgħidlek ukoll biex tixrob ħafna.
Possible side effects
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
Like all medicines, VISTIDE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, VISTIDE jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects in this section are given with an estimation of the frequency with which they may occur.
23 L- effetti l- oħra li jissemmew f’ din is- sezzjoni ser jingħataw flimkien ma ’ stima tal- frekwenza li biha jistgħu jiġru.
For this purpose, the following frequency categories and denominations have been used:
Għal dan il- għan dawn il- kategoriji ta ’ frekwenzi u denominazzjonijiet intużaw:
Very common: side effects which may occur in more than 1 in 10 patients.
Komuni ħafna: effetti oħra li jistgħu iseħħu f’ aktar minn 1 minn 10 pazjenti.
Common: side effects which may occur in 1 to 10 out of 100 patients.
Komuni: effetti oħra li jistgħu iseħħu f’ minn 1 sa 10 minn kull 100 pazjent.
Uncommon: side effects which may occur in 1 to 10 out of 1000 patients.
Mhux komuni: effetti oħra li jistgħu iseħħu f’ minn 1 sa 100 minn kull 1000 pazjent.
23 Rare: side effects which may occur in 1 to 10 out of 10 000 patients.
Rari: effetti oħra li jistgħu iseħħu f’ minn 1 sa 10 minn kull 10, 000 pazjent.
Very rare: side effects which may occur in less than 1 out of 10 000 patients.
Rari ħafna: effetti oħra li jistgħu iseħħu f’ inqas minn 1 minn kull 10, 000 pazjent.
The most common side effect observed with VISTIDE has been damage to the kidneys.
L- effett mhux mixtieq l- aktar komuni li ġie osservat b’ VISTIDE kien dak ta ’ ħsara fil- kliewi.
Very common side effects are: low white blood cell counts, headache, nausea, vomiting, protein in the urine, increase in blood creatinine (a measure of kidney function), hair loss, rash, weakness/ fatigue and fever.
Effetti oħra komuni ħafna jinkludu: għadd baxx ta ’ ċelluli bojod fid- demm, uġiegħ ta ’ ras, dardir, rimettar, proteina fl- awrina, żieda fil- livell tal- krejatinina fis- serum (li huwa kejl tal- funzjoni tal - kliewi), tfartis, raxx, dgħufija / għeja kbira u deni.
Common side effects are: inflammation of the eye, reduced pressure in the eyes, difficult or laboured breathing, shortness of breath and chills.
Effetti oħra li huma komuni jinkludu: infjammazzjoni fl- għajn, tnaqqis fil- pressjoni ta ’ ġol- għajn, diffikulta jew tbatija biex tieħu n- nifs, qtugħ ta ’ nifs u tkexkix ta ’ bard.
Any pain, redness or itching of the eye or changes in your vision should be promptly reported to your doctor so that your treatment can be reviewed.
Kull uġigħ, ħmura jew ħakk fl- għajn, jew kull tibdil fil- vista tiegħek għandhom jiġu rrapportati lit - tabib tiegħek minnufih biex jara jekk hemmx bżonn li jirrevedi t- trattament tiegħek.
Additional reactions reported from post marketing experience include kidney failure, inflammation of the pancreas and hearing impairment.
Effetti oħra li mhux mixtieqa ġew rrappurtati mill- esperjenza ta ’ wara t- tqegħid fis- suq jinkludu falliment tal- kliewi, infjammazzjoni tal- frixa u impediment tas- smigħ.
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 pharmacist immediately.
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 lill- ispiżjar tiegħek.
These side effects usually disappear when treatment with VISTIDE is stopped.
Dawn l- effetti l- oħra ġeneralment imorru meta jitwaqqaf it- trattament b’ VISTIDE.
What are the possible side effects of taking probenecid?
X’ inhuma l- effetti oħra mhux mixtieqa meta jittieħed probenecid?
Very common side effects possibly related to probenecid are nausea, vomiting, rash and fever.
Effetti oħra mhux mixtieqa li huma komuni ħafna u possibbilment ikkawżati minn probenecid huma: dardir, rimettar, raxx u deni.
Common side effects possibly related to probenecid include headache, weakness/ fatigue, chills and allergic reactions.
Effetti komuni mhux mixtieqa possibilment relatati ma ’ probenecid jinkludu uġiegħ ta ’ ras, dgħufija / għeja kbira, tkexkix ta ’ bard u reazzjonijiet allerġiċi.
To decrease the potential for nausea and/ or vomiting associated with taking probenecid, you should eat food prior to each dose of probenecid.
Biex tnaqqas il- possibilta ’ ta ’ dardir u/ jew rimettar assoċjat ma ’ l- użu ta ’ probenecid, għandek tiekol qabel kull doża ta ’ probenecid.
Your Doctor might instruct you to take other medications such as antiemetics, antihistamines and/ or paracetamol to decrease the side effects of probenecid.
It- tabib għandu mnejn jgħidlek biex tieħu xi medikazzjonijiet oħrajn bħal anti- istamini, mediċini għal kontra r- rimettar jew paracetamol biex inaqqaslek l- effetti l- oħra mhux mixtieqa ta ’ probenecid.
Probenecid may also cause other side effects including loss of appetite, sore gums, flushing, hair loss, dizziness, reduced red blood cell count and increased frequency to urinate.
Probenecid jista wkoll jikkawża effetti oħra mhux mixtieqa inkluż tnaqqis fl- aptit, uġiegħ fil- ħanek, fwawar, tfartis, sturdament, tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm u żieda fil- frekwenza ta ’ l - awrina.
Allergic reactions, with skin inflammation, itching, hives and, rarely, severe allergic reactions, and serious skin reaction have occurred.
Reazzjonijiet allerġiċi, b’ infjammazjjoni tal- ġilda, ħakk, tixwik u tingiż, u rarament, reazzjonijiet allerġiċi severi u reazzjonijiet serji fil- ġilda ġraw.
There have been reports of reduced white blood counts, liver toxicity, kidney toxicity and destruction of red blood cells.
Kien hemm ukoll rapporti ta ’ tnaqqis fl- għadd taċ- ċelluli bojod tad- demm, tossiċita ’ tal- fwied, tossiċita tal- kliewi u distruzzjoni ta ’ ċelluli ħomor tad- demm.
Reductions in blood cell and platelet counts have also occurred.
Tnaqqis fil- għadd taċ- ċelluli ħomor u tat- tromboċiti ġraw ukoll.
Therefore before being given probenecid your doctor should consult the current prescribing information for further information regarding the safety of that product.
Għalhekk qabel ma jingħata probenecid it- tabib tiegħek għandu jikkonsulta l- informazzjoni dwar l- użu tal- mediċina għal iktar informazzjoni dwar is- sigurta ’ tal- prodott.
How to store VISTIDE
KIF TAĦŻEN VISTIDE
Do not use after the expiry date stated on the label.
24 M’ għandekx tuża wara d- data li fiha jiskadi li tidher fuq it- tikketta
What VISTIDE contains
X’ fih VISTIDE
The active substance of VISTIDE 75 mg/ ml is cidofovir.
Is- sustanza attiva ta ’ VISTIDE 75 mg / ml hija Cidofovir.
Each ml contains 75 mg cidofovir anhydrous.
Kull ml fih 75 mg Cidofovir anhydrous.
Each vial contains 375 mg/ 5ml cidofovir anhydrous
Kull kunjett fih 375 mg/ 5ml cidofovir anhydrous
The other ingredients are Sodium Hydroxide Hydrochloric Acid Water for injection
Is- sustanzi l- oħra huma Sodium Hydroxide Hydrochloric Acid Ilma għall- injezzjonijiet
What VISTIDE looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
VISTIDE is supplied as a sterile concentrate for solution for infusion in clear, glass vials containing 375 mg of the active ingredient, anhydrous cidofovir, in 5 ml formulated in Water for Injection at a concentration of 75 mg/ ml.
VISTIDE jiġi bħala konċentrat sterili għal soluzzjoni għall- infużjoni ġo kunjetti tal- ħġieġ trasparenti li fihom 375 mg tas- sustanza attiva, anhydrous cidofovir, f’ 5 ml ifformulata f’ Ilma għall- Injezzjoni f’ konċentrazzjoni ta ’ 75 mg/ ml.
The formulation is pH-adjusted with sodium hydroxide (and Hydrochloric Acid if needed) and contains no preservatives.
Il- formulazzjoni għandha l- pH tagħha aġġustat b’ sodium hydroxide (u jekk ikun hemm bżonn b’ Hydrochloric Acid) u ma għandha ebda preservattivi.
Marketing Authorisation Holder Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Gilead Sciences International Limited Cambridge CB21 6GT Ir- Renju Unit
The Manufacturer Authorisation Holder responsible for batch release in the European Economic Area Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co.
Id- detentur ta ’ l- awtorizzazzjoni responsabbli mil- ħruġ tal- lott fiż- Żona Ekonomika Ewropea Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Vistide must be given with probenecid.
VISTIDE għandu jingħata flimkien ma ’ probenecid.
If you have not been provided probenecid, please contact your pharmacist or the local representative of the Marketing Authorisation Holder of Vistide for information (see also section 3 How to use VISTIDE, Why is the medication given with probenecid).
Jekk int ma ġejtx provdut b’ probenecid, jekk jogħġbok għamel kuntatt ma ’ l- ispiżjar jew mar- rappreżentant lokali tad- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq għall- informazzjoni (ara wkoll sezzjoni 3 Kif għandek tuża VISTIDE, Għaliex tingħata l- medikazzjoni probenecid ma ’ VISTIDE?)
Č eská republika Gilead Sciences International Ltd Tel: + 44 (0) 20 7136 8820
25 Česká republika Gilead Sciences International Ltd Tel: + 44 (0) 20 7136 8820
This leaflet was last approved on {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar fi{ XX/ SSSS}
26
26 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
What is Visudyne?
X’ inhu Visudyne?
Visudyne is a medicine containing the active substance verteporfin.
Visudyne hija mediċina li fiha s- sustanza attiva verteporfin.
It is available as a powder in a vial, to be made into a solution for infusion.
Tiġi bħala trab fi fjala biex titħallat f’ soluzzjoni għall- infużjoni.
What is Visudyne used for?
Għal x’ hiex jintuża Visudyne?
Visudyne is used for the treatment of patients who have subfoveal choroidal neovascularisation.
Visudyne jintuża għat- trattament ta ’ pazjenti li jkollhom subfoveal choroidal neovascularisation.
This is the abnormal growth of blood vessels under the macula, the central part of the retina (the light- sensitive membrane at the back of the eye).
Din tikkonsisti fl- iżvilupp anormali ta ’ arteji u vini taħt il- makula, il- parti ċentrali tar- retina (il- membrana sensittiva għad- dawl fuq in- naħa ta ’ wara tal- għajn).
When these blood vessels bleed or leak fluid, it causes a loss of vision.
Meta joħroġ demm jew xi likwidu ieħor minn dawn l- arterji jew vini, dan iwassal għal telf tal- vista.
Visudyne is used for two diseases where this occur, the wet form of age-related macular degeneration (AMD) and pathological myopia, a rare type of short-sightedness where the eyeball continues to grow, becoming longer than it should be.
Visudyne jintuża għal żewġ mardiet li fihom iseħħ dan, il- forma fluwida tad- deġenerazzjoni makulari relatata ma ’ l- età (AMD) u l- mijopija patoloġika, tip rari ta ’ problemi bil- vista tal- bogħod li fiha l - ballun tal- għajn ikompli jikber u jitwal iktar milli suppost.
In wet AMD, Visudyne is used when the neovascularisation is ‘ predominantly classic’ (when the blood vessels affected are well defined on an eye scan), The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb biss b’ riċetta ta ’ tabib.
How is Visudyne used?
Kif jintuża Visudyne?
Visudyne should be used only by ophthalmologists (eye specialists) who have experience in the management of patients with AMD or pathological myopia.
Visudyne għandu jintuża biss minn oftalmoloġi (speċjalisti tal- għajnejn) li jkollhom esperjenza fil - ġestjoni ta ’ pazjenti b’ AMD jew mijopija patoloġika.
Treatment with Visudyne is a two-step process.
It- trattament b’ Visudyne hu proċess f’ żewġ fażijiet.
First, the patient receives Visudyne as an intravenous infusion (drip in to a vein) at a dose of 6 mg per square metre of body surface area over 10 minutes.
L- ewwel, il- pazjent jingħata Visudyne bħala infużjoni intravenuża (drip fil- vina) b’ doża ta ’ 6 mg għal kull metru kwadru ta ’ l- erja tas- superfiċje fuq perjodu ta ’ 10 minuti.
The second step, 15 minutes after the start of the infusion, is the activation of Visudyne in the eye using the light generated by a laser beam.
It- tieni pass, 15- il minuta wara l- bidu ta ’ l- infużjoni, hu l- attivazzjoni ta ’ Visudyne fil- għajn bl- użu ta ’ dawl ġenerat minn raġġ tal- lejżer.
Treatment can be repeated every three months if necessary.
It- trattament jista ’ jiġi repetut kull tliet xhur jekk meħtieġ.
How does Visudyne work?
Kif jaħdem Visudyne?
The active substance in Visudyne, verteporfin, is a photosensitising agent (a substance that changes when exposed to light).
Is- sustanza attiva f’ Visudyne, verteporfin, hu aġent fotosensitizzanti (sustanza li tinbidel meta esposta għad- dawl).
It is used in ‘ photodynamic therapy’, a method of treatment that uses light (generally from a laser) to activate a photosensitising agent.
Tintuża fit - ‘ terapija fotodinamika ’, metodu ta ’ trattament li juża d- dawl (ġeneralment minn lejżer) biex jattiva aġent fotosensitizzanti.
When Visudyne is injected into a patient, verteporfin is distributed within the body through the blood vessels, including the blood vessels at the back of the eye.
Meta Visudyne jiġi injettat f’ pazjent, verteporfin jixtered fil- ġisem permezz ta ’ l- arterji u l- vini, inkluż dawk fuq wara tal- għajn.
When the laser light is shone into the eye, verteporfin is activated and becomes cytotoxic (able to kill cells).
Meta jintefa ’ dawl tal - lejżer fil- għajn, verteporfin jiġi attivat u jsir ċitotossiku (kapaċi joqtol iċ- ċelloli).
This helps to close the abnormal blood vessels that cause AMD.
Dan jgħin biex jingħalqu l- arterji u l- vini anormali li jikkawżaw AMD.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Visudyne been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Visudyne?
Visudyne has been studied in two studies lasting two years and involving 609 AMD patients with classic subfoveal lesions, where it was compared with placebo (a dummy treatment).
Visudyne ġie studjat f’ żewġ studji li damu sentejn u li fihom ħadu sehem 609 pazjenti b’ AMD b’ leżjonijiet klassiċi ta ’ taħt il- fovea, fejn tqabbel ma ’ plaċebo (trattament finta).
Among the patients who completed the studies, 476 were treated for longer, up to 5 years.
Fost pazjenti li kienu ħadu sehem fi studju sa tmiemu, 476 ġew trattati għal perjodu itwal, sa 5 snin.
Visudyne has also been studied for two years in 120 patients with subfoveal choroidal neovascularisation caused by pathologic myopia.
Visudyne ġie studjat ukoll għal sentejn fuq 120 pazjent b’ subfoveal choroidal neovascularisation ikkawżata minn mijopija patoloġika.
Of these, 67 continued treatment for up to 5 years.
Minn dawn, 67 komplew it- trattament sa ħames snin.
All of the studies compared the effectiveness of Visudyne with that of placebo.
L- istudji kollha qabblu l- effettività ta ’ Visudyne ma ’ dik tal- plaċebo.
The measure of effectiveness was the percentage of responders after 1 year (the proportion of patients who lost fewer than 3 lines [15 letters] on a sight chart).
Il- mezz tal- kejl ta ’ l- effettività kien il - perċentwal ta ’ nies li rrispondew wara sena (il- proporzjon ta ’ pazjenti li kienu tilfu l- vista ta ’ inqas minn tliet linji jew 15- il ittra fuq kartellun tal- vista).
Visudyne has also been compared with placebo in ‘ occult’ subfoveal choroidal neovascularisation (when the blood vessels affected are not well defined on the scan), in a 2-year study of 339 patients.
Visudyne tqabbel ukoll ma ’ plaċebo f’ subfoveal choroidal neovascularisation ‘ okkulta ’ (meta l- arterji u l- vini affettwati ma jkunux definiti sew fuq l- isken), fi studju ta ’ sentejn bis- sehem ta ’ 339 pazjent.
This was followed by a confirmatory study in a further 364 patients that was carried out at the request of the CHMP.
Dan kien segwit bi studju konfermatorju ta ’ 364 pazjent ieħor li sar fuq talba tas- CHMP.
What benefit has Visudyne shown during the studies?
X’ inhuma l- benefiċċji ta ’ Visudyne li ntwerew f’ dawn l- istudji?
In the two studies of classic subfoveal choroidal neovascularisation, Visudyne was more effective than placebo.
Fiż- żewġ studji ta ’ subfoveal choroidal neovascularisation klassika, Visudyne kien iktar effettiv mill - plaċebo.
After 12 months, the proportion of patients responding to the treatment was 61% for Visudyne-treated patients compared with 46% for placebo-treated patients.
Wara 12- il xahar, il- proporzjon ta ’ pazjenti li rrispondew għat- trattament kien ta ’ 61% għal pazjenti ttrattati b’ Visudyne meta mqabbla ma ’ 46% għal pazjenti ttrattati bil- plaċebo.
The benefit was maintained for up to 5 years.
Il- benefiċċju baqa ’ jidher sa 5 snin.
For patients with neovascularisation caused by pathologic myopia, after 12 months, 86% of the Visudyne-treated patients had a loss of less than 15 letters compared with 67% of the placebo-treated patients.
Għal pazjenti b’ neovaskularizzazzjoni kkawżata minn mijopija patoloġika, wara 12- il xahar, 86% tal - pazjenti kellhom tnaqqis ta ’ inqas minn 15- il ittra meta mqabbla ma ’ 67% tal- pazjenti ttrattati bil - plaċebo.