natgillin/translations-raw huggingface dataset:
The formulation is pH-adjusted with sodium hydroxide (and Hydrochloric Acid if needed) and contains no preservatives.
Pripravek ima pH uravnan z natrijevim hidroksidom (in klorovodikovo kislino, če je potrebno) in ne vsebuje konzervansov.
Marketing Authorisation Holder Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
Imetnik dovoljenja za promet z zdravilom Gilead Sciences International Limited Cambridge CB21 6GT Velika Britanija
The Manufacturer Authorisation Holder responsible for batch release in the European Economic Area Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co.
Izdelovalec, odgovoren za sproščanje serij v Evropskem gospodarskem prostoru Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co.
Vistide must be given with probenecid.
Zdravilo Vistide morate dobiti s probenecidom.
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).
Če niste dobili probenecida, se za informacije obrnite na svojega farmacevta ali na lokalnega predstavnika imetnika dovoljenja za promet z zdravilom Vistide (glejte tudi poglavje 3, Kako uporabljati zdravilo VISTIDE, Zakaj se zdravilo VISTIDE uporablja s probenecidom).
This leaflet was last approved on {MM/ YYYY}
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Visudyne is a medicine containing the active substance verteporfin.
Visudyne je zdravilo, ki vsebuje zdravilno učinkovino verteporfin.
It is available as a powder in a vial, to be made into a solution for infusion.
Zdravilo je na voljo v obliki praška v viali in se uporablja za pripravo raztopine za infundiranje.
Visudyne is used for the treatment of patients who have subfoveal choroidal neovascularisation.
Zdravilo Visudyne se uporablja za zdravljenje bolnikov s subfovealno horoidno neovaskularizacijo.
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).
To je nenormalna rast krvnih žil pod makulo, osrednjim delom mrežnice (na svetlobo občutljiva membrana v zadnji steni očesa).
When these blood vessels bleed or leak fluid, it causes a loss of vision.
Kadar te žile krvavijo ali iz njih izteka tekočina, pride do izgube vida.
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.
Zdravilo Visudyne se uporablja pri dveh boleznih, mokri obliki starostne makularne degeneracije in bolezenski kratkovidnosti, redkemu tipu kratkovidnosti, pri kateri očesno zrklo raste še naprej in postane daljše, kot bi moralo biti.
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.
Zdravilo se dobi samo na recept.
Visudyne should be used only by ophthalmologists (eye specialists) who have experience in the management of patients with AMD or pathological myopia.
Zdravilo Visudyne lahko uporabljajo le oftamologi (specialisti za oči), ki imajo izkušnje z zdravljenjem bolnikov s starostno makularno degeneracijo ali bolezensko kratkovidnostjo.
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.
Bolnik najprej v času 10 minut prejme zdravilo Visudyne kot intravensko infuzijo (dajanje tekočine v veno) v odmerku 6 mg na kvadratni meter telesne površine.
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.
V drugem koraku, ki se začne 15 minut po začetku infundiranja, se zdravilo Visudyne v očesu aktivira s pomočjo svetlobe laserskega žarka.
Treatment can be repeated every three months if necessary.
Po potrebi se lahko zdravljenje ponovi vsake tri mesece.
The active substance in Visudyne, verteporfin, is a photosensitising agent (a substance that changes when exposed to light).
Aktivna učinkovina zdravila Visudyne je verteporfin, ki je na svetlobo občutljivo sredstvo (snov, ki se spremeni, če jo izpostavimo svetlobi).
It is used in ‘ photodynamic therapy’, a method of treatment that uses light (generally from a laser) to activate a photosensitising agent.
Uporablja se pri „ fotodinamični terapiji “, metodi zdravljenja, ki za aktivacijo na svetlobo občutljivega sredstva uporablja svetlobo (običajno svetlobo laserja).
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.
Ko zdravnik bolniku vbrizga zdravilo Visudyne, se to preko krvnih žil porazdeli po celem telesu in s tem tudi po žilah na zadnji steni očesa.
When the laser light is shone into the eye, verteporfin is activated and becomes cytotoxic (able to kill cells).
Ko zdravnik v oko posveti z lasersko svetlobo, postane verteporfin aktiven in citotoksičen (sposoben ubijati celice).
This helps to close the abnormal blood vessels that cause AMD.
Slednje pomaga pri zapiranju nenormalnih žil, ki povzročajo starostno makularno degeneracijo.
(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 Kako je bilo zdravilo Visudyne raziskano?
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).
Zdravilo Visudyne so raziskali v dveh študijah, ki sta trajali dve leti in vključevali 609 bolnikov s starostno makularno degeneracijo in klasičnimi subfovealnimi lezijami, ter v katerih so zdravilo primerjali s placebom (zdravilom brez zdravilne učinkovine).
Among the patients who completed the studies, 476 were treated for longer, up to 5 years.
Med bolniki, ki so prišli do konca zdravljenja, so jih 476 zdravili še dlje, do največ pet let.
Visudyne has also been studied for two years in 120 patients with subfoveal choroidal neovascularisation caused by pathologic myopia.
Zdravilo Visudyne so dve leti raziskovali tudi pri 120 bolnikih s subfovealno horoidno neovaskularizacijo, ki jo povzroča bolezenska kratkovidnost.
Of these, 67 continued treatment for up to 5 years.
Od teh bolnikov jih je 67 z zdravljenjem nadaljevalo do pet let.
All of the studies compared the effectiveness of Visudyne with that of placebo.
V vseh študijah so primerjali učinkovitost zdravila Visudyne s placebom.
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).
Merilo učinkovitosti je bil odstotek bolnikov, ki so se po enem letu odzvali na zdravljenje (delež bolnikov, ki so izgubili več kot tri vrstice [15 črk] na tabeli za testiranje ostrine vida).
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.
V dve leti trajajoči študiji pri 339 bolnikih so zdravilo Visudyne primerjali s placebom tudi pri prikriti subfovealni horoidni neovaskularizaciji (ko prizadete žile na sliki niso dobro izražene).
This was followed by a confirmatory study in a further 364 patients that was carried out at the request of the CHMP.
Temu je sledila potrdilna študija na nadaljnjih 364 bolnikih, ki so jo izvedli na zahtevo CHMP.
What benefit has Visudyne shown during the studies?
Kakšne koristi je zdravilo Visudyne izkazalo med raziskavami?
In the two studies of classic subfoveal choroidal neovascularisation, Visudyne was more effective than placebo.
V dveh študijah klasične subfovealne horoidne neovaskularizacije je bilo zdravilo Visudyne bolj učinkovito kot placebo.
After 12 months, the proportion of patients responding to the treatment was 61% for Visudyne-treated patients compared with 46% for placebo-treated patients.
Po 12 mesecih je bilo razmerje bolnikov, ki so se odzivali na zdravljenje 61% pri bolnikih zdravljenih z zdravilom Visudyne in 46% pri bolnikih zdravljenih s placebom.
The benefit was maintained for up to 5 years.
Ta koristni učinek so vzdrževali do največ petih let.
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.
Pri bolnikih z neovaskularizacijo, ki jo povzroča bolezenska kratkovidnost, je po 12 mesecih 86% bolnikov, ki so jih zdravili z zdravilom Visudyne, pokazalo izgubo manj kot 15 črk v primerjavi s 67% bolnikov, ki so se zdravili s placebom.
While the first study in occult disease showed some effectiveness, this was not confirmed by the second study, and the benefit of Visudyne in occult subfoveal choroidal neovascularisation has not been established.
Čeprav je prva študija pri prikriti bolezni pokazala določeno stopnjo učinkovitosti, to ni bilo potrjeno z drugo študijo, tako da koristni učinki zdravila Visudyne pri prikriti subfovealni horoidni neovaskularizaciji še niso bili dokazani.
The most common side effects with Visudyne (seen in between 1 and 10 patients in 100) are abnormal vision (blurry, hazy, fuzzy vision, flashes of light, decreased vision, grey or dark haloes, and black spots), reactions at the injection site (pain, swelling and inflammation), and infusion-related pain such as back pain, nausea (feeling sick), photosensitivity reactions (sunburn on skin areas exposed to light), asthenia (weakness) and hypercholesteraemia (high blood cholesterol).
Najpogostejši neželeni učinki, ki so povezani z zdravilom Visudyne (opaženi med enim in 10 bolniki od 100) so nenormalen vid (zamegljen, meglen, zabrisan vid, svetlobni bliski, upad vida, sivi ali temni obročki in črne pege), reakcije na mestu vbrizganja (bolečina, otekanje in vnetje) ter bolečine, ki so povezane z infuzijo, kakršne so bolečine v hrbtu, slabost, reakcije preobčutljivosti na svetlobo (sončne opekline kože, ki je izpostavljena svetlobi), astenija (šibkost) in hiperholesterolemija (visoka raven krvnega holesterola).
For the full list of side effects reported with Visudyne, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Visudyne, glejte Navodilo za uporabo.
Visudyne should not be used in people who may be hypersensitive (allergic) to verteporfin or any of the other ingredients, in patients with porphyria (an inability to break down chemicals called porphyrins) or in patients with severe liver disease.
Zdravila Visudyne ne smejo uporabljati osebe, ki bi utegnile biti preobčutljive za (alergične na) verteporfin ali katero koli drugo sestavino zdravila, bolniki, ki imajo porfirijo (nezmožnost razgraditi kemične snovi, ki se imenujejo porfirini) ali bolniki s hudimi okvarami jeter.
The Committee for Medicinal products for Human Use (CHMP) decided that Visudyne’ s benefits are greater than its risks for the treatment of patients with subfoveal choroidal neovascularisation due to exudative age-related macular degeneration, when the lesions are predominantly classic, or due to pathological myopia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Visudyne pri zdravljenju bolnikov s subfovealno horoidno neovaskularizacijo, ki je posledica eksudativne in starostne makularne degeneracije in pri kateri so lezije v glavnem klasične ali pa so posledica bolezenske kratkovidnosti, večje od z njim povezanih tveganj.
The Committee recommended that Visudyne be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Visudyne.
The European Commission granted a marketing authorisation valid throughout the European Union, for Visudyne to Novartis Europharm Limited on 27 July 2000.
Evropska komisija je dovoljenje za promet z zdravilom Visudyne, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 27. julija 2000.
The marketing authorisation was renewed on 27 July 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 27. julija 2005.
The full EPAR for Visudyne is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Visudyne je na voljo tukaj.
Glass vial
steklena viala
1 x 10 ml vial
1 x 10 ml viala
7.5 ml of reconstituted solution contains 15 mg of verteporfin.
7, 5 ml rekonstituirane raztopine vsebuje 15 mg verteporfina.
Dark green to black powder.
Temnozelen do črn prašek.
Visudyne is indicated for the treatment of
Visudyne je indiciran za zdravljenje
- patients with exudative (wet) age-related macular degeneration (AMD) with predominantly
- bolnikov z eksudativno (vlažno) obliko starostne degeneracije makule (AMD) s prevladujočo
classic subfoveal choroidal neovascularisation (CNV) or
klasično subfovealno horioidalno neovaskularizacijo (CNV) ali
- patients with subfoveal choroidal neovascularisation secondary to pathological myopia.
- bolnikov s subfovealno horioidalno neovaskularizacijo zaradi bolezenske kratkovidnosti.
Visudyne should be used only by ophthalmologists experienced in the management of patients with age-related macular degeneration or with pathological myopia.
Visudyne naj uporabljajo samo oftalmologi, ki imajo izkušnje z zdravljenjem bolnikov s starostno degeneracijo makule ali z bolezensko kratkovidnostjo.
Adults and elderly:
Odrasli in starejši bolniki:
The first step is a 10-minute intravenous infusion of Visudyne at a dose of 6 mg/ m2 body surface area, diluted in 30 ml infusion solution (see section 6.6).
Prva stopnja je 10- minutna intravenska infuzija zdravila Visudyne v odmerku 6 mg/ m2 telesne površine, razredčenega v 30 ml infuzijske raztopine (glejte poglavje 6. 6).
The second step is the light activation of Visudyne at 15 minutes after the start of the infusion.
Druga stopnja je svetlobna aktivacija zdravila Visudyne 15 minut po začetku infundiranja.
For this, a diode laser generating non-thermal red light (wavelength 689 nm ± 3 nm) is used via a slit lamp mounted fibre optic device and a suitable contact lens.
Za to se uporablja diodni laser, ki daje hladno rdečo svetlobo (valovne dolžine 689 nm ± 3 nm), s pomočjo naprave iz optičnih vlaken, nameščene na špranjsko svetilko, in ustrezne kontaktne leče.
At the recommended light intensity of 600 mW/ cm2, it takes 83 seconds to deliver the required light dose of 50 J/ cm2.
Pri priporočeni jakosti svetlobe 600 mW/ cm2 je za zahtevani svetlobni odmerek 50 J/ cm2 potrebnih 83 sekund.
Fundus cameras with a magnification within the range of 2.4 - 2.6X are recommended.
Priporočljive so kamere za očesno ozadje z 2, 4 - do 2, 6- kratno povečavo.
The treatment spot should cover all neovasculature, blood and/ or blocked fluorescence.
Osvetljeni predel mora pokriti vse neovaskularizacije, kri in/ ali blokirano fluorescenco.
The nasal edge of the treatment spot must be at least 200 μ m from the temporal edge of the optic disc.
Nazalni rob osvetljenega predela mora biti vsaj 200 µm od temporalnega roba papile vidnega živca.
The maximum spot size used for the first treatment in the clinical studies was 6,400 μ m.
V kliničnih študijah je bila največja velikost osvetljenega predela pri prvem zdravljenju 6. 400 µm.
2 It is important to follow the above recommendations to achieve the optimal treatment effect.
2 Za dosego najboljšega možnega učinka zdravljenja je pomembno, da se ravnamo po zgornjih priporočilih.
Use in paediatric patients has not been investigated.
Uporabe pri pediatričnih bolnikih niso raziskovali.
Visudyne is also contraindicated in patients with porphyria and in patients with severe hepatic impairment.
Visudyne je kontraindiciran tudi pri bolnikih s porfirijo in pri bolnikih s hudimi okvarami jeter.
Patients who receive Visudyne will become photosensitive for 48 hours after the infusion.
Bolniki, ki prejmejo Visudyne, postanejo po infundiranju za 48 ur fotosenzitivni.
Patients should not stay in the dark and should be encouraged to expose their skin to ambient indoor light, as it will help eliminate the drug quickly through the skin by a process called photobleaching.
Bolniki naj ne bodo v temi in jih je treba spodbujati, da izpostavljajo kožo okolni svetlobi v zaprtih prostorih, ker bo to pomagalo hitro odstraniti zdravilo iz telesa skozi kožo s procesom, ki se imenuje fotobeljenje.
Chest pain, vasovagal reactions and hypersensitivity reactions, which on rare occasions can be severe, have been reported.
Poročali so o bolečini v prsih, vazovagalnih reakcijah in preobčutljivostnih reakcijah, ki so v redkih primerih lahko hude.
Both vasovagal and hypersensitivity reactions are associated with general symptoms such as syncope, sweating, dizziness, rash, dyspnoea, flushing, and changes in blood pressure and heart rate.
Tako vazovagalne kot preobčutljivostne reakcije so povezane s splošnimi simptomi, kot so sinkopa, potenje, vrtoglavost, izpuščaj, dispneja, rdečica in spremembe krvnega tlaka ter srčne frekvence.
In sedated or anaesthetised pigs, a Visudyne dose significantly higher than the recommended dose in patients given as a bolus
Pri sediranih ali anesteziranih prašičih je odmerek zdravila Visudyne, ki je bil bistveno večji od priporočenega
3 injection caused severe haemodynamic effects including death, probably as a result of complement activation.
3 odmerka za bolnike, dan v obliki bolusne injekcije, povzročil hude hemodinamske učinke, vključno s smrtjo, verjetno zaradi aktivacije komplementa.
This effect was not observed in conscious non-sedated pigs, or in any other species, including man.
Ta učinek ni bil opažen niti pri nesediranih prašičih, ki so bili pri zavesti, niti pri kakšni drugi vrsti, vključno s človekom.
No clinically relevant complement activation was reported in clinical trials but anaphylactic reactions have been reported during post-marketing surveillance.
V kliničnih preskušanjih ni bilo poročano o klinično pomembni aktivaciji komplementa, vendar je med nadzorom po prihodu zdravila na trg poročano o anafilaktičnih reakcijah.
There are no clinical data to support a concomitant treatment of the second eye.
Ni kliničnih podatkov, ki bi podpirali sočasno zdravljenje drugega očesa.
No clinical experience is available in patients with unstable heart disease (class III or IV) or in patients with uncontrolled arterial hypertension.
Z uporabo zdravila pri bolnikih z nestabilno boleznijo srca (razred III ali IV) ali pri bolnikih z neurejeno arterijsko hipertenzijo ni nikakršnih kliničnih izkušenj.
No specific drug-drug interaction studies have been conducted in humans.
Pri ljudeh niso opravljene nikakršne posebne študije medsebojnega delovanja zdravila Visudyne z drugimi zdravili.
It is possible that concomitant use of other photosensitising agents (e. g. tetracyclines, sulphonamides, phenothiazines, sulfonylurea, hypoglycaemic agents, thiazide diuretics, and griseofulvin) could increase the potential for photosensitivity reactions.
Možno je, da bi sočasna uporaba drugih sredstev, ki fotosenzitizirajo (na primer tetraciklini, sulfonamidi, fenotiazini, sulfonilurea, hipoglikemična sredstva, tiazidni diuretiki in grizeofulvin), lahko povečala možnost nastanka fotosenzitivnostnih reakcij.
Pregnancy For verteporfin no clinical data on exposed pregnancies are available.
Nosečnost Za verteporfin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Studies in animals have shown teratogenic effects in one species (rat) (see section 5.3).
Študije na živalih so pokazale teratogene učinke pri eni živalski vrsti (podgana) (glejte poglavje 5. 3).
Lactation Verteporfin and its diacid metabolic are excreted in human milk in low amounts.
Dojenje Verteporfin in njegov dvokislinski metabolit se izločata v materino mleko v majhnih količinah.
It should therefore not be administered to nursing mothers, or breast-feeding should be interrupted for 48 hours after administration.
Zato se verteporfina pri doječih materah ne sme uporabljati ali pa je treba dojenje prekiniti za 48 ur po uporabi zdravila.
In clinical trials, the following adverse reactions were considered potentially related to Visudyne therapy.
Spodaj navedeni neželeni učinki, opaženi pri kliničnih preskušanjih, so lahko povezani z zdravljenjem z zdravilom Visudyne.
Ocular side effects:
Neželeni učinki na očeh:
Abnormal vision such as blurry, hazy, fuzzy vision, or flashes of light, decreased vision, visual field defect such as grey or dark haloes, scotoma and black spots.
Pogosti učinki (1– 10%): nenormalen vid, na primer zamegljen, meglen, zabrisan vid ali svetlobni bliski, poslabšanje vida, izpadi vidnega polja, na primer sivi ali temni obroči, skotomi in črne pege.
Severe vision decrease, equivalent to 4 lines or more, within seven days after treatment was reported in 2.1% of the verteporfin-treated patients in the placebo-controlled ocular Phase III clinical studies and in less than 1% of patients in uncontrolled clinical studies.
4 O močnem poslabšanju vida, ki ustreza 4 vrstam ali več, v 7 dneh po zdravljenju so poročali pri 2, 1% bolnikov, zdravljenih z verteporfinom, v oftalmoloških kliničnih študijah faze III, kontroliranih s placebom, in pri manj kot 1% bolnikov v nekontroliranih kliničnih študijah.
The event occurred mainly in patients 4 with occult only (4.9%) or minimally classic CNV lesions in patients with AMD and was not reported for placebo-treated patients.
To se je zgodilo zlasti pri bolnikih s samo okultnimi lezijami (4, 9%) ali pri bolnikih s starostno degeneracijo makule z minimalnimi klasičnimi horioidalnimi neovaskularnimi (CNV) lezijami, niso pa o tem poročali pri bolnikih, ki so dobili placebo.
Partial recovery of vision was observed in some patients.
Pri nekaterih bolnikih so opažali delno izboljšanje vida.
Retinal detachment (non-rhegmatogenous), subretinal/ retinal haemorrhage, vitreous haemorrhage.
Občasni učinki (0, 1– 1%): odstop mrežnice (nerevmatogen), krvavitev pod mrežnico ali v mrežnico, krvavitev v steklovino.
Injection site side effects:
Neželeni učinki na mestu injiciranja:
Pain, oedema, inflammation, extravasation.
Pogosti učinki (1– 10%): bolečina, edem, vnetje, ekstravazacija.
Haemorrhage, discoloration, hypersensitivity.
Občasni učinki (0, 1– 1%): krvavitev, spremenjena barva in preobčutljivost.
Systemic side effects:
Sistemski neželeni učinki:
Infusion-related pain primarily presenting as back pain, nausea, photosensitivity reaction, asthenia, hypercholesteraemia.
Pogosti učinki (1– 10%): z infundiranjem povezana bolečina, ki se kaže predvsem kot bolečina v križu, navzea, fotosenzitivnostna reakcija, astenija in hiperholesterolemija.
Photosensitivity reactions (in 2.2% of patients and < 1% of Visudyne courses) occurred in the form of sunburn following exposure to sunlight, usually within 24 hours from Visudyne treatment.
Fotosenzitivnostne reakcije (pri 2, 2% bolnikov in < 1% ciklusov zdravljenja z zdravilom Visudyne) so se pojavljale v obliki sončnih opeklin po izpostavljanju sončni svetlobi navadno v 24 urah po zdravljenju z zdravilom Visudyne.
Such reactions should be avoided by compliance with the photosensitivity protection instructions given in section 4.4.
Bolniki naj se takim reakcijam izogibajo, tako da se ravnajo po navodilih za zaščito pri fotosenzitivnosti v poglavju 4. 4.
The higher incidence of back pain during infusion in the Visudyne group was not associated with any evidence of haemolysis or allergic reaction and usually resolved by the end of the infusion.
Večja incidenca bolečin v križu med infundiranjem v skupini z zdravilom Visudyne ni bila povezana z nikakršnimi znaki hemolize ali alergijske reakcije in je navadno do konca infundiranja izginila.