natgillin/translations-raw huggingface dataset:
Pain, hypertension, hyperesthesia, fever.
Občasni učinki (0, 1– 1%): bolečina, hipertenzija, hiperestezija, zvišana telesna temperatura.
Rare undesirable effects in clinical trials (< 0.1%) or spontaneously reported during post-marketing surveillance included:
Redki neželeni učinki, ki so jih opažali v kliničnih preizkušanjih (< 0, 1%) ali o njih spontano poročali med nadzorom po prihodu zdravila na trg, so:
Retinal or choroidal vessel non-perfusion, retinal pigment epithelial tear.
Neželeni učinki na očeh: prekinjena perfuzija mrežničnih ali horioidalnih žil, raztrganje pigmentnega epitelija mrežnice.
Blistering.
Neželeni učinki na mestu injekcije: nastajanje mehurjev.
Vasovagal reactions and hypersensitivity reactions, which on rare occasions can be severe, have been reported.
Sistemski neželeni učinki: poročali so o vazovagalnih reakcijah in preobčutljivostnih reakcijah, ki so v redkih primerih lahko hude.
General symptoms can include headache, malaise, syncope, sweating, dizziness, rash, urticaria, pruritus, dyspnoea, flushing, and changes in blood pressure and heart rate.
Splošni simptomi lahko obsegajo glavobol, splošno slabo počutje, sinkopo, potenje, vrtoglavost, izpuščaj, koprivnico, srbečico, dispnejo, napade rdečice in spremembe krvnega tlaka ter srčne frekvence.
Infusion-related back and chest pain, which may radiate to other areas, including but not limited to, the pelvis, shoulder girdle or rib cage.
Z infundiranjem povezana bolečina v križu in prsih, ki lahko seva v druge predele, med drugim v medenico, ramenski obroč ali prsni koš.
Most adverse reactions were mild to moderate and transient in nature.
Večina neželenih reakcij je bila blagih do zmernih, po naravi pa prehodnih.
Undesirable effects reported in patients with pathological myopia were similar to those reported in patients with AMD.
Neželeni učinki, o katerih so poročali pri bolnikih z bolezensko kratkovidnostjo, so bili podobni tistim pri bolnikih z AMD.
Overdose of drug and/ or light in the treated eye may result in non-selective non-perfusion of normal retinal vessels, with the possibility of severe vision decrease.
Prevelik odmerek zdravila in/ ali svetlobe v zdravljenem očesu lahko povzroči neselektivno prekinitev perfuzije normalnih mrežničnih žil z možnostjo močnega poslabšanja vida.
Overdose of the drug may result in the prolongation of the period during which the patient remains photosensitive.
5 Prevelik odmerek zdravila ima lahko za posledico podaljšanje obdobja, med katerim je bolnik fotosenzitiven.
Verteporfin, also referred to as benzoporphyrin derivative monoacids (BPD-MA) consists of a 1:1 mixture of the equally active regioisomers BPD-MAC and BPD-MAD.
Verteporfin, imenovan tudi enokislinski derivat benzoporfirina (BPD- MA), je sestavljen iz mešanice enako aktivnih regioizomer BPD- MAC in BPD- MAD v razmerju 1: 1.
It is used as a light-activated drug (photosensitiser).
Uporablja se kot zdravilo, ki se aktivira s svetlobo (fotosenzitizator).
Age-related Macular Degeneration with predominantly classic subfoveal lesions Visudyne has been studied in two randomised, placebo-controlled, double-masked, multicentre studies (BPD OCR 002 A and B or Treatment of Age-related Macular Degeneration with Photodynamic Therapy [TAP]).
Starostna degeneracija makule s pretežno klasičnimi subfovealnimi lezijami Visudyne so proučevali v dveh randomiziranih, s placebom kontroliranih dvojno maskiranih multicentričnih študijah (BPD OCR 002 A in B ali zdravljenje starostne degeneracije makule s fotodinamično terapijo [Treatment of Age- related Macular Degeneration with Photodynamic Therapy - TAP]).
A total of 609 patients were enrolled (402 Visudyne, 207 placebo).
Skupno je bilo v raziskavi zajetih 609 bolnikov (402 Visudyne, 207 placebo).
The following inclusion criteria were considered for the treatment: patients older than 50 years of age, presence of CNV secondary to AMD, presence of classic lesion components in the CNV (defined as a well-demarcated area of the fluorescence on angiography), CNV located subfoveally (involved the geometric centre of the foveal avascular zone), area of classic plus occult CNV ≥ 50% of the total lesion surface, greatest linear dimension of the entire lesion ≤ 9 Macular Photocoagulation Study (MPS) disc area, and a best-corrected visual acuity between 34 and 73 letters (i. e. approximately 20/ 40 and 20/ 200) in the treated eye.
Za zdravljenje so upoštevali naslednje vključitvene kriterije: bolniki, starejši od 50 let, prisotnost CNV zaradi AMD, prisotnost sestavin klasičnih lezij v CNV leziji (definirani kot dobro omejen predel fluorescence pri angiografiji), subfovealna lokalizacija CNV lezije (prizadetost geometričnega središča fovealnega avaskularnega predela), predel klasične in okultne CNV lezije predstavlja ≥ 50% površine celotne lezije, največja linearna dimenzija celotne lezije je ≤ 9 površin papile iz raziskave makularne fotokoagulacije (MPS - 'Macular Photocoagulation Study'), optimalno korigirana ostrina vida med 34 in 73 črkami (tj. približno 20/ 40 in 20/ 200) na zdravljenem očesu.
The studies showed a difference of 15% between treatment groups (61% for Visudyne-treated patients compared to 46% placebo-treated patients, p < 0.001, ITT analysis).
Študiji sta pokazali 15% razliko med obravnavanima skupinama (61% za bolnike, zdravljene z zdravilom Visudyne, v primerjavi s 46% za bolnike, ki so dobivali placebo, p < 0, 001, analiza ITT).
This 15% difference between treatment groups was confirmed at 24 months (53% Visudyne versus 38% placebo, p < 0.001).
Ta 15% razlika med obravnavanima skupinama je bila potrjena po 24 mesecih (53% za zdravilo Visudyne proti 38% za placebo, p < 0, 001).
After 12 months, these patients showed a difference of 28% between treatment groups (67% for Visudyne patients compared to 39% for placebo patients, p < 0.001); the benefit was maintained at 24 months (59% versus 31%, p < 0.001).
6 primerjavi z 39% za bolnike, ki so dobivali placebo, p < 0, 001); koristni učinek je pri 24 mesecih še vedno trajal (59% proti 31%, p < 0, 001).
6 In relation to TAP extension:
Podaljšanje študije TAP:
In the TAP study in all lesion types, the average number of treatments per year were 3.5 in the first year after diagnosis and 2.4 in the second for the randomised placebo-controlled phase and 1.3 in the third year, 0.4 in the fourth and 0.1 in the fifth year for the open-label extension phase.
V študiji TAP, opravljeni pri bolnikih z vsemi vrstami lezij, je bilo povprečno število ciklusov zdravljenja na leto v randomizirani, s placebom kontrolirani fazi 3, 5 v prvem letu po diagnozi in 2, 4 v drugem letu, v odprti podaljšani fazi pa 1, 3 v tretjem letu, 0, 4 v četrtem in 0, 1 v petem letu.
Age-related Macular Degeneration with occult with no classic lesions The benefit of the product in the AMD patient population who have occult subfoveal CNV with evidence of recent or ongoing disease progression has not been demonstrated consistently.
Starostna degeneracija makule z okultnimi, a brez klasičnih lezij V skupini bolnikov z okultno subfovealno CNV z znaki nedavnega ali prisotnega napredovanja bolezni koristnost zdravila Visudyne ni bila enotno dokazana.
Two randomised, placebo-controlled, double-masked, multicentre, 24-month studies (BPD OCR 003 AMD, or Verteporfin in Photodynamic Therapy-AMD [VIP-AMD], and BPD OCR 013, or Visudyne in Occult Choroidal Neovascularisation [VIO]) were conducted in patients with AMD characterised by occult with no classic subfoveal CNV.
Pri bolnikih z AMD, za katero je bila značilna okultna CNV brez klasične subfovealne CNV, so izvedli dve randomizirani s placebom kontrolirani dvojno maskirani multicentrični 24- mesečni študiji (BPD OCR 003 AMD ali Verteporfin in Photodynamic Therapy- AMD [VIP- AMD] in BPD OCR 013 ali Visudyne in Occult Choroidal Neovascularization [VIO].
The VIO study included patients with occult with no classic subfoveal CNV with a visual acuity score of 73-34 letters (20/ 40-20/ 200), and patients with lesions > 4 MPS disc areas were to have baseline visual acuity < 65 letters (< 20/ 50).
V študijo VIO so bili vključeni bolniki z okultno, a brez klasične subfovealne CNV z oceno vidne ostrine 73- 34 črk (20/ 40- 20/ 200) in bolniki z lezijami, ki so bile večje od 4 MPS površin papile, in izhodiščno vidno ostrino < 65 črk (< 20/ 50).
The study did not show statistically significant results on the primary efficacy parameter at month 12 (15-letter responder rate 62.7% versus 55.0%, p=0.150; 30-letter responder rate 84.0% versus 83.3%, p=0.868) or at month 24 (15-letter responder rate 53.3% versus 47.5%, p=0.300; 30- letter responder rate 77.5% versus 75.0%, p=0.602).
84, 0% proti 83, 3%, p=0, 868) niti po 24 mesecih (delež bolnikov z izgubo vida manj kot 15 črk 53, 3% proti 47, 5%, p=0, 300; delež bolnikov z izgubo vida manj kot 30 črk 77, 5% proti 75, 0%, p=0, 602).
A higher percentage of patients who received Visudyne, compared with those who received placebo, experienced adverse events (88.1% versus 81.7%), associated adverse events (23.0% versus 7.5%), events leading to discontinuation (11.9% versus 3.3%) and events leading to death (n=10 [4.1%] versus n=1 [0.8%]).
Med bolniki, ki so prejemali zdravilo Visudyne, je v primerjavi s tistimi, ki so prejemali placebo, pri večjem deležu prišlo do neželenih dogodkov (88, 1% proti 81, 7%), do povezanih neželenih dogodkov (23, 0% proti 7, 5%), do dogodkov, zaradi katerih so prenehali sodelovati v študiji, (11, 9% proti 3, 3%) in do dogodkov, ki so se končali s smrtjo (n=10 [4, 1%] proti n=1 [0, 8%]).
The VIP-AMD included patients with occult with no classic subfoveal CNV with a visual acuity score of > 50 letters (20/ 100).
V študijo VIP- AMD so bili vključeni bolniki z okultno, a brez klasične subfovealne CNV z oceno vidne ostrine > 50 črk (20/ 100).
This study also included patients with classic containing CNV with a visual acuity score > 70 letters (20/ 40).
V to študijo so bili vključeni tudi bolniki s CNV, ki je bila deloma klasična, in z oceno vidne ostrine > 70 črk (20/ 40).
At month 12, the study did not show statistically significant results on the primary efficacy parameter (responder rate 49.3% versus 45.6%, p=0.517).
Po 12 mesecih študija ni pokazala statistično značilnih rezultatov glede primarnega parametra učinkovitosti (pogostnost odziva 49, 3% proti 45, 6%, p=0, 517).
At month 24, a statistically significant difference of 12.9% in favour of Visudyne compared to placebo was observed (46.2% versus 33.3%, p=0.023).
Po 24 mesecih je bila ugotovljena statistično značilna razlika 12, 9% v korist zdravila Visudyne v primerjavi s placebom (46, 2% proti 33, 3%, p=0, 023).
A group of patients who had occult with no classic lesions (n=258) showed a statistically significant difference of 13.7% in favour of Visudyne compared to placebo (45.2% versus 31.5%, p=0.032).
V podskupini bolnikov z okultnimi, a brez klasičnih lezij (n=258) se je pokazala statistično značilna razlika 13, 7% v korist zdravila Visudyne v primerjavi s placebom (45, 2% proti 31, 5%, p=0, 032).
A higher percentage of patients who received Visudyne, compared with those who received placebo, experienced adverse events (89.3% versus 82.5%), associated adverse events (42.7% versus 18.4%) and events leading to discontinuation (6.2% versus 0.9%).
Med bolniki, ki so prejemali zdravilo Visudyne, je v primerjavi s tistimi, ki so prejemali placebo, pri večjem deležu prišlo do neželenih dogodkov (89, 3% proti 82, 5%), do povezanih neželenih dogodkov (42, 7% proti 18, 4%) in do dogodkov, zaradi katerih so prenehali sodelovati v študiji (6, 2% proti 0, 9%).
A lower percentage of Visudyne patients had events leading to death (n=4 [1.8%] versus n=3 [2.6%]); no death was considered to be related to treatment.
Med bolniki z zdravilom Visudyne je pri manjšem deležu prišlo do dogodkov, ki so se končali s smrtjo (n=4 [1, 8%] proti n=3 [2, 6%]); nobene smrti niso povezovali z zdravljenjem.
Pathological myopia One multicentre, double-masked, placebo-controlled, randomised study (BPD OCR 003 PM [VIP- PM]) was conducted in patients with subfoveal choroidal neovascularisation caused by pathological myopia.
7 Bolezenska kratkovidnost Ena multicentrična dvojno maskirana s placebom kontrolirana randomizirana študija (BPD OCR 003 PM [VIP- PM]) je bila opravljena pri bolnikih s subfovealno horioidalno neovaskularizacijo, ki jo je povzročila bolezenska kratkovidnost.
A total of 120 patients (81 Visudyne, 39 placebo) were enrolled in the study.
V študijo je bilo vključenih skupaj 120 bolnikov (81 Visudyne, 39 placebo).
7 At month 12, there was a benefit of Visudyne for the primary efficacy endpoint (percentage of patients who lost less than 3 lines of visual acuity) – 86% for Visudyne versus 67% for placebo, p=0.011.
Po 12 mesecih je imel Visudyne prednost glede primarnega cilja opazovanja glede učinkovitosti (odstotek bolnikov, ki so izgubili za manj kot 3 vrste ostrine vida) – 86% za Visudyne proti 67% za placebo, p=0, 011.
The percentage of patients who lost less than 1.5 lines was 72% for Visudyne and 44% for placebo (p=0.003).
Odstotek bolnikov, ki so izgubili manj kot 1, 5 vrste, je bil 72% (Visudyne) proti 44% (placebo), (p=0, 003).
At month 24, 79% Visudyne patients versus 72% placebo patients had lost less than 3 lines of visual acuity (p=0.38).
Po 24 mesecih je 79% bolnikov z zdravilom Visudyne in 72% bolnikov s placebom izgubilo manj kot 3 vrste ostrine vida (p=0, 38).
The percentage of patients who lost less than 1.5 lines was 64% for Visudyne and 49% for placebo (p=0.106).
Odstotek bolnikov, ki so izgubili manj kot 1, 5 vrste, je bil pri zdravilu Visudyne 64%, pri placebu pa 49% (p=0, 106).
In relation to VIP-PM extension:
Podaljšanje študije VIP- PM:
In the VIP-PM study in pathological myopia, the average number of treatments per year were 3.5 in the first year after diagnosis and 1.8 in the second for the randomised placebo-controlled phase and 0.4 in the third year, 0.2 in the fourth and 0.1 in the fifth year for the open-label extension phase.
V študiji VIP- PM, opravljeni pri bolnikih z bolezensko kratkovidnostjo, je bilo povprečno število ciklusov zdravljenja na leto v randomizirani, s placebom kontrolirani fazi 3, 5 v prvem letu po diagnozi in 1, 8 v drugem letu, v odprti podaljšani fazi pa 0, 4 v tretjem letu, 0, 2 v četrtem in 0, 1 v petem letu.
Distribution Cmax after a 10-minute infusion of 6 and 12 mg/ m2 body surface area in the target population is approximately 1.5 and 3.5 µg/ ml, respectively.
Porazdelitev Cmax po 10- minutnem infundiranju 6 oziroma 12 mg/ m2 telesne površine v ciljni skupini je približno 1, 5 oziroma 3, 5 µg/ ml.
These values are somewhat higher (26% for the proposed dose of 6 mg/ m2) than those observed in young healthy volunteers and may result in a higher exposure.
Ti vrednosti sta nekoliko večji (26% za načrtovani odmerek 6 mg/ m2) od tistih, ki so bile ugotovljene pri mladih zdravih prostovoljcih, in imajo lahko za posledico večjo izpostavljenost.
The clinical relevance of this age-related difference is remote, as the risk/ benefit assessment determined in the target population is favourable.
Klinični pomen te s starostjo povezane razlike je nepomemben, ker je ocena razmerja tveganja proti koristi, določenega v ciljni skupini, ugodna.
For both regioisomers, Cmax and AUC values were proportional to dose.
Pri obeh regioizomerah so bile vrednosti Cmax in AUC sorazmerne odmerku.
Cmax values obtained at the end of infusion were higher for BPD-MAD than for BPD-MAC.
Vrednosti Cmax, dobljene na koncu infundiranja, so bile večje pri BPD- MAD kot pri BPD- MAC.
The volume of distribution was 0.5 l/ kg.
Porazdelitveni prostor je bil 0, 5 l/ kg.
Protein-binding In whole human blood, 90% of verteporfin is associated with plasma and 10% associated with blood cells, of which very little was membrane associated.
Vezava na beljakovine V polni človeški krvi je 90% verteporfina vezanega v plazmi, 10% pa na krvne celice, od tega ga je zelo malo vezanega na membrane.
In human plasma, 90% of verteporfin is associated with plasma lipoprotein fractions and approximately 6% are associated with albumin.
V človeški plazmi je 90% verteporfina vezanega na frakcije plazemskih lipoproteinov in približno 6% na albumine.
Metabolism The ester group of verteporfin is hydrolysed via plasma and hepatic esterases, leading to the formation of benzoporphyrin derivative diacid (BPD-DA).
Presnova Estrsko skupino verteporfina hidrolizirajo plazemske in jetrne esteraze, tako da nastane dvokislinski derivat benzoporfirina (BPD- DA).
BPD-DA is also a photosensitiser but its systemic exposure is low (5-10% of the verteporfin exposure, suggesting that most of the drug is eliminated unchanged).
Tudi BPD- DA je fotosenzitizator, a je njegova sistemska izpostavljenost majhna (5– 10% verteporfinove izpostavljenosti, kar kaže na to, da se večina zdravila odstrani iz telesa v nespremenjeni obliki).
Elimination Plasma elimination half-life mean values ranged from approximately 5– 6 hours for verteporfin.
8 Odstranjevanje iz telesa Povprečni razpolovni čas odstranjevanja iz plazme za verteporfin je bil približno 5– 6 ur.
The mean area-under-the-curve (AUC) values for subjects with mild hepatic dysfunction were up to 1.4 times greater than those for subjects with normal hepatic function.
Povprečne vrednosti površine pod krivuljo (AUC) pri osebah z blago okvaro funkcij jeter so bile do 1, 4- krat večje kot pri osebah z normalno funkcijo jeter.
This difference is not clinically relevant and does not require any dose adjustment in patients with mild hepatic impairment.
Ta razlika ni klinično pomembna in zaradi nje ni potrebno prilagajanje odmerjanja pri bolnikih z blago okvaro funkcij jeter.
8 Combined excretion of verteporfin and BPD-DA in human urine was less than 1%, suggesting biliary excretion.
Kombinirano izločanje verteporfina in BPD- DA v človeškem urinu je bilo manjše od 1%, kar kaže na izločanje z žolčem.
In repeat-dose studies in rats and dogs (once per day without light for up to 4 weeks), mild extravascular haemolysis and haematopoietic responses were seen with exposure greater than approximately 70 times (rats) and 32 times (dogs) the exposure (based on AUC) of the recommended human dose.
V študijah ponavljajočih se odmerkov na podganah in psih (enkrat na dan brez svetlobe v obdobju do 4 tednov) so bili pri izpostavljenosti, približno 70- krat večji od izpostavljenosti (na podlagi AUC) pri priporočenem odmerku za človeka (pri podganah) oziroma 32- krat večji (pri psih), opaženi blaga ekstravaskularna hemoliza in hematopoetični odzivi.
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.
Hitra aplikacija odmerka 2, 0 mg/ kg verteporfina s hitrostjo 7 ml/ minuto anesteziranim prašičem je imela hemodinamične učinke in povzročila včasih hitro smrt, ki je nastopila najpozneje v 2 minutah po aplikaciji zdravila.
Similar effects were observed in sedated pigs.
Podobni učinki so bili opaženi pri sediranih prašičih.
Pre-dosing with diphenhydramine diminished these effects, suggesting that histamine may play a role in this process.
Aplikacija difenhidramina med aplikacijo verteporfina je te posledice zmanjšala, kar kaže na možno vpletenost histamina v ta proces.
Non-anaesthetised non-sedated animals were not affected by these dosing parameters.
Ti parametri odmerjanja na neanestezirane nesedirane živali niso vplivali.
No changes were recorded in either conscious or anaesthetised dogs receiving 20 mg/ kg verteporfin at an infusion rate of 5 ml/ minute.
Niti pri budnih niti pri anesteziranih psih, ki so dobili po 20 mg/ kg verteporfina s hitrostjo infundiranja 5 ml/ minuto, niso bile zabeležene nobene spremembe.
The effects may result from complement activation.
Možno je, da te učinke povzroča aktivacija komplementa.
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 je v koncentracijah, več kot 5- krat višjih od pričakovane največje plazemske koncentracije pri zdravljenih bolnikih, povzročil lahno aktivacijo komplementa v človeški krvi 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.
Ravni toksičnosti za oči pri normalnih kuncih in opicah, posebno na mrežnici in žilnici, so bile povezane z odmerkom zdravila, odmerkom svetlobe in časom osvetlitve.
A retinal toxicity study in normal dogs with intravenous verteporfin and ambient light on the eye showed no treatment-related ocular toxicity.
Študija toksičnosti za mrežnico pri normalnih psih z intravenskim dajanjem verteporfina in osvetljevanjem očesa z okolno svetlobo ni pokazala nikakršne toksičnosti za oči, povezane z zdravljenjem.
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.
V študiji embriotoksičnosti so imeli podganji fetusi, ki so dobili odmerek, več kot približno 67- krat večji od priporočenega odmerka za ljudi (na podlagi AUC), naraščajoče incidence anoftalmije oziroma mikroftalmije, valovitih deformacij reber in fetalnih sprememb.
No teratogenicity was observed in foetuses from rabbits given 67 times the recommended human dose.
Pri plodovih kuncev, ki so dobili 67- krat večji odmerek od priporočenega odmerka za ljudi, ni bila opažena teratogenost.
Verteporfin was not genotoxic in the absence or presence of light in the usual battery of genotoxic test.
Verteporfin pri običajnem nizu testov genotoksičnosti ni bil genotoksičen niti v odsotnosti niti v prisotnosti svetlobe.
Immunomodulatory effects have been observed in mice.
Pri miših so bili opaženi imunomodulacijski učinki.
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.
Svetlobna aktivacija vsega telesa v 3 urah po aplikaciji verteporfina je ugodno vplivala na potek več imunološko posredovanih patoloških stanj in zmanjšala imunske odzive normalne kože, ne da bi povzročila kožno reaktivnost ali generalizirano nespecifično imunosupresijo.
Lactose monohydrate Egg phosphatidylglycerol Dimyristoyl phosphatidylcholine Ascorbyl palmitate Butylated hydroxytoluene (E321)
laktoza monohidrat jajčni fosfatidilglicerol dimiristoilfosfatidilholin askorbilpalmitat butilhidroksitoluen (E321)
6.2 Incompatibilities
9 6. 2 Inkompatibilnosti
Visudyne precipitates in saline solutions.
Visudyne se v raztopinah soli obarja.
Do not use normal saline or other parenteral solutions.
Ne uporabljajte fiziološke raztopine ali drugih parenteralnih raztopin.
Shelf-life in the sealed vial:
Rok uporabnosti v zapečateni viali:
Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
4 leta Rok uporabnosti po raztopitvi (rekonstituciji) in razredčenju: kemijsko in fizikalno stabilnost med uporabo so dokazali za 4 ure pri 25 °C.
After reconstitution and dilution: see section 6.3.
Po rekonstituciji in razredčenju: glejte poglavje 6. 3.
Powder in glass vial (type I), sealed with butyl stopper and aluminium cap.
Prašek v stekleni viali (tip I), zapečateni z butilnim zamaškom in aluminijasto zaporko.
Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ ml solution.
Rekonstituirajte Visudyne v 7, 0 ml vode za injekcije, tako da nastane 7, 5 ml raztopine s koncentracijo 2 mg/ ml.
Reconstituted Visudyne is an opaque dark green solution.
Rekonstituirani Visudyne je neprozorna temnozelena raztopina.
It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration.
Priporočamo, da rekonstituirani Visudyne pred uporabo pregledate s prostim očesom, da se prepričate, da v njem ni delcev in da ni spremenjene barve.