natgillin/translations-raw huggingface dataset:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Visudyne.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
First, the patient receives Visudyne as an infusion into a vein lasting 10 minutes.
Bolnik najprej prejme zdravilo Visudyne kot infuzijo v veno, ki traja 10 minut.
Some of these patients went on to receive Visudyne for up to five years.
Nekateri od teh bolnikov so zdravilo Visudyne nato prejemali do pet let.
Visudyne must not be used in patients with porphyria (an inability to break down chemicals called porphyrins) or in patients with severe liver disease.
Zdravila Visudyne ne smejo uporabljati bolniki s porfirijo (nezmožnostjo razgradnje kemičnih snovi, imenovanih porfirini) ali bolniki s hudim obolenjem jeter.
The CHMP decided that Visudyne's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Visudyne večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about Visudyne:
Druge informacije o zdravilu Visudyne:
When the laser light is shone into the eye, verteporfin is activated and generates toxic oxygen molecules which block blood vessels, damage and even kill cells.
Ko zdravnik v oko posveti z lasersko svetlobo, postane verteporfin aktiven in proizvede toksično vrsto kisika, ki zapre krvne žile ter poškoduje in celo uniči celice.
Why has Visudyne been approved?
Zakaj je bilo zdravilo Visudyne odobreno?
• the ‘wet' form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye.
• „vlažno“ obliko starostne degeneracije makule (SDM), tj. bolezni, ki prizadene osrednji del mrežnice (imenovan makula) v zadnjem delu očesa.
The second step, 15 minutes after the start of the infusion, is the activation of Visudyne in the eye using 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.
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“, tj. metodi zdravljenja, ki za aktivacijo na svetlobo občutljivega sredstva uporablja svetlobo (običajno svetlobo laserja).
• choroidal neovascularisation caused by pathologic myopia (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
• horoidalno neovaskularizacijo, ki jo povzroča bolezenska kratkovidnost (resna oblika kratkovidnosti, pri kateri zrklo še naprej raste in postane daljše, kot bi smelo biti).
Visudyne is a medicine that contains the active substance verteporfin.
Visudyne je zdravilo, ki vsebuje zdravilno učinkovino verteporfin.
Treatment with Visudyne is a two-step process.
Zdravljenje z zdravilom Visudyne poteka v dveh korakih.
In the two studies of wet AMD, 61% of the patients receiving Visudyne had responded to treatment after a year (246 out of 402), compared with 46% of those receiving placebo (96 out of 207).
V dveh študijah za zdravljenje vlažne oblike starostne degeneracije makule se je na zdravljenje po enem letu odzvalo 61 % (246 od 402) bolnikov, v primerjavi s 46 % (96 od 207) bolnikov, ki so prejemali placebo.
Visudyne has been compared with placebo (a dummy treatment) in two studies involving a total of 609 AMD patients with classic subfoveal neovascularisation, and in one study involving 120 patients with neovascularisation caused by pathologic myopia.
Zdravilo Visudyne so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh študijah, v kateri je bilo skupno vključenih 609 bolnikov s starostno degeneracijo makule in klasično subfovealno neovaskularizacijo, ter v eni študiji, v katero je bilo vključenih 120 bolnikov z neovaskularizacijo, ki jo povzroča bolezenska kratkovidnost.
The benefit of Visudyne in occult subfoveal choroidal neovascularisation has not been established.
Koristni učinki zdravila Visudyne pri prikriti subfovealni horoidni neovaskularizaciji niso bili dokazani.
In the study of pathologic myopia, 86% of the patients receiving Visudyne had responded after a year (70 out of 81), compared with 67% of those receiving placebo (26 out of 39).
V študiji zdravljenja bolezenske kratkovidnosti se je na zdravljenje po enem letu odzvalo 86 % (70 od 81) bolnikov, v primerjavi s 67 % (26 od 39) bolnikov, ki so prejemali placebo.
The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling.
Vlažno obliko starostne degeneracije makule povzroča horoidalna neovaskularizacija (nenormalna rast krvnih žil pod makulo), iz katerih lahko iztekata tekočina in kri, kar povzroči otekanje.
For the full list of restrictions and side effects reported with Visudyne, see the package leaflet.
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Visudyne, glejte navodilo za uporabo.
This helps to close up the abnormal blood vessels that cause AMD.
Slednje pomaga pri zapiranju nenormalnih žil, ki povzročajo starostno degeneracijo makule.
Visudyne should only be given by ophthalmologists (eye specialists) who have experience in the management of patients with AMD or pathological myopia.
Zdravilo Visudyne smejo dajati le oftamologi (specialisti za oči), ki imajo izkušnje z zdravljenjem bolnikov s starostno degeneracijo makule ali bolezensko kratkovidnostjo.
What is Visudyne used for?
Za kaj se zdravilo Visudyne uporablja?
In all three studies, the main measure of effectiveness was the number of patients who had responded to treatment after a year, measured using a standard eye test chart.
Glavno merilo učinkovitosti v vseh treh študijah je bilo število bolnikov, ki so se po enem letu zdravljenja odzvali nanj, pri čemer je bil uporabljen standardni očesni test. Bolnik je bil označen kot odziven, če se je število črk, ki jih je videl, povečalo, ostalo enako oziroma se zmanjšalo za manj kot 15.
The active substance in Visudyne, verteporfin, is a photosensitising agent (a substance that changes when exposed to light).
Zdravilna učinkovina zdravila Visudyne, verteporfin, je sredstvo, občutljivo na svetlobo (snov, ki se spremeni, če jo izpostavimo svetlobi).
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 prek krvnih žil porazdeli po celem telesu torej tudi po žilah na zadnji steni očesa.
Visudyne is used when the neovascularisation is ‘predominantly classic' (when the blood vessels affected are well defined on an eye scan) and subfoveal (occurs in the area under the fovea - the central area of the macula);
Pri vlažni obliki starostne degeneracije makule se zdravilo Visudyne uporablja, če je neovaskularizacija „pretežno klasična“ (prizadete žile so dobro vidne na sliki mrežnice oči) in subfovealna (se pojavi v območju pod foveo - osrednjim delom makule).
Visudyne is used when the neovascularisation is subfoveal
Zdravilo Visudyne se uporablja, kadar je neovaskuralizacija subfovealna.
What is Visudyne?
Kaj je zdravilo Visudyne?
How is Visudyne used?
Kako se zdravilo Visudyne uporablja?
How has Visudyne been studied?
Kako je bilo zdravilo Visudyne raziskano?
Visudyne was more effective than placebo in the studies of AMD and pathologic myopia.
Zdravilo Visudyne je bilo v študijah z bolniki s starostno degeneracijo makule in bolezensko kratkovidnostjo učinkovitejše od placeba.
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 two-year study involving 339 patients.
V dve leti trajajoči študiji so pri 339 bolnikih zdravilo Visudyne primerjali s placebom tudi pri prikriti subfovealni horoidni neovaskularizaciji (ko prizadete žile na sliki niso dobro izražene).
How does Visudyne work?
Kako zdravilo Visudyne deluje?
FREQUENCY NOT KNOWN (CANNOT BE ESTIMATED FROM AVAILABLE DATA)
NEZNANA (NI MOGOČE OCENITI IZ RAZPOLOŽLJIV IH PODATKOV)
For all patients:
Vsi bolniki:
- if you have any infections, including infections which have spread to your blood stream.
- če imate kakršno koli okužbo, vključno z okužbami, ki so se razširile na krvni obtok.
They may decide to stop the infusion.
Morda se bosta odločila za ustavitev infundiranja.
Re-treatment / Long term use
Ponovno zdravljenje / Dolgotrajna uporaba
The principal efficacy results at Day 35 from the controlled phase of each study are shown in Table 3.
Glavni rezultati učinkovitosti 35. dan iz kontrolirane faze vsake študije so prikazani v preglednici 3.
The following information is intended for healthcare professionals only (see Section 3):
Naslednje informacije so namenjene samo zdravstvenemu osebju (glejte poglavje 3):
For maintenance therapy and patient monitoring, the recommendations of current guidelines (e.g. Revised European Best Practice Guidelines) should be followed.
Za vzdrževalno zdravljenje in spremljanje bolnika je potrebno upoštevati priporočila trenutnih smernic (npr. Revised European Best Practice Guidelines).
Stability and Storage
Stabilnost in shranjevanje
In total 42 fatal cases have been reported cumulatively.
Kumulativno so poročali o 42 smrtnih primerih.
Pharmacotherapeutic group: Not yet assigned, ATC code: Not yet assigned
Farmakoterapevtska skupina: še ni bila dodeljena, oznaka ATC: še ni bila dodeljena
29 of them were associated with hypersensitivity reactions.
29 jih je bilo povezanih s preobčutljivostnimi reakcijami.
31 October 2016
31. oktober 2016
You will be lying down and your blood pressure and pulse will be monitored.
Pri tem boste ležali, spremljali pa bodo tudi vaš krvni tlak in srčni utrip.
Interference with Serological Testing
Medsebojno delovanje s serološkim testiranjem
It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Pomembno je, da zdravnika obvestite, če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev.
These reactions can be associated with heart and circulation complications, loss of consciousness and may result in death.
Te reakcije so lahko povezane z zapleti srca in krvnega obtoka, izgubo zavesti in se lahko končajo s smrtjo.
Immunologic Disease or Infection
Imunološka bolezen ali okužba
- if you have rheumatoid arthritis.
- če imate revmatoidni artritis.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 June 2012
Datum prve odobritve: 15. junij 2012
The vials are for single use only.
Viale so samo za enkratno uporabo.
Adverse reactions reported in these patients were similar in character and frequency to those observed in the other clinical trials.
Neželeni učinki, o katerih so poročali pri teh bolnikih, so bili po značaju in pogostnosti podobni tistim, ki so jih opazili v drugih kliničnih preskušanjih.
• Healthcare professional checklist • Patient alert card
• kontrolni seznam za zdravstvene delavce • opozorilno kartico za bolnika
The additional four cases were reported after this PSUR was submitted for assessment.
O dodatnih štirih primerih so poročali, ko je bil ta PSUR že predložen v oceno.
There is no evidence that the risk of hypersensitivity reactions as such is increased in elderly patients however these patients have an increased risk of complications.
Ni dokazov o večjem tveganju za preobčutljivostne reakcije kot takšne pri starejših bolnikih, vendar so imeli ti bolniki večje tveganje za zaplete.
If you are older than 65 years or have an underlying condition, such as liver or heart disease, the risk of having severe consequences including death may be higher after a serious allergic reaction.
Če ste starejši od 65 let ali imate osnovno bolezen, kot je bolezen jeter ali srca, bo tveganje hudih posledic, vključno s smrtjo, po resni alergijski reakciji morda večje.
The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
Diagnoza pomanjkanja železa mora temeljiti na ustreznih laboratorijskih preiskavah (glejte poglavje 4.2).
Such effects were not seen in the male animals of that study or in the 13 weeks repeated dose toxicity study in rats (without recovery).
Takšnih učinkov niso opazili pri samcih v tej raziskavi ali v 13-tedenski študiji toksičnosti pri ponavljajočih odmerkih na podganah (brez okrevanja).
The use of Rienso is contraindicated in cases of:
Uporaba zdravila Rienso je kontraindicirana pri:
• From a microbiological point of view, the product should be used immediately after first opening or immediately after dilution.
• Z mikrobiološkega vidika je treba zdravilo uporabiti takoj po prvem odprtju ali takoj po redčenju.
Hgb = haemoglobin; TSAT = transferrin saturation; SD = standard deviation
Hgb = hemoglobin; TSAT = nasičenost transferina ; SD = standardna deviacija
• Shelf-Life - 48 months
• Rok uporabnosti - 48 mesecev
For information on post-marketing experience see section 5.1.
Za informacijo o izkušnjah po začetku trženja glejte poglavje 5.1.
If this happens to you, do not drive or use any tools or machinery.
Če opazite te učinke, ne vozite in ne upravljajte z orodjem ali s stroji.
- if you have problems with your immune system.
- če imate težave z imunskim sistemom.
The educational programme is aimed at highlighting the risks and warnings on hypersensitivity reactions and the monitoring of patients during and after administration.
Cilj izobraževalnega programa je poudariti tveganja in opozorila glede preobčutljivostnih reakcij in spremljanje bolnika med dajanjem zdravila in po njem.
It should be noted that 28 out of the 35 fatal cases of hypersensitivity reactions occurred in elderly patients (> 65 years of age).
Povdariti je treba, da se je 28 od teh 35 smrtnih primerov zaradi preobčuljivostnih reakcij zgodilo pri starejših bolnikih (> 65 let starosti).
If you are pregnant, you should not receive Rienso.
Če ste noseči, ne smete prejemati zdravila Rienso.
Your doctor will decide if additional doses of Rienso are needed and for how long.
Vaš zdravnik se bo odločil, ali potrebujete dodatne odmerke zdravila Rienso in kako dolgo jih potrebujete.
You must not receive Rienso: - if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).
Ne smete prejeti zdravila Rienso: - če ste alergični na (preobčutljivi za) zdravilo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In some patients these allergic reactions can become severe or life-threatening (known as anaphylactic reactions).
Pri nekaterih bolnikih lahko te alergijske reakcije postanejo resne ali začnejo ogrožati življenje (znane kot anafilaktične reakcije).
- if you have severe asthma, eczema or other allergies.
- če imate hudo astmo, ekcem ali drugo atopično alergijo.
- if you have systemic lupus erythematosus.
- če imate sistemski eritematozni lupus.
You can also report any side effects directly to the national reporting system via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotoviti več informacij o varnosti tega zdravila.
All six fatal hypersensitivity cases were reported in the US and involved elderly patients (> 65 years of age) with co-morbidities.
O vseh šestih smrtnih primerih zaradi preobčutljivosti so poročali v ZDA in so vključevala starejše bolnike (> 65 let starosti) s sočasnimi obolenji.
If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately.
Če se med aplikacijo zdravila pojavijo preobčutljivostne reakcije ali znaki intolerance, je potrebno zdravljenje takoj prekiniti.
In the case of symptoms of dizziness, confusion or light headedness following the administration of Rienso, patients should not drive or use machinery until the symptoms have ceased.
V primeru simptomov omotice, zmedenosti ali vrtoglavice po dajanju zdravila Rienso naj bolniki ne vozijo ali upravljajo s stroji, dokler simptomi ne izzvenijo.
Doctors are aware of these possible side effects and will monitor you during the infusion and for at least 30 minutes after the infusion, and also have emergency treatment available if required.
Zdravniki poznajo možnost teh neželenih učinkov in vas bodo med infundiranjem in še vsaj 30 minut po prejemu infuzije spremljali, na voljo pa bodo imeli tudi pripomočke za zdravljenje v nujnem primeru.
Four case reports have been published describing the supraparamagnetic effects of ferumoxytol on MR imaging and emphasized the importance for the radiologists to be aware if a patient received ferumoxytol recently.
Objavljena so bila štiri poročila, ki opisujejo supraparamagnetne učinke ferumoksitola na MR-slikanje, in poudarjajo, kako pomembno je, da se radiologa obvesti, da je bolnik pred kratkim prejel ferumoksitol.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 4 hours at 25 °C.
Če se zdravila ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik, kar pa ne sme trajati dlje kot 4 ure pri temperaturi 25 °C.
The MAH shall ensure that in each Member State where Rienso is marketed, all healthcare professionals and patients/carers who are expected to use Rienso have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, kjer bo zdravilo Rienso na trgu, vsi zdravstveni delavci in bolniki/negovalci, za katere se pričakuje, da bodo uporabljali zdravilo Rienso, imeli dostop do/prejeli naslednje izobraževalno gradivo:
The effect on vascular MR imaging lasts approximately 1-2 days while tissue diagnostic imaging may be affected for up to 6 months.
Vpliv na slikanje ožilja z magnetno resonanco traja približno 1-2 dni, medtem ko lahko vpliv na diagnostično slikanje tkiv traja 6 mesecev.
Based on a limited number of case reports, the influence of ferumoxytol on the interpretation of MRIs, due to its unique crystalline structure appears to be primarily noted in the first few weeks after administration and, based on animal data, dissipated within 3 months.
Na podlagi omejenega števila poročil o primerih kaže, da je vpliv ferumoksitola na razlago MRI, zaradi svoje edinstvene kristalne strukture, primarno opazen prvih nekaj tednov po dajanju in, na podlagi podatkov pri živalih, izgine v 3 mesecih.
- if you have a history of medicine allergy or have experienced serious allergic (hypersensitive)
- če ste v preteklosti že imeli alergijo na zdravila ali ste imeli hudo alergično (preobčutljivostno)
One of these three cases was also characterized as an anaphylactoid reaction.
En od teh treh primerov je bil označen kot anafilaktoidna reakcija.
Rienso has not been specifically studied in patients with hepatic impairment; clinical experience is limited to 8 patients.
Zdravilo Rienso ni bilo posebej preučevano pri bolnikih z jetrno okvaro; klinične izkušnje so omejene na 8 bolnikov.
• Evidence of iron overload
• dokazani preobremenitvi z železom
No drug-drug interaction studies have been performed.
Študij medsebojnega delovanja z zdravili niso izvedli.
The major study outcomes assessed the change in haemoglobin from Baseline to Day 35.
Glavni izidi študije so ocenjevali spremembo hemoglobina od izhodišča do 35. dne.
No studies regarding effects on the ability to drive or operate machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
Please immediately tell the doctor or nurse if you start to feel unwell.
Takoj obvestite zdravnika ali medicinsko sestro, če se vaše počutje poslabša.
During the post-marketing phase, several patients received an overdose of Rienso ranging from 1 g in 1 day to 2.5 g over 21 days.
V obdobju trženja je več bolnikov prejelo prevelik odmerek zdravila Rienso v razponu od 1 g v 1 dnevu do 2,5 g v 21 dneh.
However, the MAH acknowledges that Rostoker and Cohen recommend a minimum of 6 months between ferumoxytol's administration, which they base on the study with 6 healthy volunteers published by Storey et al.
Vendar pa imetnik dovoljenja za promet z zdravilom priznava, da Rostoker in Cohen priporočata, da naj mine vsaj 6 mesecev od dajanja ferumoksitola, kar utemeljujeta na študiji s 6 zdravili prostovoljci, ki jo je objavil Storey et al.
Incompatibilities • Rienso must not be mixed with other medicinal products, with the exception of the infusion
Inkompatibilnosti • Zdravila Rienso se ne sme mešati z drugimi zdravili, z izjemo zgoraj navedenih infuzijskih
Within the limitations inherent to post-marketing reporting, the following reporting rate can be calculated: As of 30 June 2014, the cumulative overall post-marketing reporting rate of hypersensitivity based on 2 g per person per year is: 527/266,914 × 100 = 0.20 %.
V okviru omejitev povezanih s poročanjem v obdobju trženja, je bilo možno izračunati naslednjo stopnjo poročanja: Do 30. junija 2014 je kumulativna celokupna stopnja poročanja preobčutljivosti v obdobju trženja na podlagi 2 g na osebo na leto: 527/266.914 × 100 = 0,20 %.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Treatment with Rienso should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Zdravljenje z zdravilom Rienso je treba omejiti na drugo in tretje trimesečje nosečnosti, če se oceni, da koristi odtehtajo možna tveganja tako za mater kot za plod.
Patients should be re-assessed at least one month after the completion of a course of Rienso and this should include laboratory testing of haematologic and blood iron parameters.
Bolnike je treba ponovno oceniti vsaj en mesec po zaključku zdravljenja z zdravilom Rienso, kar mora vključevati tudi laboratorijske preiskave hematoloških parametrov in parametrov železa v krvi.
• Patients with any known history of drug allergy including hypersensitivity to other parenteral iron products
• bolnikih s katero koli znano alergijo na zdravila v preteklosti, vključno s preobčutljivostjo na druga parenteralna zdravila, ki vsebujejo železo
The maximum dose is 1020 mg (2 vials) and the two doses of Rienso must not be administered at the same time.
Največji odmerek je 1.020 mg (2 viali), pri čemer dveh odmerkov zdravila Rienso ni dovoljeno dati hkrati.
Therefore Rienso should not be administered to children and adolescents below the age of 18 years (see section 5.1).
Zato se zdravila Rienso ne sme dajati otrokom in mladostnikom, mlajšim od 18 let (glejte poglavje 5.1).
• Information regarding the increased risk of serious including fatal hypersensitivity reactions: contraindications, special patient populations (e.g. pregnant women, elderly), warnings, symptoms of hypersensitivity reactions, monitoring by health care professionals during 30 minutes after administration, warning on late onset of allergic reactions.
• Informacije glede večjega tveganja resnih preobčutljivostnih reakcij, vključno s smrtnimi: kontraindikacije, posebne populacije bolnikov (npr. nosečnice, starejši), opozorila, simptome preobčutljivostnih reakcij, spremljanje, ki ga izvajajo zdravstveni delavci 30 minut po dajanju zdravila, opozorilo o zapoznelem pojavu alergijskih reakcij.
No change in dosage is recommended from Table 1.
Spremembe odmerjanja, odstopajoč od preglednice 1, se ne priporočajo.