natgillin/translations-raw huggingface dataset:
• Assemble and lay out on a clean surface everything you need:
• Zberite vse, kar potrebujete in razpostavite na čisto površino:
one vial containing Pergoveris powder one solvent vial two alcohol swabs one syringe one needle for reconstitution and a fine bore needle for subcutaneous injection sharp container
eno vialo s praškom Pergoveris, eno vialo z vehiklom, dve alkoholni blazinici, eno brizgo, eno iglo za rekonstitucijo in eno fino iglo za podkožno injiciranje, posodo za ostre odpadke.
22 syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark.
Na injekcijsko brizgo pritrdite iglo za rekonstitucijo in povlecite v injekcijsko brizgo malo zraka tako, da izvlečete bat približno do oznake 1 ml.
Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the solvent.
Nato zapičite iglo v vialo, potisnite bat, da izstisnete zrak, obrnite vialo navpično navzdol in nežno povlecite v injekcijsko brizgo ves vehikel.
Set the syringe down carefully on the work-surface taking care not to touch the needle.
Injekcijsko brizgo previdno položite na delovno površino in pri tem pazite, da se ne dotaknete igle.
• Prepare the injection solution:
• Pripravite raztopino za injiciranje.
Remove the protective cap from the Pergoveris powder vial, pick up your syringe and slowly inject the solvent into the vial of powder.
Odstranite zaščitno kapico z viale s Pergoveris praškom, vzemite injekcijsko brizgo in počasi injicirajte vehikel v vialo s praškom.
Swirl gently without removing the syringe.
Ne da bi odstranili injekcijsko brizgo, nežno zavrtinčite.
After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Ko se prašek raztopi (kar se občajno zgodi takoj), se prepričajte, da je nastala raztopina bistra in da ne vsebuje delcev.
• Change the needle for the fine bore needle and remove any air bubbles:
• Zamenjajte iglo s fino iglo za injiciranje in odstranite morebitne zračne mehurčke.
If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Če vidite zračne mehurčke v brizgi, jo držite tako, da igla gleda navzgor in nežno krcajte brizgo, da se ves zrak zbere na vrhu.
Push the plunger until the air bubbles are gone.
Nežno potiskajte bat, dokler zračni mehurčki ne izginejo.
Your doctor or nurse will have already advised you where to inject (e. g. tummy, front of thigh).
• Takoj injicirajte raztopino: vaš zdravnik ali sestra sta vas že poučila, kje dati injekcijo (npr. v trebuh, sprednjo stran stegna).
Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Čvrsto stisnite kožo skupaj in z gibom, podobnim metu sulice, zabodite iglo pod kotom 45° do 90°.
Inject the solution by pushing gently on the plunger.
Raztopino injicirajte tako, da nežno potiskate bat.
Once you have finished your injection, immediately discard all needles and empty glass containers in the sharp container provided.
• Zavrzite vse uporabljene predmete: čim ste končali z injiciranjem, takoj odstranite vse igle in prazne steklene vsebnike v posodo za ostre odpadke.
The effects of an overdose of Pergoveris are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in the Possible side effects Section.
Učinki prevelikega odmerka zdravila Pergoveris niso znani, vendar pa lahko pričakujemo pojav sindroma hiperstimulacije jajčnikov, ki je podrobno opisan v poglavju Možni neželeni učinki.
However this will only occur if hCG is administered (see 2.
Vendar pa se to lahko pojavi samo, če se uporabi hCG (glejte 2.
Before you use Pergoveris).
Kaj morate vedeti, preden boste uporabili zdravilo Pergoveris).
If you forget to take Pergoveris
Če ste pozabili uporabiti zdravilo Pergoveris
Do not take a double dose to make up for a forgotten dose, please contact your doctor.
Prosimo, pokličite svojega zdravnika.
Like all medicines, Pergoveris can cause side effects, although not every body gets them.
Kot vsa zdravila ima lahko tudi zdravilo Pergoveris neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
The very commun (likely to occur in more than 1 in 10 patients) reported side effects are:
Zelo pogosti neželeni učinki (verjetnost pojava pri več kot 1 od 10 bolnikov), o katerih poročajo, so:
• ovarian cysts • headache
• ovarijske ciste. • glavobol
Other commun (likely to occur in fewer than 1 in 100 patients) side effects are:
Drugi pogosti neželeni učinki (verjetnost pojava pri manj kot 1 od 100 bolnikov) so:
• abdominal pain • pelvic pain • breast pain • nausea • vomiting • diarrhoea • abdominal cramp • bloating • somnolence (sleepiness) and local reactions at the injection site (pain, redness, itching, bruising, swelling and/ or irritation).
• bolečine v trebuhu • bolečine v medenici • bolečine v prsih • slabost • bruhanje • driska • trebušni krči • napihnjenost • somnolenca (zaspanost) in lokalne reakcije na mestu injiciranja (bolečina, rdečina, srbenje, modrica, oteklina in/ ali razdraženost kože).
Following treatment with Pergoveris when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see 2.
Po zdravljenju z zdravilom Pergoveris, ki mu sledi dajanje človeškega horionskega gonadotropina, se lahko pojavi stanje, ki se imenuje sindrom hiperstimulacije jajčnikov (glejte 2.
Before you use Pergoveris) can occur.
Kaj morate vedeti, preden boste uporabili zdravilo Pergoveris).
The following are first symptoms of ovarian hyperstimulation:
Prvi znaki hiperstimulacije jajčnikov so:
• pain in the lower abdominal region, possibly in combination with nausea • vomiting and weight gain.
• bolečina v spodnjem predelu trebuha, po možnosti v kombinaciji s slabostjo • bruhanje in pridobivanje telesne teže.
In serious, but rare cases (likely to occur in fewer than 1 in 1000 patients), an ovarian hyperstimulation syndrome with clearly enlarged ovaries, can go hand in hand with possible accumulation of fluid in the abdomen or thorax as well as ovarian torsion or more serious thromboembolic complications.
V hudih, vendar redkih primerih (verjetnost pojava pri manj kot 1 od 1000 bolnikov), se lahko sindromu hiperstimulacije jajčnikov z izrazito povečanimi jajčniki, pridruži še nabiranje tekočine v trebuhu ali prsnem košu, kakor tudi zasuk jajčnika ali hujši tromboembolični zapleti.
In view of the above, to prevent such events, when the ovarian response is excessive, treatment with Pergoveris could be discontinued by your physician and the treatment with hCG abandoned.
Za preprečevanje zgoraj naštetih zapletov, lahko zdravnik pri pretiranem odzivu jajčnikov prekine zdravljenje z zdravilom Pergoveris in opusti zdravljenje s hCG- jem.
Rarely (likely to occur in fewer than 1 in 1000 patients) blood clots in blood vessels (abnormal blood clottings) have been seen to occur with similar medicines. Therefore, this could possibly occur with Pergoveris / hCG therapy.
Zato je možno, da bi se to pojavilo tudi pri zdravljenju z zdravilom Pergoveris / hCG.
Very rare (likely to occur in fewer than 1 in 10000 patients)cases of allergic reactions to follitropin alfa have occurred causing redness of the skin, rash, swelling, hives and difficulty in breathing.
Zelo redki (verjetnost pojava pri manj kot 1 od 10. 000 bolnikov) so primeri pojava alergijskih reakcij na folitropina alfa, ki se kažejo z rdečico kože, srbenjem, oteklino, koprivnico in težavami z dihanjem.
Very rarely (likely to occur in fewer than 1 in 10000 patients) patients with asthma may experience worsening of their condition.
Zelo redko (verjetnost pojava pri manj kot 1 od 10. 000 bolnikov) se lahko bolnikom z astmo poslabša njihovo stanje.
Pregnancy where the embryo is implanted outside the womb (ectopic pregnacy) may occur especially in women with a history of prior tubal disease.
Pojavi se lahko nosečnost, kjer se zarodek vgnezdi zunaj maternice (zunajmaternična nosečnost), še posebej pri ženskah, ki so imele bolezni jajcevodov.
24 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.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE PERGOVERIS
SHRANJEVANJE ZDRAVILA PERGOVERIS
Do not use Pergoveris after the expiry date which is stated on the vials and the carton after EXP.
Zdravila Pergoveris ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vialah in škatlipoleg oznake EXP.
Do not use Pergoveris if you notice any visible signs of deterioration.
Ne uporabljajte zdravila Pergoveris, če opazite vidne znake kvarjenja.
What Pergoveris contains
Kaj vsebuje zdravilo Pergoveris
The active substances are follitropin alfa and lutropin alfa.
Zdravilni učinkovini sta folitropina alfa in lutropina alfa.
One vial of powder contains 150 IU follitropin alfa and 75 IU lutropin alfa.
Ena viala s praškom vsebuje 150 i. e. folitropina alfa in 75 i. e. lutropina alfa.
The other ingredients are sucrose, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Pomožne snovi so saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, metionin, polisorbat 20, koncentrirana fosforjeva kislina in natrijev hidroksid.
Pergoveris is presented as a powder and solvent for solution for injection.
Pergoveris je v obliki praška in vehikla za raztopino za injiciranje.
The powder is a white lyophilised pellet.
Prašek so bele liofilizirane pelete.
One vial of powder contains 150 IU of follitropin alfa and 75 IU of lutropin alfa.
Ena viala s praškom vsebuje 150 i. e. folitropina alfa in 75 i. e. lutropina alfa.
One vial of solvent contains 1 ml of Water for Injections.
Ena viala z vehiklom vsebuje 1 ml vode za injekcije.
The medicine is supplied in packs of 1, 3 and 10 vials with the corresponding number of 1, 3 and 10 vials of solvent.
Zdravilo je na voljo v pakiranjih po 1, 3 in 10 vial z ustreznim številom 1, 3 in 10 vial vehikla.
25 Manufacturer
Izdelovalec
Merck Serono S. p. A, Via delle Magnolie 15, I-70026 Modugno (Bari), Italy
Merck Serono S. p. A, Via delle Magnolie 15, I- 70026 Modugno (Bari), Italija.
Dunajska cesta 119 SI 1000 Любляна, Словения Teл: +386 1 560 3 800
Dunajska cesta 119 SI 1000 Любляна, Словения Teл: +386 1 560 3 800 Česká republika Merck spol. s. r. o Zděbradská 72 CZ- 251 01 Říčany - Jažlovice
Malta Cherubino Ltd Delf Building Sliema Road MT-GZR 06 Gzira Malta Tel: +356-21-343270/ 1/ 2/ 3/ 4
MT- GZR 06 Gzira Malta Tel. +420 323619211 Tel: +356- 21- 343270/ 1/ 2/ 3/ 4
Ireland Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX United Kingdom Tel: +44-20 8818 7200
Ireland Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX United Kingdom Tel: +44- 20 8818 7200 Ísland Gróco ehf.
Dunajska cesta 119 SI-1000 Ljubljana Tel: +386 1 560 3 800
Dunajska cesta 119 SI- 1000 Ljubljana Tel: +386 1 560 3 800 Slovenská republika Merck spol. s r. o.
It contains the active substance porfimer sodium.
Vsebuje zdravilno učinkovino porfimer- natrij.
PhotoBarr is used in photodynamic therapy (treatment using light) for the ablation (destruction) of high-grade dysplasia (abnormal cells at high risk of turning into cancer) in patients with Barrett’ s oesophagus.
Zdravilo PhotoBarr se uporablja za fotodinamično zdravljenje (zdravljenje z uporabo svetlobe) za odpravo displazije visoke stopnje (nenormalnih celic z visokim tveganjem, da postanejo rakave) pri bolnikih z Barrettovim požiralnikom.
This is a disease where the lining at the lower end of the oesophagus (gullet) has changed because of damage due to acid from the stomach.
Za to bolezen je značilno, da se sluznica na spodnji strani požiralnika spremeni zaradi poškodbe, ki jo povzroči kislina iz želodca.
Because the number of patients with Barrett’ s oesophagus is low, the disease is considered ‘ rare’, and PhotoBarr was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 6 March 2002.
Ker je število bolnikov z Barretovim požiralnikom majhno, velja ta bolezen za redko, zato je bilo zdravilo PhotoBarr dne 6. marca 2002 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Photodynamic therapy with PhotoBarr should be carried out or supervised by a doctor who has experience in laser treatment using an endoscope (a thin tube used to look into the body) and who has been trained in photodynamic therapy.
Fotodinamično zdravljenje z zdravilom PhotoBarr mora izvajati ali nadzorovati zdravnik, ki ima izkušnje z laserskim zdravljenjem z uporabo endoskopa (tanke cevke za pogled v notranjost telesa) in je usposobljen za fotodinamično zdravljenje.
Treatment with PhotoBarr is a two-step process: the medicine is given first before it is activated using a laser.
Zdravljenje z zdravilom PhotoBarr je dvostopenjski postopek: zdravilo se najprej injicira, nato pa se ga aktivira z laserjem.
PhotoBarr is given by slow, careful injection into a vein at a dose of 2 mg per kilogram body weight over three to five minutes.
Zdravilo PhotoBarr se daje počasi in previdno z injekcijo v žilo v odmerku 2 mg na kilogram telesne mase v času tri do pet minut.
Around two days later, the dysplasia, plus small areas of normal tissue above and below it, is illuminated with light from a laser at a specific wavelength using a fibre-optic cable through an endoscope.
Približno dva dni pozneje je treba displazijo in majhne dele normalnega tkiva nad in pod njo osvetljevati z lasersko svetlobo s specifično valovno dolžino s pomočjo kabla iz optičnih vlaken, ki poteka skozi endoskop.
If necessary, patients may receive a second, shorter laser treatment two to three days later.
Če je potrebno, se lahko dva do tri dni pozneje pri bolnikih izvede še drugi, krajši laserski poseg.
Up to two additional treatment courses (one injection and one or two laser treatments) can be given, separated by at least three months, as long as the risk of narrowing of the gullet is taken into account.
Možna sta največ dva dodatna ciklusa zdravljenja (ena injekcija in en do dva laserska posega) v razmaku najmanj treh mesecev, če je bilo upoštevano tveganje za zoženje požiralnika.
PhotoBarr should not be used in patients aged below 18 years, because of a lack of information on its safety and effectiveness in this group.
Zdravilo PhotoBarr se pri bolnikih, mlajših od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti zdravila v tej starostni skupini ne sme uporabljati.
Patients who receive PhotoBarr must be given a special card that summarises the safety information on the medicine.
Bolniki, ki se zdravijo z zdravilom PhotoBarr, morajo prejeti posebno kartico s povzetkom podatkov o varnosti zdravila.
The active substance in PhotoBarr, porfimer sodium, is a photosensitising agent (a substance that changes when exposed to light).
Zdravilna učinkovina zdravila PhotoBarr je porfimer- natrij, ki je na svetlobo občutljiva snov (snov, ki se spremeni, kadar je izpostavljena svetlobi).
When PhotoBarr is injected, porfimer is absorbed into cells throughout the body.
Ko zdravilo PhotoBarr injiciramo, se porfimer absorbira v celice po celem telesu.
When it is illuminated with laser light of a specific wavelength, it is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen called ‘ singlet oxygen’ (a free radical).
Ko ga osvetlimo z lasersko svetlobo specifične valovne dolžine, se porfimer aktivira in reagira s kisikom v celicah, pri čemer se tvori zelo reaktivna in toksična vrsta kisika, imenovana singletni kisik (prosti radikal).
This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Ta ubije celice tako, da reagira z njihovimi komponentami, na primer z njihovimi beljakovinami in DNK, ter te komponente uniči.
By restricting the illumination to the area of dysplasia, only cells in this area are damaged, leaving other areas of the body unaffected.
Če osvetlitev omejimo na samo področje displazije, se poškodujejo samo celice v tem predelu, drugi predeli telesa pa ostanejo neprizadeti.
PhotoBarr has been studied in one main study involving 208 patients who had Barrett ’ s oesophagus with high-grade dysplasia.
Zdravilo PhotoBarr so proučevali v eni glavni študiji, ki je vključevala 208 bolnikov z Barrettovim požiralnikom z visoko stopnjo displazije.
The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone.
Učinke fotodinamičnega zdravljenja z zdravilom PhotoBarr, uporabljenim v kombinaciji z omeprazolom (antacidnim zdravilom), so primerjali z učinki omeprazola, dajanega samostojno.
Patients were followed up for at least two years.
Spremljanje bolnikov je trajalo najmanj dve leti.
Adding photodynamic therapy using PhotoBarr to omeprazole treatment increased the number of patients whose dysplasia was destroyed.
Z dodajanjem fotodinamičnega zdravljenja z zdravilom PhotoBarr k zdravljenju z omeprazolom se je povečal delež bolnikov, pri katerih je bila displazija odpravljena.
After six months, 72% of the patients using PhotoBarr in combination with omeprazole had no high-grade dysplasia left, compared with 31% of those taking omeprazole alone.
Po šestih mesecih 72% bolnikov, ki so uporabljali zdravilo PhotoBarr v kombinaciji z omeprazolom, ni imelo displazije visoke stopnje, v primerjavi z 31% bolnikov, ki so jemali samo omeprazol.
The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, oesophageal stenosis (narrowing of the oesophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea (feeling sick), photosensitivity reactions (sunburn-like reactions) and pyrexia (fever).
Najpogostejši neželeni učinki zdravila PhotoBarr (opaženi pri več kot 1 bolniku od 10) so dehidracija, ezofagealna stenoza (zoženje požiralnika), bruhanje, disfagija (težave pri požiranju), zaprtje, navzeja (slabost), preobčutljivostne reakcije na svetlobo (reakcije, podobne sončnim opeklinam) in pireksija (zvišana telesna temperatura).
For a more complete list of the side effects reported with PhotoBarr, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PhotoBarr, glejte navodilo za uporabo.
PhotoBarr should not be used in people who may be hypersensitive (allergic) to porfimer sodium and other porphyrins, or to any of the other ingredients.
Zdravila PhotoBarr ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) porfimer- natrij in druge porfirine ali za katero koli drugo sestavino zdravila.
PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
Zdravila PhotoBarr ne smejo uporabljati osebe s porfirijo (nezmožnostjo razgradnje porfirinov), hudimi težavami z jetri ali ledvicami, varicami (razširjenimi žilami) požiralnika ali želodca, velikimi razjedami požiralnika, fistulami (nenormalnimi prehodi) med požiralnikom in trahejo (sapnikom) oziroma med požiralnikom in bronhiji (dihalnimi kanali v pljučih) ali sumom za poškodbo velikih krvnih žil.
As all patients receiving PhotoBarr become more sensitive to light, they should take care to avoid exposure of their skin and eyes to bright light for at least three months after injection.
Ker postanejo vsi bolniki, ki prejmejo zdravilo PhotoBarr, občutljivejši na svetlobo, ne smejo izpostavljati kože in oči močni svetlobi vsaj tri mesece po injekciji.
See the Package Leaflet for full details.
Vse podrobnosti najdete v navodilu za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that PhotoBarr’ s benefits are greater than its risks when used in photodynamic therapy for the ablation of high-grade dysplasia in patients with Barrett’ s oesophagus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila PhotoBarr pri fotodinamičnem zdravljenju za odpravo displazije visoke stopnje pri bolnikih z Barrettovim požiralnikom večje od z njim povezanih tveganj.
The Committee recommended that PhotoBarr be given marketing authorisation.
Odbor je priporočil, da se za zdravilo PhotoBarr odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of PhotoBarr?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila PhotoBarr?
The company that makes PhotoBarr is preparing educational materials in agreement with medicines regulatory authorities in Member States.
Družba, ki izdeluje zdravilo PhotoBarr, v soglasju z zdravstvenimi regulativnimi organi držav članic pripravlja izobraževalni material.
Other information about PhotoBarr:
Druge informacije o zdravilu PhotoBarr:
The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr to Axcan Pharma International B. V. on 25 March 2004.
2/ 3 Evropska komisija je dovoljenje za promet z zdravilom PhotoBarr, veljavno po vsej Evropski uniji, odobrila družbi Axcan Pharma International B. V. dne 25. marca 2004.
The marketing authorisation was renewed on 25 March 2009.
Dovoljenje za promet z zdravilom je bilo odaljšano 25. marca 2009.
2/ 3 The summary of opinion of the Committee for Orphan Medicinal Products for PhotoBarr is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu PhotoBarr je na voljo tukaj.
The full EPAR for PhotoBarr can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo PhotoBarr je na voljo tukaj.
15 mg
Steklenička (steklo) 15 mg
75 mg
Steklenička (steklo) 75 mg
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO IZVAJATI DRŽAVE ČLANICE
The Member States shall agree the details educational materials with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that all health care professionals who intend to prescribe and/ or dispense PhotoBarr are provided with the following:
Države članice se morajo o podrobni vsebini izobraževalnih gradiv dogovoriti z imetnikom dovoljenja za promet z zdravilom v skladu z nacionalnimi predpisi in sistemom zdravstvenega varstva ter zagotoviti njihovo uvedbo na nacionalni ravni tako, da ima strokovno zdravstveno osebje, ki bo predpisovalo zdravilo PhotoBarr in/ ali delalo z njim, na voljo naslednje:
Prescriber guide and Prescriber slide kit − The educational tools are designed to aid physicians in optimising the benefit-risk ratio of porfimer treatment. − Patients should NOT be treated with porfimer if: o they have severe hepatic disease. o they have trachea or broncho-oesophageal fistulas. o they have suspected erosions of major blood vessels.
Navodila za zdravstveno osebje za pripravo zdravila in ravnanje z njim ter izobraževalno gradivo − Izobraževalna orodja so namenjena zdravnikom za optimiziranje razmerja koristi in tveganj pri zdravljenju s porfirini. − Bolnikov se NE sme zdraviti s porfirini, če: o imajo resno okvaro jeter. o če imajo odprtino (fistulo) med požiralnikom in dihalnimi potmi. o če imajo razjedo (erozijo) velikih krvnih žil.
− Caution should be exercised if patients have moderate hepatic disease
Pri bolnikih z zmerno okvaro jeter je potrebna previdnost.