FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not over tighten.
Slovenian: Ne privijte preveč.
English: • Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL.
Slovenian: • Zdravilo Nplate 125 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,44 ml sterilne vode za injekcije, s čimer dobimo 0,25 ml uporabne količine.
English: Nplate 125 micrograms powder for solution for injection romiplostim
Slovenian: Nplate 125 mikrogramov prašek za raztopino za injiciranje romiplostim
English: Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL.
Slovenian: Zdravilo Nplate 250 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,72 ml sterilne vode za injekcije, tako nastane 0,5 ml uporabne količine.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora orofaringealna bolečina***
English: No clinical sequelae were reported in association with the elevated platelet counts in any of the 3 subjects.
Slovenian: Pri nobenem od teh 3 bolnikov niso zabeležili kliničnih posledic zvišanega števila trombocitov.
English: Romiplostim
Slovenian: angioedem
English: Special care should be taken to ensure that the appropriate volume of Nplate is withdrawn from the vial for subcutaneous administration - a syringe with graduations of 0.01 mL should be used.
Slovenian: Posebno pozornost je treba nameniti temu, da iz viale potegnete ustrezno količino zdravila Nplate za subkutano dajanje.
English: • Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL.
Slovenian: • Zdravilo Nplate 250 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,72 ml sterilne vode za injekcije, s čimer dobimo 0,5 ml uporabne količine.
English: EU/1/08/497/007 - 1 pack EU/1/08/497/008 - 4 pack
Slovenian: EU/1/08/497/007 - 1 pakiranje EU/1/08/497/008 - 4 pakiranja
English: Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL.
Slovenian: Zdravilo Nplate 125 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 0,44 ml sterilne vode za injekcije; tako nastane 0,25 ml uporabne količine.
English: After dissolving, a deliverable amount of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL).
Slovenian: Po raztapljanju vsebuje uporabna količina 0,25 ml raztopine 125 mikrogramov romiplostima (500 mikrogramov/ml).
English: Remove 1 mL administration syringe from package.
Slovenian: Vzemite 1 ml brizgo za injiciranje zdravila iz njenega pakiranja.
English: Attach the 1 mL syringe to vial adapter of reconstituted solution by twisting the syringe tip onto the vial adapter until you feel a slight resistance.
Slovenian: Namestite 1 ml brizgo na nastavek za vialo pripravljene raztopine, tako da konico brizge zasučete v nastavek za vialo, dokler ne začutite rahlega upora.
English: Rhinorrhoea Dry throat Dyspnoea Nasal congestion Painful respiration
Slovenian: pljučna embolija* kašelj rinoreja suho žrelo dispneja zamašenost nosu bolečine pri dihanju
English: Turn clockwise to lock into Luer lock tip.
Slovenian: Zavrtite v smeri urinega kazalca, da boste iglo namestili na konico nastavka Luer.
English: After dissolving, a deliverable amount of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
Slovenian: Po raztapljanju vsebuje uporabna količina 0,5 ml raztopine 250 mikrogramov romiplostima (500 mikrogramov/ml).
English: After dissolving, a deliverable amount of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL).
Slovenian: Po raztapljanju vsebuje uporabna količina 1 ml raztopine 500 mikrogramov romiplostima (500 mikrogramov/ml).
English: • joint pain (arthralgia);
Slovenian: • bolečine v sklepih (artralgija),
English: Prepare new syringe for injection Step 6.
Slovenian: Odpnite brizgo za injiciranje z nastavka za vialo.
English: Injection site reaction Peripheral swelling***
Slovenian: Infekcijske in parazitske bolezni okužba zgornjega respiratornega trakta rinitis***
English: • upper abdominal pain;
Slovenian: • bolečina v zgornjem delu trebuha,
English: • Check and remove all air bubbles in the syringe.
Slovenian: • Preverite, ali so v brizgi zračni mehurčki, in jih odstranite.
English: Platelet counts should be assessed weekly until a stable platelet count
Slovenian: Število trombocitov je treba kontrolirati vsak teden, dokler ni doseženo stabilno število trombocitov (≥ 50 x 10
English: Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Slovenian: Manitol (E421), saharoza, l-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
English: Nplate 250 micrograms powder for solution for injection romiplostim
Slovenian: Nplate 250 mikrogramov prašek za raztopino za injiciranje romiplostim
English: • itchy, runny or blocked nose (rhinitis);
Slovenian: • srbeč in zamašen nos, izcedek iz nosu (rinitis),
English: Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 mL sterile water for injections, yielding a deliverable volume of 1 mL.
Slovenian: Nplate 500 mikrogramov prašek za raztopino za injiciranje Zdravilo Nplate 500 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 1,2 ml sterilne vode za injekcije, tako nastane 1 ml uporabne količine.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 25ºC in disposable syringes, or 4 hours in a refrigerator (2ºC - 8ºC) in the original vials, protected from light.
Slovenian: Čas običajno ne sme presegati 4 ure pri 25 °C za brizgo za enkratno uporabo ali 4 ure v hladilniku (2 °C do 8 °C) za originalno vialo, zaščiteno pred svetlobo.
English: Nplate 500 micrograms powder for solution for injection romiplostim
Slovenian: Nplate 500 mikrogramov prašek za raztopino za injiciranje romiplostim
English: Decreased appetite Dehydration Gout
Slovenian: Presnovne in prehranske motnje neprenašanje alkohola anoreksija zmanjšanje teka dehidracija protin
English: 1 vial of powder for solution for injection.
Slovenian: prašek za raztopino za injiciranje 1 viala
English: • tiredness (fatigue);
Slovenian: • srbeč izpuščaj (urtikarija).
English: Reproductive system and breast disorders
Slovenian: Vpliv na sposobnost razmnoževanja
English: Headache
Slovenian: Krvavitve
English: 625 mcg
Slovenian: 625 µg
English: Nplate is not recommended for use if you are breast-feeding.
Slovenian: Če dojite, uporaba zdravila Nplate ni priporočljiva.
English: After reconstitution, a deliverable volume of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL).
Slovenian: Po pripravi vsebuje uporabna količina 0,25 ml raztopine 125 mikrogramov romiplostima (500 mikrogramov/ml).
English: Set up materials for an injection
Slovenian: 1. korak: Priprava materiala za injiciranje
English: An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered.
Slovenian: Vsaka viala vsebuje presežek, ki zagotavlja, da je mogoče iz nje dobiti 125 µg romiplostima.
English: After reconstitution, a deliverable volume of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL).
Slovenian: Po pripravi vsebuje uporabna količina 1 ml raztopine 500 mikrogramov romiplostima (500 mikrogramov/ml).
English: 500 mcg
Slovenian: Za komplet 500 μg
English: Following the first 4-weeks of study romiplostim maintained platelet counts ≥ 50 x 10
Slovenian: V študijah, kontroliranih s placebom, je romiplostim po prvih 4 tednih študije med 6-mesečnim zdravljenjem ohranil število trombocitov ≥ 50 x 109/l pri 50 % do 70 % bolnikov.
English: Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Slovenian: Prašek: manitol (E421), saharoza, L-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
English: Powder: Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Slovenian: Prašek: manitol (E421), saharoza, l-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
English: Nplate 125 µg powder for injection romiplostim
Slovenian: Nplate 125 µg prašek za injiciranje romiplostim s.c.
English: After reconstitution, a deliverable volume of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
Slovenian: Po pripravi vsebuje uporabna količina 0,5 ml raztopine 250 mikrogramov romiplostima (500 mikrogramov/ml).
English: Upper abdominal pain***
Slovenian: Bolezni prebavil bolečina v zgornjem delu trebuha***
English: Nplate 500 micrograms powder and solvent for solution for injection romiplostim
Slovenian: Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje romiplostim
English: Attach vial adapter to Nplate vial by peeling off paper backing from vial adapter, keeping the vial adapter in its packaging.
Slovenian: Namestite nastavek za vialo na vialo zdravila Nplate tako, da odstranite papirnato prelepko z nastavka za vialo.
English: Nplate 250 micrograms powder and solvent for solution for injection
Slovenian: Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje
English: Nplate 250 micrograms powder and solvent for solution for injection romiplostim
Slovenian: Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje romiplostim
English: There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents.
Slovenian: Prenehanje zdravljenja z romiplostimom ob uporabi antikoagulantov ali antiagregacijskih zdravil povečuje tveganje za krvavitve.
English: Nplate 250 µg powder for injection romiplostim
Slovenian: Nplate 250 µg prašek za injiciranje romiplostim s.c.
English: Nplate 500 µg powder for injection romiplostim
Slovenian: Nplate 500 µg prašek za injiciranje romiplostim s.c.
English: 9/L at study entry.
Slovenian: 9/l od 2. do 25. tedna študije.
English: Lacrimation increased Papilloedema Visual disturbances
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica
English: Nplate 500 micrograms powder and solvent for solution for injection
Slovenian: Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje:
English: Plunger rod for pre-filled sterile water syringe x1 Pre-filled sterile water syringe x1
Slovenian: 1 vialo praška za raztopino za injiciranje 1 napolnjeno injekcijsko brizgo, ki vsebuje 1,2 ml vehikla 1 držalo bata za napolnjeno injekcijsko brizgo 1 sterilen nastavek za vialo
English: • contusion;
Slovenian: • zaprtje,
English: • Keeping the vial on the table, attach water-filled syringe to vial adapter by holding the side of the vial adapter with one hand and twisting the syringe tip clockwise onto the adapter with the other hand until you feel a slight resistance.
Slovenian: To naredite tako, da z eno roko držite stranski del nastavka za vialo, z drugo roko pa sučete konico brizge v smeri urnega kazalca v nastavek, dokler ne začutite rahlega upora.
English: Injection site haemorrhage Chest pain Irritability Malaise Face oedema Feeling hot Feeling jittery
Slovenian: krvavitev na mestu injiciranja bolečine v prsih razdražljivost splošno slabo počutje edem obraza občutek vročine občutek živčnosti
English: Prepare new syringe for injection
Slovenian: 5. korak: Priprava nove brizge za injiciranje
English: ZIMULTI is taken as one tablet once a day, before breakfast.
Slovenian: Zdravilo ZIMULTI se jemlje kot ena tableta enkrat dnevno pred zajtrkom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ZIMULTI to sanofi-aventis on 19 June 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom ZIMULTI, veljavno po vsej Evropski uniji, odobrila družbi sanofi-aventis dne 19. junija 2006.
English: The receptors are also found in adipocytes (fat tissue).
Slovenian: Receptorji se nahajajo tudi v adipocitih (maščobnem tkivu).
English: The studies in smoking cessation did not show consistent results, and the effect of ZIMULTI in this area was difficult to estimate.
Slovenian: Študije v zvezi s prenehanjem kajenja niso pokazale konsistentnih rezultatov, učinek zdravila ZIMULTI na tem področju pa je bilo težko oceniti.
English: Which measures are being taken to ensure the safe use of ZIMULTI?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila ZIMULTI?
English: Other information about ZIMULTI:
Slovenian: Druge informacije o zdravilu ZIMULTI:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije,, na podlagi katerih je oblikoval priporočila glede uporabe zdravila.
English: The company will use specific databases to monitor the side effects, especially those linked to the nervous system.
Slovenian: Specifične zbirke podatkov bo podjetje uporabilo za spremljanje neželenih učinkov, zlasti tistih, povezanih z živčnim sistemom.
English: The medicine also reduced the risk of regaining weight.
Slovenian: Zdravilo je tudi zmanjšalo tveganje za ponovno povečanje telesne mase.
English: The medicine should not be used in patients who have severe problems with their liver or their kidneys.
Slovenian: Zdravila ne smejo jemati bolniki, ki imajo hude težave z jetri ali ledvicami.
English: The effects of ZIMULTI were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila ZIMULTI so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The patients should also follow a reduced calorie diet and increase their level of physical activity.
Slovenian: Poleg tega morajo bolniki slediti dieti z zmanjšano vsebnostjo kalorij in povečati fizično aktivnost.
English: The company decided to withdraw its application for smoking cessation.
Slovenian: Podjetje se je odločilo, da umakne vlogo za uporabo zdravila pri prenehanju kajenja.
English: Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment.
Slovenian: Bolniki, pri katerih se pojavi depresija, se morajo pogovoriti z zdravnikom, zdravljenje pa bo morda porebno prekiniti.
English: The active substance in ZIMULTI, rimonabant, is a cannabinoid receptor antagonist.
Slovenian: Zdravilna učinkovina v zdravilu ZIMULTI, rimonabant, je antagonist kanabinoidnih receptorjev.
English: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/m²,
Slovenian: • so debeli (z zelo prekomerno telesno maso) s indeksom telesne mase (BMI) večjim ali enakim 30 kg/m², ali
English: After one year, all patients who received ZIMULTI lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the difference in the weight loss was 3.9 kg.
Slovenian: Po enem letu se je pri bolnikih, ki so prejemali zdravilo ZIMULTI telesna masa zmanjšala bolj kot pri tistih, ki so prejemali placebo: povprečno so izgubili 4,9 kg več kot s placebom, razen v študiji z diabetičnimi bolniki, kjer je bila razlika v zmanjšanju telesne mase 3,9 kg.
English: Therefore, ZIMULTI is not recommended as an aid for smoking cessation
Slovenian: Zdravilo ZIMULTI torej kot pomoč pri prenehanju kajenja ni priporočeno.
English: Caution should be used when taking ZIMULTI with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics).
Slovenian: Pri sočasnem jemanju zdravila ZIMULTI in nekaterih drugih zdravil, kot so ketokonazol ali itrakonazol (zdravili proti glivicam), ritonavir (ki se uporablja pri okužbi s HIV), telitromicin ali klaritromicin (antibiotika) je potrebna previdnost.
English: What benefit has ZIMULTI shown during the studies?
Slovenian: Kakšne koristi je zdravilo ZIMULTI izkazalo med raziskavami?
English: The company that makes ZIMULTI will put in place a programme to ensure that the medicine is used in patients who need it for health, rather than for cosmetic reasons, by providing educational packs for patients and doctors, and to monitor how the medicine is used.
Slovenian: Podjetje, ki izdeluje zdravilo ZIMULTI bo pripravilo program z izobraževalnim gradivom za bolnike zdravnike, s katerim bo zagotovilo, da se zdravilo uporablja pri bolnikih, ki ga potrebujejo zaradi zdravja in ne iz kozmetičnih razlogov, ter bo nadzorovalo njegovo uporabo.
English: ZIMULTI is a medicine containing the active substance rimonabant.
Slovenian: ZIMULTI so zdravilo, ki vsebuje zdravilno učinkovino rimonabant.
English: What is the risk associated with ZIMULTI?
Slovenian: Kakšna tveganja so povezana z zdravilom ZIMULTI?
English: It is available as white, teardropshaped tablets.
Slovenian: Na voljo je v obliki tablet bele barve, ki imajo obliko solze.
English: Why has ZIMULTI been approved?
Slovenian: Zakaj je bilo zdravilo ZIMULTI odobreno?
English: ©EMEA 2007
Slovenian: Zdravilo nima veā dovoljenja za promet©EMEA 2007
English: ZIMULTI should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding.
Slovenian: Zdravila ZIMULTI ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) rimonabant ali katero koli drugo sestavino zdravila ter ženske, ki dojijo.
English: The Committee recommended that ZIMULTI be given marketing authorisation.
Slovenian: Odbor je priporočil odobritev dovoljenja za promet z zdravilom ZIMULTI.
English: The Committee decided that ZIMULTI's benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Slovenian: Odločil je da so koristi zdravila ZIMULTI večje od z njim povezanih tveganj, kadar se uporablja kot dodatek k dieti in telesni dejavnosti pri zdravljenju debelih bolnikov in bolnikov s čezmerno telesno maso z dodatnimi dejavniki tveganja kot so diabetes tipa 2 ali dispidemija.
English: The Committee for Medicinal products for Human Use (CHMP) concluded that ZIMULTI had shown its effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo ZIMULTI izkazalo učinkovitost pri zmanjšanju telesne mase pri debelih bolnikih in bolnikih s čezmerno telesno maso, pri katerih obstajajo dodatni dejavniki tveganja.
English: During the studies, the most common side effects with ZIMULTI (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract.
Slovenian: Neželeni učinki zdravila ZIMULTI, ki so bili med študijami najpogosteje opaženi (pri več kot 1 od 10 bolnikov), so navzeja (občutek slabosti) in okužbe zgornjih dihal.
English: ZIMULTI is used together with diet and exercise to treat adult patients:
Slovenian: Zdravilo ZIMULTI se kot dodatek k dieti in telesni dejavnosti uporablja za zdravljenje odraslih bolnikov, ki:
English: The studies compared the effect of ZIMULTI with that of a placebo (a dummy treatment) on weight loss over one to two years.
Slovenian: V študijah so primerjali učinek zdravila ZIMULTI z učinkom placeba (zdravila brez zdravilne učinkovine) na zmanjšanje telesne mase v enem do dveh let.
English: Four studies of ZIMULTI in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg. One study looked more particularly at patients with abnormal levels of blood fat, and one at patients with type 2 diabetes.
Slovenian: Zdravilo ZIMULTI je bilo raziskano v štirih študijah, v katerih je sodelovalo skoraj 7000 debelih bolnikov in bolnikov s čezmerno telesno maso, katerih teža je bila na začetku študij povprečno med 94 in 104 kg.
English: For the full list of all side effects reported with ZIMULTI, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila ZIMULTI, glejte Navodilo za uporabo.
English: What is ZIMULTI used for?
Slovenian: Za kaj se zdravilo ZIMULTI uporablja?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZIMULTI EPAR summary for the public
Slovenian: Povzetek EPAR za javnost
English: It acts by blocking a specific type of receptors, the cannabinoid type 1 (CB1) receptors.
Slovenian: Deluje tako, da blokira specifično vrsto receptorjev, kanabinoidnih receptorjev tipa 1 (CB1), ki se nahajajo v živčnem sistemu in so del sistema, ki ga telo uporablja za nadzor vnosa hrane.
English: One study also looked at how this loss could be maintained during the second year.
Slovenian: doseženo zmanjšanje telesne mase obdržati tekom drugega leta.
English: Four studies of ZIMULTI as a help to stop smoking were also carried out in over 7,000 patients, comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one of the studies) on smoking cessation, and on relapses in the following year.
Slovenian: Zdravilo so primerjali s placebom in merili učinek zdravila, uporabljanega 10 tednov (eno leto v eni od študij), na prenehanje kajenja ter na ponoven začetek kajenja v naslednjem letu.
English: It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of depression, including thoughts about suicide in a small minority of patients.
Slovenian: Zdravilo lahko poveča tveganje za depresijo, vključno s samomorilnimi mislimi pri majhnem številu bolnikov, zato se ne sme uporabljati pri bolnikih s trenutno potekajočo veliko depresivno motnjo ali bolnikih, ki se zdravijo z antidepresivi.
English: How does ZIMULTI work?
Slovenian: Kako zdravilo ZIMULTI deluje?
English: How has ZIMULTI been studied?
Slovenian: Kako je bilo zdravilo ZIMULTI raziskano?
English: How is ZIMULTI used?
Slovenian: Kako se zdravilo ZIMULTI uporablja?
English: The full EPAR for ZIMULTI can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo ZIMULTI je na voljo tukaj.
English: • who are overweight (with a BMI greater than or equal to 27 kg/m²) and also have other risk factors,
Slovenian: • imajo čezmerno telesno maso (BMI večji ali enak 27 kg/m²) in pri katerih obstajajo dodatni dejavniki tveganja, kot so na primer diabetes tipa 2 ali dislipidemija (nenormalne ravni maščobe v krvi).
English: What is ZIMULTI?
Slovenian: Kaj je zdravilo ZIMULTI?
English: The Member States shall ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da se izvajajo vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila:
English: 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:
Slovenian: 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:
English: − You should not be treated with PhotoBarr if you have severe liver disease (eg cirrhosis)
Slovenian: − Zdravljenja s PhotoBarrom ne smete prejemati, če imate hudo okvaro jeter (npr. cirozo).