natgillin/translations-raw huggingface dataset:
Even brief interruptions in the delivery of Flolan may result in rapid symptomatic deterioration.
Simptomi se lahko hitro poslabšajo že po kratki prekinitvi dajanja zdravila Flolan.
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL for solvent vial
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNI OVOJNINI NALEPKA za vialo z vehiklom
• One 0.5 mg powder vial.
• Ena viala z 0,5 mg praška
• One vial containing sterile, freeze-dried Flolan equivalent to 1.5 mg Flolan supplied alone.
• Ena viala s sterilnim liofiliziranim zdravilom Flolan, kolikor ustreza 1,5 mg zdravila Flolan, samim.
Very rare side effects These may affect up to 1 in 10,000 people:
Zelo redki neželeni učinki Pojavijo se lahko pri največ 1 od 10.000 oseb:
Only the solvent provided may be used for the further dilution of reconstituted Flolan.
Za nadaljnje razredčenje pripravljenega zdravila Flolan se sme uporabiti le priloženi vehikel.
Abdominal colic, sometimes reported as abdominal discomfort
Pogosti trebušne kolike; bolniki jih včasih opisujejo kot nelagodje v trebuhu
Blood pressure and heart rate should be monitored during administration of Flolan.
Med dajanjem zdravila Flolan je treba kontrolirati bolnikov krvni tlak in srčno frekvenco.
Store between 2 and 8oC for the full administration period.
Med celotnim obdobjem dajanja shranjujte pri temperaturi med 2 in 8 oC.
Summary of product characteristics, labelling and package leaflet
Priloga III Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo
Higher infusion rates, and therefore, more concentrated solutions may be necessary with long-term administration of Flolan.
Med dolgotrajno uporabo zdravila Flolan je lahko potrebna večja hitrost infundiranja in zaradi tega bolj koncentrirane raztopine.
Hyperthyroidism Psychiatric Disorders Common
Zelo redki hipertiroidizem Psihiatrične motnje Pogosti anksioznost, živčnost
Flow rates in mL/h Infusion rates for a concentration of 15,000 nanograms/mL Example For Dosing Using a Concentration of 15,000 nanograms/mL
Hitrost pretoka v ml/h Hitrosti infundiranja za koncentracijo 15.000 nanogramov/ml
INSTRUCTIONS ON USE [To be completed nationally] INFORMATION IN BRAILLE [To be completed nationally]
PODATKI V BRAILLOVI PISAVI [Izpolni država članica]
0.5 mg vial powder for solution for infusion, 1 vial of solvent and 1 filter unit 0.5 mg vial powder for solution for infusion, 2 vials of solvent and 1 filter unit
Prašek in vehikel za raztopino za infundiranje Prašek za raztopino za infundiranje Vehikel za parenteralno uporabo viala z 0,5 mg praška za raztopino za infundiranje, 1 viala vehikla in 1 filtrirna enota viala z 0,5 mg praška za raztopino za infundiranje, 2 viali vehikla in 1 filtrirna enota viala z 1,5 mg praška za raztopino za infundiranje, 1 viala vehikla in 1 filtrirna enota viala z 1,5 mg praška za raztopino za infundiranje, 2 viali vehikla in 1 filtrirna enota
Rare side effects
Pogosti neželeni učinki
Store the solvent below 25°C.
Viale shranjujte pri temperaturi do 25 °C.
• dry mouth
• suha usta.
GENERAL CLASSIFICATION FOR SUPPLY Medicine subject to medicinal prescription
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Infusion rate (mL/min) = concentration of solution (nanogram/mL)
= koncentracija raztopine (nanogramov/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION Epoprostenol 0.5mg Powder for Solution for Infusion:
Epoprostenol 0,5 mg prašek za raztopino za infundiranje:
The vasodilator effects of Flolan may augment or be augmented by concomitant use of other vasodilators.
Vazodilatacijski učinki zdravila Flolan lahko povečajo učinek sočasno uporabljenih vazodilatatorjev in obratno.
Flolan must not be administered with other parenteral solutions or medications when used for pulmonary arterial hypertension.
Če se zdravilo Flolan uporablja za zdravljenje pljučne arterijske hipertenzije, se ga ne sme uporabljati z drugimi parenteralnimi raztopinami ali zdravili.
The hypotensive effect of Flolan may be enhanced by the use of acetate buffer in the dialysis bath during renal dialysis.
Uporaba acetatnega pufra v dializni kopeli med ledvično dializo lahko poveča hipotenzivni učinek zdravila Flolan.
Bradycardia associated with a considerable fall in systolic and diastolic blood pressure has followed i.v.
30 nanogramom/kg/min, je pri zdravih prostovoljcih, ki so bili pri zavesti, sledila bradikardija, povezana z občutnim padcem sistoličnega in diastoličnega krvnega tlaka.
Use only the solvent provided for reconstitution.
Za pripravo uporabljajte le priloženi vehikel.
• One 0.5 mg powder vial and one or two solvent vials and a filter unit.
• eno vialo z 0,5 mg praška, eno ali dve viali z vehiklom in filtrirno enoto,
Its use is forbidden in the presence of a discoloration or particles.
Ne sme se je uporabiti, če je spremenjene barve ali so v njej delci.
Flolan 0.5 mg Powder and Solvent for Solution for Infusion Flolan 1.5 mg Powder and Solvent for Solution for Infusion
Flolan 0,5 mg prašek in vehikel za raztopino za infundiranje Flolan 1,5 mg prašek in vehikel za raztopino za infundiranje
Each vial contains epoprostenol sodium equivalent to 1.5 mg epoprostenol One ml of reconstituted concentrate solution contains epoprostenol (as epoprostenol ) 30 000 nanogram.
En mililiter pripravljenega koncentrata raztopine vsebuje 30.000 nanogramov epoprostenola (kot natrijevega epoprostenolata).
• One 1.5 mg powder vial and one or two solvent vials and a filter unit.
• eno vialo z 1,5 mg praška, eno ali dve viali z vehiklom in filtrirno enoto,
How to store Flolan
Shranjevanje zdravila Flolan
Except in life-threatening situations (e.g. unconsciousness, collapse, etc) infusion rates of Flolan should be adjusted only under the direction of a physician.
Hitrost infundiranja zdravila Flolan se sme prilagoditi le pod nadzorom zdravnika; izjema so smrtno nevarne okoliščine (npr. nezavest, kolaps ipd.).
• tenderness
• občutljivost,
• redness.
• driska,
Each vial contains either:
Ena viala vsebuje
• overactive thyroid gland
• čezmerno dejavna žleza ščitnica,
• 5,000 nanogram/mL - One vial containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
• 5.000 nanogramov/ml - Ena viala z 0,5 mg zdravila Flolan, pripravljenega in razredčenega na celotno količino 100 ml v vehiklu.
15,000 nanograms/mL - 1.5 mg Flolan reconstituted and diluted to a total volume of 100mL in solvent.
• 15.000 nanogramov/ml - 1,5 mg zdravila Flolan, pripravljenega in razredčenega na celotno količino 100 ml v vehiklu.
• 15,000 nanogram/mL - One vial containing 1.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
• 15.000 nanogramov/ml - ena viala z 1,5 mg zdravila Flolan, pripravljenega in razredčenega v celotni količini 100 ml vehikla.
• 10,000 nanogram/mL - Two vials containing 0.5 mg Flolan reconstituted and diluted to a total volume of 100 mL in solvent.
• 10.000 nanogramov/ml - Dve viali z 0,5 mg zdravila Flolan, pripravljenega in razredčenega na celotno količino 100 ml v vehiklu.
Pallor
Odmerjanje
3 Bradycardia, sometimes accompanied by orthostatic hypotension, has occurred in healthy volunteers at doses of Flolan greater than 5 nanograms/kg/min.
3 Pri zdravih prostovoljcih so pri odmerkih zdravila Flolan, večjih od
• joint pain
• bolečine,
• burning
• bruhanje,
Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Prilogo I - izpolni država članica] {Ime in naslov} <{tel.}> <{faks}> <{e-pošta}>
• swelling
NSPVZ),
• chest pain
• bolečine v prsih,
• One vial containing sterile, freeze-dried Flolan equivalent to 0.5 mg Flolan, supplied with one or two
• Ena viala s sterilnim liofiliziranim zdravilom Flolan, kolikor ustreza 0,5 mg zdravila Flolan, z eno ali dvema 50-ml vialama vehikla in filtrirno enoto.
Methotrexate is authorised in the European Union since the 1960s.
Metotreksat je v Evropski uniji odobren od 60. let 20. stoletja.
It was also noted that current European guidelines do not mention the possibility of dividing the dose.
Ugotovljeno je bilo tudi, da trenutne evropske smernice ne omenjajo možnosti delitve odmerka.
These risk minimisation measures should be reflected in a risk management plan.
Te ukrepe za zmanjšanje tveganja je treba vključiti v načrt za obvladovanje tveganj;
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products containing methotrexate;
• Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo metotreksat;
Each group of indications has a different administration schedule:
Vsaka skupina indikacij ima drugačen urnik uporabe metotreksata:
The PRAC adopted a recommendation on 11 July 2019 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 11. julija 2019 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnaval odbor CHMP.
Methotrexate-containing products are authorised in all EU Member States, and either oral or parenteral formulation or both pharmaceutical formulations are available.
Zdravila, ki vsebujejo metotreksat, so odobrena v vseh državah članicah EU, na voljo pa so v obliki peroralne ali parenteralne formulacije ali v obeh farmacevtskih formulacijah.
This included the responses submitted by the marketing authorisation holders in writing as well as the views of patients and healthcare professionals;
To je vključevalo odzive, ki so jih pisno predložili imetniki dovoljenja za promet z zdravilom, ter stališča bolnikov in zdravstvenih delavcev;
Overall, it was considered that such practice may generate more confusion and lead to more medication errors and should therefore not be recommended.
Na splošno je bilo ocenjeno, da lahko takšna praksa povzroči več zmede in pripelje do več napak pri uporabi zdravila, zato se ne sme priporočati.
Any reference to dividing the dose in the product information should therefore be deleted.
Vsakršno sklicevanje na delitev odmerka v informacijah o zdravilu je torej treba izbrisati.
Taking into account that such replacement may require several technical changes and not to jeopardize the availability of methotrexate formulations in some Member States, the PRAC agreed to an implementation period of up to 4 years after finalisation of this procedure.
Glede na to, da bo takšna nadomestitev morda zahtevala več tehničnih sprememb, in da ne bi ogrozili razpoložljivosti formulacij metotreksata v nekaterih državah članicah, se je odbor PRAC strinjal z največ štiriletnim obdobjem uvajanja po koncu tega postopka.
In addition, splitting the dose in multiple intakes should no longer be recommended;
Poleg tega se delitev odmerka na jemanje v več delih ne sme več priporočati;
In addition, bulk packaging bear the risk of losing warning information at the time of repackaging which is e.g. common practice in medical centres/hospitals.
Poleg tega zbirna ovojnina pomeni tveganje za izgubo opozorilnih informacij ob prepakiranju, kar je npr. pogosta praksa v zdravstvenih centrih/bolnišnicah.
The feedback received from healthcare professional organisations also provided further insight on the root causes for errors.
Tudi povratne informacije, ki so jih posredovale zdravstvene organizacije, so zagotovile dodaten vpogled v ključne vzroke za napake.
• A direct healthcare professionals communication was also agreed, together with a communication plan;
• sprejet je bil dogovor o neposrednem obvestilu za zdravstvene delavce, skupaj z načrtom obveščanja;
Systematic review by Saedder and colleagues (2014)1 revealed that 47% of all serious medication errors were caused by only seven drug classes, with methotrexate topping the list in percentage of incidents.
Saedder in sodelavci (2014)1 so s sistematičnim pregledom odkrili, da 47 % vseh resnih napak pri uporabi zdravila izhaja iz samo sedmih razredov zdravil, pri čemer je metotreksat prvi na seznamu glede na odstotek incidentov.
The case report analyses showed that the elderly patient population was more predisposed for inadvertent daily use of methotrexate, with more than half of the cases reporting elderly population (65 or over).
Analize poročil o primerih so pokazale, da je populacija starejših bolnikov bolj nagnjena k nenamerni uporabi metotreksata enkrat na dan, saj je več kot polovica sporočenih primerov zadevala starejšo populacijo (65 let ali več).
In addition, the PRAC requested the development of a patient card to be inserted inside or attached to the outer packaging.
Poleg tega je odbor PRAC zahteval pripravo bolnikove kartice, ki bo vstavljena v zunanjo ovojnino ali pritrjena nanjo.
In the context of this review, the PRAC discussed, in consultation with patients and healthcare professionals, how the risk minimisation measures already in place could be further strengthen and if further measures should be implemented.
V sklopu tega pregleda je odbor PRAC po posvetovanju z bolniki in zdravstvenimi delavci razpravljal o tem, kako bi lahko nadalje okrepili že vzpostavljene ukrepe za zmanjšanje tveganja in ali bi bilo treba uvesti dodatne ukrepe.
In view of the differences, the PRAC recommended an increased consistency in the implementation of this measure by defining clear, concise and unambiguous warnings for the outer and inner packaging of these products.
Glede na razlike je odbor PRAC priporočil povečano skladnost pri izvajanju tega ukrepa, in sicer z opredelitvijo jasnih, natančnih in nedvoumnih opozoril za zunanjo in notranjo ovojnino teh zdravil.
• For the treatment of cancer, various administration schedules including daily dosage may be used;
• pri zdravljenju raka se lahko uporabljajo različni urniki uporabe, vključno z odmerjanjem enkrat na dan;
In particular, it was reported that bulk packaging such as bottles or tubes does not allow tracking, i.e. easy counting, of the remaining tablets, making it difficult both for patients and caregivers to notice the error.
Poročali so zlasti, da zbirna ovojnina, kot so stekleničke ali epruvete, ne omogoča sledenja, tj. preprostega štetja preostalih tablet, kar bolnikom in negovalcem otežuje, da bi opazili napako.
Furthermore, of the 74 articles that met the review's inclusion criteria, 73 contained information about a serious adverse reaction caused by methotrexate-related medication error (found in the FDA Adverse Event Reporting System).
Nadalje je 73 od 74 člankov, ki so izpolnjevali vključitvena merila za pregled, vsebovalo informacije o resnem neželenem učinku, ki ga je povzročila napaka pri uporabi zdravila, povezana z metotreksatom (najdeno v sistemu za poročanje o neželenih učinkih agencije FDA).
Medication errors were also associated with the use of bulk packaging.
Napake pri uporabi zdravila so bile povezane tudi z uporabo zbirne ovojnine.
Lack of knowledge and clarity on the weekly dosing schedule in some indications was also recurring feature and not limited to patient level.
Tudi pomanjkanje poznavanja in jasnosti glede odmerjanja enkrat na teden pri nekaterih indikacijah je bil ponavljajoč se razlog, ki ni bil omejen samo na raven bolnika.
A direct healthcare professional communication was also agreed, together with a communication plan, to inform relevant healthcare professionals of the new recommendations and risk minimisation measures agreed.
Dogovorjeno je bil tudi neposredno obvestilo za zdravstvene delavce, skupaj z načrtom obveščanja, za seznanjanje zadevnih zdravstvenih delavcev z novimi priporočili in dogovorjenimi ukrepi za zmanjšanje tveganja.
On 22 March 2018 Spain therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the root causes and the impact of the risk of medication errors on the benefit-risk balance of oral formulation of methotrexate and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Zato je Španija 22. marca 2018 na podlagi farmakovigilančnih podatkov sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor PRAC zaprosila, naj oceni ključne vzroke za napačno uporabo zdravila in vpliv teh napak na razmerje med koristmi in tveganji peroralne formulacije metotreksata, ter izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno umakniti ali ukiniti.
It is indicated in the treatment of cancers such as acute lymphoblastic leukaemia (ALL) and various inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, and psoriatic arthritis and as steroid sparing adjunctive therapy in Crohn's disease.
Indiciran je za zdravljenje določenih vrst raka, kot je akutna limfoblastna levkemija (ALL), in različnih vnetnih stanj, vključno z revmatoidnim artritisom, juvenilnim idiopatskim artritisom, psoriazo in psoriatičnim artritisom, ter kot dopolnilno zdravljenje za varčevanje s steroidi pri Crohnovi bolezni.
Other subgroups of patients were also identified at risk such as patients with impaired memory and cognitive functions, patients with visual impairment, patients who have difficulties to follow written instructions, patients who split their weekly oral methotrexate dose, patients with co-morbidities and co-medications.
Kot ogrožene so bile prepoznane tudi druge podskupine bolnikov, na primer bolniki z motnjami spomina in kognitivnih funkcij, bolniki z motnjami vida, bolniki, ki imajo težave pri upoštevanju pisnih navodil, bolniki, ki delijo svoj tedenski peroralni odmerek metotreksata ter bolniki s sočasnimi boleznimi in sočasnimi zdravili.
The educational material should also include a reminder for the pharmacist to counsel the patient about the inadvertent daily instead of once-weekly dosing.
To izobraževalno gradivo mora vključevati tudi opomnik za farmacevta, naj bolnika pouči o nenamernem odmerjanju enkrat na dan namesto enkrat na teden.
• For the treatment of autoimmune diseases, which require immunosuppressive therapy like rheumatoid arthritis, psoriasis, Crohn's disease and other autoimmune diseases, it is prescribed as a single low-dose, once a week.
• pri zdravljenju avtoimunskih bolezni, ki zahtevajo imunosupresivno zdravljenje, kot so revmatoidni artritis, psoriaza, Crohnova bolezen in druge avtoimunske bolezni, se zdravilo predpisuje v obliki enkratnega majhnega odmerka enkrat na teden.
Different reasons for the occurrence of medication error have been identified.
Ugotovili so različne razloge za pojav napak pri uporabi zdravila.
In EU/EEA, despite the risk minimisation measures in place, cases of medication errors are still occurring.
V EU/EGP kljub vzpostavljenim ukrepom za zmanjšanje tveganja še vedno prihaja do napak pri uporabi zdravila.
It was also agreed that for all tablet formulations of methotrexate, bottles and tubes currently used as immediate packaging should be replaced by blisters.
Dogovorili so se tudi, da je treba pri vseh formulacijah metotreksata v obliki tablet stekleničke in epruvete, ki se trenutno uporabljajo kot stična ovojnina, nadomestiti s pretisnimi omoti.
Extensive assessment of spontaneously reported post-marketing cases has been performed by the PRAC and although some relevant data might not have been provided in all spontaneously reported post-marketing cases, the root cause analysis was further substantiated by the assessment of literature data, which provided more detailed description of methotrexate medication error cases.
Odbor PRAC je opravil obširno oceno spontano sporočenih primerov iz obdobja trženja, in čeprav nekateri pomembni podatki niso bili navedeni v vseh spontano sporočenih primerih iz obdobja trženja, je bila analiza ključnih vzrokov nadalje podprta z oceno podatkov iz literature, ki je zagotovila podrobnejši opis primerov napak pri uporabi zdravila z metotreksatom.
To address this issue, the PRAC recommended that for all tablet formulations of methotrexate, bulk packaging such as bottles or tubes should be replaced by blisters.
Za obravnavo te težave je odbor PRAC priporočil, da pri vseh formulacijah metotreksata v obliki tablet zbirno ovojnino, kot so stekleničke ali epruvete, nadomestijo pretisni omoti.
It was noted that many different wordings and styles of warnings have been implemented, from very small information on one side of the packaging in black to large red framed information on several sides of the outer packaging, inclusion of a calendar or place to mark the day of intake as well as different texts for the warning.
Ugotovljeno je bilo, da so uvedena opozorila vsebovala zelo različna besedila in sloge, od informacij v zelo drobnih črnih črkah na eni strani ovojnine, do velikih, rdeče uokvirjenih informacij na več straneh zunanje ovojnine, vključitve koledarja ali mesta za označitev dneva jemanja ter različnih besedil opozorila.
The PRAC further agreed during its April 2018 plenary meeting to extend the scope to include also parenteral formulations of methotrexate, in view of a number of cases reported with these formulations as well, and due to the fact that for a high number of cases reported as “incorrect schedule of dose administration” with methotrexate, the route of administration and the pharmaceutical form had not been specified.
Odbor PRAC je med svojim plenarnim zasedanjem aprila 2018 nadalje soglašal, da bo obseg napotitve razširil in vanjo vključil tudi parenteralne formulacije metotreksata, in sicer zaradi števila primerov, o katerih so poročali tudi s temi formulacijami, ter zaradi dejstva, da pri številnih primerih, pri katerih so poročali o „napačnem urniku uporabe“ metotreksata, način uporabe in farmacevtska oblika nista bila navedena.
• The PRAC investigated the root causes for the abovementioned risk of medication errors and noted that these can occur at all stages of the medication process;
• odbor PRAC je preučil ključne vzroke za zgoraj navedeno tveganje za napake pri uporabi zdravila in opozoril, da se lahko pojavijo v vseh fazah postopka zdravljenja;
Admission to hospital and transfer of care between institutions and physicians was also noted as a root cause due to poor or a lack of communication between patient/physician, physician/physician, physician/nurse.
Kot ključni vzrok sta bila ugotovljena tudi sprejem v bolnišnico in prenos oskrbe med ustanovami in zdravniki, in sicer zaradi slabe komunikacije ali odsotnosti komunikacije med bolnikom in zdravnikom, med enim in drugim zdravnikom ter med zdravnikom in medicinsko sestro.
• In addition, the PRAC also recommended other changes to the product information of all methotrexate-containing products with at least one indication requiring once weekly dosing to include that only physicians with expertise in using methotrexate-containing medicines should prescribe them and that healthcare professionals should ensure that patients or their carers will be able to follow the once weekly dosing schedule.
• poleg tega je odbor PRAC priporočil tudi vključitev drugih sprememb v informacije o zdravilu za vsa zdravila, ki vsebujejo metotreksat in imajo vsaj eno indikacijo, ki zahteva odmerjanje enkrat na teden, in sicer da jih smejo predpisovati samo zdravniki s strokovnim znanjem o uporabi zdravil, ki vsebujejo metotreksat, in da morajo zdravstveni delavci zagotoviti, da bodo bolniki ali njihovi negovalci zmožni upoštevati urnik odmerjanja enkrat na teden.
Despite additional risk minimisation measures having already been put in place, reports continued to be received.
Kljub dodatno vzpostavljenim ukrepom za zmanjšanje tveganja o takih primerih še vedno poročajo.
Based on the available data, the PRAC noted that the abovementioned risk of medication errors can occur at all stages of the medication process, from prescription to administration.
Odbor PRAC je na podlagi razpoložljivih podatkov ugotovil, da se zgoraj navedeno tveganje za napake pri uporabi zdravila lahko pojavi v kateri koli fazi postopka zdravljenja, od predpisovanja do uporabe.