FrancophonIA/ELRC3.0 huggingface dataset:
English: Over time the implant will be absorbed by the body, this will happen within 50 to 60 days after implantation.
Slovenian: Čez čas bo telo implantat absorbiralo, kar se bo zgodilo 50 do 60 dni po vsaditvi.
English: Pack of one vial containing one implant.
Slovenian: Pakiranje z eno vialo vsebuje en implantat.
English: - With the catheter in place, aseptically remove the implant from the vial.
Slovenian: - Ko je kateter vstavljen, aseptično odstranite implantat iz viale.
English: If the implant has not been administered during the procedural steps described above, discard the implant and administer a new implant.
Slovenian: Če med zgoraj opisanimi koraki niste vstavili implantata, ga zavrzite in uporabite nov implantat.
English: Store in a refrigerator (2oC - 8oC).
Slovenian: Shranjujte v hladilniku (2 oC-8 oC).
English: A second study on embryo-fetal development in Lister-Hooded rats did not achieve sufficient exposure.
Slovenian: Druga študija razvoja zarodka in ploda pri podganah vrste Lister-Hooded ni dosegla zadostne izpostavljenosti.
English: Prior to launch of SCENESSE in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational package, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Slovenian: Pred dajanjem zdravila Scenesse v promet v posamezni državi članici mora imetnik dovoljenja za promet z zdravilom v sodelovanju z nacionalnim pristojnim organom pripraviti vsebino in obliko izobraževalnega paketa, vključno s komunikacijskimi mediji, načini razdeljevanja in kakršnimi koli drugimi vidiki.
English: The implant is absorbed by the body within 50 to 60 days after administration.
Slovenian: Implantat telo absorbira v 50 do 60 dneh po aplikaciji.
English: - Using a suitable device (such as a stylet) gently push the implant down the full length of the catheter lumen.
Slovenian: - Z ustreznim pripomočkom (kot je stilet) nežno potisnite implantat navzdol po celotnem lumnu katetra.
English: Your doctor will need to regularly check your skin (full body) to monitor changes in moles (e.g. darkening) or other skin abnormalities.
Slovenian: Zdravnik bo moral redno pregledovati kožo (po celotnem telesu), da bo spremljal spremembe kožnih znamenj (npr. potemnitev) ali druge nenormalne kožne spremembe.
English: Retrospective chart review study The MAH shall conduct a retrospective study comparing long term safety data and outcome endpoints in patients receiving and not receiving SCENESSE, or having discontinued SCENESSE use.
Slovenian: Retrospektivna študija s pregledom kartotek Imetnik dovoljenja za promet z zdravilom bo izvedel retrospektivno študijo, ki bo primerjala dolgoročne varnostne podatke in opazovane dogodke pri bolnikih, ki so prejemali zdravilo Scenesse, bolnikih, ki ga niso prejemali ali ki so prekinili uporabo zdravila Scenesse.
English: - Disinfect the skin above the supra-iliac crest.
Slovenian: - Razkužite kožo nad suprailiakalno kristo.
English: Because this medicine increases eumelanin, in most treated patients the skin will darken.
Slovenian: Ker zdravilo poveča količino evmelanina, bo koža pri večini zdravljenih bolnikov potemnela.
English: Depression Depressed mood Insomnia
Slovenian: Psihiatrične motnje depresija, depresivno razpoloženje, insomnia
English: SCENESSE should not be used during pregnancy and in women of childbearing potential not using effective contraception.
Slovenian: Zdravila Scenesse ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: This is an expected response to this medicine, and the darkening will slowly fade unless another implant is used.
Slovenian: To je pričakovan odziv na to zdravilo, potemnjena koža pa se bo počasi posvetlila, dokler ne prejmete novega implantata.
English: One implant is injected every 2 months during the spring and summer months.
Slovenian: Pomladi in med poletnimi meseci se injicira en implantat na vsaka 2 meseca.
English: A careful decision must be made whether to treat patients with any of these conditions with this medicinal product.
Slovenian: Pri odločanju o uporabi zdravila pri bolnikih, ki imajo katero koli od teh stanj, je potrebna previdnost.
English: Eumelanin contributes to photoprotection through different mechanisms including: - strong broadband absorption of UV and visible light, where eumelanin acts as a filter - antioxidant activity through scavenging of free radicals; and - inactivation of the superoxide anion and increased availability of superoxide dismutase to reduce oxidative stress.
Slovenian: Evmelanin prispeva k zaščiti pred svetlobo prek različnih mehanizmov, vključno z: - močno širokopasovno absorpcijo UV- in vidne svetlobe, pri čemer evmelanin deluje kot filter; - antioksidacijsko dejavnostjo prek čiščenja prostih radikalov; - inaktivacijo superoksidnega aniona in povečano uporabnostjo superoksidne dismutaze, kar zmanjša oksidativni stres.
English: Common (may affect up to 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Due to limited data in treatment of elderly patients, the use of afamelanotide is not recommended (see section 4.4).
Slovenian: Zaradi omejenih podatkov pri zdravljenju starejših bolnikov se afamelanotida ne sme uporabljati (glejte poglavje 4.4).
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Presence of severe hepatic disease - Hepatic impairment (see section 5.2) - Renal impairment (see section 5.2)
Slovenian: - Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1; - huda bolezen jeter; - okvara jeter (glejte poglavje 5.2); - okvara ledvic (glejte poglavje 5.2).
English: Long-term safety data for afamelanotide are limited.
Slovenian: Podatki o varnosti dolgotrajne uporabe afamelanotida so omejeni.
English: Dose-finding studies have not been conducted.
Slovenian: Študij za določanje odmerka niso izvedli.
English: The implant is given as injection under your skin using a catheter tube and needle (subcutaneous use).
Slovenian: Implantat se daje z injiciranjem pod kožo z uporabo katetrske cevke in igle (subkutana uporaba).
English: Your doctor will check the expiry date before an implant is used.
Slovenian: Zdravnik bo pred uporabo implantata preveril datum izteka roka uporabnosti.
English: By increasing the amount of eumelanin, SCENESSE can help to delay the onset of pain due to skin photosensitivity (sensitive to sunlight).
Slovenian: S povečanjem količine evmelanina lahko zdravilo Scenesse pomaga upočasniti pojav bolečine zaradi občutljivosti kože za sončno svetlobo.
English: - Apply some pressure to the insertion area with your finger while removing the stylet and the catheter.
Slovenian: - S prstom nekoliko pritisnite na mesto vboda in sočasno odstranite stilet ter kateter.
English: Before inserting this medicine, your doctor may decide to give you a local anaesthetic to numb the area where the implant is to be inserted.
Slovenian: Pred vsaditvijo tega zdravila se lahko zdravnik odloči za uporabo anestetika, da omrtviči območje vstavljanja implantata.
English: The overall duration of treatment is at the specialist physician's discretion (see section 4.4).
Slovenian: Skupno trajanje zdravljenja je odvisno od presoje specialista (glejte poglavje 4.4).
English: E. SPECIFIC OBLIGATIONS TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures: Description
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: Afamelanotide works in a way similar to the natural hormone, by making skin cells produce eumelanin which is a brown-black type of melanin pigment in the body.
Slovenian: Afamelanotid deluje na podoben način kot naravni hormon, tako da v kožnih celicah spodbuja tvorbo evmelanina, ki je rjavo črni melaninski pigment v telesu.
English: This can be accompanied by a darkening of the skin pigmentation in areas with melanocytes which gradually fades unless a further implant is administered.
Slovenian: To lahko spremlja potemnitev kožne pigmentacije na predelih z melanociti, ki sčasoma posvetli, če se ne vsadi nov implantat.
English: Following administration of this medicinal product, somnolence, fatigue, dizziness, and nausea have been reported.
Slovenian: Po uporabi tega zdravila so poročali o somnolenci, utrujenosti, omotici in navzei.
English: Afamelanotide has moderate influence on the ability to drive and use machines, especially within 72 hours of administration.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Afamelanotid ima zmeren vpliv na sposobnost vožnje in upravljanja strojev, predvsem v 72 urah po vsaditvi.
English: The implant may be removed by a simple surgical procedure if needed.
Slovenian: Implantat se lahko po potrebi odstrani s preprostim kirurškim posegom.
English: Pharmacokinetic data for afamelanotide or any of its metabolites are very limited.
Slovenian: Farmakokinetični podatki o afamelanotidu ali njegovih presnovkih so zelo omejeni.
English: The MAH shall also agree the details of the controlled access programme to ensure distribution of SCENESSE only to centres where the physicians received the educational materials and have been trained.
Slovenian: Imetnik dovoljenja za promet z zdravilom se bo prav tako dogovoril glede programa z nadzorovanim dostopom, ki bo zagotavljal distribucijo zdravila Scenesse samo centrom, v katerih so zdravniki prejeli izobraževalno gradivo in opravili usposabljanje.
English: - Select a 14 gauge (1.6 mm inner diameter) catheter with needle.
Slovenian: - Izberite kateter velikosti 14 G (z notranjim premerom 1,6 mm) z iglo.
English: It presumably undergoes hydrolysis within a short time; its metabolites' pharmacokinetics and pharmacodynamics are not understood yet.
Slovenian: Predvidevajo, da je hitro izpostavljen hidrolizi; farmakokinetika in farmakodinamika njegovih presnovkov pa še ni znana.
English: Afamelanotide is a melanocortin receptor agonist and binds predominantly to the melanocortin-1 receptor (MC1R).
Slovenian: Afamelanotid je agonist receptorjev melanokortina in se večinoma veže na receptor melanokortina-1 (MC1R).
English: Administration of afamelanotide may, therefore, result in increased production of eumelanin in the skin of the EPP patient independently of exposure to sunlight or artificial UV light.
Slovenian: Farmakodinamični učinki Uporaba afamelanotida lahko posledično poveča tvorbo evmelanina v koži bolnika z EPP, ne glede na izpostavljenost sončni svetlobi ali umetni UV-svetlobi.
English: SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Slovenian: Zdravilo Scenesse je indicirano za preprečevanje fototoksičnosti pri odraslih bolnikih z eritropoetsko protoporfirijo (EPP).
English: - Apply a small pressure dressing to the injection site.
Slovenian: - Na mesto injiciranja namestite majhno kompresijsko obvezo.
English: The implant will be inserted by a doctor who has been trained in the administration procedure.
Slovenian: Implantat bo vstavil zdravnik, ki se je usposobil za postopek vsaditve.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 implant
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 implantat
English: Afamelanotide is used to increase the tolerance to sunlight in adults with a confirmed diagnosis of erythropoietic protoporphyria (EPP).
Slovenian: Afamelanotid se uporablja za povečanje odpornosti (tolerance) proti sončni svetlobi pri odraslih s potrjeno diagnozo eritropoetske protoporfirije (EPP).
English: It is unknown whether afamelanotide or any of its metabolites are excreted in breast milk.
Slovenian: Ni znano, ali se afamelanotid ali njegovi presnovki izločajo v materino mleko.
English: A regular full body skin examination (every 6 months) is recommended to monitor all pigmentary lesions and other skin abnormalities.
Slovenian: Priporočljivo je redno pregledovanje kože po celem telesu (vsakih 6 mesecev) zaradi spremljanja pigmentnih lezij in drugih kožnih sprememb.
English: There are no clinical data on the effects of afamelanotide on fertility.
Slovenian: Kliničnih podatkov o učinkih afamelanotida na plodnost ni.
English: SPECIFIC OBLIGATIONS TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: System Organ Class Very common Common
Slovenian: Organski sistem Zelo pogosti
English: Clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes, Cushing's disease, Addison's disease, Peutz-Jeghers syndrome), neurological (including seizures) and haematological (especially anaemia) systems have not been evaluated.
Slovenian: Klinično pomembne gastrointestinalne, kardiovaskularne, respiratorne, endokrine (vključno s sladkorno boleznijo, Cushingovo boleznijo, Addisonovo boleznijo, Peutz-Jeghersovim sindromom), nevrološke (vključno z epileptičnimi napadi) in hematološke motnje (predvsem anemije) niso bile ocenjene.
English: • Face to face training material,
Slovenian: • gradivo za neposredno usposabljanje,
English: - Swollen eye lids, red eyes, dry eye, difficulty focusing on close objects, ringing in ears
Slovenian: − otekle očesne veke, rdeče oči, suho oko, težave pri osredotočanju na predmete v bližini,
English: SCENESSE should only be prescribed by specialist physicians in recognised porphyria centres and administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant.
Slovenian: Zdravilo Scenesse smejo predpisati samo specialisti v priznanih centrih za porfirijo, uporabljajo pa ga lahko samo zdravniki, ki jih je imetnik dovoljenja za promet z zdravilom usposobil in pooblastil za uporabo implantata.
English: - The other ingredient is poly (D,L-lactide-co-glycolide).
Slovenian: - Druga sestavina zdravila je poli (D,L-laktid-ko-glikolid).
English: Afamelanotide is thought to mimic the endogenous compound's pharmacological activity by activating the synthesis of eumelanin mediated by the MC1R receptor.
Slovenian: Domneva se, da afamelanotid posnema farmakološko delovanje endogene sestavine, tako da aktivira sintezo evmelanina, v katero je vključen receptor MC1R.
English: Prior to launch in Member States, the MAH shall establish a disease registry to gather long term safety data and outcome endpoints in patients with EPP.
Slovenian: Pred dajanjem zdravila v promet v državah članicah bo imetnik dovoljenja za promet vzpostavil register bolezni, s katerim bo zbiral dolgoročne varnostne podatke in opazovane dogodke pri bolnikih z
English: What SCENESSE looks like and contents of the pack
Slovenian: Izgled zdravila Scenesse in vsebina pakiranja
English: Patients taking substances which reduce coagulation, such as vitamin K antagonists (e.g. warfarin), acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.
Slovenian: Pri bolnikih, ki jemljejo učinkovine za zmanjševanje koagulacije, kot so denimo antagonisti vitamina K (npr. varfarin), acetilsalicilna kislina in nesteroidna protivnetna zdravila (NSAID), se lahko pojavi povečanje podplutb ali krvavitev na mestu vsaditve.
English: Animal studies are insufficient with respect to developmental toxicity (see section 5.3).
Slovenian: Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmoževanja (glejte poglavje 5.3).
English: Blood urine present Biopsy skin
Slovenian: prisotnost krvi v urinu, biopsija kože
English: Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH).
Slovenian: Afamelanotid je sintetični tridekapeptid in strukturni analog α-melanocit stimulirajočega hormona (α-MSH).
English: The implant can be surgically removed if needed.
Slovenian: Po potrebi se lahko implantat kirurško odstrani.
English: - Wound complication, open wound
Slovenian: − zapleti na rani, odprta rana.
English: A study in Sprague-Dawley rats showed no adverse effects on embryo-fetal development at exposures approximately 135-fold the human exposure (based on Cmax).
Slovenian: Sprague-Dawley ni pokazala nobenih neželenih učinkov na razvoj zarodka in ploda pri izpostavljenosti, približno 135-krat večji kot pri človeku (na podlagi Cmax).
English: If such patients are treated they must be monitored after administration of every implant, including vital signs, routine haematology and biochemistry.
Slovenian: Če se zdravilo uporablja pri takih bolnikih, jih je treba spremljati po vsaki vsaditvi implantata, vključno z vitalnimi znaki in rednimi hematološkimi ter biokemijskimi preiskavami.
English: The implant is a solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter in an amber glass vial sealed with a PTFE coated rubber stopper.
Slovenian: Implantat je bela do umazano bela paličica z dolžino približno 1,7 cm in premerom 1,5 mm v rumenorjavi stekleni viali, zatesnjeni z gumijastim zamaškom, obloženim s PTFE.
English: Afamelanotide is a synthetic form of a body hormone called alpha-melanocyte stimulating hormone (α-MSH).
Slovenian: Afamelanotid je sintetična oblika telesnega hormona, imenovanega alfa-melanocit stimulirajoči hormon (α-MSH).
English: Always verify the presence of the implant, if in doubt of its presence, check whether the implant has remained in the catheter.
Slovenian: Če niste prepričani glede njegove prisotnosti, preverite, ali je implantat ostal v katetru.
English: - Transfer the implant to the outlet of the catheter.
Slovenian: - Implantat prenesite na izhodno odprtino katetra.
English: Education and training programme for physicians
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Program izobraževanja in usposabljanja za zdravnike
English: - The active substance is afamelanotide.
Slovenian: - Učinkovina je afamelanotid.
English: Haematoma Diastolic hypertension Hypertension
Slovenian: diastolična hipertenzija,
English: SCENESSE should not be used during breastfeeding.
Slovenian: Uporabi zdravila Scenesse med dojenjem se je treba izogibati.
English: Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter.
Slovenian: Bela do umazano bela paličica z dolžino približno 1,7 cm in premerom 1,5 mm.
English: The following side effects are considered to be:
Slovenian: Ti neželeni učinki so lahko:
English: If such patients are treated they must be monitored after each implant administration, including vital signs, routine haematology, and biochemistry.
Slovenian: Če se zdravilo uporablja za take bolnike, jih je treba spremljati po vsaki vsaditvi implantata, vključno z vitalnimi znaki in rednimi hematološkimi ter biokemijskimi preiskavami.
English: - Anaesthetise the insertion area if deemed necessary and in consultation with the patient.
Slovenian: - Anestezirajte mesto vboda, če menite, da je to potrebno, oziroma če to želi bolnik.
English: - Decrease white blood cells, abnormal liver function tests, decreased iron binding, increased cholesterol, increased sugar level, decreased blood iron level, increased blood pressure, blood in urine
Slovenian: − zmanjšano število rdečih krvničk, nenormalne preiskave delovanja jeter, zmanjšana vezava železa, povišana raven holesterola, povišana raven sladkorja, znižana raven železa v krvi, povišan krvni tlak, kri v urinu;
English: In a fertility study no effects on the reproductive function of male or female Sprague-Dawley rats were observed after subcutaneous application of afamelanotide.
Slovenian: V študiji plodnosti po subkutani uporabi afamelanotida niso opazili nobenih učinkov na razmnoževalno funkcijo samcev in samic podgan vrste Sprague-Dawley.
English: • Registry information sheet.
Slovenian: • list z registracijskimi podatki.
English: Skin exfoliation Skin hypopigmentation Hair colour changes Hyperhidrosis
Slovenian: hipopigmentacija kože, sprememba barve las, hiperhidroza
English: There is a risk of feeling drowsy and tired when using this medicine, especially within 72 hours of administration.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri uporabi tega zdravila ste lahko izpostavljeni tveganju za dremavost in utrujenost, predvsem v 72 urah po vsaditvi.
English: Pharmacotherapeutic group: Emollients and protectives, protectives against UV-radiation for systemic use, ATC code: D02BB02
Slovenian: UV-sevanjem za sistemsko uporabo, oznaka ATC: D02BB02 Mehanizem delovanja
English: SCENESSE contains the active substance afamelanotide.
Slovenian: Zdravilo Scenesse vsebuje učinkovino afamelanotid.
English: If you experience discomfort and are concerned, speak to your doctor.
Slovenian: Če občutite neugodje ali ste zaskrbljeni, se posvetujte z zdravnikom.
English: Keep in mind that increased exposure to UV light will contribute to skin cancer development.
Slovenian: UV-svetlobi prispevala k razvoju kožnega raka.
English: Afamelanotide may induce darkening of pre-existing pigmentary lesions due to its pharmacological effect.
Slovenian: Afamelanotid lahko zaradi svojega farmakološkega učinka spodbudi potemnitev obstoječih pigmentnih lezij.
English: The adverse reactions reported during clinical trials conducted with afamelanotide are listed in the table below by MedDRA system organ class and frequency convention.
Slovenian: Preglednica z neželenimi učinki Neželeni učinki, o katerih so poročali v kliničnih preskušanjih z afamelanotidom, so navedeni v spodnji preglednici glede na organske sisteme po MedDRA in naslednjo pogostnost.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Scenesse Vsebina pakiranja in dodatne informacije
English: This finding is not considered relevant to human safety since the Harderian gland is not present in man.
Slovenian: Ta ugotovitev ni pomembna za varnost pri človeku,
English: It is recommended that sun protection measures routinely adopted by each patient to manage their photosensitivity related to EPP and in accordance with their skin type (Fitzpatrick scale) are maintained during treatment with this medicinal product.
Slovenian: Priporočljivo je, da vsak bolnik med zdravljenjem s tem zdravilom vzdržuje izvajanje običajnih rednih ukrepov za zaščito pred soncem, s katerimi obvladuje občutljivost za svetlobo, povezano z EPP, glede na svoj kožni tip (po Fitzpatrickovi lestvici).
English: Instruction for use
Slovenian: Navodila za uporabo
English: - Palpitations, fast heart rate, bruising, high blood pressure, difficulty to make some sounds
Slovenian: − palpitacije (občutek hitrega ali močnega utripanja srca), hiter srčni utrip, podplutbe, visok krvni tlak, težave pri proizvajanju nekaterih zvokov;
English: What you need to know before you receive SCENESSE 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Scenesse Ne uporabljajte zdravila Scenesse:
English: These may include warfarin, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever or to prevent blood clotting) and a group of medicines called non-steroidal antiinflammatory drug (NSAIDs), used to treat common ailments, such as arthritis, headaches, mild fever, rheumatism and sore throats.
Slovenian: Ti lahko vključujejo varfarin, acetilsalicilno kislino (učinkovino v mnogih zdravilih, ki se uporabljajo za lajšanje bolečine, zniževanje zvišane telesne temperature ali preprečevanje strjevanja krvi) in skupino zdravil, imenovanih nesteroidna protivnetna zdravila, ki se uporabljajo za zdravljenje pogostih stanj,
English: This is recommended to be performed every 6 months.
Slovenian: To je priporočljivo izvajati vsakih
English: There are no data available on symptoms or treatment of overdose with afamelanotide.
Slovenian: 4.9 Preveliko odmerjanje Podatki o simptomih ali zdravljenju prevelikega odmerjanja afamelanotida niso na voljo.