FrancophonIA/ELRC3.0 huggingface dataset:
English: The open label study (Wenzel-E et al, 1989) that became available after the granting of the initial marketing authorisation discusses the use of dihydroergotamine in venous insufficiency.
Slovenian: Uporabo dihidroergotamina pri venski insuficienci je obravnavala odprta študija (Wenzel-E in sodelavci 1989), ki je bila objavljena po odobritvi prvotnega dovoljenja za promet z zdravilom.
English: There is little evidence from double-blind, placebo-controlled clinical trials and no uniform picture of the efficacy of oral ergotamine compared to placebo or other substances in the prevention of migraine emerges from these studies since studies reported both positive and negative results.
Slovenian: Rezultati teh študij glede učinkovitosti peroralnega dihidroergotamina v primerjavi s placebom ali drugimi učinkovinami pri preprečevanju migrene niso bili dosledni, saj so poročali o pozitivnih in negativnih rezultatih.
English: − Prophylaxis of migraine headache.
Slovenian: • preprečevanje migrenskega glavobola.
English: • Prophylaxis of migraine headache
Slovenian: • preprečevanje migrenskega glavobola;
English: How to report side effects
Slovenian: Kako poročati o stranskih učinkih
English: What does the black triangle mean?
Slovenian: Kaj pomeni črn trikotnik?
English: For more information, visit www.ema.europa.eu
Slovenian: Za več informacij obiščite spletno stran www.ema.europa.eu
English: It does not mean that the medicine is unsafe.
Slovenian: To ne pomeni, da zdravilo ni varno.
English: Why are medicines monitored after they are approved?
Slovenian: Zakaj se zdravila spremljajo po tem, ko so odobrena za uporabo?
English: The European Union (EU) has introduced a new way of identifying medicines that are being monitored particularly closely.
Slovenian: Evropska unija (EU) je uvedla nov način označevanja zdravil, ki se posebej pozorno spremljajo.
English: This ensures that patients can access the treatments they need without being exposed to unacceptable side effects.
Slovenian: S tem se zagotovi dostop bolnikov do potrebnih zdravljenj, ne da bi bili izpostavljeni nesprejemljivim stranskim učinkom.
English: They may have other diseases and they may be taking other medicines.
Slovenian: Bolniki bodo morda imeli druge bolezni in bodo jemali druga zdravila.
English: In a real-life setting, a larger and more diverse group of patients will use the medicine.
Slovenian: V resničnem življenju bo zdravilo uporabljala večja in bolj raznolika skupina bolnikov.
English: European regulatory authorities decide to authorise medicines after assessing the results of laboratory tests and clinical trials.
Slovenian: Evropski regulativni organi odobrijo zdravila za promet, potem ko ocenijo rezultate laboratorijskih preiskav in kliničnih preskušanj.
English: Clinical trials usually involve a limited number of patients for a defined time period in controlled conditions.
Slovenian: V klinična preskušanja je običajno vključeno omejeno število bolnikov za določeno časovno obdobje v nadzorovanih pogojih.
English: Examples of medicines under additional monitoring include new medicines authorised since the start of 2011 and medicines for which regulators require more studies to be carried out, e.g. on long-term use or on rare side effects seen in clinical trials.
Slovenian: Med primere zdravil, za katere se zahteva dodatno spremljanje, spadajo nova zdravila, odobrena od začetka leta 2011, in zdravila, za katera regulativni organi zahtevajo izvedbo več študij, npr. o dolgotrajni uporabi ali redkih neželenih učinkih, o katerih so poročali v kliničnih preskušanjih.
English: This is generally because there is less information available about them compared with other medicines, for example because they are new on the market.
Slovenian: Razlog za to je običajno, da je o teh zdravilih manj razpoložljivih podatkov kot o drugih, na primer, ker je zdravilo novo na trgu.
English: It is therefore vital that the safety of all medicines continues to be monitored while they are on the market.
Slovenian: Zato je bistvenega pomena, da se varnost vseh zdravil na trgu nadalje spremlja.
English: You can report side effects to your doctor, pharmacist or nurse.
Slovenian: O stranskih učinkih lahko poročate svojemu zdravniku, farmacevtu ali medicinski sestri.
English: You should report any suspected side effects with a medicine you are taking, particularly if it displays the black triangle.
Slovenian: Poročati morate o vseh domnevnih stranskih učinkih zdravila, ki ga jemljete, zlasti kadar je zdravilo označeno s črnim trikotnikom.
English: Only medicines whose benefits have been shown to be greater than their risks can be marketed.
Slovenian: Tržijo se lahko samo zdravila, katerih koristi so dokazano večje od z njimi povezanih tveganj.
English: However, medicines with the black triangle are being monitored even more closely than others.
Slovenian: Vendar pa se tista, označena s črnim trikotnikom, spremljajo natančneje kot druga.
English: Some less common side effects may only be apparent when a medicine has been used for a long time by a large number of people.
Slovenian: Nekateri manj pogosti stranski učinki se lahko pokažejo šele, ko večje število ljudi zdravilo uporablja dalj časa.
English: By reporting side effects, you can help medicines regulators assess whether the benefits of a medicine remain greater than its risks.
Slovenian: S poročanjem o stranskih učinkih organom za regulacijo zdravil pomagate pri oceni, ali so koristi zdravila še naprej večje od z njim povezanih tveganj.
English: You can also report side effects directly to your national medicines regulator, using the reporting system in your country.
Slovenian: O stranskih učinkih lahko poročate tudi neposredno svojemu nacionalnemu organu za regulacijo zdravil prek sistema poročanja v vaši državi.
English: Information on how to do this can be found in the package leaflet of your medicine or on your national medicines regulator's website.
Slovenian: Informacije o tem lahko najdete v navodilu za uporabo vašega zdravila ali na spletni strani vašega nacionalnega organa za regulacijo zdravil.
English: These medicines have a black inverted triangle displayed in their package leaflet, together with a short sentence that reads:
Slovenian: Ta zdravila imajo v navodilu za uporabo črn navzdol obrnjen trikotnik in kratek stavek z naslednjim opisom:
English: Visit your national medicines regulator at: www.mhra.gov.uk (United Kingdom) www.imb.ie (Ireland) www.medicinesauthority.gov.mt (Malta)
Slovenian: www.jazmp.si
English: All medicines are carefully monitored after they are placed on the EU market.
Slovenian: „Za to zdravilo se izvaja dodatno spremljanje varnosti.″ Vsa zdravila se po dajanju na trg EU pozorno spremljajo.
English: EU Number
Slovenian: EU Število
English: Pharmaceutical Form Route of Administration Packaging
Slovenian: Farmacevtska oblika
English: Repeat every 24 hours.
Slovenian: Ponavljajte na vsakih 24 ur.
English: Use immediately.
Slovenian: Uporabite nemudoma.
English: It is not known whether they respond differently from younger subjects.
Slovenian: Ni znano, ali se odzivajo drugače kot mlajše osebe.
English: If not coinciding with week 26 visit.
Slovenian: Če se ne ujema s 26. tednom.
English: The contents of the pack are:
Slovenian: Vsebnosti pakiranja je:
English: ATC code: B02BD04.
Slovenian: Oznaka ATC: B02BD04.
English: Uferstraße 15
Slovenian: Uferstrasse 15
English: Your doctor may need to treat you promptly for these reactions.
Slovenian: Zdravnik vas bo morda moral nemudoma zdraviti zaradi teh reakcij.
English: Your doctor may need to treat you promptly for these reactions (see section 2 ‘Warnings and precautions').
Slovenian: Zdravnik vas bo morda moral nemudoma zdraviti zaradi teh reakcij (glejte poglavje 2 „Opozorila in previdnostni ukrepi“).
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30°C.
Slovenian: Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za obdobje 3 ur pri temperaturi do 30 °C.
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru šoka je treba začeti s standardnimi medicinskimi postopki za šok.
English: Date of first authorisation: 19 December 2014 Date of latest renewal: DD month YYYY
Slovenian: Datum prve odobritve: 19. december 2014 Datum zadnjega podaljšanja: DD. mesec LLLL
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Slovenian: Pričakuje se, da so pogostnost, vrsta in resnost neželenih reakcij pri otrocih enake kot pri odraslih.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) - allergic reactions (hypersensitivity).
Slovenian: Neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - alergijske reakcije (preobčutljivost).
English: Pack size of 1.
Slovenian: Velikost pakiranja po 1.
English: The product dissolves rapidly (within 2 minutes).
Slovenian: Prašek se hitro raztaplja (ponavadi prej kot v 2 minutah).
English: Frequency of doses (hours)/Duration of therapy (days)
Slovenian: Pogostnost odmerkov (ure)/trajanje zdravljenja (dnevi)
English: The osmolality is greater than 240 m osmol/kg.
Slovenian: Osmolalnost je večja od 240 m osmol/kg.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates and published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: For intravenous use, single use only.
Slovenian: Za intravensko uporabo, samo za enkratno uporabo.
English: Haemophilia B very rarely occurs in women.
Slovenian: Hemofilija B je pri ženskah zelo redka.
English: Be sure that RIXUBIS is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Slovenian: Prepričajte se, da se je prašek RIXUBIS popolnoma raztopil, sicer vsa rekonstituirana raztopina ne bo prešla skozi filter v pripomočku.
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Slovenian: To je zlasti pomembno pri menjavi laboratorija in/ali reagentov za test.
English: One vial contains 19 mg sodium.
Slovenian: Ena viala vsebuje 19 g natrija.
English: Frequencies have been evaluated according to the following convention: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnost je bila ocenjena z naslednjimi dogovorjenimi izrazi: zelo pogosti (1/10), pogosti (1/100 do < 1/10), občasni (1/1000 do <1/100), redki (1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: 6.5 Nature and contents of container and special equipment for use
Slovenian: 6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo
English: Posology is the same in adults and paediatric population from 12 to 17.
Slovenian: Odmerjanje je enako pri odraslih in pediatrični populaciji v starosti od 12 do 17 let.
English: Do not use RIXUBIS - if you are allergic to nonacog gamma or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hamster proteins
Slovenian: Ne uporabljajte zdravila RIXUBIS - če ste alergični na nonakog gama ali katerokoli sestavino tega zdravila (navedeno v poglavju 6), - če ste alergični na proteine hrčka.
English: A-2304 Orth an der Donau Austria
Slovenian: A-2304 Orth an der Donau Avstrija
English: Therefore if you are known to have such a mutation, your doctor will monitor you more closely for signs of an allergic reaction.
Slovenian: Če imate dokazano mutacijo, vas bo zdravnik natančneje spremljal za pojav znakov alergijske reakcije.
English: Tell your doctor if you are using or have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate ali ste pred kratkim uporabljali katero koli drugo zdravilo.
English: Paediatric population (previously treated patients younger than 12 years)
Slovenian: Pediatrična populacija (predhodno zdravljeni bolniki, mlajši od 12 let)
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni 'brez natrija'.
English: Factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Faktor IX smete med nosečnostjo in dojenjem uporabljati le, če obstaja jasna indikacija.
English: Factor IX is a normal constituent of human blood necessary for effective blood clotting.
Slovenian: Faktor IX je normalna sestavina človeške krvi in je potreben za učinkovito strjevanje krvi.
English: Twenty procedures were major including 13 orthopaedic and 3 dental surgeries.
Slovenian: Dvajset posegov je bilo večjih, vključno s 13 ortopedskimi in 3 zobozdravstvenimi kirurškimi posegi.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Slovenian: Pediatrična populacija Navedena opozorila in previdnostni ukrepi veljajo tako za odrasle bolnike kot za otroke.
English: Place the vials on a flat clean surface.
Slovenian: Viali položite na ravno, čisto površino.
English: See tables below.
Slovenian: Glejte spodnje preglednice.
English: Talk to your doctor immediately if your bleeding does not stop as expected or if you experience a significant increase in your usage of RIXUBIS in order to control a bleed.
Slovenian: Nemudoma se posvetujte s svojim zdravnikom, če se krvavitev ne ustavi po pričakovanjih ali če opazite bistveno povečanje porabe zdravila RIXUBIS, ko želite obvladati krvavitev.
English: - Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Slovenian: - Pripomočka BAXJECT II ne uporabite, če sta njegov sistem sterilne bariere ali njegova ovojnina poškodovana ali če ima pripomoček znake okvare.
English: Treatment was individualised based on the severity, cause and site of bleed.
Slovenian: Zdravljenje je bilo individualno prilagojeno glede na resnost, vzrok in mesto krvavitve.
English: Minor surgery including tooth extraction
Slovenian: Kirurški poseg Manjši, vključno z izdrtjem zoba
English: The subjects received either of the products as a single intravenous infusion.
Slovenian: Preiskovanci so prejeli eno od zdravil kot eno intravensko infuzijo.
English: The specific activity of RIXUBIS is approximately 200-390 IU/mg protein.
Slovenian: Specifična aktivnost zdravila RIXUBIS je približno 200-390 i.e./mg beljakovin.
English: Every 24 hours, at least 1 day, until healing is achieved.
Slovenian: Na vsakih 24 ur najmanj 1 dan, do zacelitve.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Slovenian: Zato je treba bolnike, pri katerih se pojavi alergijska reakcija, pregledati za prisotnost zaviralca.
English: In some cases, depending upon the individual patient´s pharmacokinetics, age, bleeding phenotype and physical activity, shorter dosage intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, odvisno od bolnikove farmakokinetike, starosti, fenotipa krvavitve in telesne dejavnosti, so lahko potrebni krajši razmiki med odmerki ali večji odmerki.
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Slovenian: Infuzijo ponavljajte na vsakih 8 do 24 ur, dokler ne mine ogroženost.
English: If you stop using RIXUBIS Do not stop using RIXUBIS without consulting your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo RIXUBIS Uporabe zdravila RIXUBIS ne smete prekiniti brez posvetovanja s svojim zdravnikom.
English: 17 procedures, including 10 dental extractions, were considered minor.
Slovenian: Sedemnajst posegov, vključno z 10 izdrtji zoba, je bilo manjših.
English: No investigations on carcinogenicity, fertility impairment, and fetal development have been conducted.
Slovenian: Raziskave karcinogenosti, okvar plodnosti in učinkov na razvoj ploda niso bile opravljene.
English: The per-protocol efficacy analysis includes 37 surgeries performed in 27 patients between 17 and 57 years of age undergoing major or minor surgical, dental or other surgical invasive procedures.
Slovenian: Analiza učinkovitosti po protokolu je vključevala 37 kirurških posegov pri 27 bolnikih, starih od 17 do 57 let, pri katerih so opravili večje ali manjše kirurške posege, zobozdravstvene ali druge kirurške invazivne posege.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Slovenian: V takšnih primerih je priporočljivo, da se obrnete na specializirani center za hemofilijo.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Slovenian: Trombin potem pretvori fibrinogen v fibrin in tako nastane krvni strdek.
English: The effects of higher than recommended doses of RIXUBIS have not been characterised.
Slovenian: Učinki odmerkov zdravila RIXUBIS, ki so večji od priporočenih, niso bili raziskani.
English: RIXUBIS is indicated in patients of all age groups.
Slovenian: Zdravilo RIXUBIS je indicirano za bolnike vseh starostnih skupin.
English: It is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line.
Slovenian: Pridobljen je s tehnologijo rekombinantne DNA v celični liniji jajčnika kitajskega hrčka (CHO).
English: RIXUBIS Initial cross-over study (N=25)
Slovenian: RIXUBIS Prvotna navzkrižna študija (N = 25)
English: If you injected more RIXUBIS than recommended, tell your doctor as soon as possible.
Slovenian: Če ste injicirali večji odmerek zdravila RIXUBIS, kot je priporočeno, se čimprej posvetujte z zdravnikom.
English: Use the reconstituted solution immediately.
Slovenian: Rekonstituirano raztopino uporabite nemudoma.
English: What RIXUBIS is and what it is used for
Slovenian: Kaj je zdravilo RIXUBIS in za kaj ga uporabljamo
English: Fifty-six of these PTPs who received RIXUBIS for a minimum of 3 months were included in the efficacy evaluation for prophylaxis.
Slovenian: Šestinpetdeset teh predhodno zdravljenih bolnikov, ki so prejemali zdravilo RIXUBIS vsaj 3 mesece, je bilo vključenih v oceno učinkovitosti profilakse.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Odmerek, ki temelji na telesni masi, je morda treba prilagoditi pri prelahkih in pretežkih bolnikih.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvjalca, odgovornega za sprostitev zadevne serije.
English: Other medicines and RIXUBIS
Slovenian: Druga zdravila in zdravilo RIXUBIS
English: Store below 30°C.
Slovenian: Shranjujte pri temperaturi do 30 °C.
English: If the product is stored in a refrigerator, take both the RIXUBIS powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 30°C).
Slovenian: Če je zdravilo shranjeno v hladilniku, iz hladilnika vzemite vialo praška RIXUBIS in vialo vehikla RIXUBIS in počakajte, da se ogrejeta na sobno temperaturo (med 15 °C in 30 °C).
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Slovenian: Faktor IX je enoverižni glikoprotein z molekulsko maso približno 68.000 daltonov.
English: Reconstitution and administration
Slovenian: Rekonstitucija in uporaba
English: Common side effects (may affect up to 1 in 10 patients) - altered taste - pain in limbs.
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov) - spremenjeno okušanje, - bolečine v okončinah.
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Slovenian: O medsebojnem delovanju pripravkov humanega koagulacijskega faktorja IX (rDNA) z drugimi zdravili niso poročali.
English: Open the package of BAXJECT II device by peeling away the paper lid without touching the inside (Fig. a).
Slovenian: Pakiranje pripomočka BAXJECT II odprite tako, da odlepite papirnati del ovojnine, ne da bi se dotaknili notranjosti (slika a).
English: Incorrect dosing can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment.
Slovenian: Nepravilno odmerjanje je lahko posledica adsorbcije humanega koagulacijskega faktorja IX na notranje površine infuzijske opreme.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba razredčeno zdravilo nemudoma uporabiti, razen če način rekonstitucije izključi tveganje mikrobne kontaminacije.
English: Repeat infusion every 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Slovenian: Infuzijo ponavljajte na vsakih 24 ur 3 do 4 dni ali več, dokler ne izgine bolečina in preneha akutna onesposobljenost.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Slovenian: Zlasti pri velikih kirurških posegih je nujno natančno spremljanje nadomestnega zdravljenja z analizo koagulacije (aktivnosti faktorja IX v plazmi).
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
Slovenian: V nekaterih primerih so te reakcije napredovale do hude anafilaksije in so nastopile v časovni povezavi s pojavom zaviralcev faktorja IX (glejte tudi poglavje 4.4).
English: The product contains traces of hamster proteins.
Slovenian: Zdravilo vsebuje sledove proteinov hrčka.
English: If you forget to use RIXUBIS
Slovenian: Če ste pozabili uporabiti zdravilo RIXUBIS
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Slovenian: Zaradi potencialnega tveganja za nastanek trombotičnih zapletov je potrebno klinično opazovanje zgodnjih znakov trombotične in porabnostne koagulopatije z ustreznimi biološkimi testi, kadar dajemo to zdravilo bolnikom z jetrno boleznijo, bolnikom po operaciji, novorojenčkom ali bolnikom s tveganjem za nastanek trombotičnih zapletov ali DIK.
English: The recommended dose range for paediatric patients less than 12 years is 40 to 80 IU/kg at intervals of 3 to 4 days.
Slovenian: Razpon priporočenih odmerkov za pediatrične bolnike, mlajše od 12 let, je 40 do 80 i.e./kg v presledkih po 3 do 4 dni.
English: The European Medicines Agency has waived the obligation to submit the results of studies with RIXUBIS in previously untreated patients in the treatment and prophylaxis of bleeding in haemophilia B (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom RIXUBIS za predhodno nezdravljene bolnike za zdravljenje in profilakso pri krvavitvah pri hemofiliji B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).