FrancophonIA/ELRC3.0 huggingface dataset:
English: They include angioedema (swelling of the face and limbs), burning and stinging at the injection site, chills, flushing, urticaria (itchy rash), headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (fast heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Slovenian: Vključujejo angioedem (otekanje obraza in okončin), pekoč občutek in zbadanje na mestu injiciranja, mrzlico, rdečico, urtikarijo (srbeč izpuščaj), glavobol, koprivnico, hipotenzijo (nizek krvni tlak), letargijo, navzejo (slabost), nemir, tahikardijo (pospešen srčni utrip), tiščanje v prsnem košu, mravljinčenje, bruhanje in sopenje.
English: Out of 972 infusions, 84% were rated as bringing about ‘good' or ‘excellent' responses.
Slovenian: Od 972 infundiranj je bil odziv pri 84 % primerov ocenjen kot „dober“ ali „odličen“.
English: During treatment, the doctor should regularly carry out blood tests to adjust the dose to be given.
Slovenian: Med zdravljenjem mora zdravnik redno opraviti krvne preiskave za določitev ustreznega odmerka.
English: BeneFIX is intended for either short-term or long-term use.
Slovenian: Zdravilo BeneFIX je namenjeno za kratkotrajno ali dolgotrajno uporabo.
English: The CHMP decided that BeneFIX's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila BeneFIX večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX.
Slovenian: Pri predhodno zdravljenih bolnikih je 82 % od 693 zdravljenih epizod krvavitve izzvenelo po prvem dajanju zdravila BeneFIX.
English: Patients or their carers can give injections of BeneFIX, provided that they have been trained appropriately.
Slovenian: Bolniki ali njihovi negovalci lahko sami injicirajo zdravilo BeneFIX, če so bili za to ustrezno usposobljeni.
English: The studies assessed the number of bleeding episodes that occurred and rated BeneFIX's effectiveness using a scale from ‘no response' to ‘excellent'.
Slovenian: V študijah so beležili število krvavitev, ki so se pojavile, in vrednotili učinkovitost zdravila BeneFIX na podlagi lestvice z ocenami od „ni odziva“ do „odličen odziv“.
English: This document is a summary of the European Public Assessment Report (EPAR) for BeneFIX.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo BeneFIX.
English: A risk management plan has been developed to ensure that BeneFIX is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila BeneFIX je bil pripravljen načrt obvladovanja tveganj.
English: For more information about treatment with BeneFIX, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom BeneFIX preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: BeneFIX is used to replace the missing factor IX.
Slovenian: Zdravilo BeneFIX se uporablja za nadomestitev manjkajočega faktorja IX.
English: Full details on how to calculate the dose are included in the summary of product characteristics.
Slovenian: Podrobnosti o tem, kako izračunati ustrezni odmerek, so na voljo v povzetku glavnih značilnosti zdravila.
English: It has also been studied in patients who have not received any treatment for their haemophilia.
Slovenian: Proučevali so ga tudi pri bolnikih, ki zaradi hemofilije še niso bili zdravljeni.
English: Other information about BeneFIX
Slovenian: Druge informacije o zdravilu BeneFIX
English: Nonacog alfa is not extracted from human blood but produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce human coagulation factor IX.
Slovenian: Nonakog alfa se ne pridobiva iz človeške krvi, temveč se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celice prejmejo gen (DNK), s katerim lahko tvorijo človeški koagulacijski faktor IX.
English: If antibodies develop, BeneFIX will not work effectively, which may result in a loss of bleeding control.
Slovenian: Če se razvijejo protitelesa, zdravilo Benefix ne deluje več učinkovito, zaradi česar lahko pride do izgube nadzora nad krvavitvami.
English: The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs.
Slovenian: Pomanjkanje faktorja IX povzroči težave pri strjevanju krvi, med drugim krvavenje v sklepe, mišice in notranje organe.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BeneFIX, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: It is available as a powder and solvent that are mixed together to form a solution for injection.
Slovenian: Na voljo je v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for BeneFIX.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The dose and the frequency of injection depend on whether BeneFIX is used to treat or prevent bleeding, or to reduce bleeding during surgery, and on the patient's condition.
Slovenian: Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo BeneFIX uporablja za zdravljenje ali preprečevanje krvavitev ali za zmanjšanje krvavitev med kirurškim posegom, in od bolnikovega stanja.
English: What benefit has BeneFIX shown during the studies?
Slovenian: Kakšne koristi je zdravilo BeneFIX izkazalo med študijami?
English: For the full list of all side effects reported with BeneFIX, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila BeneFIX, glejte navodilo za uporabo.
English: BeneFIX is a medicine that contains the active substance nonacog alfa.
Slovenian: BeneFIX je zdravilo, ki vsebuje zdravilno učinkovino nonakog alfa.
English: BeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder).
Slovenian: Zdravilo BeneFIX se uporablja za zdravljenje in preprečevanje krvavitev pri odraslih in otrocih s hemofilijo B (prirojeno motnjo strjevanja krvi).
English: BeneFIX should be started by a doctor who has experience in the treatment of haemophilia.
Slovenian: Zdravljenje z zdravilom BeneFIX mora uvesti zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
English: It corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Slovenian: Zdravilo odpravi pomanjkanje faktorja IX in vzpostavi začasen nadzor nad krvavitvami.
English: Patients with haemophilia B lack a protein called factor IX, which is involved in blood clotting.
Slovenian: Bolnikom s hemofilijo B primanjkuje beljakovine, imenovane faktor IX, ki sodeluje pri strjevanju krvi.
English: Hypersensitivity (allergic) reactions have been seen in patients treated with products containing factor IX and may sometimes be severe.
Slovenian: Pri bolnikih, ki so prejemali zdravila s faktorjem IX, so bile opažene preobčutljivostne (alergijske) reakcije, ki so lahko bile včasih hude.
English: The active substance in BeneFIX, nonacog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot).
Slovenian: Zdravilna učinkovina v zdravilu BeneFIX, nonakog alfa, je beljakovinski krvni koagulacijski faktor (snov, ki pomaga pri strjevanju krvi).
English: What is the risk associated with BeneFIX?
Slovenian: Kakšna tveganja so povezana z zdravilom BeneFIX?
English: Patients with haemophilia B may also develop neutralising antibodies (inhibitors) to factor IX.
Slovenian: Pri bolnikih s hemofilijo B se lahko razvijejo tudi nevtralizirajoča protitelesa (inhibitorji) proti faktorju IX.
English: The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery.
Slovenian: Odmerek je treba prilagoditi glede na stopnjo resnosti in mesto krvavitve ali vrsto posega.
English: BeneFIX has been studied in previously treated patients with moderate or severe haemophilia B for prevention or to treat bleeding episodes during and after surgery.
Slovenian: Zdravilo BeneFIX so pri predhodno zdravljenih bolnikih z zmerno ali hudo hemofilijo B proučevali kot zdravilo za preprečevanje ali zdravljenje krvavitev med kirurškim posegom ali po njem.
English: BeneFIX must not be used in people who are hypersensitive (allergic) to recombinant coagulation factor IX, to any of the other ingredients, or to hamster proteins.
Slovenian: Zdravila BeneFIX ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rekombinantni koagulacijski faktor IX, katero koli drugo sestavino zdravila ali beljakovine hrčka.
English: Why has BeneFIX been approved?
Slovenian: Zakaj je bilo zdravilo BeneFIX odobreno?
English: How has BeneFIX been studied?
Slovenian: Kako je bilo zdravilo BeneFIX raziskano?
English: BeneFIX is given by a slow injection into a vein, usually at up to 4 ml per minute and should not be mixed with other infusion solutions or given using a kit other than the one supplied with the medicine.
Slovenian: Zdravilo BeneFIX se v veno injicira počasi, običajno s hitrostjo infuzije do 4 ml na minuto.
English: How is BeneFIX used?
Slovenian: Kako se zdravilo BeneFIX uporablja?
English: What is BeneFIX used for?
Slovenian: Za kaj se zdravilo BeneFIX uporablja?
English: 90 (3 x 30) tablets (multipack)
Slovenian: 90 (3 x 30) tablet (skupno pakiranje)
English: More information about Inovelon is available on EMA's website.
Slovenian: Več informacij o zdravilu Inovelon je na voljo na spletni strani agencije EMA.
English: It is currently approved only for children aged 4 years or older.
Slovenian: Trenutno je odobreno le za otroke, starejše od štirih let.
English: The CHMP considered that the data available at this point in time were not sufficient to recommend this change.
Slovenian: Odbor CHMP je presodil, da podatki, ki so na voljo v tem trenutku, ne zadoščajo, da bi lahko priporočil to spremembo.
English: Inovelon contains the active substance rufinamide and has been authorised since January 2007.
Slovenian: Zdravilo Inovelon vsebuje zdravilno učinkovino rufinamid in je odobreno od januarja 2007.
English: Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Slovenian: Lennox-Gastautov sindrom je ena najhujših oblik epilepsije pri otrocih.
English: By attaching to these channels, rufinamide prevents them from becoming activated.
Slovenian: Z vezavo na te kanalčke rufinamid prepreči njihovo aktivacijo.
English: However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Inovelon's product information.
Slovenian: Vendar pa je menil, da utegnejo biti podatki pomembni za zdravstvene delavce, in priporočil, da se ti vključijo v informacije o zdravilu Inovelon.
English: The active substance in Inovelon, rufinamide acts by attaching to special channels on the surface of brain cells (sodium channels), which control their electrical activity.
Slovenian: Zdravilna učinkovina v zdravilu Inovelon, rufinamid, deluje tako, da se veže na posebne kanalčke na površini možganskih celic (natrijeve kanalčke), ki nadzorujejo njihovo električno aktivnost.
English: This reduces the likelihood of a seizure occurring.
Slovenian: S tem se zmanjša verjetnost za epileptični napad.
English: Its signs and symptoms include multiple types of seizures (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Slovenian: Njegovi znaki in simptomi vključujejo več vrst epileptičnih napadov, nenormalno električno aktivnost v možganih, motnje pri učenju in vedenjske težave.
English: Inovelon is used for treating Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but can continue into adulthood.
Slovenian: Zdravilo Inovelon se uporablja za zdravljenje Lennox-Gastautovega sindroma, redke vrste epilepsije, ki običajno prizadene otroke, vendar se lahko nadaljuje tudi v odrasli dobi.
English: What is happening with Inovelon for the treatment of other diseases?
Slovenian: Kaj to pomeni za nadaljnjo uporabo zdravila Inovelon za zdravljenje drugih bolezni?
English: The study investigated the safety of Inovelon and also its impact on the child's behavioural and emotional development assessed by the patient's parent or guardian on a standardised scoring system.
Slovenian: V študiji so proučevali varnost zdravila Inovelon in njegov učinek na otrokov vedenjski in čustveni razvoj, kot so ga po standardiziranem sistemu točkovanja ocenili bolnikovi starši oziroma skrbniki.
English: However, the CHMP considered that including the data obtained in these children in Inovelon's product information could help the healthcare professionals who manage them.
Slovenian: Vendar pa je menil, da bi z vključitvijo podatkov, pridobljenih pri teh otrocih, v informacije o zdravilu Inovelon pomagali zdravstvenim delavcem, ki jih vodijo.
English: While the study showed that the safety of Inovelon in patients aged 1 to less than 4 years was consistent with the known safety profile in older children, the CHMP concluded that the study was too small to make conclusions on the medicine's effectiveness.
Slovenian: Študija je sicer pokazala, da je varnost zdravila Inovelon pri otrocih, starih od enega do manj kot štiri leta, skladna z znanim varnostnim profilom pri starejših otrocih, vendar je odbor CHMP zaključil, da je študija premajhna, da bi lahko sprejeli zaključke o učinkovitosti zdravila.
English: Inovelon was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 20 October 2004 for Lennox-Gastaut syndrome.
Slovenian: Zdravilo Inovelon je bilo dne 20. oktobra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje Lennox-Gastautovega sindroma.
English: Regarding the data that the company used to make predictions for use in children aged 1 to less than 4 years, the CHMP considered that further analyses were needed in order to make dosing recommendations in the younger age group.
Slovenian: V zvezi s podatki, ki jih je družba uporabila pri napovedovanju uporabe pri otrocih, starih od enega do manj kot štiri leta, je odbor CHMP presodil, da so potrebne nadaljnje analize, na podlagi katerih bi lahko oblikovali priporočila za odmerjanje v mlajši skupini.
English: There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Inovelon.
Slovenian: Odobritev ali zavrnitev te vloge nima nobenih posledic za bolnike, ki trenutno sodelujejo ali bodo morda sodelovali v kliničnih preskušanjih zdravila Inovelon.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of the epilepsy medicine Inovelon to children aged 1 to 4 years.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil pregled vloge za razširitev uporabe zdravila Inovelon za zdravljenje epilepsije na otroke, stare od enega do štirih let.
English: The company presented data from a study in which 37 children aged between 1 and 4 years with Lennox-Gastaut syndrome received either Inovelon or another epilepsy medicine in addition to their existing treatment.
Slovenian: Družba je predložila podatke študije, v kateri je 37 otrok, starih od enega do štirih let, z LennoxGastautovim sindromom prejemalo poleg obstoječega zdravila še zdravilo Inovelon ali drugo zdravilo za zdravljenje epilepsije.
English: What was Inovelon expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Inovelon uporabljalo?
English: The CHMP therefore concluded that based on the currently available data, Inovelon could not be approved for patients with Lennox-Gastaut syndrome aged less than 4 years.
Slovenian: Na podlagi trenutno razpoložljivih podatkov je zaključil, da zdravila Inovelon ni mogoče odobriti za bolnike z Lennox-Gastautovim sindromom, mlajše od štirih let.
English: How does Inovelon work?
Slovenian: Kako zdravilo Inovelon deluje?
English: and prevents abnormal electrical activity from spreading through the brain.
Slovenian: Tako zmanjša aktivnost možganskih celic in prepreči, da bi se nenormalna električna aktivnost širila po možganih.
English: What is Inovelon?
Slovenian: Kaj je zdravilo Inovelon?
English: The company that markets Inovelon applied for it to be used to treat Lennox-Gastaut syndrome in children aged 1 to 4 years.
Slovenian: Družba, ki trži zdravilo Inovelon, je vložila vlogo, na podlagi katere naj bi se zdravilo uporabljalo za zdravljenje Lennox-Gastautovega sindroma pri otrocih, starih od enega do štirih let.
English: The company also proposed a way to make predictions on the use of Inovelon in children aged between 1 and 4 years based on existing data in patients aged 4 years and older.
Slovenian: Družba je na podlagi obstoječih podatkov pri bolnikih, starejših od štirih let, tudi predlagala način napovedovanja uporabe zdravila Inovelon pri otrocih, starih od enega do štirih let.
English: There are no consequences on the use of Inovelon in patients with Lennox-Gastaut syndrome aged 4 years and over.
Slovenian: Pri bolnikih z Lennox-Gastautovim sindromom, starejših od štirih let, ni nobenih posledic za uporabo zdravila Inovelon.
English: This will prevent misuse and help to protect the environment.
Slovenian: To prepreči napačno uporabo in pomaga varovati okolje.
English: (see section 5.2)
Slovenian: (glejte poglavje 5.2).
English: • A core text as agreed by the Rapporteur
Slovenian: • osnovno besedilo, kot je bilo dogovorjeno s poročevalcem
English: If this happens to you, it is not known if your periods will come back.
Slovenian: Če se vam to zgodi, ni znano, ali se vam bodo menstruacije vrnile.
English: • every month during treatment.
Slovenian: • vsak mesec med zdravljenjem.
English: Many of these genes are involved in proliferation, survival, and differentiation.
Slovenian: Številni od teh genov so vključeni v proliferacijo, preživetje in diferenciacijo.
English: Date of latest renewal: 26 May 2016
Slovenian: Datum zadnjega podaljšanja: 26. maj 2016
English: • National specific requirements as agreed with the National Competent Authority regarding:
Slovenian: • nacionalno specifične zahteve, dogovorjene s pristojnim nacionalnim organom, glede:
English: Hard capsule (capsule).
Slovenian: Trda kapsula (kapsula).
English: The recommended dose is one capsule each day.
Slovenian: Priporočeni odmerek je ena kapsula vsak dan.
English: Please refer to these documents for further information.
Slovenian: Prosimo, poglejte ta dokumenta za nadaljnje informacije.
English: Talk to your doctor if you wish to have children in the future.
Slovenian: Posvetujte se z zdravnikom, če želite v prihodnosti imeti otroke.
English: Objective response was defined as a complete or partial response determined on two consecutive assessments separated by at least 4 weeks.
Slovenian: Objektivni odziv je bil opredeljen kot popoln ali delen odziv, določen na dveh zaporednih ocenjevanjih, med katerima so minili vsaj 4 tedni.
English: • a sexually mature female who
Slovenian: spolno zrelo žensko, ki
English: Each pack contains one bottle.
Slovenian: Vsako pakiranje vsebuje eno plastenko.
English: Key data are summarised in Table 2:
Slovenian: Ključni podatki so povzeti v preglednici 2.
English: The size of the capsule is ‘Size 1' (dimensions 19.0 x 6.6 mm).
Slovenian: Velikost kapsule je "Velikost 1" (dimenzije 19,0 x 6,6 mm).
English: • you think your contraception has failed for any reason,
Slovenian: • mislite, da je kontracepcija zaradi kakršnega koli razloga odpovedala,
English: Patients should be instructed never to give this medicinal product to another person.
Slovenian: Bolnikom je treba naročiti, da tega zdravila nikoli ne dajo drugim osebam.
English: (18.1, NE)
Slovenian: (18,1; N.o.)
English: You must follow the contraception advice described in this leaflet.
Slovenian: Upoštevajte nasvete o kontracepciji, opisane v tem navodilu.
English: This interaction is not expected to be clinically significant.
Slovenian: Ni pričakovati, da bi bila ta interakcija klinično pomembna.
English: IRF-Assessed
Slovenian: ocena IRF
English: Pregnancy tests should have a minimum sensitivity of 25 mIU/mL as per local availability.
Slovenian: Testi nosečnosti morajo imeti minimalno občutljivost 25 mi.e./ml, v skladu z lokalno dostopnostjo.
English: Frequencies are defined as:
Slovenian: Pogostnosti so opredeljene takole:
English: The PRAC therefore recommends that the Product Information should be updated accordingly.
Slovenian: PRAC zato priporoča, da se informacije o zdravilu ustrezno posodobijo.
English: • Information on the recommended forms of contraception both for women and men
Slovenian: • informacije o priporočenih oblikah kontracepcije za ženske in moške
English: Very rare ( < 1/10,000)
Slovenian: Zelo redki (< 1/10.000)
English: It is used when the cancer:
Slovenian: To zdravilo se uporabi, če se je rak:
English: This is because it is not known if it is safe or effective in this age group.
Slovenian: Ni namreč znano, ali je to zdravilo v tej starostni skupini varno ali učinkovito.
English: Effects on specific enzymes and transporters
Slovenian: Učinki na specifične encime in prenašalce
English: • loss of water from the body (dehydration),
Slovenian: • izguba vode iz telesa (dehidracija),
English: Four patients were excluded from the figure: 3 patients with stable disease were assessed by non-target lesions only and 1 patient was unevaluable.
Slovenian: Štirje bolniki niso vključeni v sliko: 3 bolniki s stabilno boleznijo so bili ocenjeni samo po neciljnih lezijah, 1 bolnik pa ni bil ocenljiv.
English: No correlative histopathologic changes were observed.
Slovenian: Prav tako niso opazili korelacijskih histopatoloških sprememb.
English: Carcinogenicity studies were performed in mice and rats.
Slovenian: Študije kancerogenosti so izvedli na miših in podganah.
English: You must also use one barrier method, such as:
Slovenian: Uporabljati morate tudi enega od pregradnih načinov, na primer:
English: • you stop using contraception,
Slovenian: • prenehate uporabljati kontracepcijo,
English: Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
Slovenian: Skrbno preberite in sledite navodilom iz knjižice za bolnike in opozorilne kartice, ki vam ju je dal vaš zdravnik.
English: • Information for men
Slovenian: • Informacije za moške
English: • pain (in general) or pain in your arms, legs,
Slovenian: • bolečina (na splošno) ali bolečine v rokah, nogah,
English: Do not take this medicine if any of the above apply to you.
Slovenian: Ne vzemite tega zdravila, če kaj od naštetega velja za vas.
English: Do not stop taking this medicine without talking to your doctor first as this could make your treatment less effective.
Slovenian: Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom, sicer lahko postane vaše zdravljenje manj učinkovito.
English: Although the number of identified cases is limited, the reactions are serious and the association with vismodegib is plausible.
Slovenian: Kljub majhnemu številu ugotovljenih primerov so reakcije resne in povezanost z vismodegibom verjetna.
English: Response assessment was based on a composite endpoint defined as above.
Slovenian: Ocena odziva je temeljila na sestavljenem cilju preskušanja, kot je opredeljen zgoraj.