FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je zato sklenila, da koristi zdravila Fampyra odtehtajo z njim povezana tveganja pri bolnikih, ki ne morejo hoditi, in priporočila, da se zanj odobri dovoljenje za promet.
English: For more information about treatment with Fampyra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Fampyra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The studies with Fampyra showed that the medicine is likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients.
Slovenian: Študije z zdravilom Fampyra so pokazale, da zdravilo verjetno koristi približno eni tretjini bolnikov z multiplo sklerozo z nezmožnostjo hoje ter da je že v zgodnji fazi zdravljenja mogoče ugotoviti, katerim bolnikom zdravilo koristi, kar omogoča, da se pri drugih bolnikih zdravljenje prekine.
English: It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells.
Slovenian: Deluje na poškodovane živce, tako da preprečuje, da bi nabiti delci kalija zapustili živčne celice.
English: Two main studies in 540 patients with multiple sclerosis showed that Fampyra was more effective than placebo (a dummy treatment) at improving walking speed.
Slovenian: Dve glavni študiji s 540 bolniki z multiplo sklerozo sta pokazali, da zdravilo Fampyra izboljša hitrost hoje učinkoviteje od placeba (zdravila brez zdravilne učinkovine).
English: For practical information about using Fampyra, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Fampyra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.
Slovenian: To domnevno omogoča nadaljevanje pretoka električnih impulzov po živcih, kar zagotavlja stimulacijo mišic in bolnikom omogoča lažjo hojo.
English: How does Fampyra work?
Slovenian: Kako zdravilo Fampyra deluje?
English: For the full list of all side effects reported with Fampyra, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fampyra, glejte navodilo za uporabo.
English: In one of the studies 35% of patients taking Fampyra had higher walking speed on at least three out of four occasions than their quickest speed before treatment compared with 8% of patients taking placebo .
Slovenian: V eni od študij je doseglo 35 % bolnikov, ki so jemali zdravilo Fampyra, višjo hitrost hoje, kot je bila njihova največja hitrost pred zdravljenjem, vsaj v treh od štirih primerov, v primerjavi z 8 % bolnikov, ki so jemali placebo.
English: In MS, this transmission of electrical impulses is impaired when the protective sheaths around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.
Slovenian: Pri multipli sklerozi je prenos električnih impulzov okvarjen, ker je zaščitna ovojnica, ki obdaja živce, poškodovana, kar lahko povzroči mišično oslabelost, togost mišic in težave s hojo.
English: MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Slovenian: Multipla skleroza je bolezen živčnega sistema, pri kateri vnetje uničuje zaščitno ovojnico, ki obdaja živce.
English: In the second study the results were similar, with 43% of patients in the Fampyra group surpassing their previous best speed on three out of four occasions, compared with 9% in the placebo group.
Slovenian: V drugi študiji so bili rezultati podobni, najboljšo hitrost pa je v treh od štirih primerov preseglo 43 % bolnikov, ki so jemali zdravilo Fampyra, v primerjavi z 9 % bolnikov, ki so jemali placebo.
English: How is Fampyra used?
Slovenian: Kako se zdravilo Fampyra uporablja?
English: In this study, 43% of patients taking Fampyra had at least an 8-point improvement in their MSWS score compared with 34% of those on placebo.
Slovenian: V tej študiji je doseglo izboljšanje ocene MSWS vsaj za osem točk 43 % bolnikov, ki so jemali zdravilo Fampyra, v primerjavi s 34 % bolnikov, ki so jemali placebo.
English: For the body's muscles to contract, electrical impulses are transmitted along the nerves to the muscles.
Slovenian: Telesne mišice se krčijo tako, da se po živcih do njih prenašajo električni impulzi.
English: The medicine can only be obtained with a prescription, and should be prescribed by a doctor experienced in treating MS. For further information, see the package leaflet.
Slovenian: Predpisovanje in izdaja zdravila Fampyra je le na recept, predpisati pa ga mora zdravnik z izkušnjami z zdravljenjem multiple skleroze.
English: EU/2/10/112/001 BTVPUR AlSap 1
Slovenian: EU/2/10/112/001 BTVPUR Alsap 1 Bluetongue virus serotip 1:
English: Suspension for injection.
Slovenian: Suspenzija za injiciranje
English: Packaging Content Package size Withdrawal period
Slovenian: Ovojnina Vsebina Velikost pakiranja
English: (*) equivalent to titre prior to inactivation (log10)
Slovenian: (*) Ekvivalent titru pred inaktivacijo
English: Subcutaneous Type I glass bottle with butyl elastomere closure
Slovenian: Ovce in govedo Subkutano Steklenička (steklo tipa I) z butil elastomerno zaporko
English: Invented Name
Slovenian: Izmišljeno ime Jakost
English: Medicinal product no longer authorised
Slovenian: Zdravilo nima veā dovoljenja za promet
English: Strength
Slovenian: Karenca
English: Note:
Slovenian: Opomba:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko pristojni organi države članice v sodelovanju z referenčno državo članico naknadno dopolnijo, kot je primerno, v skladu s postopki iz Poglavja 4 Naslova III Direktive 2001/83/ES.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Slovenian: Te informacije o zdravilu so rezultat napotitvenega postopka, na katerega se nanaša ta sklep Komisije.
English: Product information
Slovenian: Informacije o zdravilu
English: Annex III Product information
Slovenian: Priloga III Informacije o zdravilu
English: The valid product information is the final version achieved during the Coordination group procedure.
Slovenian: Veljavne informacije o zdravilu so končna različica, dogovorjena med postopkom skupine za usklajevanje.
English: This summary was last updated in 07-2016.
Slovenian: Povzetek je bil nazadnje posodobljen 07-2016.
English: This study was extended to almost 4 years and confirmed the long-term benefits and safety of HyQvia.
Slovenian: Ta študija je bila podaljšana na skoraj štiri leta, pri čemer so bile potrjene dolgoročne koristi in varnost zdravila HyQvia.
English: The European Commission granted a marketing authorisation valid throughout the European Union for HyQvia on 16 May 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom HyQvia, veljavno po vsej Evropski uniji, izdala 16. maja 2013.
English: The main measure of effectiveness was the number of serious bacterial infections that developed over one year of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število resnih bakterijskih okužb, ki so se pojavile v enem letu zdravljenja.
English: IgG has been used as a medicine since the 1950s and has a wide range of activity against organisms that can cause infection.
Slovenian: IgG se v medicini uporablja od petdesetih let preteklega stoletja in ima širok razpon delovanja proti organizmom, ki povzročajo okužbe.
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Slovenian: Vsebuje imunoglobulin G (IgG), ki je vrsta protitelesa.
English: What measures are being taken to ensure the safe and effective use of HyQvia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila HyQvia?
English: The full EPAR for HyQvia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo HyQvia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The study showed that HyQvia was able to reduce this number to 0.03 per year.
Slovenian: Študija je pokazala, da se je z uporabo zdravila HyQvia število okužb zmanjšalo na 0,03 na leto.
English: This is a summary of the European public assessment report (EPAR) for HyQvia.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo HyQvia.
English: The dose and frequency of infusions (how often it is given) depend on the individual patient and may need to be adjusted depending on their response.
Slovenian: Odmerek in pogostost infundiranja (pogostost dajanja zdravila) se določi za vsakega bolnika posebej in se ju po potrebi prilagodi glede na njegov odziv.
English: Other information about HyQvia
Slovenian: Druge informacije o zdravilu HyQvia
English: The most common side effects with HyQvia (which may affect more than 1 in 10 people) are local reactions such as swelling and discomfort at the site of the infusion.
Slovenian: Najpogostejši neželeni učinki zdravila HyQvia (ki lahko prizadenejo več kot 1 osebo od 10) so lokalne reakcije, kot so otekline in neprijeten občutek na mestu infundiranja.
English: HyQvia must not be given into a blood vessel or a muscle.
Slovenian: Zdravila HyQvia se ne sme dajati v krvno žilo ali mišico.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of HyQvia have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila HyQvia, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The Committee therefore decided that HyQvia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: CHMP je zato zaključil, da so koristi zdravila HyQvia večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: HyQvia is used as ‘replacement therapy' to treat:
Slovenian: Zdravilo HyQvia se uporablja kot „nadomestno zdravljenje‟ pri:
English: What are the risks associated with HyQvia?
Slovenian: Kakšna tveganja so povezana z zdravilom HyQvia?
English: What benefits of HyQvia have been shown in studies?
Slovenian: Kakšne koristi je zdravilo HyQvia izkazalo v študijah?
English: What is HyQvia and what is it used for?
Slovenian: Kaj je zdravilo HyQvia in za kaj se uporablja?
English: In accordance with current guidelines for these medicines, HyQvia was investigated in one main study lasting over a year and involving 89 patients with PID who had already had treatment with human normal immunoglobulin for at least three months.
Slovenian: Zdravilo HyQvia so v skladu s trenutnimi smernicami za tovrstna zdravila proučevali v eni glavi študiji, ki je trajala več kot eno leto in v katero je bilo vključenih 89 bolnikov s PID, ki so že pred tem najmanj tri mesece prejemali humani polispecifični imunoglobulin.
English: • low levels of antibodies in the blood in patients who have chronic lymphocytic leukaemia or myeloma (two cancers affecting different types of white blood cell) and who have frequent infections.
Slovenian: • nizkih ravneh protiteles v krvi pri bolnikih s kronično limfocitno levkemijo ali mielomom (dvema vrstama raka, ki prizadeneta različne vrste belih krvnih celic), ki so dovzetni za pogoste okužbe.
English: These are patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
Slovenian: To so bolniki, ki imajo v krvi premalo protiteles (beljakovin, ki pomagajo telesu pri premagovanju okužb in drugih bolezni), ki jih imenujemo tudi imunoglobulini.
English: It is not intended to provide practical advice on how to use HyQvia.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Patients or their carers may be able to give HyQvia themselves once they have been trained appropriately.
Slovenian: Bolniki ali njihovi negovalci lahko zdravilo HyQvia dajejo sami, če so bili za to ustrezno usposobljeni.
English: Why is HyQvia approved?
Slovenian: Zakaj je bilo zdravilo HyQvia odobreno?
English: The possibility of patients or their carers giving the medicine themselves at home may also improve the convenience of the product.
Slovenian: Ker lahko bolniki ali njihovi negovalci zdravilo dajejo doma sami, je zdravilo zato tudi priročnejše.
English: Human normal immunoglobulin has been used to treat these diseases for many years.
Slovenian: Humani polispecifični imunoglobulin se za zdravljenje zgoraj omenjenih bolezni uporablja že vrsto let.
English: • primary immunodeficiency syndromes (PID, when patients are born with an inability to produce enough antibodies);
Slovenian: • sindromih primarne imunske pomanjkljivosti (PID, pri bolnikih s prirojeno nezmožnostjo tvorjenja zadostnega števila protiteles);
English: Although there had been concerns that antibodies that develop against recombinant hyaluronidase could cause side effects by affecting the natural version of the enzyme, the results of studies were reassuring.
Slovenian: Čeprav so obstajali pomisleki, da bi lahko protitelesa, ki se tvorijo proti rekombinantni hialuronidazi, povzročila neželene učinke zaradi vpliva na naravni encim, so rezultati študij te zadržke ovrgli.
English: For more information about treatment with HyQvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom HyQvia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: HyQvia must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or hyaluronidase or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Slovenian: Zdravila HyQvia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani polispecifični imunoglobulin ali hialuronidazo ali katero koli drugo sestavino zdravila, ter bolniki, ki so alergični na druge vrste imunoglobulinov, zlasti če imajo pomanjkanje (zelo nizke ravni) imunoglobulina A (IgA) s protitelesi proti IgA.
English: This is a form of the natural human enzyme, hyaluronidase, which breaks down a substance called hyaluronic acid that is present in the tissues in the tiny spaces between cells and so makes the area between cells temporarily more liquid.
Slovenian: To je oblika naravnega človeškega encima, hialuronidaze, ki razgrajuje snov, imenovano hialuronska kislina, ki je prisotna v tkivih v majhnih prostorih med celicami, in tako povzroči, da so medcelični prostori začasno bolj tekoči.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that HyQvia produces a similar reduction in the number of serious bacterial infections to that seen with other immunoglobulin products, and using recombinant hyaluronidase allows subcutaneous infusions to be given at much longer intervals, although local reactions are slightly more common.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ugotovil, da zdravilo HyQvia podobno zmanjšuje število resnih bakterijskih okužb kot druga zdravila, ki vsebujejo imunoglobulin, in da se lahko zaradi uporabe rekombinantne hialuronidaze subkutane infuzije dajejo v veliko daljših premorih, četudi so lokalne reakcije nekoliko pogostejše.
English: This was below the predefined number needed to show effectiveness (which is one infection per year), and was similar to that seen with other licensed human normal immunoglobulin products.
Slovenian: Ta številka je bila nižja od predhodno določene, ki naj bi dokazala učinkovitost zdravila (tj. ena okužba na leto), in je bila podobna tisti, ki so jo zabeležili pri drugih odobrenih zdravilih, ki vsebujejo humani polispecifični imunoglobulin.
English: HyQvia can only be obtained with a prescription and treatment should be started and monitored by a doctor or nurse experienced in treating immunodeficiency syndromes.
Slovenian: Predpisovanje in izdaja zdravila HyQvia je le na recept, zdravljenje z njim pa lahko predpiše in spremlja samo zdravnik ali medicinska sestra, ki ima izkušnje z zdravljenjem sindromov imunske pomanjkljivosti.
English: HyQvia also contains recombinant human hyaluronidase.
Slovenian: Zdravilo HyQvia vsebuje tudi rekombinantno humano hialuronidazo.
English: HyQvia is available as two solutions for infusion (drip) under the skin.
Slovenian: Zdravilo HyQvia vsebuje dve raztopini za infundiranje (kapalno infuzijo) pod kožo.
English: HyQvia works by restoring abnormally low IgG levels to their normal range in the blood.
Slovenian: Zdravilo HyQvia deluje tako, da nenormalno nizke ravni IgG v krvi zviša na normalno raven.
English: For practical information about using HyQvia, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila HyQvia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Detailed information about using HyQvia is provided in the package leaflet.
Slovenian: Podrobne informacije o uporabi zdravila HyQvia so na voljo v navodilu za uporabo.
English: The active substance in HyQvia, human normal immunoglobulin, is a highly purified protein extracted from the blood.
Slovenian: Zdravilna učinkovina zdravila HyQvia, humani polispecifični imunoglobulin, je visoko prečiščena beljakovina, pridobljena iz krvi.
English: For the full list of all side effects reported with HyQvia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila HyQvia, glejte navodilo za uporabo.
English: HyQvia is used in patients with immunodeficiency syndromes.
Slovenian: Uporablja se pri odraslih s sindromi imunske pomanjkljivosti.
English: When given under the skin before the normal human immunoglobulin, it helps to deliver the active substance under the skin, and assists its absorption into the body.
Slovenian: Ko se infundira pod kožo pred humanim polispecifičnim imunoglobulinom, omogoči lažje prehajanje zdravilne učinkovine pod kožo in pospeši njeno absorpcijo v telo.
English: Human normal immunoglobulin
Slovenian: HyQvia humani polispecifični imunoglobulin
English: A solution containing recombinant human hyaluronidase is given first and a solution containing human normal immunoglobulin (100 mg/ml) is then given by infusion in the same place.
Slovenian: Najprej se infundira raztopina z rekombinantno humano hialuronidazo, nato pa na istem mestu še raztopina s humanim polispecifičnim imunoglobulinom (100 mg/ml).
English: The product also contains recombinant human hyaluronidase, which is an enzyme used to help deliver the human normal immunoglobulin under the skin and improve its absorption into the body.
Slovenian: Zdravilo vsebuje tudi rekombinantno humano hialuronidazo, tj. encim, ki omogoči lažje prehajanje humanega polispecifičnega imunoglobulina pod kožo in pospeši njegovo absorpcijo v telo.
English: How does HyQvia work?
Slovenian: Kako zdravilo HyQvia deluje?
English: How is HyQvia used?
Slovenian: Kako se zdravilo HyQvia uporablja?
English: HyQvia contains the active substance human normal immunoglobulin.
Slovenian: Zdravilo HyQvia vsebuje zdravilno učinkovino humani polispecifični imunoglobulin.
English: These signs include:
Slovenian: Ti znaki so:
English: Ref.: EMA/777733/2009 EMEA/H/C/253
Slovenian: : EMA/777733/2009 EMEA/H/C/253
English: This summary was last updated in 12-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 12-2009.
English: In addition, the baby must have a normal heart rate.
Slovenian: Poleg tega mora imeti plod normalno srčno frekvenco.
English: The main measure of effectiveness was whether the treatment had worked after a week.
Slovenian: Glavno merilo učinkovitosti je bila uspešnost zdravljenja po enem tednu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tractocile on 20 January 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tractocile, veljavno po vsej Evropski uniji, odobrila dne 20. januarja 2000.
English: Tractocile atosiban EPAR summary for the public
Slovenian: Tractocile atosiban Povzetek EPAR za javnost
English: No side effects have been noted in the newborn baby.
Slovenian: Pri novorojenčkih niso opazili nobenih neželenih učinkov.
English: Treatment should be started as soon as possible after diagnosis of pre-term labour.
Slovenian: Zdravljenje je treba začeti čim prej po diagnozi prezgodnjega porajanja.
English: The marketing authorisation holder is Ferring Pharmaceuticals A/S.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba Ferring Pharmaceuticals A/S.
English: Both contain the active substance atosiban (7.5 mg per millilitre).
Slovenian: Obe vsebujeta zdravilno učinkovino atosiban (7,5 mg na mililiter).
English: • regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
Slovenian: • - redne kontrakcije maternice, ki trajajo vsaj 30 sekund, s pogostnostjo najmanj štiri v 30 minutah,
English: Other information about Tractocile:
Slovenian: Druge informacije o zdravilu Tractocile:
English: If contractions come back, treatment with Tractocile can be repeated up to three more times during the pregnancy.
Slovenian: Če se kontrakcije maternice spet pojavijo, se lahko zdravljenje z zdravilom Tractocile v času nosečnosti ponovi največ trikrat.
English: The active substance in Tractocile, atosiban, is an antagonist of the natural hormone oxytocin.
Slovenian: Učinkovina v zdravilu Tractocile, atosiban, je antagonist naravnega hormona oksitocina.
English: Tractocile should not be used in people who may be hypersensitive (allergic) to atosiban or any of the other ingredients.
Slovenian: Zdravila Tractocile ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) atosiban ali katero koli drugo sestavino zdravila.
English: The Committee decided that Tractocile's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je zaključil, da so koristi zdravila Tractocile večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Looking at the results of the three main studies together, 60% of the women treated with Tractocile were still pregnant one week after treatment (201 out of 337) compared with 48% of the women treated with the comparator medicines (163 out of 342).
Slovenian: Rezultati vseh treh glavnih študij skupaj kažejo, da je bilo en teden po zdravljenju nosečih še 60 % žensk (201 od 337), zdravljenih z zdravilom Tractocile, v primerjavi z 48 % žensk (163 od 342), zdravljenih s primerjalnimi zdravili.