FrancophonIA/ELRC3.0 huggingface dataset:
English: Special precautions for use in animals Not applicable.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Ni smiselno.
English: Each dose (1 ml) contains:
Slovenian: En odmerek (1 ml) vsebuje:
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: This vaccine is designed to stimulate the development of an active immune response to porcine circovirus type 2.
Slovenian: Cepivo je namenjeno za spodbujanje razvoja aktivnega imunskega odziva na prašičji cirkovirus tipa 2.
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: Ne odvrzite zdravila v odpadno vodo ali v gospodinjske odpadke.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogodnost neželeni učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali ) - pogosti (pri več kot 1, toda manj kot10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot od 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot od 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines for pigs ATCvet code: QI09AA07
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za Suidae, inaktivirano virusno cepivo za prašiče Oznaka ATC vet: QI09AA07
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini, razen z zgoraj omenjenim.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Slovenian: Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo (ES)
English: Suspension for injection.
Slovenian: Suspenzija za injiciranje.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Slovenian: Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila odločamo od primera od primera.
English: Avoid introduction of contamination during use.
Slovenian: Pazite, da med uporabo ne bi prišlo do kontaminacije.
English: Avoid multiple vial broaching.
Slovenian: Izogibajte se večkratnega odpiranja viale.
English: In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.
Slovenian: Poleg tega se je pokazalo, da cepljenje zmanjša izločanje PCV2 iz nosu, virusno breme v krvi in limfnih tkivih ter trajanje viremije.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti (EXP), navedenega na škatli in plastenki po EXP.
English: Duration of immunity:
Slovenian: Trajanje imunosti:
English: MANUFACTURER'S BATCH NUMBER
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE
English: Shake well before use.
Slovenian: Pred uporabo dobro pretresite.
English: • Use a pre-sterilised transfer needle.
Slovenian: • Uporabite sterilno iglo za prenos.
English: Each bottle is closed with a chlorobutyl stopper and lacquered aluminium seal.
Slovenian: Vsaka staklenica je zaprta s klorobutilnim zamaškom in lakirano aluminijasto zaporko.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
English: Carbomer
Slovenian: Karbomer
English: Any unused mixture or waste material should be disposed according to the instructions given in section 6.6.
Slovenian: Morebitno neporabljeno mešanico ali odpadni material zavrzite v skladu z navodili v poglavju 6.6.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
English: For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related disease (PCVD).
Slovenian: Za aktivno imunizacijo prašičev od starosti 2 tednov proti prašičjemu cirkovirusu tipa 2 (PCV2) z namenom zmanjšati smrtnost, klinične znake - tudi hujšanje - in poškodbe v limfnih tkivih, ki jih povzročajo bolezni zaradi okužbe s PCV2 (PCVD).
English: Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section 4.6 have been observed.
Slovenian: Po dajanju 4-krat prevelikega odmerka cepiva niso zasledili neželenih učinkov, ki bi se razlikovali od tistih, ki so opisani v poglavju 4.6.
English: Do not freeze.
Slovenian: Ne shranjujte v zamrzovalniku.
English: Avoid multiple broaching.
Slovenian: Izogibajte se večkratnega odpiranja.
English: Can be used during pregnancy and lactation.
Slovenian: Lahko se uporablja v obdobju brejosti in laktacije.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavo, uvoz/vnos,
English: Vaccination devices should be used in accordance with the device instructions provided by the manufacturer.
Slovenian: Opremo za cepljenje uporabljajte v skladu z izdelovalčevimi navodili za uporabo opreme.
English: Ingelvac MycoFLEX may be not authorised in certain Member States.
Slovenian: Cepivo Ingelvac MycoFLEX v nekaterih državah članicah mogoče ni odobreno.
English: PACKAGE SIZES
Slovenian: VELIKOST PAKIRANJA
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
English: 10 ml (10 doses) 50 ml (50 doses) 100 ml (100 doses) 250 ml (250 doses) 12 x 10 ml (12 x 10 doses) 12 x 50 ml (12 x 50 doses) 12 x 100 ml (12 x 100 doses) 12 x 250 ml (12 x 250 doses)
Slovenian: 10 ml (10 odmerkov) 50 ml (50 odmerkov) 100 ml (100 odmerkov) 250 ml (250 odmerkov) 12 x 10 ml (12 x 10 odmerkov) 12 x 50 ml (12 x 50 odmerkov) 12 x 100 ml (12 x 100 odmerkov) 12 x 250 ml (12 x 250 odmerkov)
English: A mild and transient hyperthermia very commonly occurs on the day of vaccination.
Slovenian: Na dan cepljenja se zelo pogosto pojavi blaga in prehodna hipertermija.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
English: Not applicable.
Slovenian: Niso znane.
English: Ingelvac MycoFLEX may be not authorised to use in certain Member States.
Slovenian: Cepivo Ingelvac MycoFLEX v nekaterih državah članicah mogoče ni odobreno za uporabo.
English: Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s Ingelvac MycoFLEX (not for use in pregnant or lactating pigs).
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen s cepivom Ingelvac MycoFLEX družbe Boehringer Ingelheim (mešanica ni za uporabo pri brejih ali doječih svinjah).
English: Ingelvac CircoFLEX suspension for injection for pigs
Slovenian: Ingelvac CircoFLEX, suspenzija za injiciranje za prašiče
English: EXP {month/year} Once broached use immediately.
Slovenian: EXP {mesec/leto} Odprto zdravilo uporabite takoj.
English: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine
Slovenian: * relativna učinkovitost (preskus ELISA) v primerjavi z referenčnim cepivom
English: INDICATIONS
Slovenian: INDIKACIJE
English: Clear to slightly opalescent, colourless to yellowish suspension for injection.
Slovenian: Bistra do rahlo opalescentna, brezbarvna do rumenkasta suspenzija za injiciranje.
English: QUANTITY OF THE ACTIVE SUBSTANCE
Slovenian: KOLIČINA UČINKOVIN
English: 10 ml (10 doses) 50 ml (50 doses)
Slovenian: 10 ml (10 odmerkov) 50 ml (50 odmerkov)
English: METHOD AND ROUTE OF ADMINISTRATION
Slovenian: NAČIN IN POT UPORABE
English: During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.
Slovenian: Med cepljenjem pazite, da bo barva mešanice enakomerna, vzdržujte jo s stalnim stresanjem.
English: Shelf life after first opening the bottle: use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
English: Boehringer Ingelheim Vetmedica GmbH GERMANY
Slovenian: Boehringer Ingelheim Vetmedica GmbH
English: • Cannot be administered in pregnant or lactating pigs.
Slovenian: • Mešanice ne smete dajati brejim ali doječim svinjam.
English: Any unused mixture or waste material should be disposed according with local requirements.
Slovenian: Morebitno neporabljeno mešanico ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Shelf life after first opening the immediate packaging: use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: uporabite takoj.
English: • Use the same volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
Slovenian: • Uporabite enak volumen cepiv Ingelvac CircoFLEX in Ingelvac MycoFLEX.
English: One dose (1 ml) contains: Porcine circovirus type 2 ORF2 protein Carbomer
Slovenian: En odmerek (1 ml) vsebuje: beljakovino ORF2 prašičjega cirkovirusa tipa 2 karbomer
English: To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycoFLEX until the mixture is of uniform orange to reddish colour.
Slovenian: Nežno stresajte plastenko s cepivom Ingelvac MycoFLEX, dokler ni mešanica enakomerne oranžne do rdečkaste barve.
English: - After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.
Slovenian: - Ko prenesete celotno vsebino plastenke cepiva Ingelvac CircoFLEX, odstranite z vsebnika iglo za prenos in prazno plastenko za cepivo Ingelvac CircoFLEX in ju zavrzite.
English: Administer one single injection dose (2 ml) of the mixture intramuscularly per pig, irrespective of body weight.
Slovenian: Injicirajte en sam odmerek (2 ml) mešanice intramuskularno vsakemu prašiču, ne glede na telesno maso.
English: Pack sizes of 1 or 12 bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses).
Slovenian: Pakiranja vsebujejo 1 ali 12 steklenic po 10 ml (10 odmerkov), 50 ml (50 odmerkov), 100 ml (100 odmerkov) ali 250 ml (250 odmerkov).
English: 100 ml (100 doses) 250 ml (250 doses)
Slovenian: 100 ml (100 odmerkov) 250 ml (250 odmerkov)
English: When mixed with Ingelvac MycoFLEX the following equipment should be used:
Slovenian: Kadar nameravate cepivo zmešati s cepivom Ingelvac MycoFLEX, uporabite naslednjo opremo:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 10 ml; 50 ml, 100 ml, 250 ml cardboard box
Slovenian: PODATKI NA ZUNANJI OVOJNINI 10 ml, 50 ml, 100 ml, 250 ml, kartonska škatla
English: PACKAGE LEAFLET: Ingelvac CircoFLEX suspension for injection for pigs
Slovenian: NAVODILO ZA UPORABO Ingelvac CircoFLEX, suspenzija za injiciranje za prašiče
English: Porcine circovirus type 2 ORF2 protein
Slovenian: beljakovino ORF2 prašičjega cirkovirusa tipa 2
English: Pack sizes of 1 or 12 high density polyethylene bottles of 10 ml, 50 ml, 100 ml or 250 ml.
Slovenian: Pakiranja vsebujejo 1 ali 12 steklenicami iz polietilena velike gostote, ki vsebujejo po 10 ml, 50 ml, 100 ml ali 250 ml.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Ni smiselno.
English: U.S.A.
Slovenian: i.m.
English: Carbomer Sodium chloride Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi karbomer natrijev klorid voda za injekcije
English: When mixed with Ingelvac MycoFLEX:
Slovenian: Kadar cepivo mešate s cepivom Ingelvac MycoFLEX:
English: Single intramuscular injection of one dose (1 ml), irrespective of body weight.
Slovenian: Enkratni odmerek (1 ml) intramuskularno, ne glede na telesno maso.
English: Onset of immunity:
Slovenian: Začetek imunosti :
English: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Slovenian: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Overdose (symptoms, emergency procedures, antidotes) Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section “Adverse reactions” have been observed.
Slovenian: Po uporabi 4-kratnega prevelikega odmerka cepiva niso opazili drugih neželenih učinkov, razen tistih, ki so opisani v poglavju »Neželeni učinki«.
English: Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Single IM injection of 1 ml.
Slovenian: odmerek 1 ml.
English: - Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX.
Slovenian: - Povežite drugi konec igle za prenos s plastenko s cepivom Ingelvac CircoFLEX.
English: Date of first authorisation: Date of last renewal:
Slovenian: Datum pridobitve dovoljenja za promet: Datum podaljšanja dovoljenja za promet: 14.01.2013
English: Active substance:
Slovenian: NAVEDBA UČINKOVIN
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Slovenian: Na voljo so podatki o varnosti in učinkovitosti, ki dokazujejo, da lahko to cepivo zmešamo s cepivom
English: If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.
Slovenian: Če je treba, previdno stisnite plastenko s cepivom Ingelvac
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: - Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX.
Slovenian: Povežite en konec igle za prenos s plastenko s cepivom, ki vsebuje Ingelvac MycoFLEX.
English: WITHDRAWAL PERIOD
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: 2621 North Belt Highway,
Slovenian: Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph, Missouri, 64506-2002 ZDA
English: This summary was last updated in 07-2017
Slovenian: Povzetek je bil nazadnje posodobljen 07-2017.
English: Fampyra fampridine
Slovenian: Fampyra fampridin
English: (An 8-point improvement is considered clinically significant in this scale, which ranges from 0 to 100).
Slovenian: (Izboljšanje za osem točk se po tej lestvici, ki sega od 0 do 100, šteje kot klinično pomembno.)
English: This was switched to a full marketing authorisation on 22 May 2017.
Slovenian: To je bilo 22. maja 2017 spremenjeno v običajno dovoljenje za promet.
English: What measures are being taken to ensure the safe and effective use of Fampyra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fampyra?
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Fampyra on 20 July 2011.
Slovenian: Evropska komisija je pogojno dovoljenje za promet z zdravilom Fampyra, veljavno po vsej Evropski uniji, izdala 20. julija 2011.
English: The full EPAR for Fampyra 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 Fampyra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The patients were treated for 9 or 14 weeks, with their waking speed measured along a 25 feet (7.5 metres) footpath.
Slovenian: Bolnike so zdravili devet ali štirinajst tednov, njihovo hitrost hoje pa so merili na dolžini 25 čevljev (7,5 metra).
English: Fampyra is available as 10 mg tablets taken without food twice a day, 12 hours apart.
Slovenian: Zdravilo Fampyra je na voljo v obliki 10-miligramskih tablet, ki se jemljejo brez hrane dvakrat na dan, v razmiku 12 ur.
English: Other information about Fampyra
Slovenian: Druge informacije o zdravilu Fampyra
English: Treatment should also be stopped if a patient's walking ability worsens or if the patient does not report any benefit.
Slovenian: Zdravljenje je treba prekiniti tudi, če se bolnikova sposobnost hoje poslabša ali če bolnik ne poroča o napredku.
English: After two to four weeks, patients are evaluated and those who have not shown an improvement should stop treatment.
Slovenian: Po dveh do štirih tednih je treba bolnike oceniti in pri tistih, pri katerih ni izboljšanja, zdravljenje prekiniti.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Slovenian: Ker je družba predložila dodatne zahtevane podatke, je bilo dovoljenje za promet spremenjeno iz pogojnega v običajno.
English: This is a summary of the European public assessment report (EPAR) for Fampyra.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fampyra.
English: With regard to the medicine's safety, serious side effects with Fampyra are rare.
Slovenian: Kar zadeva varnost, so resni neželeni učinki zdravila Fampyra redki.
English: Fampyra was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Slovenian: Zdravilo Fampyra je prvotno pridobilo „pogojno dovoljenje za promet“, ker so bili pričakovani še dodatni dokazi o zdravilu.
English: What benefits of Fampyra have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Fampyra izkazalo v študijah?
English: Fampyra must not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2' such as cimetidine.
Slovenian: Zdravila Fampyra se ne sme uporabljati sočasno z drugimi zdravili, ki vsebujejo fampridin, ali zdravili, znanimi kot „zaviralci organskih kationskih prenašalcev 2“, kot je cimetidin.
English: It is not intended to provide practical advice on how to use Fampyra.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What are the risks associated with Fampyra?
Slovenian: Kakšna tveganja so povezana z zdravilom Fampyra?
English: The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness).
Slovenian: Neželeni učinki zdravila Fampyra so večinoma nevrološki (povezani z možgani ali živci) in vključujejo epileptične napade (krče), nespečnost, tesnobo, motnje ravnotežja, omotico, parestezijo (nenavadna občutja, kot zbadanje z iglami), tremor, glavobol in astenijo (šibkost).
English: What is Fampyra and what is it used for?
Slovenian: Kaj je zdravilo Fampyra in za kaj se uporablja?
English: The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection.
Slovenian: Najpogostejši neželeni učinek, o katerem so poročali v kliničnih študijah in ki se je pojavil pri približno 12 % bolnikov, je okužba sečil.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fampyra have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Fampyra upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: A third study in 633 patients measured improvements in walking ability over 24 weeks using a rating scale known as the multiple sclerosis walking scale (MSWS), where patients rated how well they were able to do various activities such as walking, running or climbing stairs.
Slovenian: Tretja študija s 633 bolniki je merila izboljšanje sposobnosti hoje v 24 tednih z uporabo ocenjevalne lestvice, imenovane lestvica za ocenjevanje hoje pri multipli sklerozi (MSWS), pri kateri so bolniki ocenjevali, kako dobro lahko opravljajo različne dejavnosti, kot so hoja, tek ali hoja po stopnicah.
English: It must not be used in patients who have seizures or have ever had seizures or in patients with kidney problems.
Slovenian: Ne smejo ga uporabljati bolniki, ki imajo ali so že imeli epileptične napade, in bolniki, ki imajo težave z ledvicami.
English: The active substance in Fampyra, fampridine, is a potassium channel blocker.
Slovenian: Zdravilna učinkovina v zdravilu Fampyra, fampridin, je zaviralec kalijevih kanalčkov.
English: Fampyra is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.
Slovenian: Fampyra je zdravilo, ki se uporablja za izboljšanje sposobnosti hoje pri odraslih z multiplo sklerozo (MS), ki ne morejo hoditi.
English: Why is Fampyra approved?
Slovenian: Zakaj je bilo zdravilo Fampyra odobreno?
English: It contains the active substance fampridine.
Slovenian: Vsebuje zdravilno učinkovino fampridin.