FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET
English: Special warnings for each target species: Vaccinate healthy animals only.
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Slovenian: BESEDILO “SAMO ZA ŽIVALI” Samo za živali
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Slovenian: Vsak odmerek po 1 ml vsebuje:
English: For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
Slovenian: Na primer, na mestu injiciranja lahko opazite lokalno oteklino do 5 cm premera, ki lahko popolnoma izgine po več kot 5 tednih.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Nobivac series containing Bordetella bronchiseptica and/or parainfluenza virus components for intranasal administration.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko daje isti dan toda ne mešano s cepivi serije Nobivac za intranazalno dajanje, ki vsebujejo bakterijo Bordetella bronchiseptica in/ali virus parainfluence.
English: 4.2 Indications for use, specifying the target species
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: None.
Slovenian: Jih ni.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
English: Cardboard box with 1 vial of 10 ml (10 doses).
Slovenian: Kartonska škatla z 1 vialo po10 ml (10 odmerkov).
English: To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.
Slovenian: Za stimulacijo aktivne imunosti pri psih proti serološkim skupinam L. interrogans Canicola serovar Canicola, L. interrogans Icterohaemorrhagiae serovar Copenhageni, L. interrogans Australis serovar Bratislava in L. kirschneri Grippotyphosa serovar Bananal/Lianguang.
English: The product information of the relevant Nobivac vaccines should be consulted before administration of the mixed product.
Slovenian: Pred dajanjem mešanega cepiva je treba preučiti navodila ustreznih cepiv Nobivac.
English: Plastic box with 5, 10, 25 or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Slovenian: Plastična škatla s 5, 10, 25 ali 50 vialami po 1 ml Kartonska škatla z 1 vialo po10 ml
English: Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi tiomersal natrijev klorid kalijev klorid dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
English: Once broached, use within 10 hours.
Slovenian: Načeto/odprto zdravilo uporabite v 10 urah.
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Slovenian: - serološka skupina L. interrogans Australis serovar Bratislava (sev As-05-073)
English: PHARMACEUTICAL FORM Suspension for injection.
Slovenian: Suspenzija za injiciranje.
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Slovenian: - serološka skupina L. kirschneri Grippotyphosa serovar Dadas (sev Gr-01-005)
English: 4.1 Target species
Slovenian: KLINIČNI PODATKI 4.1 Ciljne živalske vrste
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Slovenian: Serološka skupina L. interrogans Canicola serovar Portland-vere (sev Ca-12-000)
English: PACKAGE LEAFLET: Nobivac L4 suspension for injection for dogs
Slovenian: Nobivac L4 suspenzija za injiciranje za pse
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Slovenian: - serološka skupina L. interrogans Icterohaemorrhagiae serovar Copenhageni (sev Ic-02-001)
English: Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccines.
Slovenian: Farmakoterapevtska skupina: Imunološko zdravilo za pse (Canidae), inaktivirano bakterijsko cepivo Oznaka ATC vet QI07AB01.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Slovenian: NAČIN IN POT(I) UPORABE
English: For simultaneous use, 1 dose of a Nobivac vaccine containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components should be reconstituted with 1 dose (1 ml) of Nobivac L4.
Slovenian: Za sočasno dajanje je treba 1 odmerek cepiva Nobivac, ki vsebuje virus pasje kuge, pasji adenovirus tipa 2, pasji parvovirus in/ali virus pasje parainfluence, rekonstituirati z 1 odmerkom (1 ml) cepiva Nobivac L4.
English: Vial of 1 ml or 10 ml
Slovenian: Viala po 1 ml in 10 ml
English: 4.5 Special precautions for use
Slovenian: 4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih
English: PHARMACEUTICAL FORM Suspension for injection
Slovenian: Suspenzija za injiciranje
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC BIOLOŠKIH UČINKOVIN IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4 suspension for injection for dogs
Slovenian: NAVODILO ZA UPORABO Nobivac L4 suspenzija za injiciranje za pse
English: Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.
Slovenian: Pse od 6 tednov starosti dalje cepite dvakrat s po 1 odmerkom (1 ml) cepiva z razmikom 4 tednov.
English: Plastic box with 5, 10, 25 or 50 vials of 1 ml (1 dose).
Slovenian: Velikosti pakiranj: Plastična škatla s 5, 10, 25 ali 50 vialami po 1 ml (1 odmerek)
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Nizozemska Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus, and/or canine parainfluenza virus components for subcutaneous administration.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša s cepivi serije Nobivac za subkutano dajanje, ki vsebujejo virus pasje kuge, pasji adenovirus tipa 2, pasji parvovirus ali virus pasje parainfluence.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: 5831 AN Boxmeer
English: For active immunisation of dogs against: - L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion - L. interrogans serogroup Australis serovar Bratislava to reduce infection - L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion.
Slovenian: Za aktivno imunizacijo psov proti: - serološka skupina L. interrogans Canicola serovar Canicola za zmanjšanje okužbe in izločanja z urinom - serološka skupina L. interrogans Icterohaemorrhagiae serovar Copenhageni za zmanjšanje okužbe in izločanja z urinom
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Slovenian: Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of crossprotection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Slovenian: Podatki in vivo in in vitro pri neciljnih živalskih vrstah kažejo, da cepivo lahko zagotovi določeno navzkrižno zaščito proti serološki skupini L. interrogans Icterohaemorrhagiae serovar
English: BATCH NUMBER Lot {number}
Slovenian: Serija {številka}
English: Excipient:
Slovenian: Učinkovine:
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Slovenian: Po dajanju dvojnega odmerka cepiva niso opazili drugih neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Slovenian: Wim de Körverstraat 35
English: 3550-7100 U
Slovenian: 3550-7100 E1
English: 500-1700 U1
Slovenian: 500-1700 E1
English: Active substances:
Slovenian: Pomožna snov:
English: No adverse reactions other than those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Slovenian: Po dajanju dvojnega odmerka cepiva niso opazili drugih neželenih učinkov razen tistih, ki so navedeni v poglavju 6.
English: 5 x 1 ml (1 dose) 10 x 1 ml (1 dose) 25 x 1 ml (1 dose) 50 x 1 ml (1 dose) 10 ml (10 doses)
Slovenian: 25x 1 ml (1 odmerek)
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components for subcutaneous administration.
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje s cepivi serije Nobivac za subkutano dajanje, ki vsebujejo virus pasje kuge, pasji adenovirusa tipa 2, pasji parvovirus in/ali virus pasje parainfluence.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4
Slovenian: Nobivac L4
English: 4.11 Withdrawal period
Slovenian: 6.3 Rok uporabnosti
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) See package leaflet.
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
English: ADVERSE REACTIONS
Slovenian: NEŽELENI UČINKI
English: STATEMENT OF ACTIVE SUBSTANCES Read the package leaflet before use.
Slovenian: NAVEDBA UČINKOVIN(E) Pred uporabo preberite navodilo za uporabo.
English: Marketing authorisation holder and manufacturer responsible for batch release:
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij
English: EXPIRY DATE EXP {month/year} Once broached, use within 10 hours.
Slovenian: Načeto/odprto zdravilo uporabite v 10 urah (samo za vialo po 10 ml.
English: 6.3 Shelf life
Slovenian: 4.11 Karenca
English: PACKAGE SIZE
Slovenian: ŠTEVILKA SERIJE
English: London, 26 June 2008 Doc.
Slovenian: London, 26. junij 2008 Sklic dok.
English: International non-proprietary name (INN): gusperimus
Slovenian: Mednarodno nelastniško ime (INN): gusperimus
English: The CHMP normally takes up to 210 days to evaluate a new application.
Slovenian: CHMP običajno potrebuje do 210 dni za ocenjevanje nove vloge.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SPANIDIN
Slovenian: VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom SPANIDIN
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preskušanje ali program sočutne uporabe ter potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: Ref. EMEA/309003/2008
Slovenian: EMEA/378432/2008 Error!
English: If left untreated, it can result in organ damage or death.
Slovenian: Če se bolezen ne zdravi, lahko pride do poškodbe organov ali celo smrti.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Slovenian: Dopis, s katerim družba agencijo EMEA obvešča o umiku vloge, je na voljo tukaj.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a license.
Slovenian: Potem ko CHMP izda svoje mnenje, navadno traja približno dva meseca, preden Evropska komisija dovoljenje odobri.
English: Spanidin was designated as an orphan medicine on 29 March
Slovenian: Zdravilo Spanidin je bilo dne 29. marca 2001 določeno kot zdravilo sirota.
English: The main measure of effectiveness was the number of patients who stayed in remission (with no signs of active disease) for at least two months during treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so med zdravljenjem ostali v remisiji (brez znakov aktivne bolezni) vsaj dva meseca.
English: The effects of Spanidin were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Spanidin so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The CHMP noted that an additional study would be necessary to overcome these concerns.
Slovenian: CHMP je pripomnil, da bo potrebno izvesti dodatno študijo, s katero bodo omenjeni zadržki odpravljeni.
English: The CHMP was concerned that the main study was not sufficient to demonstrate the effectiveness of Spanidin, because of the way it was designed and carried out.
Slovenian: CHMP je bil zaskrbljen glede tega, da glavna študija ne zadostuje za dokaz učinkovitosti zdravila Spanidin zaradi načina, na katerega je bila načrtovana in izvedena.
English: This causes a range of symptoms that mainly affect the airways, lungs and kidneys.
Slovenian: Posledica tega je vrsta simptomov, ki večinoma prizadenejo dihalne poti, pljuča in ledvice.
English: In particular, the study included some patients who could have taken other treatments for their disease, so could not be considered to be ‘refractory'.
Slovenian: Še zlasti pa ker je študija vključevala nekaj bolnikov, ki bi lahko jemali druga zdravila za svojo bolezen, zato jih ni mogoče šteti za „refraktarne“.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Slovenian: Potem ko je CHMP ocenil odgovore družbe na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
English: In addition, Spanidin was not compared with any other treatment, so it was not possible to distinguish the effects of Spanidin and of steroids.
Slovenian: Poleg tega zdravila Spanidin niso primerjali z nobenim drugim zdravljenjem, zato ni mogoče ločiti med učinki zdravila Spanidin in učinki steroidov.
English: What documentation did the company present to support its application to the CHMP?
Slovenian: Katero dokumentacijo je družba predložila CHMP v podporo svoji vlogi?
English: What is Spanidin?
Slovenian: Kaj je zdravilo Spanidin?
English: What were the main concerns of the CHMP at that time?
Slovenian: Kateri so bili takrat glavni zadržki CHMP?
English: It contains the active substance gusperimus.
Slovenian: Vsebuje zdravilno učinkovino gusperimus.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Slovenian: Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (120. dan), ki ga pošlje družbi.
English: On 17 June 2008, Euro Nippon Kayaku GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Spanidin, for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Slovenian: Družba Euro Nippon Kayaku GmbH je dne 17. junija 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Spanidin, namenjenim indukciji remisije pri odraslih bolnikih s klinično refraktarno Wegenerjevo granulomatozo.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Spanidin?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Spanidin?
English: What were the reasons given by the company to withdraw the application?
Slovenian: Kakšni so bili razlogi družbe za umik vloge?
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Slovenian: Ko družba predloži odgovore na vprašanja, jih CHMP pregleda in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
English: In this disease, the immune system attacks neutrophils (a type of white blood cell), causing inflammation of small and medium-sized blood vessels and the formation of granulomas (clumps of white blood cells).
Slovenian: Pri tej bolezni imunski sistem napade nevtrofilce (vrsto belih krvnih celic), kar povzroči vnetje majhnih in srednje velikih krvnih žil in nastajanje granulomov (skupkov belih krvnih celic).
English: What was Spanidin expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Spanidin uporabljalo?
English: The CHMP was also concerned that the study included some patients for whom induction treatment was not necessary, and others who did not have the symptoms of ‘classic' Wegener's granulomatosis affecting the airways, lungs or kidneys.
Slovenian: CHMP je imel zadržke tudi glede dejstva, da je študija vključevala nekaj bolnikov, pri katerih indukcijsko zdravljenje ni bilo potrebno, in nekatere bolnike brez simptomov „klasične“ Wegenerjeve granulomatoze, ki prizadene dihalne poti, pljuča ali ledvice.
English: Spanidin is a powder that is made up into a solution for injection.
Slovenian: Zdravilo Spanidin je prašek za pripravo raztopine za injiciranje.
English: Wegener's granulomatosis is a rare, auto-immune disease (a disease which is caused by the body's own defence system attacking normal tissue).
Slovenian: Wegenerjeva granulomatoza je redka avtoimunska bolezen (bolezen, pri kateri obrambni sistem napade normalno tkivo lastnega telesa).
English: This study would need to involve patients who are truly refractory to other treatments, or it would need to compare Spanidin directly with cyclophosphamide (the standard treatment for inducing remission in Wegener's granulomatosis).
Slovenian: Taka študija bo morala zajeti bolnike, ki so resnično neodzivni na ostala zdravljenja, ali pa bo morala primerjati zdravilo Spanidin neposredno s ciklofosfamidom (standardnim zdravljenjem za indukcijo remisije pri Wegenerjevi granulomatozi).
English: Spanidin was expected to be used to control the symptoms of Wegener's granulomatosis in patients who were not responding to other treatments.
Slovenian: Zdravilo Spanidin bi se naj uporabljalo za nadzor nad simptomi Wegenerjeve granulomatoze pri bolnikih, ki se niso odzvali na druga zdravljenja.
English: How is Spanidin expected to work?
Slovenian: Kako naj bi zdravilo Spanidin delovalo?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Spanidin could not have been approved for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Spanidin ni mogoče odobriti za indukcijo remisije pri odraslih bolnikih s klinično refraktarno Wegenerjevo granulomatozo.
English: The active substance in Spanidin, gusperimus, is an immunosuppressive medicine, which means that it reduces the activity of the immune system (the body's natural defences).
Slovenian: Zdravilna učinkovina v zdravilu Spanidin, gusperimus, je imunosupresivno zdravilo, kar pomeni, da zavira delovanje imunskega sistema (naravne obrambe telesa).
English: The application was at day 194 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 194. dan postopka.
English: Spanidin has been studied in one main study involving 45 patients with Wegener's granulomatosis who were ‘refractory' (not responding) to standard treatment.
Slovenian: Zdravilo Spanidin so preučevali v eni glavni študiji, ki je vključevala 45 bolnikov z Wegenerjevo granulomatozo, ki so bili „refraktarni“ (neodzivni) na standardno zdravljenje.
English: They received Spanidin for six ‘cycles', with each cycle consisting of three weeks ‘on' treatment followed by one week ‘off'.
Slovenian: Zdravilo Spanidin so prejemali v šestih ciklusih, pri čemer je vsak ciklus obsegal tri tedne prejemanja zdravila, ki mu je sledil en teden brez dajanja zdravila.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that a benefit of Spanidin had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: CHMP je zato v času umika menil, da koristi zdravila Spanidin niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Spanidin.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Spanidin.
English: It is expected to work in Wegener's granulomatosis by disrupting the growth and activity of white blood cells called lymphocytes, which are involved in the inflammation process.
Slovenian: Pri Wegenerjevi granulomatozi bi naj delovala tako, da bi zavirala rast in aktivnost belih krvnih celic, imenovanih limfociti, ki sodelujejo v vnetnem procesu.
English: Spanidin was not compared with any other treatment in this study, but the patients could take corticosteroids (a group of immunosuppressive medicines) in addition to Spanidin.
Slovenian: V tej študiji zdravila Spanidin niso primerjali z nobenim drugim zdravilom, so pa bolniki lahko kot dodatek k zdravilu Spanidin jemali kortikosteroide (skupina imunosupresivnih zdravil).
English: By reducing the number of lymphocytes and interfering with the way they work, Spanidin is expected to reduce the inflammation in the blood vessels that causes the symptoms of the disease.
Slovenian: Zdravilo Spanidin bi naj z zmanjšanjem števila limfocitov in oviranjem njihovega delovanja zmanjšalo vnetje v krvnih žilah, ki povzroča simptome te bolezni.
English: 24 June 2016
Slovenian: 24. junij 2016
English: • bad taste in your mouth
Slovenian: • slab okus v ustih
English: Reconstitution time is less than 2 minutes.
Slovenian: Priprava traja manj kot 2 minuti.
English: Each vial is for single use only.
Slovenian: Vsaka viala je samo za enkratno uporabo.
English: This reaction may be life-threatening.
Slovenian: Ta reakcija je lahko smrtno nevarna.
English: A risk to newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojenčke/dojenčke ni mogoče izključiti.