FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore recommended that use of the medicines for prevention can continue, but the companies must provide further data on safety and effectiveness from new clinical studies by 2026.
Croatian: Stoga je CHMP preporučio nastavak korištenja tih lijekova za prevenciju, ali tvrtke do 2026. moraju dostaviti dodatne podatke o sigurnosti i učinkovitosti na temelju novih kliničkih ispitivanja.
English: • If you have any questions or concerns about your medicine, discuss them with your doctor or pharmacist.
Croatian: • Ako ste zabrinuti u pogledu lijeka koji uzimate, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: Bacterial lysate medicines have been authorised via national procedures.
Croatian: Lijekovi bakterijskog lizata odobreni su nacionalnim postupcima.
English: • If you have an infection and are taking a bacterial lysate medicine to treat it, or if you are taking one of these medicines to prevent pneumonia, contact your doctor or pharmacist for advice on alternatives.
Croatian: • Ako imate infekciju i uzimate lijek bakterijskog lizata protiv nje, odnosno ako uzimate neki od tih lijekova za prevenciju upale pluća, kontaktirajte svojeg liječnika ili ljekarnika za savjet ili alternativnu terapiju.
English: Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system to recognise and fight infections.
Croatian: Lijekovi bakterijskog lizata sastoje se od bakterijskih stanica koje su razgrađene te im je namjera stimulirati imunosni sustav da prepozna infekcije i bori se protiv njih.
English: On 27 June 2019, EMA recommended that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia.
Croatian: EMA je 27. lipnja 2019. preporučila da se lijekove bakterijskog lizata odobrene za poremećaje dišnih puteva koristi samo za prevenciju opetovanih infekcija dišnih puteva, s izuzetkom upale pluća.
English: Although data are limited, the review found some evidence of effectiveness of these medicines in the prevention of recurrent respiratory tract infections and the safety profile is in line with what is expected for this type of product.
Croatian: Iako su podatci ograničeni, pregledom su utvrđeni određeni dokazi o učinkovitosti tih lijekova u prevenciji opetovanih infekcija dišnih puteva, dok je sigurnosni profil u skladu s očekivanjima za ovu vrstu lijekova.
English: In the review, EMA's human medicines committee (CHMP) considered the results of clinical studies, data on side effects reported with these medicines, and advice from an expert group on infectious diseases.
Croatian: U pregledu je EMA-in Odbor za lijekove za humanu uporabu (CHMP) razmotrio rezultate kliničkih ispitivanja, zaprimljene podatke o nuspojavama za te lijekove te savjete stručne skupine za infektivne bolesti.
English: 09 September 2019 EMA/502527/2019
Croatian: 9. rujna 2019.
English: This followed a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not be used for these purposes.
Croatian: Preporuka je rezultat pregleda kojim je zaključeno da ne postoje pouzdani podatci koji bi ukazivali na učinkovitost tih lijekova u liječenju respiratornih infekcija niti za prevenciju upale pluća te ih se stoga ne bi smjelo primjenjivati u te svrhe.
English: • The prescribing information of the medicines is being updated with the new indication and a warning against use for prevention of pneumonia.
Croatian: • Informacije o propisivanju lijekova trenutno se ažuriraju novim indikacijama i upozorenjem da se ne smiju koristiti za prevenciju upale pluća.
English: • Bacterial lysate medicines should not be used to treat existing infections of the airways or to prevent pneumonia (a lung infection) because there are not enough data to show that they work for these uses.
Croatian: • Lijekovi bakterijskog lizata ne bi se trebali primjenjivati za liječenje postojećih infekcija dišnih puteva niti za prevenciju upale (infekcije) pluća jer nema dovoljno podataka koji bi ukazivali na njihovu učinkovitost za tu primjenu.
English: • The indications of bacterial lysate medicines have been restricted to prophylaxis of recurrent respiratory tract infections, with the exception of pneumonia.
Croatian: • Indikacije lijekova bakterijskog lizata ograničene su na profilaksu opetovanih infekcija dišnih puteva s izuzetkom upale pluća.
English: Bacterial lysate medicines should not
Croatian: Lijekovi bakterijskog lizata ne smiju se propisivati za liječenje
English: • Bacterial lysate medicines can continue to be used to prevent infections of the airways (except pneumonia) from coming back in patients who regularly get infections.
Croatian: • Lijekovi bakterijskog lizata i dalje se mogu primjenjivati za prevenciju infekcija dišnih puteva (osim upale pluća) kako se ne bi vratile u bolesnika s učestalim infekcijama.
English: be prescribed for treatment of existing respiratory infections or for prophylaxis of pneumonia due to lack of efficacy data.
Croatian: postojećih infekcija dišnih puteva niti za profilaksu upale pluća zbog manjka podataka o učinkovitosti.
English: 1 x 2 tablets (unit dose)
Croatian: 1 x 2 tablete (jedinična doza)
English: Oral use blister (alu/PVC/PCT FE)
Croatian: 90 mg filmom obložena tableta kroz usta blister (Al/PVC/PCTFE)
English: This overview was last updated in June 2018.
Croatian: Pregled je posljednji put ažuriran u 06. 2018.
English: Further studies were carried out under laboratory conditions to confirm the other benefits of vaccination.
Croatian: Provedena su dodatna ispitivanja u laboratorijskim uvjetima kako bi se potvrdile druge koristi cijepljenja.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Croatian: Cjepiva djeluju „učeći” imunosni sustav (prirodna obrana tijela) kako se obraniti od bolesti.
English: In the future, the cat's immune system will be able to produce antibodies more quickly when it is exposed to the disease-causing forms of the viruses.
Croatian: Ubuduće će imunosni sustav mačke moći brže proizvoditi protutijela ako je izložen oblicima virusa koji uzrokuju bolest.
English: The vaccine helps to reduce the signs of these diseases.
Croatian: Cjepivo pomaže pri ublažavanju znakova bolesti.
English: Further information on Leucofeligen FeLV/RCP can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Leucofeligen FeLV/RCP nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The first injection is given when the kitten is about eight weeks old, and the second three or four weeks later.
Croatian: Prva injekcija daje se mačićima u dobi od otprilike osam tjedana, a druga injekcija tri ili četiri tjedna poslije.
English: The contents of the two vials are mixed together before use to make up a suspension for injection.
Croatian: Sadržaj dviju bočica miješa se prije primjene kako bi se pripremila suspenzija za injekciju.
English: The vaccine also contains aluminium hydroxide and extract of Quillaja saponaria as adjuvants (ingredients that strengthen the immune response).
Croatian: Cjepivo također sadrži aluminijev hidroksid te ekstrakt Quillaja saponaria kao adjuvanse (sastojci koji pojačavaju imunosni odgovor).
English: It also contains a protein of feline leukaemia virus (FeLV).
Croatian: Također sadrži protein virusa mačje leukemije (FeLV).
English: The FeLV protein used in the vaccine is not extracted from viruses but is made in a bacterium using ‘recombinant DNA technology'.
Croatian: Protein FeLV koji se upotrebljava u cjepivu nije izvađen iz virusa, nego se dobiva iz bakterije primjenom „tehnologije rekombinantne DNK”.
English: The vaccine can only be obtained with a prescription.
Croatian: Cjepivo se izdaje samo na veterinarski recept.
English: The most common side effects with Leucofeligen FeLV/RCP (which may affect up to 1 in 10 cats) are a moderate and short-lived local reaction (<2 cm) after the first injection which resolves without treatment within 3 to 4 weeks, raised body temperature (lasting 1 to 4 days), apathy (listlessness) and digestive disturbances.
Croatian: Najčešće nuspojave VMP-a Leucofeligen FeLV/RCP (mogu se javiti u manje od 1 na 10 mačaka) umjerene su i prolazne lokalne reakcije (≤ 2 cm) nakon prve injekcije koje se povlače bez liječenja u roku od 3 do 4 tjedna, povišena tjelesna temperatura (traje od jednog do četiri dana), apatija (bezvoljnost) i probavne smetnje.
English: Leucofeligen FeLV/RCP should not be used in pregnant cats.
Croatian: Leucofeligen FeLV/RCP ne smije se primjenjivati u gravidnih mačaka.
English: Because Leucofeligen FeLV/RCP is made up of two vaccines that have been available in the European Union (EU) since the 1980s (Feligen RCP and Leucogen), the company used data from studies carried out with these vaccines to support the use of Leucofeligen FeLV/RCP.
Croatian: Budući da je VMP Leucofeligen FeLV/RCP sastavljen od dvaju cjepiva koja su dostupna u Europskoj uniji od 1980-ih (Feligen RCP i Leucogen), tvrtka je koristila podatke iz ispitivanja koja su provedena s tim dvama cjepivima kako bi iznijela dokaze u korist uporabe VMP-a Leucofeligen FeLV/RCP.
English: Leucofeligen FeLV/RCP has been examined in two main ‘field' studies involving kittens aged eight to nine weeks.
Croatian: Leucofeligen FeLV/RCP ispitan je u dvama glavnim „terenskim” ispitivanjima koja su obuhvatila mačiće u dobi od osam do devet tjedana.
English: When a cat is given the vaccine, the immune system recognises the weakened viruses and the FeLV proteins as ‘foreign' and makes antibodies against them.
Croatian: Kad mačka primi cjepivo, imunosni sustav prepoznaje oslabljene viruse i FeLV proteine kao „strano tijelo” te proizvodi protutijela na virus.
English: The vaccine starts to protect against panleucopenia and leukaemia 3 weeks after the second injection and protection against calicivirosis and viral rhinotracheitis starts 4 weeks after the second injection.
Croatian: Cjepivo postaje djelotvorno u zaštiti od panleukopenije i leukemije tri tjedna nakon druge injekcije, a zaštita od kaliciviroze i virusnog rinotraheitisa započinje četiri tjedna nakon druge injekcije.
English: A laboratory study in which cats were exposed to feline leukaemia virus confirmed that following the first annual booster vaccination cats were protected for a three year period against leukaemia.
Croatian: U laboratorijskom ispitivanju u kojemu su mačke izložene virusu mačje leukemije potvrđeno je trogodišnje razdoblje zaštite mačaka od leukemije nakon prve godišnje doze docjepljivanja.
English: Leucofeligen FeLV/RCP is available as two vials, one containing a white powder pellet and one containing a liquid.
Croatian: Leucofeligen FeLV/RCP dostupan je u obliku dviju bočica, od kojih jedna sadrži prah u bijelim peletama, a druga sadrži tekućinu.
English: The European Medicines Agency decided that Leucofeligen FeLV/RCP's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove je odlučila da koristi od VMP-a Leucofeligen FeLV/RCP nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: Leucofeligen FeLV/RCP contains small amounts of the three weakened viruses as listed above and a protein from the outer layer of FeLV called ‘envelope p45 protein'.
Croatian: Leucofeligen FeLV/RCP sadrži male količine triju oslabljenih virusa koji su prethodno navedeni i protein iz vanjskog sloja virusa FeLV naziva „antigen omotača p45”.
English: One year after the initial vaccination a booster vaccination should be given.
Croatian: Jednu godinu nakon početnog cijepljenja potrebno je docjepljivanje.
English: For more information about using Leucofeligen FeLV/RCP, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Leucofeligen FeLV/RCP pročitajte uputu o VMP-u, odnosno obratite se svom veterinaru ili ljekarniku.
English: The studies showed that Leucofeligen FeLV/RCP provided protection against the diseases listed above as measured by the presence of antibodies against the viruses in the vaccinated kittens' blood.
Croatian: U ispitivanjima je dokazano da VMP Leucofeligen FeLV/RCP pruža zaštitu od prethodno navedenih bolesti, što je izmjereno na temelju prisutnosti protutijela na viruse u krvi cijepljenih mačića.
English: In addition, it reduced the excretion of feline viral rhinotracheitis viruses, prevented a fall in white blood cell counts in feline panleucopenia and prevented FeLV from remaining in the blood.
Croatian: Osim toga, VMP-om je smanjena ekskrecija virusa mačjeg rinotraheitisa, spriječen je pad broja bijelih krvnih stanica kod panleukopenije mačaka te je spriječeno zadržavanje virusa FeLV u krvi.
English: The vaccine contains live feline viruses that have been attenuated (weakened) so they do not cause disease: feline calicivirus (strain F9), viral rhinotracheitis virus (strain F2) and feline panleucopenia virus (strain LR 72).
Croatian: Cjepivo sadrži žive mačje viruse koji su atenuirani (oslabljeni) radi sprečavanja pojave bolesti: mačji kalicivirus (soj F9), virus mačjeg rinotraheitisa (soj F2) i virus panleukopenije mačaka (soj LR 72).
English: Leucofeligen FeLV/RCP is given to kittens as two injections under the skin.
Croatian: VMP Leucofeligen FeLV/RCP daje se mačićima ubrizgavanjem dviju injekcija pod kožu.
English: Leucofeligen FeLV/RCP is a vaccine.
Croatian: Leucofeligen FeLV/RCP je cjepivo.
English: An overview of Leucofeligen FeLV/RCP and why it is authorised in the EU
Croatian: Pregled VMP-a Leucofeligen FeLV/RCP i zašto je odobren u EU-u
English: Other information about Leucofeligen FeLV/RCP
Croatian: Ostale informacije o VMP-u Leucofeligen FeLV/RCP
English: Protection against leukaemia lasts for 3 years once a booster has been given and lasts for one year for calicivirosis and viral rhinotracheitis.
Croatian: Zaštita od leukemije traje tri godine nakon docjepljivanja te jednu godinu za kalicivirozu i virusni rinotraheitis.
English: It also prevents feline panleucopenia and persistent viraemia for feline leukaemia (the presence of feline leukaemia virus in the blood).
Croatian: Također sprečava panleukopeniju mačaka i trajnu viremiju kod leukemije mačaka (prisutnost virusa mačje leukemije u krvi).
English: Its use is not recommended in cats nursing kittens.
Croatian: Primjena VMP-a ne preporučuje se tijekom laktacije mačaka.
English: What is Leucofeligen FeLV/RCP and what is it used for?
Croatian: Što je Leucofeligen FeLV/RCP i za što se primjenjuje?
English: What are the risks associated with Leucofeligen FeLV/RCP?
Croatian: Koji su rizici povezani s VMP-om Leucofeligen FeLV/RCP?
English: Why is Leucofeligen FeLV/RCP authorised in the EU?
Croatian: Zašto je lijek Leucofeligen FeLV/RCP odobren u EU-u?
English: Leucofeligen FeLV/RCP (Feline calicivirosis, feline viral rhinotracheitis, feline panleucopenia (live attenuated) and feline leukaemia (inactivated) vaccine)
Croatian: Leucofeligen FeLV/RCP (cjepivo protiv kaliciviroze mačaka, virusnog rinotraheitisa mačaka, panleukopenije mačaka (atenuirano živo) i leukemije mačaka
English: FeLV/RCP only every 3 years, with annual revaccination in intervening years with the vaccine Feligen RCP to protect against calicivirosis, rhinotracheitis and panleucopenia.
Croatian: Stoga je starije mačke potrebno ponovno cijepiti VMP-om Leucofeligen FeLV/RCP svake tri godine, uz ponovno cijepljenje VMP-om Feligen RCP jedanput godišnje kako bi ih se zaštitilo od kaliciviroze, virusnog rinotraheitisa i panleukopenije.
English: For the full list of side effects and restrictions with Leucofeligen FeLV/RCP, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni VMP-a Leucofeligen FeLV/RCP potražite u uputi o VMP-u.
English: How does Leucofeligen FeLV/RCP work?
Croatian: Kako djeluje Leucofeligen FeLV/RCP?
English: What benefits of Leucofeligen FeLV/RCP have been shown in studies?
Croatian: Koje su koristi od VMP-a Leucofeligen FeLV/RCP utvrđene u ispitivanjima?
English: How is Leucofeligen FeLV/RCP used?
Croatian: Kako se Leucofeligen FeLV/RCP primjenjuje?
English: Leucofeligen FeLV/RCP received a marketing authorisation valid throughout the EU on <date of issue of the Marketing Authorisation>.
Croatian: Za VMP Leucofeligen FeLV/RCP izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 25. lipnja 2009.
English: Leucofeligen FeLV/RCP is a vaccine used to protect cats from eight weeks of age against the following diseases: feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus); feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus); feline panleucopenia (a serious illness causing bloody diarrhoea and a fall in white blood cell counts caused by a parvovirus); feline leukaemia (an illness affecting the immune system causing loss of appetite, weight loss, poor fur condition, fever, pale gums and diarrhoea caused by a retrovirus).
Croatian: leukemije mačaka (bolest koja djeluje na imunosni sustav, što izaziva gubitak apetita, gubitak tjelesne težine, loše stanje krzna, vrućicu, blijede desni i proljev, koju uzrokuje retrovirus).
English: Edvard Thomsens Vej 14 DK-2300 København S Denmark
Croatian: Edvard Thomsens Vej 14 DK-2300 København
English: Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Croatian: Velika Britanija Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Croatian: Dodatak I Popis naziva, farmaceutskog oblika, jačina lijekova, puta primjene,
English: Perryment Ltd 42-46 High street Esher, KT10 9QY Surrey United Kingdom
Croatian: Nizozemska Perryment Ltd 42-46 High street Esher, KT10 9QY Surrey United Kingdom
English: Levonorgestrel-containing emergency contraceptive medicinal products Member State (in EEA)
Croatian: Za hitne kontraceptive koji sadrže levonorgestrel Država članica (u
English: Maksimirska 120 Zagreb 10000 Croatia
Croatian: Sandoz d.o.o. Maksimirska 120 Zagreb 10000 Croatia
English: Belgium Sandoz N.V. Telecom Gardens Medialaan 40
Croatian: Telecom Gardens Medialaan 40
English: 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland
Croatian: Gedeon Richter Polska Sp. z o.o. 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland
English: Luxembourg Laboratoire HRA Pharma 15, rue Béranger
Croatian: Luksemburg Laboratoire HRA Pharma 15, rue Béranger
English: Belgium Laboratoire HRA Pharma 15, rue Béranger
Croatian: Nizozemska Laboratoire HRA Pharma 15, rue Béranger
English: Sandoz d.o.o.
Croatian: Sandoz N.V.
English: Luxembourg Medimpex UK Limited 127 Shirland Road
Croatian: Luksemburg Medimpex UK Limited 127 Shirland Road
English: Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain
Croatian: Laboratorios León Farma S.A. Calle La Vallina s/n Polígono Industrial Navatejera 24008 - Navatejera - León Spain
English: Belgium Medimpex UK Limited 127 Shirland Road
Croatian: Velika Britanija Medimpex UK Limited 127 Shirland Road
English: Polígono Industrial Navatejera 24008 - Navatejera - León Spain
Croatian: Poligono Industrial Navatejera Navatejera, Leon E-24008
English: Czech Republic Laboratorios León Farma S.A. Calle La Vallina s/n
Croatian: Velika Britanija Laboratorios Leon Farma SA Calle La Vallina S/N
English: Czech Republic Gedeon Richter Plc.
Croatian: Velika Britanija Gedeon Richter Plc. Gyömröí út 19-21
English: The recommended dose is 3 mg for each kg of bodyweight.
Croatian: Preporučena je doza od 3 mg po svakom kilogramu tjelesne težine.
English: The full EPAR for Cinqaero can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Cinqaero nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The infusion should be given once every four weeks, for as long as the patient is considered to benefit, and doctors should re-assess at least once a year whether treatment should be continued.
Croatian: Infuziju treba dati jedanput svaka četiri tjedna i sve dok pacijent osjeća dobrobit, a liječnici bi trebali najmanje jedanput godišnje ponovno procijeniti je li potrebno nastaviti s liječenjem.
English: Overall the medicine was well tolerated, and appropriate measures to monitor and manage risks have been put in place.
Croatian: Općenito je lijek vrlo dobro toleriran te su uspostavljene odgovarajuće mjere za nadzor i upravljanje rizicima.
English: Flare-ups were seen in 32% of patients (151 out of 477) given Cinqaero compared with 50% (237 out of 476) of those given placebo.
Croatian: Pogoršanje je zabilježeno kod 32 % pacijenata (151 od 477) koji su uzimali Cinqaero u usporedbi s 50 % (237 od 476) onih koji su dobivali placebo.
English: Cinqaero EMA/450050/2016
Croatian: Cinqaero EMA/450050/2016x
English: Anaphylactic (severe allergic) reactions may affect less than 1 person in 100.
Croatian: Anafilaktičke (jake alergijske) reakcije mogu se javiti u manje od jedne osobe na 100.
English: Other information about Cinqaero
Croatian: Ostale informacije o lijeku Cinqaero
English: This is a summary of the European public assessment report (EPAR) for Cinqaero.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Cinqaero.
English: The main measure of effectiveness was based on the number of flare-ups (exacerbations) of asthma during treatment.
Croatian: Glavna mjera djelotvornosti temeljila se na broju razbuktavanja (pogoršanja) astme tijekom liječenja.
English: What measures are being taken to ensure the safe and effective use of Cinqaero?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cinqaero?
English: Cinqaero was compared with placebo (a dummy infusion), both given every 4 weeks for a year.
Croatian: Cinqaero je uspoređen s placebom (prividna infuzija), a oboje je primjenjivano svaka 4 tjedna tijekom godine dana.
English: It is not intended to provide practical advice on how to use Cinqaero.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Cinqaero.
English: What is Cinqaero and what is it used for?
Croatian: Što je Cinqaero i za što se koristi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cinqaero's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Cinqaero nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Why is Cinqaero approved?
Croatian: Zašto je Cinqaero odobren?
English: What are the risks associated with Cinqaero?
Croatian: Koji su rizici povezani s lijekom Cinqaero?
English: The most common side effect with Cinqaero (which may affect about 2 people in 100) is an increase in levels of the enzyme creatine phosphokinase in the blood (a measure of possible damage to muscles).
Croatian: Najčešća nuspojava lijeka Cinqaero (koja se može javiti u dvije osobe od 100) je povećanje razine enzima kreatin fosfokinaze u krvi (indikacija mogućeg oštećenja mišića).
English: The medicine contains the active substance reslizumab.
Croatian: Lijek sadrži djelatnu tvar reslizumab.
English: Supportive data suggested that the benefit was maintained for up to two years.
Croatian: Podaci koji govore u prilog primjeni lijeka sugeriraju da je korist zadržana do dvije godine nakon liječenja.