FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you are allergic to denosumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete primjenjivati lijek XGEVA Nemojte primjenjivati lijek XGEVA: - ako ste alergični na denosumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: XGEVA is not recommended for use if you are pregnant.
Croatian: Ne preporučuje se korištenje lijeka XGEVA u trudnoći.
English: A grade 3 decrease in serum calcium levels was experienced in 2.5% of patients treated with XGEVA and 1.2% of patients treated with zoledronic acid.
Croatian: Smanjenje razina kalcija u serumu stupnja 3 primijećeno je u 2,5% bolesnika liječenih lijekom XGEVA i u 1,2% bolesnika liječenih zoledronatnom kiselinom.
English: • persistent pain in the mouth and/or jaw, and/or swelling or non-healing of sores in the mouth or jaw, discharge, numbness or feeling of heaviness in the jaw, or loosening of a tooth could be signs of bone damage in the jaw (osteonecrosis).
Croatian: • trajna bol u ustima i/ili čeljusti, i/ili oticanje ili nezarastanje rana u ustima ili čeljusti, iscjedak,
English: Supplementation of at least 500 mg calcium and 400 IU vitamin D daily is required in all patients, unless hypercalcaemia is present (see section 4.4).
Croatian: D dnevno nužan je u svih bolesnika, osim u slučaju prisutne hiperkalcijemije (vidjeti dio 4.4).
English: Objective treatment response in patients with giant cell tumour of bone
Croatian: Tablica 4. Objektivni terapijski odgovor u bolesnika s gigantocelularnim tumorom kosti Broj bolesnika procjenjivih na odgovor
English: Density/Size4
Croatian: Gustoća/veličina4
English: A higher incidence of ONJ among subjects treated with denosumab compared to zoledronic acid has been observed in SRE prevention clinical trials.
Croatian: Opažena je veća incidencija ONČ u skupini ispitanika koji su primali denosumab nego u ispitanika koji su primali zoledronatnu kiselinu u kliničkim ispitivanjima prevencije koštanih događaja.
English: In the post-marketing setting, events of hypersensitivity, including rare events of anaphylactic reactions, have been reported in patients receiving XGEVA.
Croatian: Nakon stavljanja lijeka u promet u bolesnika koji primaju lijek XGEVA zabilježeni su slučajevi preosjetljivosti, uključujući rijetke slučajeve anafilaktičkih reakcija.
English: • diarrhoea.
Croatian: • proljev.
English: A grade 3 decrease in serum calcium levels was experienced in 1.4% of patients treated with XGEVA and 0.6% of patients treated with zoledronic acid.
Croatian: Smanjenje razina kalcija u serumu stupnja 3 primijećeno je u 1,4% bolesnika liječenih lijekom XGEVA i u 0,6% bolesnika liječenih zoledronatnom kiselinom.
English: A grade 4 decrease in serum calcium levels was experienced in 0.4% of patients treated with XGEVA and 0.1% of patients treated with zoledronic acid.
Croatian: Smanjenje razina kalcija u serumu stupnja 4 primijećeno je u 0,4% bolesnika liječenih lijekom XGEVA i u 0,1% bolesnika liječenih zoledronatnom kiselinom.
English: Efficacy results in patients with advanced malignancies involving bone Study 1 breast cancer
Croatian: Tablica 2. Rezultati djelotvornosti u bolesnika s uznapredovalim malignim bolestima koje zahvaćaju kosti
English: Efficacy and safety of 120 mg XGEVA SC every 4 weeks or 4 mg zoledronic acid (dose-adjusted for reduced renal function) IV every 4 weeks were compared in three randomised, double-blind,
Croatian: Dmab = Denosumab 120 mg svaka 4 tjedna ZA = Zoledronatna kiselina 4 mg svaka 4 tjedna N = Broj randomiziranih ispitanika * = Statistički značajno za superiornost, ** = Statistički značajno za ne-inferiornost
English: Drug hypersensitivity1
Croatian: Preosjetljivost na lijek1
English: active-controlled studies, in IV-bisphosphonate naïve patients with advanced malignancies involving bone: adults with breast cancer (study 1), other solid tumours or multiple myeloma (study 2), and castrate-resistant prostate cancer (study 3).
Croatian: Djelotvornost i sigurnost 120 mg lijeka XGEVA primijenjenog s.c. svaka 4 tjedna ili 4 mg zoledronatne kiseline (doza prilagođena za smanjenu funkciju bubrega) primijenjene i.v. svaka 4 tjedna uspoređene su u tri randomizirana, dvostruko slijepa, aktivno kontrolirana ispitivanja u bolesnika koji do tada nisu primali intravenski bisfosfonat, s uznapredovalim malignim bolestima koje zahvaćaju kosti: odrasli s rakom dojke (ispitivanje 1), drugim solidnim tumorima ili multiplim mijelomom (ispitivanje 2) i rakom prostate rezistentnim na kastraciju (ispitivanje 3).
English: NR NR NR NR NR 28.6
Croatian: NP NP NP NP NP 28,6
English: Water for injections * Acetate buffer is formed by mixing acetic acid with sodium hydroxide
Croatian: 6.1 Popis pomoćnih tvari acetatna kiselina, ledena* natrijev hidroksid (za podešavanje pH)* sorbitol (E420) polisorbat 20 voda za injekcije * acetatni pufer dobiva se miješanjem acetatne kiseline s natrijevim hidroksidom
English: Protect from light.
Croatian: Zaštićeno od svjetlosti.
English: Date of last renewal: 10/06/2015
Croatian: Datum zadnjeg produženja: 10/06/2015
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Croatian: Djelatne tvari kao načelo biološkog podrijetla namijenjene za proizvodnju aktivnog imuniteta nisu u okviru regulativa (EC) 470/2009.
English: PACKAGE SIZE 10 x 1 dose
Croatian: VELIČINA PAKOVANJA 10 x 1 doza
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
Croatian: SADRŽAJ: TEŽINA, VOLUMEN ILI BROJ DOZA
English: Interaction with other medicinal products and other forms of interaction:
Croatian: Interakcija sa drugim medicinskim proizvodima i drugi oblici interakcije:
English: Store in a refrigerator.
Croatian: Čuvati u hladnjaku
English: Thereafter a maximum interval of two years is recommended (see scheme).
Croatian: Nakon toga preporuča se maksimalno period od 2 godine do sljedećeg cijepljenja (vidi skicu).
English: Keep out of the sight and reach of children.
Croatian: Čuvati izvan pogleda i dosega i djece.
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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/07/2005
Croatian: Datum prvog odobrenja za stavljanje u promet: 08/07/2005
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Croatian: Inkompatibilnost: Ne miješati sa drugim veterinarsko-medicinskim proizvodima.
English: Store in a refrigerator (2 °C - 8 °C).
Croatian: Čuvati u hladnjaku (2°C-8 °C),
English: In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
Croatian: U vrlo rijetkim slučajevima može se javiti lokalna reakcija koja prelazi 5 cm i može trajati duže od 2 dana.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA LIJEČENJE ŽIVOTINJA” I UVETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
English: Equilis Te [a clear pictogram of a horse]
Croatian: Equilis Te [piktogram konja]
English: This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
Croatian: To će dovesti do pasivne zaštite protiv tetanusa kroz najmanje 21 dana nakon pravilne upotrebe.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajkte vašeg veterinara kako odlagati lijekove koji više nisu u upotrebi.
English: Following the administration of a double dose of vaccine, no side effects other than those described under section 4.6 have been observed except for some depression at the day of vaccination.
Croatian: Nakon administracije dvostrukih doza cjepiva, nema nikakvih drugih nuspojava osim onih koje su opisane u poglavlju 4.6., osim moguće utučenosti do kojih dođe na dan cijepljenja.
English: 24 months after the first revaccination
Croatian: 24 mjeseca nakon prvog docjepljivanja
English: To stimulate active immunity against tetanus.
Croatian: Poticanje aktivnog imuniteta protiv tetanusa
English: Only healthy animals should be vaccinated.
Croatian: Samo zdrave životinje mogu biti cijepljenje.
English: Package size:
Croatian: Veličina pakiranja:
English: Administer 1 ml of vaccine intramuscularly.
Croatian: Upotrijebiti 1ml cjepiva intramuskularno.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Croatian: Ne koristiti ovaj veterinarsko medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiven primjenom tih veterinarsko-medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
English: The second dose of the vaccine (V2) should be administered 4 weeks later.
Croatian: Druga doza cjepiva (C2) mora biti upotrebljena 4 tjedana kasnije.
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children.
Croatian: I DOSEGA DJECE” Čuvati izvan dosega i pogleda djece.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili nuspojave koje nisu opisane u priloženoj uputi o VMP, molimo da se javite veterinaru.
English: A clear opalescent suspension.
Croatian: Bistra opalescentna suspenzija.
English: Can be used during pregnancy and lactation.
Croatian: Može se upotrijebiti tijekom graviditeta i laktacije.
English: In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum at a separate injection site, using separate syringes and needles.
Croatian: U tom slučaju, prva doza (C1) cjepiva može se dati istovremeno s odgovarajućom profilaktičkom dozom Tetanus-Seruma na različitim mjestima uboda upotrebom različitih šprica i igli.
English: Concurrent active and passive immunisation (emergency vaccination)
Croatian: Simultana aktivna i pasivne imunizacija ( u slučaju hitnosti )
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.
Croatian: Ne postoje dostupni podaci o sigurnosti i efikasnosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom osim gore navedenim proizvodom.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tetanus toxoid 40 Lf/ml
Croatian: Tetanus toksoid 40 Lf/ml
English: The first revaccination is given not later than 17 months after the primary vaccination course.
Croatian: Prvo docjepljivanje se daje najkasnije do 17 mjeseci nakon primljenog primarnog cjepiva.
English: Active immunisation of horses from 6 months of age against tetanus to prevent mortality.
Croatian: Aktivna imunizacija konja od 6 mjeseci starosti protiv tetanusa kako bi se spriječila smrtnost.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju samoinjiciranja, odmah potražiti liječničku pomoć i pokazati uputu ili etiketu.
English: Emil-von-Behring-Str. 76 35 041 Marburg Germany
Croatian: GSK Vaccines GmbH Emil-von-Behring-Str. 76 35 041 Marburg
English: Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Croatian: Ždrebad ne treba cijepiti prije navršenih 6 mjeseci, pogotovo ako je oždrijebljena kobila bila docijepljena u posljednja dva mjeseca graviditeta, zbog mogućih preklapanja s materinskim antitijelima.
English: Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Croatian: U rijetkim slučajevima može se javiti bol na mjestu injiciranja koje može rezultirati privremenom funkcionalnom nelagodom (ukočenost).
English: ATC vet code: QI05AB03
Croatian: Farmakoterapijska grupa: Inaktivirano virusno cjepivo ATCvet kod: QI05AB03
English: Purified Saponin
Croatian: Pročišćeni saponin
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 8).
Croatian: Podaci o sigurnosti i efikasnosti su dostupni što je dokaz da ovo cjepivo smije biti primijenjeno istog dana ali ne pomiješano s Tetanus Serum od Interveta ( vidjeti odjeljak 8).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1 ml vial and 1 ml pre-filled syringe
Croatian: OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA 1 ml bočice i 1 ml punjene igle
English: Administer one dose (1ml), by intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Croatian: Primjeniti jednu dozu (1ml) intamuskularne injekcije primjenjuje se na sljedeći način: • Primarno cijepljenje: prva injekcija se daje sa 6 mjeseci starosti a druga injekcija 4 tjedana kasnije
English: Cardboard box with 10 glass vials.
Croatian: Kartonska kutija sa 10 staklenih bočica.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Croatian: RIJEČI “SAMO ZA LIJEČENJE ŽIVOTINJA” Samo za liječenje životinja.
English: PACKAGE LEAFLET FOR Equilis Te suspension for injection for horses
Croatian: Equilis Te suspenzija za injekciju za konje
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet.
Croatian: Podaci o sigurnosti i efikasnosti su dostupni, što je dokaz da ovo cjepivo smije biti primijenjeno istog dana ali ne pomiješano s Tetanus Serum od Interveta
English: 4.4 Special warnings for each target species
Croatian: 4.4 Posebna upozorenja za svaku vrstu životinja
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)
Croatian: U slučaju povećanog rizika od infekcija ili nedovoljnog unosa kolostruma, dodatna inicialno početna injekcija može biti data u dobi od 4 mjeseca kao slijed punog programa cijepljenja ( primarno cijepljenje sa 6 mjeseci starosti te ponovljeno nakon 4 tjedana).
English: 375 µg
Croatian: Pročišćeni saponin 375 µg
English: The vaccine can be used together with Tetanus-Serum for treatment of injured horses that have not been immunised against tetanus.
Croatian: Cjepivo može biti upotrebljeno zajedno s Tetanus-Serum za tretiranje ozljeđenih konja koji nisu bili imunizirani protiv tetanusa.
English: Store in a refrigerator (2°C -8°C).
Croatian: Čuvati u hladnjaku 2°C-8°C,.
English: A third vaccination with Equilis Te should be repeated at least four weeks later.
Croatian: Treće cjepivo sa Equilis Te trebalo bi biti ponovljeno najkasnije 4 tjedna nakon drugog cjepiva.
English: Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph. Eur.
Croatian: Flokulacijski ekvivalent; odgovara ≥ 30 IU/ml seruma zamoraca u Ph. Eur. testu potencije.
English: 62.5 µg For the full list of excipients, see section 6.1
Croatian: Za potpuni popis pomoćnih tvari vidi 6.1.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: Equilis Te, suspenzija za injekciju, za konje NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer
Croatian: Wim de Kőrverstraat 35 5831 AN Boxmeer
English: Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.
Croatian: Istovremena upotreba Equilis Te i Tetanus-Seruma od Interveta može smanjiti aktivni imunitet protiv tetanusa konjima koji su cijepljeni s Equilis Te u nedostataku tetanus antioksina seruma.
English: Intervet International B.V. NL-5831 AN Boxmeer
Croatian: Nl-5831 an Boxmeer
English: ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach room temperature before use.
Croatian: Prija davanja cjepivo treba biti na sobnoj temperaturi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/ ).
Croatian: Europske agencije za lijekove (http://www.ema.europe.eu/).
English: Name and address of the manufacturers of the biological active substance GSK Vaccines GmbH
Croatian: Naziv i adresa proizvođača biološki djelatneih tvari
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box with 10 vials
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija s 10 bočica
English: 1 ml suspension in type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Croatian: I staklena šprica, koja sadrži klip od halogenobutila zatvorenog s halogenobutil čepom.
English: Phosphate buffer Chloride buffer
Croatian: Fosfatni pufer, Kloridni pufer, Formaldehid u tragovima
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNETVARI I NOSITELJI PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
Croatian: U rijetkim slučajevima može se javiti temperatura, 1 do najviše 3 dana, koju nekada prati letargija.
English: Name and address of the manufacturer responsible for batch release
Croatian: Njemačka Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: 1 ml suspension in type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Croatian: I staklena bočica zatvorena sa halogenobutil gumenim čepom i zapečaćen sa aluminijskim čepom.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: • jako rijetka (od ukupno 10 000 životinja pogađa manje od 1 životinje, uključujući izolirane slučajeve)
English: Cardboard box with 10 pre-filled syringes with needles.
Croatian: Kartonska kutija sa 10 staklenih šprica s iglama.
English: Special warnings for each target species:
Croatian: Posebna upozorenja za upotrebu kod životinja:
English: 125 µg Phosphatidylcholine 62.5 µg
Croatian: 62.5 µg Bistra opalescentna suspenzija.
English: Do not mix with any other veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom 6.3 Rok valjanosti
English: Lactose
Croatian: NUSPOJAVE
English: Cardboard box with 10 pre-filled syringes with needles
Croatian: Kutija s 10 punjenih injekcija s iglom
English: Active substance:
Croatian: Način primjene cjepiva:
English: A diffuse hard or soft swelling (max. diameter 5 cm) may rarely occur at the injection site, regressing within 2 days.
Croatian: 5cm) na mjestu injiciranja, koje se povuče unutar 2 dana.
English: Read package leaflet before use.
Croatian: POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene.
English: Phosphatidylcholine
Croatian: Kolesterol Fosfatidilkolin
English: 2 weeks after the primary vaccination course
Croatian: Početak imunosti: 2 tjedna nakon primarnog cijepljenja Trajanje imunosti: 17 mjeseci nakon primarnog cijepljenja
English: Adjuvants:
Croatian: Plodnost:
English: Concurrent active and passive immunisation (emergency vaccination) The vaccine can be used together with Tetanus-Serum for treatment of injured horses that have not been immunised against tetanus.
Croatian: Cjepivo može biti upotrijebljeno zajedno s Tetanus-Serum za tretiranje ozlijeđenih konja koji nisu bili imunizirani protiv tetanusa.
English: SPECIAL STORAGE CONDITIONS
Croatian: 11. POSEBNI UVIJETI ČUVANJA
English: potency test
Croatian: Istovremena uptreba
English: Vaccination schedule: Primary vaccination course
Croatian: Primarno cjepljenje
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
English: Pack size blister (PVC/alu) 90 x 1 tablets (unit dose)
Croatian: 90 x 1 tableta (jedinična doza)
English: Invented Name Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje
English: The full EPAR and risk management plan summary for Duaklir Genuair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Duaklir Genuair nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose of Duaklir Genuair is one inhalation twice a day.
Croatian: Preporučena doza lijeka Duaklir Genuair je jedna inhalacija dva puta na dan.
English: Why is Duaklir Genuair approved?
Croatian: Zašto je Duaklir Genuair odobren?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duaklir Genuair on 19 November 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Duaklir Genuair na snazi u Europskoj uniji od 19. studenog 2014.
English: This is a summary of the European public assessment report (EPAR) for Duaklir Genuair.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Duaklir Genuair.
English: Duaklir Genuair is used for maintenance (regular) treatment.
Croatian: Duaklir Genuair koristi se za terapiju održavanja (redovitu terapiju).
English: Other information about Duaklir Genuair
Croatian: Ostale informacije o lijeku Duaklir Genuair
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duaklir Genuair'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 Duaklir Genuair nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.