FrancophonIA/ELRC3.0 huggingface dataset:
English: medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol).
Croatian: Veća je vjerojatnost za nuspojave. lijekove zvane beta blokatori koji se koriste za visoki krvni tlak ili druge srčane probleme (kao što je propranolol), ili za problem s očima koji se zove glaukom (kao što je timolol). lijekove koji snižavaju količinu kalija u Vašoj krvi.
English: Some people occasionally cough soon after inhaling the medicine.
Croatian: Neki ljudi povremeno kašlju ubrzo nakon udisanja lijeka.
English: Both doses demonstrated statistically significant improvements in symptom relief over placebo for dyspnoea and health status (as evaluated by Transitional Dyspnoea Index [TDI] and St. George's Respiratory Questionnaire [SGRQ], respectively).
Croatian: Obje doze su pokazale statistički značajna poboljšanja s obzirom na smanjenje simptoma dispneje i zdravstvenog stanja u usporedbi s placebom (procijenjeno pomoću Prijelaznog indeksa dispnejeengl.
English: Do not take the inhaler apart.
Croatian: Nemojte rastavljati inhalator.
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Croatian: Beta2-adrenergički agonisti mogu uzrokovati znatnu hipokalijemiju u nekih bolesnika što može uzrokovati kardiovaskularne nuspojave.
English: • if you get crushing chest pain, (common).
Croatian: • ako imate razarajuću bol u prsima, (često).
English: Breathe out:
Croatian: Izdahnite:
English: Oslif Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Croatian: Oslif Breezhaler nije indiciran za liječenje akutnih epizoda bronhospazma, tj. kao lijek za hitna stanja.
English: What you need to know before you use Oslif Breezhaler
Croatian: Što morate znati prije nego počnete primjenjivati Oslif Breezhaler
English: Oslif Breezhaler contains lactose
Croatian: Oslif Breezhaler sadrži laktozu
English: Pooled efficacy analysis over 6 months' treatment demonstrated that the rate of COPD exacerbations was statistically significantly lower than the placebo rate.
Croatian: Objedinjena analiza djelotvornosti tijekom 6 mjeseci liječenja pokazala je značajno nižu stopu egzacerbacija KOPB-a nego u placebo grupi.
English: The capsules must only be removed from the blister immediately before use.
Croatian: Kapsule se smiju izvaditi iz blistera tek neposredno prije primjene.
English: If you forget to inhale a dose, inhale just one dose at the usual time the next day.
Croatian: Ako ste zaboravili primijeniti Oslif Breezhaler Ako ste zaboravili udahnuti svoju dozu, udahnite samo jednu dozu u uobičajeno vrijeme sljedećeg dana.
English: What Oslif Breezhaler contains - Each Oslif Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Croatian: Što Oslif Breezhaler sadrži - Svaka Oslif Breezhaler 150 mikrogramska kapsula sadrži 150 mikrograma indakaterola u obliku indakaterolmaleata.
English: The Oslif Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Croatian: Program ispitivanja faze III tijekom razvoja Oslif Breezhalera uključivao je bolesnike s kliničkom dijagnozom umjerenog do teškog KOPB-a.
English: Only use the capsules with the inhaler provided in this pack (Oslif Breezhaler inhaler).
Croatian: Koristite samo kapsule koje ste dobili uz inhalator u ovom pakiranju (Oslif Breezhaler inhalator).
English: If you do, don't worry.
Croatian: Nemojte biti zabrinuti ako kašljete.
English: Tiotropium once a day
Croatian: Tiotropij jedanput na dan
English: Release the side buttons fully.
Croatian: Potpuno otpustite bočne tipke.
English: Hold the base of the inhaler firmly and tilt the mouthpiece.
Croatian: Čvrsto držite donji dio inhalatora i otklopite nastavak za usta.
English: The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on Day 14 compared to Day 1, was in the range of 2.9 to 3.5 for once-daily inhaled doses between 150 microgram and 600 microgram.
Croatian: AUC tijekom 24-satnog razdoblja doziranja 14. dana u usporedbi s 1. danom bio je u rasponu od 2,9 do 3,5 za doze od 150 mikrograma do 600 mikrograma inhalirane jedanput na dan.
English: There are no data available for use of Oslif Breezhaler in patients with severe hepatic impairment.
Croatian: Nema podataka o primjeni Oslif Breezhalera u bolesnika s teškim oštećenjem jetre.
English: Mean peak improvements in FEV1 relative to baseline were 250-330 ml at steady state.
Croatian: U stanju dinamičke ravnoteže srednja vršna poboljšanja FEV1-a u odnosu na početne vrijednosti bila su 250-330 ml.
English: Each capsule contains 24.6 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Svaka kapsula sadrži 24,6 mg laktoze.
English: In the event of deterioration of COPD during treatment with Oslif Breezhaler, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Croatian: Ako dođe do pogoršanja KOPB-a tijekom liječenja Oslif Breezhalerom, bolesnika treba ponovno pregledati i provesti liječenje KOPB-a.
English: Lung function
Croatian: Plućna funkcija
English: Do not wash your inhaler with water.
Croatian: Nemojte prati inhalator vodom.
English: What Oslif Breezhaler is and what it is used for
Croatian: Što je Oslif Breezhaler i za što se koristi
English: The 300 microgram dose resulted in a 170-180 ml increase compared to placebo (p<0.001) and a 100 ml increase compared to formoterol 12 microgram twice a day (p<0.001).
Croatian: Doza od 300 mikrograma dovela je do povećanja od 170-180 ml u usporedbi s placebom (p<0,001) te do povećanja od 100 ml u usporedbi s formoterolom u dozi od 12 mikrograma dva puta na dan (p<0,001).
English: • if you get symptoms of an allergic reaction such as rash, itching, hives, difficulty breathing or swallowing, dizziness (uncommon).
Croatian: • ako imate simptome alergije poput osipa, svrbeži, urtikarije, poteškoće u disanju ili gutanju,
English: Each capsule contains 24.8 mg lactose.
Croatian: Pomoćna tvar s poznatim učinkom Svaka kapsula sadrži 24,8 mg laktoze.
English: Oslif Breezhaler is a single-dose inhalation device.
Croatian: Oslif Breezhaler je jednodozni inhalator.
English: Oslif Breezhaler 150 microgram capsules have a black product code “IDL 150” printed above a black bar and a black company logo ( ) printed below the black bar.
Croatian: Oslif Breezhaler 150 mikrograma kapsule imaju crnu oznaku „IDL 150“ otisnutu iznad crne crte i crni logo proizvođača ( ) otisnut ispod crne crte.
English: Upon initiation of treatment with Oslif Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Croatian: Nakon početka liječenja Oslif Breezhalerom, u bolesnika sa šećernom bolešću treba pomno pratiti glukozu u plazmi.
English: The Oslif Breezhaler inhaler provided with each new prescription should be used.
Croatian: Potrebno je koristiti Oslif Breezhaler inhalator koji se dobije sa svakim novim receptom.
English: Percentage of days with no rescue medication use a
Croatian: Postotak dana bez primjene lijeka za hitno ublažavanje simptoma
English: Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse.
Croatian: To mogu biti znaci stanja koje se naziva bronhospazam. odmah se obratite svom liječniku ako Vam se simptomi KOPB-a (nedostatak daha prilikom udisanja, piskanje pri disanju, kašalj) nisu popravili ili ako su se pogoršali.
English: Other medicines and Oslif Breezhaler
Croatian: Drugi lijekovi i Oslif Breezhaler
English: At the 12-week primary endpoint (24-hour trough FEV1), the 150 microgram dose resulted in a 130-180 ml increase compared to placebo (p<0.001) and a 60 ml increase compared to salmeterol 50 microgram twice a day (p<0.001).
Croatian: Kao primarni ishod nakon 12 tjedana (24satni najniži FEV1), doza od 150 mikrograma dovela je do povećanja od 130-180 ml u usporedbi s placebom (p<0,001) te povećanje od 60 ml u usporedbi sa salmeterolom u dozi od 50 mikrograma dva puta na dan (p<0,001).
English: 300 microgram, tiotropium and placebo;
Croatian: 300 mikrograma, formoterolom i placebom
English: Each inhaler should be disposed of after 30 days of use.
Croatian: Svaki nhalator treba baciti nakon 30 dana uporabe.
English: Mark daily dose tracker:
Croatian: Označite uzimanje dnevne doze na kalendariću:
English: Oslif Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed above a blue bar and a blue company logo ( ) printed below the blue bar.
Croatian: Oslif Breezhaler 300 mikrograma kapsule imaju plavu oznaku „IDL 300“ otisnutu iznad plave crte i plavi logo proizvođača ( ) otisnut ispod plave crte.
English: The Oslif Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
Croatian: Oslif Breezhaler inhalator Vam omogućava udisati lijek koji se nalazi u kapsuli.
English: Stop using the medicine and tell your doctor immediately if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Croatian: Tijekom liječenja Oslif Breezhalerom, prestanite primjenjivati lijeka i odmah se obratite svom liječniku ako osjetite stezanje grudnog koša, kašljanje, piskanje ili kratkoću daha odmah nakon primjene lijeka.
English: Always keep the Oslif Breezhaler inhaler and capsules in a dry place.
Croatian: Uvijek držite Oslif Breezhaler inhalator i kapsule na suhom mjestu.
English: 1.0 b a n/e a
Croatian: 1,2 a n/p
English: Show the pack of Oslif Breezhaler.
Croatian: Pokažite pakiranje Oslif Breezhalera.
English: Do not use Oslif Breezhaler capsules with any other inhaler, and do not use Oslif Breezhaler inhaler to take any other capsule medicine.
Croatian: Oslif Breezhaler kapsule s nekim drugim inhalatorom i ne koristite Oslif Breezhaler inhalator za primjenu bilo kojeg drugog lijeka u kapsulama.
English: These were in the vast majority mild or moderate and became less frequent if treatment was continued.
Croatian: One su najčešće bile blage do umjerene, a nastavkom liječenja bi se prorijedile.
English: Pull off the cap.
Croatian: Skinite poklopac.
English: Inhalation powder, hard capsules
Croatian: Prašak inhalata, tvrde kapsule
English: Driving and using machines It is unlikely that Oslif Breezhaler will affect your ability to drive and use machines.
Croatian: Nije vjerojatno da će Oslif Breezhaler utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 240 microgram indacaterol.
Croatian: Doza indakaterolmaleata koja izlazi iz nastavka za usta inhalatora odgovara 240 mikrograma indakaterola.
English: Oslif Breezhaler capsules must not be swallowed.
Croatian: Oslif Breezhaler kapsule se ne smiju progutati.
English: The magnitude of response was generally greater than seen with active comparators (Table 2).
Croatian: U odnosu na druge aktivne komparativne lijekove, stupanj odgovora bio je općenito veći (Tablica 2).
English: Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: Oslif Breezhaler je indiciran za terapiju održavanja bronhodilatacije kod opstrukcije dišnih puteva u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (KOPB).
English: Renal impairment No dose adjustment is required for patients with renal impairment.
Croatian: Nije potrebno prilagođavanje doze u bolesnika s oštećenjem bubrega.
English: Oslif Breezhaler inhaler
Croatian: Oslif Breezhaler inhalator
English: • Close the inhaler and replace the cap.
Croatian: • Zatvorite inhalator i vratite poklopac natrag.
English: The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 120 microgram indacaterol.
Croatian: Doza indakaterolmaleata koja izlazi iz nastavka za usta inhalatora odgovara 120 mikrograma indakaterola.
English: Carton containing 30 capsules and one Oslif Breezhaler inhaler.
Croatian: Kutija sadrži 30 kapsula i jedan Oslif Breezhaler inhalator.
English: • Do not swallow the capsules.
Croatian: • Ne gutajte kapsule.
English: The Oslif Breezhaler inhaler enables you to inhale the medicine contained in an Oslif Breezhaler capsule.
Croatian: Oslif Breezhaler inhalator Vam omogućuje udisanje lijeka koji se nalazi u Oslif Breezhaler kapsuli.
English: - Each Oslif Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
Croatian: - Svaka Oslif Breezhaler 300 mikrogramska kapsula sadrži 300 mikrograma indakaterola u obliku indakaterolmaleata.
English: When you start a new pack, use the new Oslif Breezhaler inhaler that is supplied in the pack.
Croatian: Kada otvorite novo pakiranje, upotrijebite novi Oslif Breezhaler inhalator koji je priložen u pakiranju.
English: You will feel tired, very thirsty and hungry (without gaining weight) and will pass more urine than usual (common).
Croatian: Osjećat ćete se umorno, vrlo žedno i gladno
English: An increase in the daily dose of Oslif Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Croatian: Povećanje dnevne doze iznad doze od 300 mikrograma nije primjereno.
English: Musculoskeletal and connective tissue disorders Muscle spasm
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Grčevi mišića
English: Carton containing 10 capsules and one Oslif Breezhaler inhaler.
Croatian: Kutija sadrži 10 kapsula i jedan Oslif Breezhaler inhalator.
English: Sympathomimetic medicinal products
Croatian: Simpatomimetički lijekovi
English: 0.4 b
Croatian: 0,3 a b
English: INSTRUCTIONS FOR USE OF OSLIF BREEZHALER INHALER
Croatian: UPUTE ZA PRIMJENU OSLIF BREEZHALER INHALATORA
English: Blisters
Croatian: BLISTERI
English: Store in the original package in order to protect from moisture and do not remove until immediately before use.
Croatian: Čuvati u originalnom pakiranju radi zaštite od vlage te izvaditi tek neposredno prije primjene.
English: Always use the new Oslif Breezhaler inhaler that comes with your new pack.
Croatian: Uvijek koristite Oslif Breezhaler inhalator koji se nalazi u Vašem novom pakiranju.
English: Open inhaler:
Croatian: Otvorite inhalator:
English: Store in the original blister in order to protect from moisture and do not remove until immediately before use.
Croatian: Čuvati u originalnom blisteru radi zaštite od vlage i izvaditi tek neposredno prije primjene.
English: if you have epilepsy.
Croatian: ako imate epilepsiju. ako imate problema sa štitnjačom (tireotoksikoza). ako imate šećernu bolest.
English: In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Croatian: T val, produljenje QT intervala i depresija ST segmenta, iako nije poznata klinička važnost tih pojava.
English: Never place a Oslif Breezhaler capsule directly into the mouthpiece of the Oslif Breezhaler inhaler.
Croatian: Nikada ne stavljajte Oslif Breezhaler kapsulu direktno u nastavak za usta Oslif Breezhaler inhalatora.
English: Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Oslif Breezhaler.
Croatian: Prema iskustvima nakon stavljanja gotovog lijeka u promet zabilježeni su slučajevi preosjetljivosti povezani s primjenom Oslif Breezhalera.
English: Upper respiratory tract infection
Croatian: Infekcije gornjeg dišnog sustava
English: Transparent (uncoloured) capsules containing a white powder, with “IDL 300” printed in blue above a blue bar and company logo ( ) printed in blue below the blue bar.
Croatian: Prozirne (bezbojne) kapsule koje sadrže bijeli prašak, s plavom oznakom „IDL 300“ otisnutom iznad plave crte te plavim logom proizvođača ( ) otisnutim ispod plave crte.
English: • Hold the inhaler upright with the mouthpiece pointing up.
Croatian: • Držite inhalator uspravno tako da nastavak za usta gleda prema gore.
English: • Dispose of each inhaler after 30 days of use.
Croatian: • Svaki inhalator treba baciti nakon 30 dana primjene.
English: 60 capsules + 2 inhalers
Croatian: 60 kapsula + 2 inhalatora
English: Only use the Oslif Breezhaler inhaler contained in this pack.
Croatian: Koristite samo Oslif Breezhaler inhalator koji se nalazi u ovom pakiranju.
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Oslif Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended therapeutic dose.
Croatian: Iskustvo iz ispitivanja vezanih uz sigurnost liječenja Oslif Breezhalerom u trajanju do jedne godine u dozama dvostruko većim od najveće preporučene terapijske doze pokazuje da se s porastom izloženosti zbog interakcija ne smanjuje sigurnost primjene lijeka.
English: 10 capsules and 1 inhaler.
Croatian: 10 kapsula i 1 inhalator.
English: • Only use the Oslif Breezhaler inhaler contained in this pack.
Croatian: • Koristite samo Oslif Breezhaler inhalator koji se nalazi u ovom pakiranju.
English: • When you start a new pack, only use the new Oslif Breezhaler inhaler that is supplied in the pack.
Croatian: • Kada otvorite novo pakiranje, koristite samo novi Oslif Breezhaler inhalator koji se nalazi u ovom pakiranju.
English: Transparent (uncoloured) capsules containing a white powder, with “IDL 150” printed in black above a black bar and company logo ( ) printed in black below the black bar.
Croatian: Prozirne (bezbojne) kapsule koje sadrže bijeli prašak, s crnom oznakom „IDL 150“ otisnutom iznad crne crte te crnim logom proizvođača ( ) otisnutim ispod crne crte.
English: 90 capsules + 3 inhalers
Croatian: 90 kapsula + 3 inhalatora
English: 30 capsules and 1 inhaler.
Croatian: 30 kapsula i 1 inhalator.
English: 300 capsules + 30 inhalers
Croatian: 300 kapsula + 30 inhalatora
English: What Oslif Breezhaler is
Croatian: Što je Oslif Breezhaler
English: Never take the Oslif Breezhaler inhaler apart.
Croatian: Nikad nemojte rastavljati Oslif Breezhaler inhalator.
English: Do not swallow the capsules.
Croatian: Ne gutajte kapsule.
English: • itching/rash
Croatian: • svrbež/osip
English: Carton containing 30 capsules and 1 inhaler.
Croatian: Kutija koja sadrži 30 kapsula i 1 inhalator.
English: Do not store the capsules in the Oslif Breezhaler inhaler.
Croatian: Ne čuvajte kapsule u Oslif Breezhaler inhalatoru.
English: How to store Oslif Breezhaler Contents of the pack and other information
Croatian: Kako Oslif Breezhaler izgleda i sadržaj pakiranja
English: Carton containing 10 capsules and 1 inhaler.
Croatian: Kutija koja sadrži 10 kapsula i 1 inhalator.
English: Multipack: 90 (3 packs of 30 capsules and 1 inhaler).
Croatian: Višestruko pakiranje: 90 (3 pakiranja od 30 kapsula i 1 inhalator).
English: Multipack: 300 (30 packs of 10 capsules and 1 inhaler).
Croatian: Višestruko pakiranje: 300 (30 pakiranja od 10 kapsula i 1 inhalator).
English: Do not swallow Oslif Breezhaler capsules.
Croatian: Ne gutajte Oslif Breezhaler kapsule.
English: Multipack: 60 (2 packs of 30 capsules and 1 inhaler).
Croatian: Višestruko pakiranje: 60 (2 pakiranja od 30 kapsula i 1 inhalator).
English: Immediately before use, with dry hands, remove one capsule from the blister.
Croatian: Suhim rukama izvadite jednu kapsulu iz blistera neposredno prije primjene.
English: 10 capsules + 1 inhaler 30 capsules + 1 inhaler
Croatian: Prašak inhalata, tvrde kapsule 10 kapsula + 1 inhalator 30 kapsula + 1 inhalator
English: Never blow into the mouthpiece of the Oslif Breezhaler inhaler.
Croatian: Nikad ne pušite u nastavak za usta Oslif Breezhaler inhalatora.
English: How much Oslif Breezhaler to use
Croatian: Koliko Oslif Breezhalera primijeniti
English: Oslif Breezhaler 150 microgram inhalation powder, hard capsules Oslif Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Croatian: Oslif Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule Oslif Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule indakaterol
English: Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol.
Croatian: Svaka kapsula sadrži 150 mikrograma indakaterola u obliku indakaterolmaleata.
English: Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol.
Croatian: Svaka kapsula sadrži 300 mikrograma indakaterola u obliku indakaterolmaleata.
English: 42 b
Croatian: 42 a b
English: Dizziness
Croatian: Nuspojave
English: b: indacaterol 150 and
Croatian: c: indakaterolom u dozi od
English: What Oslif Breezhaler is used for
Croatian: Za što se koristi Oslif Breezhaler
English: Store in the blister in order to protect from moisture and only remove immediately before use.
Croatian: Čuvati u blisteru radi zaštite od vlage te ih se smije vaditi samo neposredno prije primjene.
English: Oslif Breezhaler 150 microgram inhalation powder, hard capsules
Croatian: Oslif Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule
English: Oslif Breezhaler 300 microgram inhalation powder, hard capsules
Croatian: Oslif Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule
English: Oslif Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Croatian: Oslif Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule indakaterol
English: 53 b 55 c
Croatian: 53 a b b c b
English: • chest pain
Croatian: • bol u prsima
English: General disorders and administration site conditions Chest pain
Croatian: Opći poremećaji i reakcije na mjestu primjene Bol u prsima
English: Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler).
Croatian: Višestruko pakiranje koje sadrži 30 pakiranja (svaki sadrži 10 kapsula i 1 inhalator).
English: Oslif Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Croatian: Oslif Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule indakaterol
English: How to use Oslif Breezhaler
Croatian: Kako primijeniti Oslif Breezhaler
English: Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler).
Croatian: Višestruko pakiranje koje sadrži 3 pakiranja (svaki sadrži 30 kapsula i 1 inhalator).
English: Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler).
Croatian: Višestruko pakiranje koje sadrži 2 pakiranja (svako sadrži 30 kapsula i 1 inhalator).
English: How to store Oslif Breezhaler
Croatian: Kako čuvati Oslif Breezhaler
English: Never wash the Oslif Breezhaler inhaler with water.
Croatian: Nikad nemojte prati Oslif Breezhaler vodom.
English: Gelatin
Croatian: Tahikardija
English: 46 b a n/e a
Croatian: 55 a n/p
English: Button
Croatian: Poklopac
English: Tachycardia
Croatian: Tipka
English: Reduction in puffs/day of rescue medication use vs. baseline a
Croatian: Smanjenje broja inhalacija/dan primijenjenog lijeka za hitno ublažavanje simptoma naspram početne vrijednosti
English: 1.5 b
Croatian: 1,3 a b b b
English: By 30 June 2019
Croatian: Do 30. lipnja 2019.
English: In order to remove any traces of cow's milk proteins from their finished product, the MAHs should replace the current formulations in their marketing authorisations with formulations free from cow's milk proteins and submit for assessment the corresponding documentation to the relevant National Competent Authorities:
Croatian: Kako bi uklonili sve tragove bjelančevina iz kravljeg mlijeka iz gotovog proizvoda, nositelji odobrenja za stavljanje u promet moraju zamijeniti postojeće formulacije u svojim odobrenjima za stavljanje u promet formulacijama koje ne sadrže bjelančevine iz kravljeg mlijeka i predati na procjenu odgovarajuću dokumentaciju mjerodavnim nacionalnim nadležnim tijelima:
English: Condition
Croatian: Uvjet
English: Annex IV Condition to the marketing authorisations
Croatian: Prilog IV. Uvjeti odobrenja za stavljanje u promet
English: Condition to the marketing authorisations
Croatian: Uvjeti odobrenja za stavljanje u promet
English: Date of opening: _______
Croatian: Datum otvaranja: _______
English: Risk Management Plan (RMP)
Croatian: - Plan upravljanja rizikom (RMP)
English: Date of first authorisation: 8 February 2018
Croatian: Datum prvog odobrenja: 8. veljače 2018.