FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the benefits and risks of Ivabradine Zentiva?
Croatian: Koje su koristi i rizici lijeka Ivabradine Zentiva?
English: Other information about Ivabradine Zentiva
Croatian: Ostale informacije o lijeku Ivabradine Zentiva
English: The active substance in Ivabradine Zentiva, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Croatian: Djelatna tvar u lijeku Ivabradine Zentiva, ivabradin, blokira „If struju” u sinusnom čvoru, prirodnom elektrostimulatoru koji regulira srčanu frekvenciju.
English: For practical information about using Ivabradine Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Ivabradine Zentiva bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Why is Ivabradine Zentiva approved?
Croatian: Zašto je Ivabradine Zentiva odobren?
English: How is Ivabradine Zentiva used?
Croatian: Kako se koristi Ivabradine Zentiva?
English: How has Ivabradine Zentiva been studied?
Croatian: Kako je Ivabradine Zentiva ispitivan?
English: Ivabradine Zentiva contains the active substance ivabradine.
Croatian: Ivabradine Zentiva sadržava djelatnu tvar ivabradin.
English: 10 DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Croatian: 10 DATUM REVIZIJE TEKSTA {MM/GGGG}
English: Str. Maravet nr.1 Tel: +40262211964
Croatian: Maravet nr.1 Tel: +40262211964
English: Box 374
Croatian: P.O. Box 374
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: 4.10 Overdose (symptoms, emergency procedures, antidotes)
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti)
English: EXP {m Once bro
Croatian: EXP{mj Jednom
English: Tel. +43 7242 4900 office@richter-pharma.at
Croatian: +43 7242 4900 office@richter-pharma.at
English: - Dogs: intravenous or intramuscular use - Cats: intramuscular use
Croatian: - Pse: intravenska ili intramuskularna primjena - Mačke: intramuskularna primjena
English: Pharmacotherapeutic group: Psycholeptics, hypnotics and sedatives.
Croatian: Farmakoterapijska grupa: Psiholeptici, hipnotici i sedativi.
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 pogleda i dosega djece.
English: B. Braun VetCare SA Carretera de Terrassa 121 E-08191 Rubi (Barcelona) Tel: +34 93 586 62 00
Croatian: Braun VetCare SA Carretera de Terrassa 121 E-08191 Rubi (Barcelona) Tel: +34 93 586 62 00
English: It is recommended that animals are fasted for 12 hours prior to Sedadex administration.
Croatian: Preporuča se da životinje prije primjene Sedadexa budu 12 sati natašte.
English: Marketing authorisation holder: Name:
Croatian: Nositelj odobrenja za stavljanje u promet: Naziv:
English: Address: Forellenweg 16 4941 SJ Raamsdonksveer The Netherlands
Croatian: Adresa: Forellenweg 16 4941 SJ Raamsdonksveer Nizozemska
English: Est. Consiglieri Pedroso, 80 Queluz Park - Queluz de Baixo P-2730-053 Barcarena Tel: +351 21 4368251
Croatian: Consiglieri Pedroso, 80 Queluz Park - Queluz de Baixo P-2730-053 Barcarena Tel: +351 21 4368251
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, METODA(E) I NAČIN PRIMJENE
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
English: België/Belgique/Belgien Kela Veterinaria N.V./S.A.
Croatian: België/Belgique/Belgien Kela Veterinaria N.V./S.A. Industriepark west 68
English: Sedadex contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats.
Croatian: Sedadex kao djelatnu tvar sadrži deksmedetomidin, koji dovodi do sedacije i analgezije u pasa i mačaka.
English: Luxembourg/Luxemburg Kela Veterinaria N.V./S.A.
Croatian: Luxembourg/Luxemburg Kela Veterinaria N.V./S.A. Industriepark west 68
English: Advice to physicians: Sedadex is an α2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Croatian: Savjet liječnicima: Sedadex je agonist α2-adrenergičkih receptora, simptomi nakon apsorpcije mogu uključivati kliničke učinke, uključujući sedaciju ovisnu o dozi, depresiju disanja, bradikardiju, hipotenziju, suhoću usne šupljine i hiperglikemiju.
English: 6.5 Nature and composition of immediate packaging
Croatian: 6.5 Vrsta i sastav unutarnjeg pakovanja
English: Sedation may be reversed with atipamezole (see section 12 overdose).
Croatian: Sedacija se može prekinuti pomoću atipamezola (vidjeti dio 12. Predoziranje).
English: Chwaszcyńska 198a 81-571 Gdynia Tel: +48 58 572 24 38
Croatian: LIVISTO Sp. z o.o. ul. Chwaszcyńska 198a 81-571 Gdynia Tel: +48 58 572 24 38
English: 1 ml con Dexmed (equivale
Croatian: NA 1 ml sad Deksmed (ekvival
English: Dogs: Dexmedetomidine doses are based on body surface area:
Croatian: Psi: Doze deksmedetomidina određuju se prema površini tijela:
English: Manufacturer responsible for batch release: Name:
Croatian: Proizvođač odgovoran za puštanje proizvodne serije: Naziv:
English: PRODULAB PHARMA B.V. Forellenweg 16, Raamsdonksveer 4941SJ
Croatian: Forellenweg 16, Raamsdonksveer 4941SJ
English: When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal, or prolonged sedation may occur.
Croatian: Kad se u pasa istodobno upotrebljavaju deksmedetomidin i butorfanol, može doći do bradipneje, tahipneje, nepravilnog obrasca respiracije (apneja u trajanju 20-30 sekundi nakon koje slijedi nekoliko brzih udisaja), hipoksemije, mišićnih trzaja ili tremora, ili „veslanja“, ekscitacije, hipersalivacije, nagona na povraćanje, povraćanja, mokrenja, kožnog eritema, naglog buđenja ili prolongirane sedacije.
English: Pack size: 1 vial.
Croatian: Veličina pakovanja: 1 bočica.
English: MANUFACTURER'S BATCH NUMBER Lot.
Croatian: 17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: C/O Oriola Oy P.O.
Croatian: FaunaPharma Oy. C/O Oriola Oy P.O. Box 8
English: The specific α2adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans only experimentally to antagonize dexmedetomidine-induced effects.
Croatian: Specifični α2 -adrenoreceptorski antagonist, atipamezol, koji je odobren za upotrebu na životinjama, upotrebljavan je u ljudi samo eksperimentalno za poništavanje učinaka deksmedetomidina.
English: PHARMACEUTICAL FORM Solution for injection Clear, colourless solution.
Croatian: OBLIK Otopina za injekciju Bistra, bezbojna otopina
English: Sodium hydroxide (E 524) (for pH adjustment)
Croatian: Natrijev hidroksid (E 524) (za podešavanje pH)
English: TARGET SPECIES Dogs and cats
Croatian: CILJNE VRSTE ŽIVOTINJA Psi i mačke.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS, IF ANY
Croatian: 13. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENIH VETERINARSKO-MEDICINSKIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Sodium hydroxide (E 524) (for pH adjustment) Hydrochloric acid (E507) (for pH adjustment) Water for injections
Croatian: Natrijev hidroksid (E 524) (za podešavanje pH) Klorovodična kiselina (E 507) (za podešavanje pH) Voda za injekcije
English: For higher weight ranges, use Sedadex 0.5 mg/ml and its dosing tables.
Croatian: Za veće raspone težina, primijeniti Sedadex 0,5 mg/ml i pripadajuće tablice doziranja.
English: OUTE(S) O V , IM M
Croatian: UT(EVI) PR , i.v. i.m.
English: METHOD AN ntravenous or tramuscular u e package lea
Croatian: METODE I N avenska ili in intramuskula otrebe pročit
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/198/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/16/198/002
English: Colourless Type I glass vials of 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Croatian: I od 10 ml zatvorene obloženim brombutilnim gumenim čepom i aluminijskim poklopcem u kartonskoj kutiji.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/198/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/16/198/001
English: Q 0.5 mg/m
Croatian: K 0,5 mg/m
English: 0.1 m 0.08 m
Croatian: 0,5 m u
English: Address: Wilgenweg 7 3421 TV Oudewater The Netherlands
Croatian: Wilgenweg 7 3421 TV Oudewater Nizozemska Proizvođač odgovora za puštanje proizvodne serije: Naziv:
English: EUTICAL F n
Croatian: ELIČINA P
English: Q 0.1 mg/m
Croatian: K 0,1 mg/m
English: R ON THE O
Croatian: IMJENU NA a
English: UANTITY ml
Croatian: UTSKI OBL
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.08 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Croatian: Doza za mačke je 40 mikrograma deksmedetomidin hidroklorida/kg tjelesne mase, jednako volumenu doze od 0,08 ml Sedadex/kg tjelesne mase pri korištenju za neinvazivne, blago do umjereno bolne zahvate koji zahtijevaju obuzdavanje, sedaciju i analgeziju.
English: TO APPEAR
Croatian: NALAZITI
English: NDICATION
Croatian: NDIKACIJA
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.4 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Croatian: Doza za mačke je 40 mikrograma deksmedetomidin hidroklorida/kg tjelesne mase, jednako volumenu doze od 0,4 ml Sedadexa/kg tjelesne mase pri korištenju za neinvazivne, blago do umjereno bolne zahvate koji zahtijevaju obuzdavanje, sedaciju i analgeziju.
English: PARTIC Cardboa
Croatian: PODAC Kartons
English: Dogs: in Cats: int Read the
Croatian: Psi: intra Mačke: i Prije upo
English: People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Croatian: Osobe preosjetljive na djelatnu tvar ili na bilo koju od pomoćnih tvari trebaju oprezno primijenjivati ovaj veterinarsko-medicinski proizvod.
English: BSTANCES
Croatian: NUSPOJAVE
English: UNITS
Croatian: M JEDINIC
English: N(S)
Croatian: A(E)
English: ONLY”
Croatian: NJAMA”
English: Excipient(s): Methyl parahydroxybenzoate (E 218)
Croatian: Pomoćna(e) tvar(i): Metil parahidroksibenzoat (E 218)
English: Dogs: IV Cats: IM
Croatian: Psi: i.v., Mačke: i
English: HE VETER injection ydrochloride
Croatian: injekcija droklorid
English: Special warnings
Croatian: Posebna upozorenja:
English: Hydrochloric acid (E507) (for pH adjustment)
Croatian: Klorovodična kiselina (E 507) (za podešavanje pH) Voda za injekcije
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.5 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Sedadex 0,5 mg/ml otopina za injekciju za pse i mačke deksmedetomidin hidroklorid
English: Excipients: Methyl parahydroxybenzoate (E 218)
Croatian: Pomoćne tvari: Metil parahidroksibenzoat (E 218)
English: Dogs: IM Cats: IM
Croatian: Mačke: i
English: Sedadex dexmede
Croatian: Sedadex deksmed
English: CKAGING U
Croatian: GIH TVAR
English: e
Croatian: VE
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 ml contains:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA 1 ml sadrži: Djelatna tvar: Deksmedetomidin hidroklorid
English: MBER
Croatian: BR
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Sedadex 0,1 mg/ml otopina za injekciju za pse i mačkedeksmedetomidin hidroklorid
English: ydrochloride edetomidine
Croatian: Deksmedetomidin hidroklorid
English: Dexmedetomidine hydrochloride
Croatian: Djelatna tvar: Deksmedetomidin hidroklorid
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.5 mg/ml solution for injection for dogs and cats
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Sedadex 0,5 mg/ml otopina za injekciju za pse i mačke
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Sedadex 0,1 mg/ml otopina za injekciju za pse i mačke
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-tenth (1/10) the volume of Sedadex 0.1 mg/ml that was given to the cat.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml jednak je jednoj desetini (1/10) volumena Sedadexa 0,1 mg/ml koji je primijenjen na mački.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Sedadex 0.1 mg/ml that was given to the dog, regardless of route of administration of Sedadex.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml iznosi jednu petinu (1/5) volumena doze Sedadexa 0,1 mg/ml koji je primijenjen na psu, neovisno o putu primjene Sedadexa.
English: NIMAL TRE
Croatian: NA MALIM
English: Once broached use by:
Croatian: otrijebiti do:
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals the dose volume of Sedadex 0.5 mg/ml that was given to the dog, regardless of route of administration of Sedadex.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml jednaka je dozi volumena doze Sedadexa 0,5 mg/ml primijenjenom na psu, neovisno o putu primjene Sedadexa.
English: ER OF DOS
Croatian: IKO JE PO
English: HE VETER solution for i ydrochloride
Croatian: ERINARSK otopina za inj droklorid
English: W
Croatian: u
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half the volume of Sedadex 0.5 mg/ml that was given to the cat.
Croatian: Volumen doze atipamezola pri koncentraciji od 5 mg/ml jest jedna polovina volumena Sedadexa 0,5 mg/ml primijenjenog na mački.
English: HARMACE n for injection
Croatian: ARMACEU za injekciju.
English: AME OF TH x 0.5 mg/ml s etomidine hy
Croatian: AZIV VETE x 0,5 mg/ml o detomidin hid
English: PACKAGE LEAFLET FOR Sedadex 0.5 mg/ml solution for injection for dogs and cats
Croatian: UPUTA O VMP ZA Sedadex 0,5 mg/ml otopina za injekciju za pse i mačke
English: AME OF TH x 0.1 mg/ml s etomidine hy
Croatian: AZIV VETE x 0,1 mg/ml o detomidin hid
English: Box 8
Croatian: Forellenweg 16
English: EDICINAL dogs and cat
Croatian: INSKOG PR se i mačke
English: P.O.
Croatian: i.m.
English: ECIES
Croatian: JA
English: CTIVE SUB
Croatian: ZVODNE S
English: CKAGE
Croatian: PAKOVANJ
English: EDICINAL
Croatian: ANOSTI
English: ACKAGE S
Croatian: KO-MEDICI
English: ST
Croatian: SA
English: C
Croatian: K
English: FORM
Croatian: LIK
English: ND ROUTE r intramuscu use aflet before u
Croatian: NAČIN PRI ntramuskular arna primjen tati uputu o V
English: S “FOR AN t only.
Croatian: IMJENU NA a.
English: MINIM Glass vi
Croatian: Bezbojne staklene bočice Tipa
English: EATMENT
Croatian: DJELATNE
English: SARY
Croatian: ERINARSK
English: WAL PERIO
Croatian: ROJ PROIZ
English: Only do this once.
Croatian: Učinite to samo jednom.
English: Wait 5 to 15 minutes;
Croatian: Pričekajte 5 do 15 minuta.
English: Elderly patients (≥65 years)
Croatian: Stariji pacijenti (≥ 65 godina)
English: Absolute mL
Croatian: Apsolutni ml
English: The first dose is taken in 4 steps:
Croatian: Prva doza uzima se u 4 koraka:
English: If the capsule has not emptied you may need to repeat steps 6 to 8.
Croatian: Ako kapsula nije prazna, možda ćete morati ponoviti korake od 6 do 8.
English: - Worsening of symptoms.
Croatian: - Pogoršanje simptoma.
English: This is because there is limited information in this group of people.
Croatian: Razlog tome su ograničeni podaci za tu skupinu osoba.
English: There are no data available for children under 12 years of age.
Croatian: Nema dostupnih podataka za djecu mlađu od 12 godina.
English: This effect was not noted in any other species and did not result in clinical signs.
Croatian: Taj učinak nije primijećen u drugih vrsta i nije rezultirao kliničkim znakovima.
English: - Have the evening dose at least 2 to 3 hours before you go to bed.
Croatian: - Večernju dozu uzmite barem 2 do 3 sata prije odlaska na spavanje.
English: Patients should be advised to carefully read them.
Croatian: Pacijente treba savjetovati da pažljivo pročitaju uputu.
English: Aluminium/polyamide/PVC/aluminium blisters.
Croatian: Aluminij/poliamid/PVC/aluminij blisteri.
English: - Use a new inhaler each week.
Croatian: - Svaki tjedan upotrijebite novi inhalator.
English: Your doctor will tell you how long to use this medicine for.
Croatian: Liječnik će Vam reći koliko dugo morate uzimati lijek.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, međutim, nije moguće dati preporuku o doziranju.
English: The suggested order is as follows, unless otherwise advised by your doctor:
Croatian: Preporučen je sljedeći redoslijed, osim ako Vas liječnik nije drugačije savjetovao:
English: The doctor may give you oxygen and medicines to help you breathe.
Croatian: Liječnik će Vam možda dati kisik i lijekove za pomoć pri disanju.
English: - Do not use a double dose to make up for a forgotten dose.
Croatian: - Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: • acute bleeding ≥240 ml in a 24-hour period
Croatian: • akutno krvarenje ≥ 240 ml tijekom razdoblja od 24 sata
English: For patients receiving several respiratory therapies, the recommended order is:
Croatian: Za pacijente koji primaju nekoliko respiratornih terapija preporučen je sljedeći redoslijed:
English: If this does not happen, the capsule may be stuck.
Croatian: Ako se to ne dogodi, kapsula je možda zapela.
English: Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017
Croatian: Datum posljednje obnove odobrenja: 11. siječanj 2017.
English: ATC code: R05CB16
Croatian: ATK oznaka: R05CB16
English: Adults 18 years of age and over
Croatian: Odrasle osobe u dobi od 18 godina i više
English: Leave it to dry in the air - lay it on its side with the mouth-piece open.
Croatian: Pustite da se osuši na zraku - položite ga na bok s otvorenim nastavkom za usta.
English: If you stop using Bronchitol your symptoms may get worse.
Croatian: Ako prestanete uzimati Bronchitol, simptomi bi Vam se mogli pogoršati.
English: - Coughing up blood or blood in your sputum.
Croatian: - Iskašljavanje krvi ili krv u sputumu.
English: p value
Croatian: p vrijednost
English: - Then twist the mouth-piece into the closed position - when it is closed you will hear a ‘click'.
Croatian: - Okrenite nastavak za usta u zatvoreni položaj - kada bude zatvoren, čut ćete ‘škljocaj'.
English: However, if it is nearly time for the next dose, skip the missed dose.
Croatian: Međutim, ako se bliži vrijeme za sljedeću dozu, preskočite zaboravljenu dozu.
English: Absolute % predicted Relative % predicted
Croatian: Apsolutna promjena % predviđene vrijednosti Relativna promjena % predviđene vrijednosti
English: The mean terminal half-life in adults was approximately 4 to 5 hours from serum and approximately 3.66 hours from urine.
Croatian: Srednja vrijednost terminalnog poluvijeka u odraslih osoba iznosila je približno 4 do 5 sati iz seruma te približno 3,66 sati iz urina.
English: Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Croatian: Prije stavljanja lijeka u promet u svakoj državi članici, nositelj odobrenja usuglasit će sadržaj i format edukativnih materijala s nadležnim nacionalnim tijelom.
English: Do not stop using your Bronchitol without talking to your doctor first, even if you feel better.
Croatian: Ne prekidajte terapiju Bronchitolom bez da se prethodno ne posavjetujete s liječnikom, čak ni ako se osjećate bolje.
English: - Breathe out, and then breathe normally again.
Croatian: - Izdahnite, a zatim počnite ponovno disati.
English: Do not try to loosen the capsule by pressing the piercing buttons again.
Croatian: Ne pokušavajte otpustiti kapsulu ponovnim pritiskanjem gumba za bušenje.
English: It also helps improve the condition of your lungs and your breathing.
Croatian: Također pomaže u poboljšanju funkcije pluća i disanja.
English: The educational pack should contain the following:
Croatian: Edukativni paket mora sadržavati sljedeće:
English: The recommended dose of Bronchitol is 400 mg twice a day.
Croatian: Preporučena doza Bronchitola je 400 mg dva puta dnevno.
English: The inhaler device is to be replaced after one week of use.
Croatian: Inhalator se mora zamijeniti nakon jednog tjedna uporabe.
English: - Take a steady deep breath in, to fill your lungs - then hold your breath for 5 seconds.
Croatian: - Ravnomjerno i duboko udahnite kako biste napunili pluća - zatim zadržite dah 5 sekundi.
English: A massive/serious haemoptysis is considered to be:
Croatian: Smatra se da je obilna/teška hemoptiza:
English: Talk to your doctor if the cough won't go away or worries you.
Croatian: Posavjetujte se s liječnikom ako kašalj ne prestaje ili ako ste zabrinuti.
English: You may: - feel that you cannot breathe; - become wheezy; - cough a lot.
Croatian: Možete: - osjećati da ne možete disati - početi piskati (pri disanju) - mnogo kašljati.
English: At the end of the initiation dose you will have taken 10 capsules (400 mg) which is the same as the usual dose.
Croatian: Na kraju početne doze, uzet ćete 10 kapsula (400 mg), što je jednako uobičajenoj dozi.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kako slijedi: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i <1/100); rijetko (≥ 1/10 000 i <1/1000); vrlo rijetko (≥ 1/100 000 i < 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: FEV1 (95% CI)
Croatian: (95 % CI)
English: Initiation dose (6 to 17 years of age)
Croatian: Početna doza (u dobi od 6 do 17 godina)
English: The initiation dose assessment must be performed according to the following steps:
Croatian: Procjena početne doze mora se provesti u skladu sa sljedećim koracima:
English: As a result you may get a ‘productive cough', which also helps to remove mucus from your lungs.
Croatian: Kao rezultat toga, može se pojaviti ‘produktivni kašalj', koji također pomaže pri uklanjanju sluzi iz pluća.
English: The educational material for Healthcare Professionals should be a leaflet that includes information on the following key elements:
Croatian: Edukativni materijali za zdravstvene djelatnike moraju biti u obliku uputa s informacijama o sljedećim ključnim elementima:
English: Do not use Bronchitol - if you are allergic to mannitol - if you are sensitive to mannitol.
Croatian: Nemojte primjenjivati Bronchitol - ako ste alergični na manitol - ako ste osjetljivi na manitol.
English: All FEV1 measurements and SpO2 monitoring should be performed 60 seconds after dose inhalation.
Croatian: Sva mjerenja FEV1 i praćenje SpO2 moraju se obaviti 60 sekundi nakon inhalacije doze lijeka.
English: Cleaning the inhaler - Usually your inhaler will give you the correct dose of medicine for 7 days without needing cleaning.
Croatian: Čišćenje inhalatora - Inhalator će Vam obično točno dozirati lijek tijekom 7 dana bez potrebe za čišćenjem.