natgillin/translations-raw huggingface dataset:
Irbesartan Zentiva 300 mg film-coated tablets irbesartan
Irbesartan Zentiva 300 mg filmom obložene tablete irbesartan
Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest
Kardiovaskularna smrt i moždani udar oboje su numerički bili učestaliji u skupini koja je primala aliskiren nego u onoj koja je primala placebo, a štetni događaji i ozbiljni štetni događaji od značaja (hiperkalemija, hipotenzija i bubrežna disfunkcija) bili su učestalije zabilježeni u skupini koja je primala aliskiren nego u onoj koja je primala placebo.
impaired renal function including cases of renal failure in patients at risk (see section 4.4) Reproductive system and breast disorders Uncommon: sexual dysfunction
oštećena funkcija bubrega, uključujući slučajeve zatajenja bubrega u rizičnoj skupini bolesnika (vidjeti dio 4.4.).
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Zentiva can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1)..
U bolesnika u kojih se bolest ne može dostatno kontrolirati dozom od 150 mg jedanput na dan, doza lijeka Irbesartan Zentiva može se povećati na 300 mg ili se mogu dodati drugi antihipertenzivi (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1) . Pokazalo se da dodavanje diuretika poput hidroklorotiazida ostvaruje aditivan učinak s lijekom Irbesartan Zentiva (vidjeti dio 4.5).
 The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Drugi sastojci su mikrokristalična celuloza, umrežena karmelozanatrij, laktoza hidrat, magnezijev stearat, koloidni hidratizirani silicijev dioksid, prethodno geliran kukuruzni škrob i poloksamer 188. Vidjeti dio 2., „Irbesartan Zentiva sadrži laktozu“
Irbesartan Zentiva 150 mg film-coated tablets irbesartan
Irbesartan Zentiva 150 mg filmom obložene tablete irbesartan
Package leaflet: Information for the user Irbesartan Zentiva 75 mg tablets irbesartan
Uputa o lijeku: Informacija za korisnika Irbesartan Zentiva 75 mg tablete irbesartan
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”).
“Nemojte uzimati Irbesartan Zentiva” i “Upozorenja i mjere opreza”).
Irbesartan Zentiva 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Zentiva 75 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg tablets irbesartan
NAZIV LIJEKA Irbesartan Zentiva 150 mg tablete irbesartan NAZIV NOSITELJA
Irbesartan Zentiva 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Zentiva 300 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
MARKETING AUTHORISATION HOLDER Zentiva k.s.
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zentiva k.s. ROK VALJANOSTI
Irbesartan Zentiva 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Irbesartan Zentiva 75 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84, 90 ili 98 filmom obloženih tableta.
Losartan
LotSerija
Irbesartan Zentiva 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Irbesartan Zentiva 150 mg tablete dostupne su u blister pakiranjima s 14, 28, 56 ili 98 tableta.
Package leaflet: Information for the user Irbesartan Zentiva 300 mg tablets irbesartan
Uputa o lijeku: Informacija za korisnika Irbesartan Zentiva 300 mg tablete irbesartan
Package leaflet: Information for the user Irbesartan Zentiva 75 mg film-coated tablets irbesartan
Uputa o lijeku: Informacija za korisnika Irbesartan Zentiva 75 mg filmom obložene tablete irbesartan
Tablet core:
Oštećena funkcija jetre
EU/1/06/376/011 - 14 tablets EU/1/06/376/012 - 28 tablets EU/1/06/376/013 - 56 tablets EU/1/06/376/014 - 56 x 1 tablets EU/1/06/376/015 - 98 tablets
EU/1/06/376/011 - 14 tableta EU/1/06/376/012 - 28 tableta EU/1/06/376/013 - 56 tableta EU/1/06/376/014 - 56 x 1 tableta EU/1/06/376/015 - 98 tableta
Metabolism and nutrition disorders
Poremećaji bubrega i mokraćnog sustava
Package leaflet: Information for the user Irbesartan Zentiva 150 mg tablets irbesartan
Uputa o lijeku: Informacija za korisnika Irbesartan Zentiva 150 mg tablete irbesartan
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
NAZIV LIJEKA Irbesartan Zentiva 75 mg tablete irbesartan NAZIV NOSITELJA
Hepatobiliary disorders Uncommon: jaundice Not known:
Poremećaji jetre i žuči Manje često: žutica Nepoznato:
Package leaflet: Information for the user Irbesartan Zentiva 300 mg film-coated tablets irbesartan
Uputa o lijeku: Informacija za korisnika Irbesartan Zentiva 300 mg filmom obložene tablete irbesartan
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Kako Irbesartan Zentiva izgleda i sadržaj pakiranja Irbesartan Zentiva 300 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2873 na drugoj strani.
Iif you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”).
Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza: Ako uzimate ACE inhibitor ili aliskiren (vidjeti također informacije pod naslovima
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Kako Irbesartan Zentiva izgleda i sadržaj pakiranja Irbesartan Zentiva 75 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2871 na drugoj strani.
EU/1/06/376/006 - 14 tablets EU/1/06/376/007 - 28 tablets EU/1/06/376/008 - 56 tablets EU/1/06/376/009 - 56 x 1 tablets EU/1/06/376/010 - 98 tablets
EU/1/06/376/006 - 14 tableta EU/1/06/376/007 - 28 tableta EU/1/06/376/008 - 56 tableta EU/1/06/376/009 - 56 x 1 tableta EU/1/06/376/010 - 98 tableta
Irbesartan Zentiva 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Irbesartan Zentiva 300 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
EU/1/06/376/001 - 14 tablets EU/1/06/376/002 - 28 tablets EU/1/06/376/003 - 56 tablets EU/1/06/376/004 - 56 x 1 tablets EU/1/06/376/005 - 98 tablets
EU/1/06/376/001 - 14 tableta EU/1/06/376/002 - 28 tableta EU/1/06/376/003 - 56 tableta EU/1/06/376/004 - 56 x 1 tableta EU/1/06/376/005 - 98 tableta
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Kako Irbesartan Zentiva izgleda i sadržaj pakiranja Irbesartan Zentiva 75 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2771 na drugoj strani.
Package leaflet: Information for the user Irbesartan Zentiva 150 mg film-coated tablets irbesartan
Uputa o lijeku: Informacija za korisnika Irbesartan Zentiva 150 mg filmom obložene tablete irbesartan
Irbesartan Zentiva 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Irbesartan Zentiva 150 mg filmom obložene tablete dostupne su u blister pakiranjima s 14, 28, 30, 56, 84 i 98 filmom obloženih tableta.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg (dvijetablete na dan) jedanput na dan.
EU/1/06/376/016 - 14 tablets EU/1/06/376/017 - 28 tablets EU/1/06/376/034 - 30 tablets EU/1/06/376/018 - 56 tablets EU/1/06/376/019 - 56 x 1 tablets EU/1/06/376/020 - 84 tablets EU/1/06/376/035 - 90 tablets EU/1/06/376/021 - 98 tablets
EU/1/06/376/016 - 14 tableta EU/1/06/376/017 - 28 tableta EU/1/06/376/034 - 30 tableta EU/1/06/376/018 - 56 tableta EU/1/06/376/019 - 56 x 1 tableta EU/1/06/376/020 - 84 tableta EU/1/06/376/035 - 90 tableta EU/1/06/376/021 - 98 tableta
EU/1/06/376/022 - 14 tablets EU/1/06/376/023 - 28 tablets EU/1/06/376/036 - 30 tablets EU/1/06/376/024 - 56 tablets EU/1/06/376/025 - 56 x 1 tablets EU/1/06/376/026 - 84 tablets EU/1/06/376/037 - 90 tablets EU/1/06/376/027 - 98 tablets
EU/1/06/376/022 - 14 tableta EU/1/06/376/023 - 28 tableta EU/1/06/376/036 - 30 tableta EU/1/06/376/024 - 56 tableta EU/1/06/376/025 - 56 x 1 tableta EU/1/06/376/026 - 84 tableta EU/1/06/376/037 - 90 tableta EU/1/06/376/027 - 98 tableta
NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
NAZIV LIJEKA Irbesartan Zentiva 300 mg tablete irbesartan NAZIV NOSITELJA
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Kako Irbesartan Zentiva izgleda i sadržaj pakiranja Irbesartan Zentiva 300 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2773 na drugoj strani.
EU/1/06/376/028 - 14 tablets EU/1/06/376/029 - 28 tablets EU/1/06/376/038 - 30 tablets EU/1/06/376/030 - 56 tablets EU/1/06/376/031 - 56 x 1 tablets EU/1/06/376/032 - 84 tablets EU/1/06/376/039 - 90 tablets EU/1/06/376/033 - 98 tablets
EU/1/06/376/028 - 14 tableta EU/1/06/376/029 - 28 tableta EU/1/06/376/038 - 30 tableta EU/1/06/376/030 - 56 tableta EU/1/06/376/031 - 56 x 1 tableta EU/1/06/376/032 - 84 tableta EU/1/06/376/039 - 90 tableta EU/1/06/376/033 - 98 tableta
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Kako Irbesartan Zentiva izgleda i sadržaj pakiranja Irbesartan Zentiva 150 mg tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2772 na drugoj strani.
The efficacy of Irbesartan Zentiva is not influenced by age or gender.
Dob i spol ne utječu na djelotvornost lijeka Irbesartan Zentiva.
S.C. ZENTIVA S.A.
Sanofi S.p.A.
What Irbesartan Zentiva contains  The active substance is irbesartan.
Što Irbesartan Zentiva sadrži
PV-Greece@zentiva.com
PV-Norway@zentiva.com
What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Irbesartan Zentiva 150 mg filmom obložene tablete su bijele do gotovo bijele, bikonveksne i ovalne, s utisnutom oznakom srca na jednoj i brojem 2872 na drugoj strani.
ONCE DAILY
JEDANPUT NA DAN
contact your doctor as soon as possible.
obratite se svom liječniku što je prije moguće.
This will help to keep you free of symptoms throughout the day and night.
Na taj ćete se način lakše osloboditi simptoma danju i noću.
Date of latest renewal: 26 July 2018
Datum posljednje obnove odobrenja: 26. srpnja 2018.
if you have low potassium in your blood.
ako imate niski kalij u Vašoj krvi.
Just take your next dose at the usual time.
Samo primijenite sljedeću dozu u uobičajeno vrijeme.
Hold this breath for as long as possible (at least 3-4 seconds).
Zadržite dah koliko god dugo možete (barem 3-4 sekunde).
• suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)
• osjećaj iznenadne slabosti ili ošamućenosti (koji mogu dovesti do kolapsa ili gubitka svijesti)
Always use this medicine exactly as your doctor has told you to.
Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
No risk factors were identified.
Nisu otkriveni čimbenici rizika.
if you have heart problems or high blood pressure.
ako imate srčane tegobe ili povišen krvni tlak.
This dose is also used once daily at the same time each day.
Ta se doza također primjenjuje jedanput na dan, u isto vrijeme svakoga dana.
Children aged under 12 years
Djeca mlađa od 12 godina
Symptoms and signs
Simptomi i znakovi
**Fractures
**Frakture
A risk to breastfed newborns/infants cannot be excluded.
Ne može se isključiti rizik za novorođenčad/dojenčad.
Results for the primary and key secondary endpoints in these studies are described in Table 1.
Rezultati za primarne i ključne sekundarne mjere ishoda u tim ispitivanjima opisani su u Tablici 1.
Interaction with beta-blockers
Interakcija s beta-blokatorima
if you have ever been told you have diabetes or high blood sugar.
ako Vam je ikada rečeno da imate šećernu bolest ili visoku razinu šećera u krvi.
You may notice that your heart is beating faster than usual, you feel shaky or have a headache.
Možda ćete primijetiti da Vam srce kuca brže nego inače, da drhtite ili da imate glavobolju.
Studies > 1 year duration
Ispitivanja u trajanju > 1 godine
These differences are unlikely to be of clinical relevance.
Nije izgledno da bi te razlike mogle biti klinički značajne.
Multipack: 90 (3 packs of 30) doses
Višestruko pakiranje: 90 (3 pakiranja s 30) doza
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Dozu treba titrirati na najmanju dozu kojom je moguće održavati učinkovitu kontrolu simptoma.
When it is taken regularly, it helps the small air passages to remain open.
Ako se uzima redovito, pomaže u održavanju malih dišnih putova otvorenima.
No dose adjustment is required in this population (see section 5.2).
Nije potrebno prilagođavati dozu u ovoj populaciji (vidjeti dio 5.2).
It should be administered at the same time of the day, each day.
Treba ga uzimati svakoga dana, u isto vrijeme.
If a dose is missed the next dose should be taken at the usual time the next day.
Ako bolesnik zaboravi uzeti dozu, sljedeću dozu treba uzeti u uobičajeno vrijeme sljedećega dana.
It is not known whether the ingredients of this medicine can pass into breast milk.
Nije poznato mogu li se sastojci ovog lijeka izlučivati u majčino mlijeko.
Do not block the air-vents with your fingers.
Nemojte prstima blokirati otvore za zrak.
Treatment Dose of FF/VI*(micrograms)
Terapijska doza FF/VI* (u mikrogramima)
• Remove the inhaler from your mouth.
• Izvadite inhalator iz usta.
United Kingdom.
Ujedinjeno Kraljevstvo.
See section 4 for information on symptoms to look out for while you are using this medicine.
Pogledajte dio 4. za informacije o simptomima na koje treba obratiti pozornost prilikom primjene ovog lijeka.
Take it back to a pharmacist for advice.
Vratite ga ljekarniku i zatražite savjet.
Corticosteroids reduce inflammation.
Kortikosteroidi smanjuju upalu.
*, ** See below ‘Description of selected adverse reactions'
*, ** Vidjeti u nastavku ''Opis odabranih nuspojava''
if you have tuberculosis (TB) of the lung, or any long standing or untreated infections.
ako imate tuberkulozu (TB) pluća ili dugotrajne ili neliječene infekcije.
Do not use Relvar Ellipta if you are allergic to fluticasone furoate, vilanterol or any other ingredients of this medicine (listed in section 6).
Nemojte primjenjivati Relvar Ellipta ako ste alergični na flutikazonfuroat, vilanterol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Check with your doctor, nurse or pharmacist if you are not sure.
medicinskom sestrom ili ljekarnikom ako niste sigurni.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 November 2013
Datum prvog odobrenja: 13. studenog 2013.
Allergic reactions to Relvar Ellipta are rare (may affect up to 1 in 1,000 people).
Alergijske reakcije Alergijske reakcije na lijek Relvar Ellipta su rijetke (mogu se javiti u do 1 na 1000 osoba).
NAME OF THE MARKETING AUTHORISATION HOLDER GSK Logo
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GSK Logo
Administration of fluticasone furoate/vilanterol to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Primjenu flutikazonfuroata/vilanterola u trudnica treba razmotriti samo ako je očekivana korist za majku veća od svih mogućih rizika za plod.
It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Nije moguće slučajno uzeti veću dozu lijeka ili dvostruku dozu u jednoj inhalaciji.
Similar effects in reduction of moderate and severe exacerbations were observed in this subgroup as compared with the overall population.
Slični učinci na smanjenje incidencije umjerenih i teških egzacerbacija zabilježeni su u toj podskupini u odnosu na ukupnu populaciju.
Interaction with CYP3A4 inhibitors
Interakcija s inhibitorima CYP3A4
Tell your doctor or pharmacist if you are taking any of these medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od tih lijekova.
What Relvar Ellipta is and what it is used for
Što je Relvar Ellipta i za što se koristi
What is the Ellipta inhaler?
Što je Ellipta inhalator?
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 14 doses
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 14 doza
These effects are much less likely to occur than with oral corticosteroids.
Vjerojatnost pojave tih učinaka puno je manja nego kod primjene peroralnih kortikosteroida.
Concurrent use of both non-selective and selective beta2-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Istodobnu primjenu neselektivnih i selektivnih blokatora beta2-adrenergičkih receptora treba izbjegavati, osim ako ne postoje opravdani razlozi za njihovu primjenu.
Adults aged 18 years and over
Odrasli u dobi od 18 i više godina
Table 2: Analysis of Exacerbation Rates following 12 months of treatment
Tablica 2: Analiza stopa egzacerbacija nakon 12 mjeseci liječenja
This leaflet was last revised in <{MM/YYYY}>
Ova uputa je zadnji puta revidirana u <{MM/GGGG}> Drugi izvori informacija
• increase in blood sugar (hyperglycaemia)
• povećanje razine šećera u krvi (hiperglikemija)
• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis).
• bolne, uzdignute mrlje u ustima ili grlu izazvane gljivičnom infekcijom (kandidijaza).
Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use.
Čuvati inhalator u zatvorenom podlošku radi zaštite od vlage i otvoriti ga tek neposredno prije prve uporabe.
PHARMACEUTICAL FORM AND CONTENTS 30 doses
OBLIK I SADRŽAJ 30 doza
92/22 micrograms
92/22 mikrograma
With the exception of pneumonia and fractures, the safety profile was similar in patients with asthma and COPD.
Uz iznimku pneumonije i fraktura, sigurnosni profil bio je sličan u bolesnika s astmom i u onih s KOPB-om.
Relvar Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD and asthma.
Relvar Ellipta se mora primjenjivati svaki dan, a ne samo onda kada imate dišne tegobe ili druge simptome KOPB-a i astme.
Gender, weight and BMI
Spol, tjelesna težina i ITM
After inhalation, patients should rinse their mouth with water without swallowing.
Nakon inhalacije, bolesnici trebaju isprati usta vodom, ali vodu ne smiju progutati.
Adults and adolescents aged 12 years and over
Odrasle osobe i adolescenti u dobi od 12 i više godina
P value (95% CI)
P vrijednost (95% CI)
If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol).
U slučaju takvog napadaja morate primijeniti brzodjelujući inhalacijski lijek (kao što je salbutamol).
Tell your doctor as soon as possible if you develop any of these symptoms.
Obavijestite svog liječnika što je prije moguće ako se pojavi neki od navedenih simptoma.
Systemic corticosteroid effects
Sistemski učinci kortikosteroida
Corticosteroids also help to prevent attacks of asthma and aggravation of COPD.
Kortikosteroidi također pomažu u sprječavanju napadaja astme i pogoršanja KOPB-a.
If your symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:
Ako Vam se simptomi (nedostatak zraka, piskanje pri disanju, kašalj) ne poboljšaju ili se pogoršaju, ili primjenjujete brzodjelujući inhalacijski lijek češće nego inače:
It relaxes the muscles of the small air passages in the lungs.
Opušta mišiće malih dišnih putova u plućima.
Table 1 - Results of primary and key secondary endpoints in HZA106827 and HZA106829
Tablica 1 - Rezultati primarnih i ključnih sekundarnih mjera ishoda u ispitivanjima HZA106827 i HZA106829
Close the inhaler and rinse your mouth
Zatvorite inhalator i isperite usta
HZA106837 was of variable treatment duration (from a minimum of 24 weeks to a maximum of 76 weeks with the majority of patients treated for at least 52 weeks).
U ispitivanju HZA106837 trajanje liječenja je variralo (od najmanje 24 tjedna do najviše 76 tjedana, s time da je većina ispitanika liječena najmanje 52 tjedna).
184/22 micrograms
184/22 mikrograma
If you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia.
Ako primjenjujete ovaj lijek za KOPB, može postojati povećan rizik od nastanka infekcije pluća poznate kao upala pluća.
The allergen was house dust mite, cat dander, or birch pollen; the selection was based on individual screening tests.
Alergeni su bili kućne grinje, ljuskice mačje kože ili pelud breze, a odabir se temeljio na individualnim rezultatima testova probira.
Do not give this medicine to children under the age of 12 years for the treatment of asthma, or in children and adolescents of any age for the treatment of COPD.
Ovaj se lijek ne smije davati djeci mlađoj od 12 godina za liječenje astme ni djeci i adolescenatima bilo koje dobi za liječenje KOPB-a.
The date should be added as soon as the inhaler has been removed from the tray.
Datum treba dodati čim je inhalator izvađen iz podloška.
Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving remains optimal and is only changed on medical advice.
Liječnici moraju redovito kontrolirati bolesnike kako bi jačina flutikazonfuroata/vilanterola koju primaju ostala optimalna i mijenjala se isključivo na savjet liječnika.
In the 12 months prior to the study, 61% of subjects reported no COPD exacerbations and 39% of subjects reported ≥1 moderate/severe COPD exacerbation.
U razdoblju od 12 mjeseci prije početka ispitivanja, 61% ispitanika nije prijavilo egzacerbacije KOPB-a, dok je 39% ispitanika prijavilo ≥ 1 umjerene/teške egzacerbacije KOPB-a.
Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see section 5.3).
Ispitivanja na životinjama ukazala su na reproduktivnu toksičnost kod razina izloženosti koje nisu klinički značajne (vidjeti dio 5.3).
• infection of the nose sinuses or throat
• infekcija nosnih sinusa ili grla
Description of selected adverse reactions *Pneumonia (see section 4.4)
Opis odabranih nuspojava *Pneumonija (vidjeti dio 4.4)
Some medicines may affect how this medicine works, or make it more likely that you will have side effects.
Neki lijekovi mogu utjecati na način djelovanja ovog lijeka ili mogu povećati vjerojatnost pojave nuspojava.
The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.
Vrećicu sa sredstvom za sušenje treba baciti, ne smije se otvoriti, pojesti ili inhalirati.