natgillin/translations-raw huggingface dataset:
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h.
Vanjska strana je boje kože s otisnutim natpisom Neupro 2 mg/24 h.
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Vanjska strana je boje kože s otisnutim natpisom Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h ili 8 mg/24 h.
Do not breast-feed during treatment with Neupro.
Nemojte dojiti dok uzimate
Weight decreased e, hepatic enzyme increasede (incl.
Pretrage smanjenje tjelesne težinee, povećanje vrijednosti jetrenih enzimae
Neupro 6 mg/24 h transdermal patch EU/1/05/331/007
Neupro 6 mg/24 h transdermalni flaster EU/1/05/331/007
At the end of the maintenance treatment in 91% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i.e. 6 mg/24 h. An improvement of 20% was seen in 48% of the subjects receiving rotigotine and in 19% of the subjects receiving placebo (Difference 29%, CI95% 18%; 39%, p<0.0001).
Poboljšanje od 20% zabilježeno je u 48% ispitanika liječenih rotigotinom i u 19% ispitanika koji su primali placebo (razlika 29%, CI95%: 18%; 39%, p <0,0001).
Neupro 4 mg/24 h transdermal patch EU/1/05/331/004
Neupro 4 mg/24 h transdermalni flaster EU/1/05/331/004
Neupro 3 mg/24 h transdermal patch EU/1/05/331/047
Neupro 3 mg/24 h transdermalni flaster EU/1/05/331/047
EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/058 [14 transdermal patches]
EU/1/05/331/047 [7 transdermalnih flastera] EU/1/05/331/049 [28 transdermalnih flastera] EU/1/05/331/050 [30 transdermalnih flastera] EU/1/05/331/058 [14 transdermalnih flastera]
EU/1/05/331/038 [7 transdermal patches] EU/1/05/331/040 [28 transdermal patches] EU/1/05/331/041 [30 transdermal patches] EU/1/05/331/056 [14 transdermal patches]
EU/1/05/331/038 [7 transdermalnih flastera] EU/1/05/331/040 [28 transdermalnih flastera] EU/1/05/331/041 [30 transdermalnih flastera] EU/1/05/331/056 [14 transdermalnih flastera]
You may have to use more than one patch to reach your dose, as prescribed by your doctor.
Za primjenu odgovarajuće doze koju je propisao Vaš liječnik, možda ćete trebati primijeniti više od jednog flastera.
EU/1/05/331/010 [7 transdermal patches] EU/1/05/331/011 [28 transdermal patches] EU/1/05/331/033 [30 transdermal patches] EU/1/05/331/061 [14 transdermal patches]
EU/1/05/331/010 [7 transdermalnih flastera] EU/1/05/331/011 [28 transdermalnih flastera] EU/1/05/331/033 [30 transdermalnih flastera] EU/1/05/331/061 [14 transdermalnih flastera]
neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
16. PODACI NA BRAILLEOVOM PISMU neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
Neupro 8 mg/24 h transdermal patch rotigotine
Neupro 8 mg/24 h transdermalni flaster rotigotin
LABELLING AND PACKAGE LEAFLET
Kako Neupro izgleda i sadržaj pakiranja
Neupro 8 mg/24 h transdermal patch
Neupro 8 mg/24 h transdermalni flaster
hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disordersa,d (incl.
Psihijatrijski poremećaji napadi spavanja/iznenadne epizode spavanja, poremećaji spolne željea (uključujući hiperseksualnost, povećanje libida), nesanica, poremećaj spavanja, abnormalni snovi, poremećaji kontrole nagonaa, d
EU/1/05/331/004 [7 transdermal patches] EU/1/05/331/005 [28 transdermal patches] EU/1/05/331/021 [30 transdermal patches] EU/1/05/331/059 [14 transdermal patches]
EU/1/05/331/004 [7 transdermalnih flastera] EU/1/05/331/005 [28 transdermalnih flastera] EU/1/05/331/021 [30 transdermalnih flastera] EU/1/05/331/059 [14 transdermalnih flastera]
Neupro 6 mg/24 h transdermal patch
Neupro 6 mg/24 h transdermalni flaster
Neupro 1 mg/24 h transdermal patch rotigotine
Neupro 1 mg/24 h transdermalni flaster rotigotin
EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/060 [14 transdermal patches]
EU/1/05/331/007 [7 transdermalnih flastera] EU/1/05/331/008 [28 transdermalnih flastera] EU/1/05/331/027 [30 transdermalnih flastera] EU/1/05/331/060 [14 transdermalnih flastera]
EU/1/05/331/001 [7 transdermal patches] EU/1/05/331/002 [28 transdermal patches] EU/1/05/331/015 [30 transdermal patches] EU/1/05/331/057 [14 transdermal patches]
EU/1/05/331/001 [7 transdermalnih flastera] EU/1/05/331/002 [28 transdermalnih flastera] EU/1/05/331/015 [30 transdermalnih flastera] EU/1/05/331/057 [14 transdermalnih flastera]
4 mg/24 h may be an effective dose in some patients.
Za neke bolesnike učinkovita doza može biti 4 mg/24 h.
Neupro 6 mg/24 h transdermal patch rotigotine
Neupro 6 mg/24 h transdermalni flaster rotigotin
Neupro 4 mg/24 h transdermal patch
Neupro 4 mg/24 h transdermalni flaster
Neupro 3 mg/24 h transdermal patch
Neupro 3 mg/24 h transdermalni flaster
The signs include: loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, low level of consciousness (such as a coma).
Pretrage smanjenje tjelesne težine povećanje vrijednosti jetrenih enzima (uključujući AST, ALT, GGT), povećanje tjelesne težine, ubrzanje srčane frekvencije, povišena kreatin fosfokinaza (CPK)d (vidjeti
EU/1/05/331/018 [84 transdermal patches (3 packs of 28)]
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/018 [84 transdermalna flastera (3 pakiranja od 28)]
Neupro 3 mg/24 h transdermal patch rotigotine
Neupro 3 mg/24 h transdermalni flaster rotigotin
EU/1/05/331/053 [84 transdermal patches (3 packs of 28)]
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/053 [84 transdermalna flastera (3 pakiranja od 28)]
On the first day of treatment the patient starts with Neupro 2 mg/24 h. During the second week, the patient takes Neupro 4 mg/24 h. During the third week, he or she takes Neupro 6 mg/24 h and during the fourth week Neupro 8 mg/24 h. The packages are marked with “Week 1 (2, 3 or 4)”.
Tijekom trećeg tjedna, on ili ona primjenjuje Neupro 6 mg/24 h, a tijekom četvrtog tjedna Neupro 8 mg/24 h.
Neupro 2 mg/24 h transdermal patch rotigotine
Neupro 2 mg/24 h transdermalni flaster rotigotin
Neupro 4 mg/24 h transdermal patch rotigotine
Neupro 4 mg/24 h transdermalni flaster rotigotin
EU/1/05/331/036 [84 transdermal patches (3 packs of 28)]
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/036 [84 transdermalna flastera (3 pakiranja od 28)]
EU/1/05/331/044 [84 transdermal patches (3 packs of 28)]
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/044 [84 transdermalna flastera (3 pakiranja od 28)]
EU/1/05/331/024 [84 transdermal patches (3 packs of 28)]
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/024 [84 transdermalna flastera (3 pakiranja od 28)]
EU/1/05/331/030 [84 transdermal patches (3 packs of 28)]
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/331/030 [84 transdermalna flastera (3 pakiranja od 28)]
Erectile dysfunction e
Poremećaji reproduktivno g sustava i dojki erektilna disfunkcija
Neutropenia lasted on average 1.6 days with both medicines.
Neutropenija je u prosjeku trajala 1,6 dana s oba lijeka.
Further information on Pelgraz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Više informacija o lijeku Pelgraz nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The most common side effect with Pelgraz (which may affect more than 1 in 10 people) is pain in the bones.
Najčešća nuspojava lijeka Pelgraz (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
This means that Pelgraz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Drugim riječima, Pelgraz je visoko sličan drugom biološkom lijeku („referentni lijek“) koji je već odobren u EU-u.
What measures are being taken to ensure the safe and effective use of Pelgraz?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pelgraz?
Pelgraz is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Pelgraz se daje kao pojedinačna doza od 6 mg koja se ubrizgava ispod kože najmanje 24 sata nakon kraja svakog ciklusa kemoterapije (terapije protiv raka).
What is Pelgraz and what is it used for?
Što je Pelgraz i za što se koristi?
Pelgraz is a ‘biosimilar medicine'.
Pelgraz je „biosličan lijek”.
Because Pelgraz is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelgraz.
Budući da je lijek Pelgraz biosličan lijek, ispitivanja djelotvornosti i sigurnosti pegfilgrastima provedena za lijek Neulasta nije potrebno ponavljati za lijek Pelgraz.
Side effects reported with Pelgraz are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Pelgraz pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelgraz has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Pelgraz ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Neulasta te se u tijelu raspoređuje na isti način.
Pelgraz can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Pelgraz izdaje se samo na liječnički recept, a terapiju mora započeti i pratiti liječnik s iskustvom u liječenju raka ili poremećaja krvi.
An overview of Pelgraz and why it is authorised in the EU
Pregled informacija o lijeku Pelgraz i zašto je odobren u EU-u
Why is Pelgraz authorised in the EU?
Zašto je lijek Pelgraz odobren u EU-u?
What are the risks associated with Pelgraz?
Koji su rizici povezani s lijekom Pelgraz?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pelgraz have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Pelgraz nalaze se u sažetku opisa svojstava i u uputi o lijeku.
Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelgraz outweighs the identified risk and it can be authorised for use in the EU.
Stoga je stav Agencije da korist od lijeka Pelgraz, kao i od lijeka Neulasta, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
The reference medicine for Pelgraz is Neulasta.
Referentni lijek za Pelgraz je Neulasta.
Other information about Pelgraz
Ostale informacije o lijeku Pelgraz
Pelgraz is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Pelgraz nije namijenjen za korištenje u bolesnika s rakom krvi, kroničnom mijeloičnom leukemijom i mijelodisplastičnim sindromima (stanjima kod kojih se stvara veliki broj abnormalnih krvnih stanica, koja se mogu razviti u leukemiju).
In addition, a study involving 589 patients who had chemotherapy after surgery for breast cancer showed that Pelgraz was as effective as Neulasta in reducing the duration of neutropenia.
Nadalje, ispitivanje koje je obuhvaćalo 589 bolesnika koji su prošli kemoterapiju nakon operativnog zahvata zbog raka dojke pokazalo je da je Pelgraz jednako učinkovit kao Neulasta u smanjivanju trajanja neutropenije.
As for all medicines, data on the use of Pelgraz are continuously monitored.
Kao za sve lijekove, podatci o primjeni lijeka Pelgraz kontinuirano se prate.
How does Pelgraz work?
Kako djeluje Pelgraz?
For more information about using Pelgraz, see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Pelgraz pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
The active substance in Pelgraz, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Djelatna tvar u lijeku Pelgraz, pegfilgrastim, sastoji se od filgrastima, koji je vrlo sličan ljudskoj bjelančevini naziva faktor stimulacije rasta granulocita (G-CSF).
Pelgraz is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Pelgraz je lijek koji se primjenjuje u bolesnika s rakom radi ublaživanja neutropenije (niskih razina neutrofila, vrste bijelih krvnih stanica), koja je česta nuspojava liječenja raka i koja može dovesti do osjetljivosti bolesnika na infekcije.
All these data were considered sufficient to conclude that Pelgraz will behave in the same way as Neulasta in terms of effectiveness and safety in its approved uses.
Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Pelgraz za odobrene indikacije djelovati na isti način kao lijek Neulasta u pogledu djelotvornosti i sigurnosti.
In addition, a study in breast cancer patients undergoing chemotherapy has shown that the effectiveness of Pelgraz is equivalent to that of Neulasta in reducing the duration of neutropenia.
Nadalje, u ispitivanju provedenom na bolesnicima s rakom dojke koji prolaze kemoterapiju pokazalo se da je djelotvornost lijeka Pelgraz jednaka djelotvornosti lijeka Neulasta u skraćivanju trajanja neutropenije.
How is Pelgraz used?
Kako se Pelgraz koristi?
In Pelgraz, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
U lijeku Pelgraz filgrastim je „pegiliran” (konjugiran s kemijskom tvari koja se naziva polietilenglikol).
Laboratory studies comparing Pelgraz with Neulasta have shown that the active substance in Pelgraz is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Pelgraz i Neulasta pokazala su da je djelatna tvar u lijeku Pelgraz vrlo slična djelatnoj tvari u lijeku Neulasta u pogledu strukture, čistoće i biološke aktivnosti.
Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
stvaranje više bijelih krvnih stanica, što dovodi do povećanja broja bijelih krvnih stanica i liječenja neutropenije.
Studies have also shown that giving Pelgraz produces similar levels of the active substance in the body to giving Neulasta.
Ispitivanja su pokazala i da primjena lijeka Pelgraz dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Neulasta.
For the full list of side effects and restrictions with Pelgraz, see the package leaflet.
Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Pelgraz potražite u uputi o lijeku.
What benefits of Pelgraz have been shown in studies?
Koje su koristi od lijeka Pelgraz utvrđene u ispitivanjima?
Pelgraz received a marketing authorisation valid throughout the EU on 21 September 2018.
Pelgraz (pegfilgrastim) EMA/518618/2018
Date of first authorisation: 23 April 2014 Date of latest renewal: 15 January 2019
Datum posljednje obnove odobrenja: 15. siječnja 2019.
COPD is a long-term disease and you should use Ulunar Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
KOPB je dugoročna bolest i trebate primijeniti Ulunar Breezhaler svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
Ulunar Breezhaler is recommended to be administered at the same time of the day each day.
Preporučuje se da se Ulunar Breezhaler primjenjuje u isto vrijeme svakoga dana.
The safety and efficacy of Ulunar Breezhaler in children have not been established.
Sigurnost i djelotvornost Ulunar Breezhalera u djece nisu ustanovljeni.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ulunar Breezhaler should any of these signs or symptoms develop.
Bolesnike treba obavijestiti o znakovima i simptomima akutnog glaukoma uskog kuta i uputiti ih da prestanu koristiti Ulunar Breezhaler ako se pojavi bilo koji od tih znakova i simptoma.
- When you start a new pack, use the new Ulunar Breezhaler inhaler that is supplied in the pack.
- Kada otvorite novo pakiranje, upotrijebite novi Ulunar Breezhaler inhalator koji je priložen u pakiranju.
The recommended dose is the inhalation of the content of one capsule once daily using the Ulunar Breezhaler inhaler.
Preporučena doza je inhalacija sadržaja jedne kapsule jedanput na dan korištenjem Ulunar Breezhaler inhalatora.
Talk to your doctor, pharmacist or nurse before using Ulunar Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Ulunar Breezhaler ako se bilo što od navedenoga odnosi na Vas: - ako imate astmu - ovaj lijek se ne smije koristiti za liječenje astme.
There is no relevant use of Ulunar Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Nema relevantne primjene Ulunar Breezhalera u pedijatrijskoj populaciji (mlađih od 18 godina) u indikaciji KOPB-a.
Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ulunar Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Druge najčešće nuspojave povezane s lijekom (u najmanje 3% bolesnika za Ulunar Breezhaler i uz to češće nego za placebo) bile su kašalj, nazofaringitis i glavobolja.
Ulunar Breezhaler should be used with caution in these patient groups.
Ulunar Breezhaler treba koristiti s oprezom u tih skupina bolesnika.
Therefore Ulunar Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Zbog toga Ulunar Breezhaler ne treba primjenjivati istodobno s beta-adrenergičkim blokatorima (uključujući kapi za oči), osim ako za to ne postoje uvjerljivi razlozi.
The capsules must be administered only using the Ulunar Breezhaler inhaler (see section 6.6).
Kapsule se moraju primjenjivati isključivo korištenjem inhalatora Ulunar Breezhaler (vidjeti dio 6.6).
Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
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You should not use Ulunar Breezhaler unless your doctor tells you to do so.
Nemojte koristiti Ulunar Breezhaler osim ako Vam to nije rekao liječnik.
If you use more Ulunar Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Ako ste inhalirali previše ovog lijeka ili ako netko zabunom uzme Vaše kapsule, morate odmah obavijestiti svog liječnika ili otići u najbližu hitnu pomoć.
The effect was significantly greater for Ulunar Breezhaler, when compared to indacaterol, glycopyrronium or tiotropium alone (difference 110 ml, for each comparison).
Učinak je bio značajno veći za Ulunar Breezhaler kada se uspoređuje sa samim indakaterolom, glikopironijem ili tiotropijem (razlika 110 ml, za svaku usporedbu).
If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Ako se pojave znakovi koji ukazuju na alergijsku reakciju osobito angioedem (poteškoće u disanju ili gutanju, oticanje jezika, usana i lica), urtikarija ili osip na koži, liječenje treba odmah prekinuti i započeti alternativnu terapiju.
Therefore, Ulunar Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Stoga se Ulunar Breezhaler smije koristiti tijekom trudnoće samo ako očekivana korist za bolesnika opravdava potencijalni rizik za fetus.
Overall the effect on heart rate over time did not show a consistent pharmacodynamic effect of Ulunar Breezhaler.
Sveukupno, učinak na srčanu frekvenciju tijekom vremena nije pokazao dosljedan farmakodinamički učinak Ulunar Breezhalera.
• Ulunar Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
• Ulunar Breezhaler kapsule moraju se uvijek čuvati u blister kartici i izvaditi tek neposredno prije primjene.
There was no evidence for tachyphylaxis to the effect of Ulunar Breezhaler over time when compared to placebo or its monotherapy components.
Nije bilo dokaza tahifilaksije na učinak Ulunar Breezhalera tijekom vremena u usporedbi s placebom ili monoterapijama njegovim komponentama.
Ulunar Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Ulunar Breezhaler, primijenjen ujutro, smanjio je dinamičku hiperinflaciju i povećao vrijeme tijekom kojeg se može održavati napor od prve doze nadalje.
The use of Ulunar Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Primjenu Ulunar Breezhalera u dojilja treba uzeti u obzir samo ako je očekivana korist za ženu veća od bilo kojeg mogućeg rizika za dojenče (vidjeti dio 5.3).
- The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ulunar Breezhaler contains lactose”).
- Drugi sastojci praška inhalata su laktoza hidrat i magnezijev stearat stearat (vidjeti dio 2 ispod „Ulunar Breezhaler sadrži laktozu“).
What Ulunar Breezhaler is and what it is used for What you need to know before you use Ulunar Breezhaler How to use Ulunar Breezhaler Possible side effects
Što je Ulunar Breezhaler i za što se koristi Što morate znati prije nego počnete primjenjivati Ulunar Breezhaler Kako primjenjivati Ulunar Breezhaler Moguće nuspojave
Ulunar Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Astma Ulunar Breezhaler ne smije se koristiti za liječenje astme zbog nedostatka podataka u ovoj indikaciji.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP),, koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMPa.
Following inhalation of Ulunar Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Nakon inhalacije Ulunar Breezhalera apsolutna bioraspoloživost indakaterola procijenjena je na raspon od 61 do 85% isporučene doze, i za glikopironij oko 47% isporučene doze.
Ulunar Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Ulunar Breezhaler se može koristiti u preporučenoj dozi u starijih bolesnika (u dobi od 75 i više godina).
When indacaterol and glycopyrronium are administered together in Ulunar Breezhaler, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve smooth muscle relaxation.
Kada se indakaterol i glikopironij primjenjuju zajedno u Ulunar Breezhaleru, pružaju dodatnu djelotvornost zbog svog različitog mehanizma djelovanja koji je usmjeren na različite receptore i puteve da bi se postiglo opuštanje glatkih mišića.