natgillin/translations-raw huggingface dataset:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, vendar manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 žival od 10.000 zdravljenih živali, vključno s posameznimi primeri).
For the full list of excipients, see section 6.1.
Pomožne snovi: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
The blocking of IL-31 by lokivetmab prevents IL-31 from binding to its co-receptor and thereby inhibits IL-31 mediated cell signalling, providing relief from Atopic Dermatitis-related pruritus and anti-inflammatory activity.
Blokiranje IL-31, ki ga izvaja lokivetmab, preprečuje vezavo IL-31 s svojimi koreceptorji in s tem zavira celično signalizacijo IL-31, ki zagotavlja olajšanje pri atopijskem dermatitisu, povezanim s srbenjem in protivnetnim delovanjem.
Agents for dermatitis, excluding corticosteroids.
Učinkovine za zdravljenje dermatitisa, razen kortikosteroidov.
In case of adverse clinical signs after an overdose the dog should be treated symptomatically.
V primeru neželenih kliničnih znakov po prevelikem odmerjanju je treba psa zdraviti simptomatsko.
Each vial of 1 ml contains:
Vsaka 1 ml viala vsebuje:
Do not use this veterinary medicinal product after the expiry date which stated on the label after EXP Shelf life after first opening the container: use immediately.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti po prvem odpiranju vsebnika: uporabite takoj.
In field studies up to 9 months, treatment of dogs with atopic dermatitis was demonstrated to have a favourable effect on the reduction of pruritus and on the reduction of disease severity as evaluated by Canine Atopic Dermatitis Extent and Severity Index (CADESI) 03 scores.
V terenskih študijah do 9 mesecev se je pri zdravljenju psov z atopijskim dermatitisom pokazalo, da ima ugoden učinek na zmanjšanje srbenja in na zmanjšanje resnosti bolezni, kot jih ocenjuje indeks obsega in resnosti atopijskega dermatitisa pri psih (CADESI) 03.
Administer the entire contents (1 ml) of the vial.
Uporabite celotno vsebino (1 ml) viale.
The induction of such antibodies is uncommon and may have no effect (transient anti-drug antibodies) or may result in a noticeable decrease in efficacy (persistent anti-drug antibodies) in animals that responded to treatment previously.
Nastanek takih protiteles je redek in lahko nima nobenega učinka (prehodna protitelesa proti zdravilom) oziroma lahko povzroči opazno zmanjšanje učinkovitosti (obstojna protitelesa proti zdravilom) pri živalih, ki so se prej odzvale na zdravljenje.
The product should appear clear to opalescent without any visible particle.
Zdravilo je bistra do opalescentna raztopina brez vidnih delcev.
MARKETING AUTHORISATION NUMBER(S) EU/2/17/205/001-012
ŠTEVILKA (E) DOVOLJENJ(A) ZA PROMET EU/2/17/205/001-012
Avoid excessive shaking.
Izogibajte se prekomernemu stresanju.
If the animal does not show a better response after a second dose, the veterinary surgeon should consider alternative treatments.
V primeru, da žival ne pokaže boljšega odziva po drugem odmerku, se mora veterinar odločiti za alternativna zdravljenja.
If no or limited response is obtained within one month after initial dosing, a second dose one month later may increase effectiveness.
Če v roku enega meseca po začetnem odmerjanju ni odziva na zdravljenje ali je le-ta omejen, bo do boljšega odziva prišlo po drugem odmerku, en mesec kasneje.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse reactions other than those mentioned in section 4.6 were observed in laboratory overdose studies.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) V laboratorijskih študijah prevelikega odmerjanja zdravila niso opazili nobenih neželenih reakcij, razen tistih, ki so omenjene v poglavju 4.6.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25/04/2017
Datum pridobitve dovoljenja za promet: 25/04/2017.
EU/2/17/205/009 10 mg/ml 1 vial EU/2/17/205/001 10 mg/ml 2 vials EU/2/17/205/002 10 mg/ml 6 vials EU/2/17/205/010 20 mg/ml 1 vial EU/2/17/205/003 20 mg/ml 2 vials EU/2/17/205/004 20 mg/ml 6 vials EU/2/17/205/011 30 mg/ml 1 vial EU/2/17/205/005 30 mg/ml 2 vials EU/2/17/205/006 30 mg/ml 6 vials
EU/2/17/205/009 10 mg/ml 1 vial EU/2/17/205/001 10 mg/ml 2 viali EU/2/17/205/002 10 mg/ml 6 vial EU/2/17/205/010 20 mg/ml 1 vial EU/2/17/205/003 20 mg/ml 2 viali EU/2/17/205/004 20 mg/ml 6 vial EU/2/17/205/011 30 mg/ml 1 vial EU/2/17/205/005 30 mg/ml 2 viali EU/2/17/205/006 30 mg/ml 6 vial
Special warnings for each target species
Posebna opozorila za vsako ciljno živalsko vrsto:
EU/2/17/205/012 40 mg/ml 1 vial EU/2/17/205/007 40 mg/ml 2 vials EU/2/17/205/008 40 mg/ml 6 vials
EU/2/17/205/012 40 mg/ml 1 vial EU/2/17/205/007 40 mg/ml 2 viali EU/2/17/205/008 40 mg/ml 6 vial
Shelf life after first opening the immediate packaging: use immediately
Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
In a laboratory model study lokivetmab demonstrated an onset of efficacy for pruritus by the first time point at 8 hours post administration.
Laboratorijska modelska študija lokivetmaba je pokazala začetek učinkovitosti proti srbečici v prvi časovni točki 8 ur po dajanju.
It is recommended to monitor dogs for bacterial infections associated with atopic dermatitis, especially during the first weeks of treatment.
Priporočljivo je spremljati pse zaradi bakterijskih okužb, povezanih z atopijskim dermatitisom, zlasti v prvih tednih zdravljenja.
CYTOPOINT strength (mg) to be administered
Količina zdravila CYTOPOINT (mg) za odmerjanje
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodila za uporabo ali ovojnino.
Active substance stability: The applicant should complete the ongoing lokivetmab stability evaluation up to 36 months at the different batch sizes.
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Stabilnost aktivne učinkovine: Predlagatelj mora zaključiti oceno stabilnosti lokivetmaba, ki je v teku, do 36 mesecev na različnih serijah.
Special precautions for use in animals
Posebni previdnostni ukrepi za uporabo pri živalih:
INDICATION(S) Treatment of clinical manifestations of atopic dermatitis in dogs.
INDIKACIJA(E) Zdravljenje klinično izraženega atopijskega dermatitisa pri psih.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Ne uporabite v primeru preobčutljivosti na učinkovino ali na katerokoli pomožno snov.
In cases of atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
V primeru atopijskega dermatitisa je priporočljivo, da se razišče in zdravi dejavnike, ki povzročajo zaplete, kot so bakterijske, glivične ali parazitske okužbe/infestacije (npr. bolhe in garje).
*Lokivetmab is a caninised monoclonal antibody expressed through recombinant techniques in Chinese hamster ovary (CHO) cells
*lokivetmab je pasje monoklonsko protitelo, izraženo z rekombinantnimi tehnikami pri celicah jajčnika kitajskega hrčka (CHO)
4.2 Indications for use, specifying the target species Treatment of clinical manifestations of atopic dermatitis in dogs.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje klinično izraženega atopijskega dermatitisa pri psih.
MANUFACTURER'S BATCH NUMBER
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot {številka}
Lokivetmab is a caninised monoclonal antibody (mAb) specifically targeting canine interleukin-31.
Lokivetmab je pasje monoklonsko protitelo (mAb), ki izrecno deluje na pasji interlevkin-31.
If a vaccine(s) is to be administered at the same time as treatment with lokivetmab, the vaccine(s) should be administered at a different site to that of lokivetmab administration.
Če dajete cepivo(-a) istočasno kot poteka zdravljenje z lokivetmabom, ga (jih) morate dati na drugo mesto od tistega, kjer ste dali lokivetmab.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
NAVEDBA UČINKOVIN(E) IN DRUGEIH SESTAVIN
QUALITATIVE AND QUANTITATIVE COMPOSITION
KAKOVOSTNA IN KOLIČINSKA SESTAVA Učinkovina(e):
Refer also to section 4.5 of the SPC.
Glejte tudi poglavje 4.5 povzetka glavnih značilnosti zdravila.
Avoid excessive shaking or foaming of the solution.
Izogibajte se pretiranemu tresenju in penjenju raztopine.
It is recommended to monitor dogs for bacterial infections, especially during the first weeks of treatment.
Priporočljivo je spremljati pse zaradi bakterijskih okužb povezanih z atopijskim dermatitisom, zlasti v prvih tednih zdravljenja.
Methionine
KARENCA
No adverse reactions other than those mentioned in section 6 were observed in laboratory overdose studies.
V laboratorijskih študijah prevelikega odmerjanja zdravila niso opazili nobenih neželenih reakcij, razen tistih, ki so omenjene v poglavju 6.
Vomiting and/or diarrhoea have been reported to occur in rare cases from spontaneous reports and may occur in connection with hypersensitivity reactions.
Na podlagi spontanih poročil so v redkih primerih poročali tudi o bruhanju in/ali driski, ki se lahko pojavijo v povezavi s preobčutljivostno reakcijo.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine ( učinkovin) Zoetis Inc.
Dosage and treatment schedule:
Odmerjanje in potek zdravljenja
Primary packaging: Single dose clear glass Type I vials with chlorobutyl rubber stopper.
Primarna ovojnina: en odmerek v prozorni viali iz stekla tipa I, z zamaškom iz klorobutilne gume.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous use.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
Neurological signs (seizure, convulsion or ataxia) have been rarely observed in spontaneous reports following use of the veterinary medicinal product.
Na podlagi spontanih poročil so redko poročali o nevroloških znakih (epileptičnem napadu, konvulziji ali ataksiji) po uporabi zdravila.
2 vials 1 vial
1 viala 1 viala
No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials antiinflammatories and vaccines.
V terenskih študijah pri sočasni uporabi lokivetmaba in zdravili za uporabo v veterinarski medicini kot so endo- in ektoparaziti, protimikrobna in protivnetna zdravila ter cepiva, niso opazili nobenih medsebojnih interakcij.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE ( UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Marketing authorisation holder and Manufacturer responsible for batch release:
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation; therefore its use is not recommended during pregnancy, lactation or in breeding dogs.
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena, zato uporaba v obdobju brejosti,
CARDBOARD BOX
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
Pharmacotherapeutic group: Other dermatological preparations.
IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: Druga zdravila za bolezni kože in podkožnega tkiva.
Histidine hydrochloride monohydrate Trehalose dihydrate Disodium edetate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi histidin histidinijev klorid monohidrat trehaloza dihidrat dinatrijev edetat metionin polisorbat 80 voda za injekcije
Bodyweight (kg) of dog
Telesna masa (kg) psa 10 1 viala
Dose according to the dosing chart below.
Odmerjanje na podlagi spodnje tabele.
PACKAGE LEAFLET:
Odmerjanje na podlagi spodnje tabele:
2 x 1 ml
1 x 1 ml 2 x 1 ml
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
4.3 Kontraindikacije Ne uporabite v primerih preobčutljivosti na učinkovino ali na katerokoli pomožno snov.
CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs lokivetmab
CYTOPOINT 10 mg raztopina za injiciranje za pse CYTOPOINT 20 mg raztopina za injiciranje za pse CYTOPOINT 30 mg raztopina za injiciranje za pse CYTOPOINT 40 mg raztopina za injiciranje za pse lokivetmab
1 vial 2 vials
2 viali
CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg solution for injection for dogs CYTOPOINT 40 mg solution for injection for dogs
CYTOPOINT 10 mg raztopina za injiciranje za pse CYTOPOINT 20 mg raztopina za injiciranje za pse CYTOPOINT 30 mg raztopina za injiciranje za pse CYTOPOINT 40 mg raztopina za injiciranje za pse
Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Preobčutljivostne reakcije, vključno z anafilakso, se lahko pojavijo v primeru nenamernega samoinjiciranja.
Active substance:
Subkutana uporaba.
Hypersensitivity reactions (anaphylaxis, facial oedema, urticaria) have been reported to occur in rare cases from spontaneous reports.
Na podlagi spontanih poročil so v redkih primerih poročali o preobčutljivostnih reakcijah (anafilaksiji, obraznem edemu, urtikariji).
Lokivetmab may induce transient or persistent anti-drug antibodies.
Zdravilo lahko povzroči nastanek prehodnih ali obstojnih protiteles proti zdravilom.
Name and address of the manufacturer responsible for batch release
ZDRUŽENE DRŽAVE AMERIKE Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
4.6 Adverse reactions (frequency and seriousness)
4.6 Neželeni učinki (pogostost in resnost) Na podlagi spontanih poročil so v redkih primerih poročali o preobčutljivostnih reakcijah
4.9 Amounts to be administered and administration route Subcutaneous use.
4.9 Odmerjanje in pot uporabe
CYTOPOINT 30 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
CYTOPOINT 30 mg raztopina za injiciranje za pse: Kartonska škatla z 1 vialo po 1 ml Kartonska škatla z 2 vialama po 1 ml Kartonska škatla s 6 vialami po 1 ml
CYTOPOINT 20 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
CYTOPOINT 20 mg raztopina za injiciranje za pse: Kartonska škatla z 1 vialo po 1 ml Kartonska škatla z 2 vialama po 1 ml
Zoetis Inc.
Rp-Vet.
CYTOPOINT 40 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
CYTOPOINT 40 mg raztopina za injiciranje za pse: Kartonska škatla z 1 vialo po 1 ml Kartonska škatla z 2 vialama po 1 ml
CYTOPOINT 10 mg solution for injection for dogs: Cardboard box with 1 vial of 1 ml Cardboard box with 2 vials of 1 ml Cardboard box with 6 vials of 1 ml
CYTOPOINT 10 mg raztopina za injiciranje za pse: Kartonska škatla z 1 vialo po 1 ml Kartonska škatla z 2 vialama po 1 ml
The relevance of these findings to humans is unknown.
Pomen teh ugotovitev za človeka ni znan.
Date of first authorisation: 05 July 2010 Date of latest renewal: 24 April 2015
Datum prve odobritve: 05. julij 2010 Datum zadnjega podaljšanja: 24. april 2015
None of these changes were considered to be clinically meaningful.
Nobena od teh sprememb ni bila prepoznana kot klinično pomembna.
The majority of these adverse reactions were mild or moderate.
Večina teh neželenih učinkov je bila blagih ali zmernih.
Swallow the tablet with some water.
Tableto pogoltnite z nekaj vode.
The specific indication approved.
Odobrena specifična indikacija.
A risk to the breastfed infant cannot be excluded.
Tveganja za dojenega otroka ni mogoče izključiti.
Symptoms you should be aware of
Simptomi na katere morate biti še posebej pozorni
Ratio Roflumilast/Placebo
Razmerje roflumilast/placebo
In case of overdose, it is recommended that the appropriate supportive medical care is provided.
V primeru prevelikega odmerjanja je priporočljivo zagotoviti ustrezno podporno zdravstveno oskrbo.
Children and adolescents Daxas should not be used by children and adolescents under 18 years of age.
Otroci in mladostniki Zdravila Daxas se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Analysis model
Analizni model
Continue taking your medicine at the usual times.
Nadaljujte z jemanjem zdravila ob običajnem času.
Do not stop taking these medicines or reduce their dose unless advised by your doctor.
Ne prenehajte z uporabo teh zdravil ali zmanjšajte odmerka, razen če vam tako svetuje zdravnik.
Interim Study Reports - with each PSUR.
Vmesna poročila o študiji - z vsakim PSUR-om.
You may need to take Daxas for several weeks to achieve its beneficial effect.
Morda boste morali jemati zdravilo Daxas več tednov, da doseže svoj ugoden učinek.
The tablet should be swallowed with water and taken at the same time every day.
Tableto je treba pogoltniti z vodo in vzeti vsak dan ob istem času.
Body weight <60 kg
Telesna masa, manjša od 60 kg
- if you have moderate or severe liver problems.
- če imate zmerne ali hude težave z jetri.
The tablet can be taken with or without food.
Tableto se lahko jemlje s hrano ali brez nje.
Take the tablet at the same time every day.
Tableto vzemite vsak dan ob istem času.
• Educational material for the physician.
• Izobraževalno gradivo za zdravnika
Moderate or severe
Zmerno ali hudo
In uncommon cases allergic reactions may occur.
Občasno se lahko pojavijo alergijske reakcije.
• severe infection
• resno okužbo.
A combination of factors, such as in black, non-smoking females, might lead to an increase of exposure and persistent intolerability.
Kombinacija dejavnikov, npr. pri temnopoltih ženskah nekadilkah, bi lahko povzročila povečano izpostavljenost in trajno intoleranco.
Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).
Pogovorite se z zdravnikom, če v času jemanja tega zdravila opazite nenamerno izgubo telesne mase (ki ni povezana z dieto ali programom telesne vadbe).
The major reasons for trial discontinuation were withdrawal of consent and reported adverse events.
Glavni razlogi za izključitev iz preskušanja so bili umik soglasja in sporočeni neželeni učinki.
Patients with no history of exacerbations were excluded.
Bolniki brez anamneze poslabšanj so bili izključeni.
Negative binomial regression
Negativna binomska regresija
Talk to your doctor if these side effects do not resolve within the first weeks of treatment.
Pogovorite se z zdravnikom, če ti neželeni učinki ne minejo v prvih tednih zdravljenja.
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 (<1/10,000), not known (cannot be estimated from the available data).
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The improvement in lung function was apparent at the first visit after 4 weeks and was maintained up to one year (end of treatment period).
Izboljšanje pljučne funkcije je bilo opazno že ob prvem obisku po 4 tednih in se je obdržalo do enega leta (zaključek zdravljenja).
Some side effects could be serious.
Nekateri neželeni učinki so lahko resni.
EU/1/10/636/001 10 film-coated tablets EU/1/10/636/002 30 film-coated tablets EU/1/10/636/003 90 film-coated tablets EU/1/10/636/004 14 film-coated tablets EU/1/10/636/005 28 film-coated tablets EU/1/10/636/006 84 film-coated tablets EU/1/10/636/007 98 film-coated tablets
EU/1/10/636/001 10 filmsko obloženih tablet EU/1/10/636/002 30 filmsko obloženih tablet EU/1/10/636/003 90 filmsko obloženih tablet EU/1/10/636/004 14 filmsko obloženih tablet EU/1/10/636/005 28 filmsko obloženih tablet EU/1/10/636/006 84 filmsko obloženih tablet EU/1/10/636/007 98 filmsko obloženih tablet
At this low dose you will not get the full effect from the medicinetherefore it is important that you move on to the full dose (called a ‘maintenance dose') after 28 days.
S tem majhnim odmerkom ne boste dosegli polnega učinka zdravila, zato je pomembno, da po 28 dneh preidete na polni odmerek (imenujemo ga tudi "vzdrževalni odmerek").
If on one day you have forgotten to take a tablet of Daxas, just carry on the next day with the next tablet as usual.
Če ste na določen dan pozabili vzeti tableto zdravila Daxas, potem naslednji dan samo nadaljujte z naslednjo tableto kot običajno.
Each pack contains 28 tablets.
Eno pakiranje vsebuje 28 tablet.
Placebo (N=966) Rate (n)
Placebo (N=966) Delež (n)
Long-acting beta-agonists (LABAs) were allowed in the studies and were used in approximately 50% of the study population.
V študijah je bila dovoljena uporaba dolgo-delujočih beta agonistov (LABA), uporabljalo jih je približno 50 % preučevane populacije.
Daxas 500 micrograms has been studied in clinical trials for up to one year, and is intended for maintenance treatment.
Zdravilo Daxas 500 mikrogramov je bilo preučevano v kliničnih študijah, ki so trajale do enega leta, in je namenjeno vzdrževalnemu zdravljenju.
• infection with tuberculosis, herpes, hepatitis, HIV
• okužba s tuberkulozo, herpes, hepatitis, HIV
If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same day.
Če ste pozabili vzeti tableto ob običajnem času, jo isti dan vzemite takoj, ko se spomnite.
Tell your doctor or pharmacist straight away.
Nemudoma obvestite zdravnika ali farmacevta.
The Marketing Authorisation Holder shall agree the content and format of the updated educational material with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se dogovori glede vsebine in oblike posodobljenega izobraževalnega gradiva s pristojnim organom države članice.
The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
Potencialno tveganje za maligne tumorje in pomanjkanje izkušenj pri bolnikih z anamnezo raka v preteklosti.
That patients should tell their doctor if they are taking any other medicines.
Bolniki morajo zdravniku povedati, če jemljejo katera koli druga zdravila.
The affinity to the PDE4C splicing variants is 5 to 10-fold lower.
Afiniteta za različice PDE4C je 5 do 10-krat nižja.
In case of an allergic reaction, stop taking Daxas and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
V primeru pojava alergijske reakcije prenehajte jemati zdravilo Daxas in se nemudoma posvetujte z zdravnikom ali poiščite nujno zdravniško pomoč na urgentnem oddelku najbližje bolnišnice.
28 tablets - 28-day starter pack.
28 tablet - 28-dnevni začetni paket