natgillin/translations-raw huggingface dataset:
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Navodila za mešanje in injiciranje cepiva: Preden obe komponenti zmešate skupaj, morate emulzijo (adjuvans) in suspenzijo (antigen) vsaj 15 minut pustiti na sobni temperaturi.
Total enrolled subjects N=67 [95% CI]
Skupno vključeni preiskovanci n = 67 [95 % IZ]
Total subjects4 N=30 [95% CI]
Vsi preiskovanci4 n=30 [95% IZ]
Day 21 N=22
21.dan n=22
Day 42 N=18
42. dan n=18
Immune response to A/California/7/2009 (H1N1)v-like 12-23 months
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 12-23 mesecev
Total subjects4 N=51 [95% CI]
Vsi preiskovanci4 n=51 [95% IZ]
• A hard lump and warmth at the injection site
• trda bula na mestu injiciranja in toplo mesto injiciranja,
Total subjects4 N=28 [95% CI]
Vsi preiskovanci4 n=28 [95% IZ]
Day 21 N=17
21. dan n=17
Total subjects5 [95% CI]
Vsi preiskovanci5 [95% IZ]
Month 12 after 2 doses of 0.5 ml
12. mesec po 2 odmerkih po 0,5 ml
• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Neželeni učinki, našteti spodaj, so se pojavili po začetku trženja cepiva Pandemrix (H1N1)v.: • alergijske reakcije z nevarnim znižanjem krvnega tlaka, ki lahko brez zdravljenja povzročijo šok;
Total subjects4 N=55 [95% CI]
Vsi preiskovanci4 n=55 [95% IZ]
Immune response to A/California/7/2009 (H1N1)v-like 24-35 months
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 24-35 mesecev
Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix).
V primeru, da trivalentnih/štirivalentnih cepiv ni na voljo, je mogoče uporabiti cepivo Pandemrix, če potrebujete zaščito proti gripi A(H1N1)v (glejte poglavje Bodite posebno pozorni pri cepljenju s cepivom Pandemrix).
Month 12 after 1 dose of 0.5 ml
12. mesec po 1 odmerku po 0,5 ml
NAME OF THE MEDICINAL PRODUCT Pandemrix suspension and emulsion for emulsion for injection.
Izgled cepiva Pandemrix in vsebina pakiranja suspenzija in emulzija za emulzijo za injiciranje
Day 42 N=22
42. dan n=22
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Pandemrix Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Suspenzija za emulzijo za injiciranje za Pandemrix cepivo proti gripi (H1N1)v z delci virionov, inaktivirano (z adjuvansom)
Day 42 N=17
42. dan n=17
The anti-HA antibody responses were as follows: anti-HA antibody
0,5 ml) naslednji: anti-HA protitelesa
Month 6 after 2 doses of 0.5 ml
6. mesec po 2 odmerkih po 0,5 ml
There are no data with Pandemrix using the subcutaneous route.
Podatkov o subkutani uporabi cepiva Pandemrix ni.
Seronegative subjects prior to vaccination N=48 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=48 [95% IZ]
Seronegative subjects prior to vaccination N=37 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=37 [95% IZ]
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti artralgija, mialgija
Total subjects4 [95% CI]
Vsi preiskovanci4 [95% IZ]
Immune response to A/Netherlands/602/9 (H1N1)v-like1 12-23 months
Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1 12-23 mesecev
• Dizziness
• drgetanje,
Total enrolled subjects N=40 [95% CI]
Skupno vključeni preiskovanci n=40 [95% IZ]
N=2 [95% CI]
seronegativni n=19 [95% IZ]
Immune response to A/California/7/2009 (H1N1)v-like
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu
Seronegative subjects prior to vaccination [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni [95% IZ]
Adult dose (D-Pan-H1N1-010)
Odmerek za odrasle (D-Pan-H1N1-010)
Total enrolled subjects N=51 [95% CI]
Skupno vključeni preiskovanci n =51 [95 % IZ]
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Pandemrix je na voljo v dveh vsebnikih:
Seronegative subjects prior to vaccination N=36 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=36 [95% IZ]
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 2all subjects seronegative prior to vaccination
haemagglutination inhibition) ≥1:40 2delež preiskovancev, ki so bili pred cepljenjem seronegativni
Twelve months after the first dose, the seroprotection rate was as follows: anti-HA antibody
Dvanajst mesecev po prvem odmerku je bil delež serološke zaščite naslednji:
Uncommon: may affect up to 1 in 100 people
Občasni: pojavijo se lahko pri največ 1 od 100 cepljenih oseb
Other side effects:
Drugi neželeni učinki
Seronegative subjects prior to vaccination N=26 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=26 [95% IZ]
Seronegative subjects prior to vaccination N=42 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=42 [95% IZ]
Antigen suspension for Pandemrix Influenza vaccine
Shranjevanje cepiva Pandemrix
Seronegative subjects prior to vaccination N=19 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n =19 [95 % IZ]
Uncommon Insomnia
Psihiatrične motnje občasni nespečnost
Seronegative subjects prior to vaccination N=23 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n =23 [95 % IZ]
Seronegative subjects prior to vaccination N=32 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n=32 [95% IZ]
Immune response to A/Netherlands/602/9 (H1N1)v-like1
Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1
Total enrolled subjects N=52 [95% CI]
Skupno vključeni preiskovanci n=52 [95% IZ]
Seronegative subjects prior to vaccination N=43 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n =43 [95 % IZ]
Two clinical studies evaluated the administration of a half (0.25 ml) dose and a full (0.5 ml) adult dose of Pandemrix in healthy children 10 to 17 years of age.
(0,5 ml) cepiva Pandemrix za odrasle pri zdravih otrocih, starih od 10 do 17 let.
Post dose N=37
Po 2. odmerku n=33
Seronegative subjects prior to vaccination N=7 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n =7 [95 % IZ]
Total enrolled subjects2 N=2 [95% CI]
Skupno vključeni preiskovanci2 n =2 [95 % IZ]
Common: may affect up to 1 in 10 people
Pogosti: pojavijo se lahko pri največ 1 od 10 cepljenih oseb
Seronegative subjects prior to vaccination N=1 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n =1 [95 % IZ]
Total enrolled subjects N=3 [95% CI]
Skupno vključeni preiskovanci n =3 [95 % IZ]
Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-11 months
Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1 6 do 11 mesecev
Seronegative subjects prior to vaccinatio n N=15 [95% CI]
Preiskovanci, ki so bili pred cepljenjem seronegativni n =15 [95 % IZ]
Immune response to A/California/7/2009 (H1N1)v-like 6-9 years
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 6-9 let
Thiomersal
urtikarija
Immune response to A/Netherlands/602/9 (H1N1)v-like1 6-9 years
Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1 6-9 let
The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Po mešanju je količina cepiva Pandemrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 4.2).
Serum neutrali-sing antibody
Nevtra-lizira-joča protitelesa v serumu
Febrile convulsions
Delež serokonverzije
Nervous system disorders
Bolezni živčevja febrilne konvulzije zelo redki1
Pandemrix may be administered in lactating women.
Cepivo Pandemrix se lahko uporabi v obdobju dojenja.
Do not freeze
Če ne prenehajo, SE
tection rate1 92.7%
serokonverzije2 97,1% Faktor serokonverzije3
• Generally feeling unwell
• srbenje, izpuščaj, • splošno slabo počutje,
Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk
Dodatne spremembe informacij o zdravilu bodo prispevale k temu, da bodo zdravstveni delavci in uporabnice bolje seznanjeni s tveganjem za trombembolijo;
Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili ter podrobna obrazložitev odstopanj od priporočila odbora PRAC
Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should
Glede na to, da se dejavniki tveganja za VTE sčasoma spremenijo, je PRAC izpostavil, da je treba tveganje pri posameznicah redno ocenjevati.
The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk
PRAC je potrdil že znano tveganje za trombembolijo, povezano z zdravili, ki vsebujejo kombinirane hormonske kontraceptive, in priporočil, naj se jasno označijo simptomi trombemboličnih dogodkov ter tudi dejavniki tveganja za trombembolične dogodke;
In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrel
Poleg tega je PRAC zahteval, da se opravi študija varnosti zdravila v obdobju trženja, s katero bi podrobneje opredelili, kakšno je relativno tveganje za trombembolične dogodke zaradi klormadinona v primerjavi z zdravili, ki vsebujejo levonorgestrel.
These are combined with varying doses of ethinylestradiol
Ti so kombinirani z različnimi odmerki etinilestradiola (EE) ali z estradiolom (E2).
• The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the
• PRAC je menil, da so za kombinirane hormonske kontraceptive, ki vsebujejo klormadinon, potrebni dodatni podatki, in zahteval, da se opravi študija varnosti zdravila v obdobju trženja (PASS), s katero se bo ocenilo, kakšno je relativno tveganje za trombembolične dogodke zaradi teh zdravil v primerjavi s tistimi, ki vsebujejo levonorgestrel.
The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation
Posledično je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil Evra, Ioa in Zoely za indikacijo kontracepcije še naprej ugodno pod pogojem, da se upoštevajo dogovorjeni pogoji, omejitve, opozorila in druge spremembe informacij o zdravilu ter dodatni ukrepi za zmanjšanje tveganja.
It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between
Znano je, da se z uporabo kombiniranih hormonskih kontraceptivov poveča tudi tveganje za arterijsko trombembolijo (ATE, tj. srčni infarkt in cerebrovaskularni dogodki), vendar pa ni dokazov, da bi med kombiniranimi hormonskimi kontraceptivi obstajale razlike v relativnem tveganju za ATE.
EMEA/301122/2007-EN
EMEA/301122/2007-SL
The rapporteur was Dr. J. Schefferlie and the co-rapporteur was Prof. R. Kroker.
Poročevalec je bil dr. J. Schefferlie, soporočevalec pa prof. R. Kroker.
London, 24 July 2007 EMEA/301122/2007
London, 24. julij 2007 EMEA/301122/2007
The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain, and the United Kingdom.
Referenčna država članica je bila Francija, zadevne države članice pa Belgija, Češka republika, Nemčija, Italija, Španija in Velika Britanija.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Seznam zadevnih imen izdelkov je podan v dodatku I. Znanstveni zaključki so podani v dodatku II.
The product was accepted by the Czech Republic, Italy and Spain.
Zdravilo so sprejele Češka republika, Italija in Španija.
The final opinion was converted into a Decision by the European Commission on 13 June 2007.
Končno mnenje je Evropska komisija v Odločbo spremenila dne 13. junija 2007.
The arbitration procedure started on 8 September 2005 with the adoption of list of questions.
Postopek arbitraže se je pričel 8. septembra 2005 s sprejemom seznama vprašanj.
Belgium referred the reason for disagreement to the EMEA on 28 July 2005.
Belgija je razloge za nesoglasje dne 28. julija 2005 poslala agenciji EMEA.
On 25 October 2006 the European Commission forwarded a draft decision to the Standing Committee on Veterinary Medicinal Products for adoption by written procedure.
25. oktobra 2006 je Evropska komisija posredovala osnutek odločbe Stalnemu odboru za zdravila za uporabo v veterinarski medicini v sprejem po pisnem postopku.
The reasons for the suspension were the same as those identified in the May 2006 CVMP meeting.
Razlogi za začasni preklic so bili isti kot na zasedanju CVMP maja 2006.
• the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer.
• trenutno odobrene karence ne zagotavljajo, da živila, proizvedena iz zdravljenih živali, ne vsebujejo za potrošnikovo zdravje potencialno nevarnih ostankov.
During their June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Med svojim zasedanjem junija 2006 je CVMP določil dr. R. Breathnacha za poročevalca pri ocenjevanju podlage prošnje za ponovno presojo mnenja.
Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries.
Belgija, Nemčija in Velika Britanija so izrazile pomisleke v zvezi z (ne)ustreznostjo karenc in vloge so bile v teh državah umaknjene.
During the written procedure a request was received from the France for new studies made available by the Marketing Authorisation Holder to be scientifically assessed.
Med pisnim postopkom je Francija posredovala prošnjo za znanstveno oceno novih študij, ki jih je dal na razpolago imetnik dovoljenja za promet z zdravilom.
The scope of the referral was to agree whether the proposed withdrawal periods of 58 days for cattle and 35 days for pigs were adequately established.
Namen napotitve je bila uskladitev mnenj, ali sta bili predlagani karenci 58 dni za govedo in 35 dni za prašiče pravilno določeni.
The detailed grounds for the request were submitted to the EMEA on 18 July 2006 and the evaluation procedure for the re-examination started on 19 July 2006.
Podrobna podlaga za to prošnjo je bila EMEA predložena dne 18. julija 2006, 19. julija 2006 pa se je pričel postopek vrednotenja v okviru ponovne presoje.
o in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point; o in pigs, residue concentrations at the injection site were still above the MRL at the last slaughter time point.
o pri govedu so bile koncentracije ostankov na mestu injiciranja še pri zadnji časovni točki zakola višje od MRL; o pri prašičih so bile koncentracije ostankov na mestu injiciranja še pri zadnji časovni točki zakola višje od MRL.
On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP, to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Dne 14. novembra 2006 je Evropska komisija prekinila pisni postopek ter 16. novembra 2006 zaprosila CVMP, naj v oceni postopka napotitve upošteva nove študije ostankov in ustrezno popravi svoje mnenje z dne 13. septembra 2006.
In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice at 48 hours interval.
Pri obeh vrstah se zdravilo daje intramuskularno v odmerku 15 mg amoksicilina/1 kg tm (enakovredno 1 ml zdravila Suramox 15 % LA/10 kg tm) dvakrat v 48-urnem razmiku.
On 1 June 2006, the representative of the MAH notified the EMEA on his intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Dne 1. junija 2006 je zastopnik imetnika dovoljenja za promet z zdravilom obvestil EMEA, da namerava zaprositi za ponovno preučitev mnenja CVMP v skladu s členom 36(4)2.
The Marketing Authorisation Holder (MAH) provided written explanations on 16 January 2006.
Imetnik dovoljenja za promet z zdravilom je predložil pisna pojasnila 16. januarja 2006.
The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007 including presentation of a new residue study in pigs and a new calculation and proposal for the withdrawal period for pigs.
Imetnik dovoljenja za promet je nove študije ostankov posredoval CVMP 9. januarja 2007 ter 13. marca 2007 podal ustno razlago Odboru, vključno s predstavitvijo nove študije ostankov pri prašičih in novim izračunom in predlogom karence za prašiče.
A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S.A. in France on 6 July 2004 based on an abridged application having Duphamox LA as reference medicinal product, with a withdrawal period of 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Dovoljenje za promet za zdravilo Suramox 15 % LA je bilo prvotno podeljeno podjetju Virbac S.A. iz Francije dne 6. julija 2004, in sicer na podlagi skrajšane vloge za Duphamox LA kot referenčno zdravilo, s karenco 58 dni pri govedu za meso in drobovino ter 35 dni pri prašičih za meso in drobovino.
• the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
• trenutno določene karence za govedo in prašiče ne zagotavljajo, da ostanki ne presegajo
At the request of the MAH the evaluation procedure was suspended on 15 March 2006 in order to allow for the MAH to prepare for the provision of oral explanations.
Na prošnjo imetnika dovoljenja za promet z zdravilom je bil 15. marca 2006 postopek vrednotenja začasno ustavljen, da bi tako imetniku dovoljenja za promet z zdravilom omogočili pripravo na ustno pojasnjevanje.
• it was not possible to establish a withdrawal period for cattle and pigs based on the data available;
• na podlagi predloženih podatkov karence za govedo in prašiče ni bilo mogoče določiti;
OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA zdravilo Suramox 15 % LA in z njim povezano ime Stabox 15 % LA Mednarodno nelastniško ime (INN): amoksicilin
During its March 2007 meeting, the CVMP, considered the new residue studies submitted with regard to Suramox 15% LA and concluded that the new data did not allow establishment of withdrawal periods for edible tissues in cattle and pigs.
Med svojim zasedanjem marca 2007 je CVMP preučil nove študije ostankov za zdravilo Suramox 15 % LA ter zaključil, da novi podatki ne omogočajo določitve karence za užitna tkiva goveda in prašičev.
Therefore the Committee adopted by consensus a revised opinion confirming its previous recommendation for the suspension of the marketing authorizations for Suramox 15% LA and the associated invented name, Stabox 15% LA.
Posledično je Odbor soglasno sprejel revidirano mnenje, potrjujoče njegovo predhodno priporočilo za začasni preklic dovoljenja za promet z zdravilom Suramox 15 % LA in z njim povezanim izmišljenim imenom Stabox 15 % LA.
On 13 September 2006 the CVMP, considered the detailed grounds the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
13. septembra 2006 je CVMP obravnaval podrobno podlago za ponovno presojo mnenja in potrdil svoje prvotno mnenje, s katerim priporoča začasni preklic dovoljenja za promet za zdravilo Suramox 15 % LA.
The oral explanations were presented on 17 May 2006 by the MAH to the Committee.
Imetnik dovoljenja za promet je dal ustna pojasnila Odboru 17. maja 2006.
Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic, belonging to the group of penicillins.
Zdravilo Suramox 15 % LA je suspenzija za injiciranje, ki vsebuje amoksicilin, t.j.
During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the
Med svojim zasedanjem maja 2006 je CVMP, z ozirom na vse posredovane podatke in znanstveno razpravo v okviru Odbora, soglasno sprejel mnenje in z njim priporočil začasni preklic dovoljenja za promet z zdravilom Suramox 15 % LA in z njim povezanim izmišljenim imenom Stabox 15 % LA, namenjenim za govedo in prašiče.
Frequency of this reactin cannot be estimated from the available data.
Pogostnosti te reakcije ni mogoče oceniti na podlagi podatkov, ki so na voljo.
• Risk Management Plan (RMP)
• • Načrt za obvladovanje tveganja (RMP)
Medical attention may be needed.
Morda boste potrebovali zdravniško pomoč.
This reaction may rarely occur (may affect up to 1 in 1,000 people).
Ta reakcija se lahko pojavi redko (pojavi se lahko pri največ 1 od 1.000 bolnikov).
To be used within 60 days of opening the bag.
Uporabite v 60 dneh od odprtja vrečke.
Both belong to a group of medicines called bronchodilators.
Obe spadata v skupino zdravil, imenovanih bronhodilatatorji.
A behavioural intervention program was added to both treatment groups for an additional 4 weeks.
Obema terapevtskima skupinama so za dodatne 4 tedne dodali vedenjski intervencijski program.
Hypokalaemia is usually transient, not requiring supplementation.
Hipokaliemija je po navadi prehodna, zato ne zahteva dodatnega zdravljenja.
When you press the button all the way down, the control window changes from red to green.
Ko pritisnete gumb do konca, se kontrolno okence spremeni iz rdečega v zelenega.
The medicine must be used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Zdravilo je treba uporabljati vsak dan dvakrat na dan, in ne samo takrat, ko se pojavijo težave z dihanjem ali drugi simptomi KOPB.
Breathlessness and other symptomatic outcomes:
Zadihanost in drugi simptomatski izidi:
Make sure the orange button is on top.
Prepričajte se, da je oranžni gumb na vrhu.
Use of rescue medication
Uporaba reševalnega zdravila
The recommended dose is one inhalation twice daily.
Priporočen odmerek je en vdih dvakrat na dan.
Further information regarding these two substances is provided below.
Več informacij o teh dveh učinkovinah je na voljo v nadaljevanju.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, in objavljenem na evropskem spletnem portalu o zdravilih.