natgillin/translations-raw huggingface dataset:
You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, 
Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete - zdravila, ki lahko povečajo tveganje za krvavitve, kot so: o peroralni antikoagulanti, zdravila, ki preprečujejo nastanek krvnih strdkov, o nesteroidna protivnetna zdravila, ki se običajno uporabljajo za lajšanje bolečine in/ali vnetja mišic ali sklepov, o heparin, ali katerokoli drugo zdravilo v obliki injekcij, ki se uporablja za zmanjševanje strjevanja krvi, o tiklopidin, peroralno antiagregacijsko zdravilo, o selektivni zaviralci privzema serotonina (na primer fluoksetin ali fluvoksamin, a ne le tadva),
o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, - carbamazepine, a medicine to treat some forms of epilepsy - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer. 
ki se po navadi uporabljajo za zdravljenje depresije, - omeprazol ali esomeprazol, zdravila za zdravljenje težav z želodcem, - flukonazol ali vorikonazol, zdravila za zdravljenje glivičnih okužb, - efavirenz, zdravilo za zdravljenje infekcij z virusom HIV (virus humane imunske pomanjkljivosti), - karbamazepin, zdravilo za zdravljenje nekaterih oblik epilepsije, - moklobemid, zdravila za zdravljenje depresije, - repaglinid, zdravilo za zdravljenje sladkorne bolezni, - paklitaksel, zdravilo za zdravljenje raka.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as besilate). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega besilata.
Clopidogrel Acino contains hydrogenated castor oil May cause stomach upset or diarrhoea. 
Zdravilo Klopidogrel Acino vsebuje hidrogenirano ricinusovo olje Lahko povzroči želodčne motnje ali drisko.
Clopidogrel Acino 75 mg film-coated tablets are white to off-white, marbled, round and biconvex. 
Klopidogrel Acino 75 mg tablete so bele do belkaste, marmorirane, okrogle, bikonveksne filmsko obložene tablete.
if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the if you have kidney or liver disease. 
• če ste imeli strdek v možganski arteriji (ishemična kap), ki se je pojavil v zadnjih sedmih
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin. 
Bolniki so dobivali klopidogrel (300 mg udarni odmerek, nato pa 75 mg na dan, n=1.752) ali placebo (n=1.739), oboje v kombinaciji z ASA (150 mg do 325 mg kot udarni odmerek, nato 75 mg do 162 mg na dan), fibrinolitičnim sredstvom in po potrebi heparinom.
Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies. 
Bolniki so bili naključno razporejeni v skupino, ki je prejemala klopidogrel (začetni odmerek 300 mg, nato 75 mg/dan, n=6.259) ali skupino, ki je prejemala placebo (n=6.303), oboje prejeto v kombinaciji z ASA (75 - 325 mg enkrat na dan) in drugimi standardnimi terapijami.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4). 
Če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4).
ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300 mg loading dose in combination with ASA and with or without thrombolytics. 
- Akutni miokardni infarkt z elevacijo ST spojnice: klopidogrel je potrebno dajati v enkratnem dnevnem odmerku 75 mg, zdravljenje pa je potrebno začeti z udarnim odmerkom 300 mg v kombinaciji z ASA ter z/brez uporabe trombolitikov.
This leaflet was last revised in <MM/YYYY>. 
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}>
Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favour of clopidogrel (95% CI: 24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries. 
Primarni opazovani dogodek je bil opažen pri 15,0 % bolnikov v skupini s klopidogrelom in 21¸7 % bolnikov v skupini s placebom, kar predstavlja absolutno zmanjšanje za 6,7 % in 36 % zmanjšanje verjetnosti v prid klopidogrela (95 % IZ od 24 % do 47 %; p<0,001) v glavnem zaradi zmanjšanja zaradi infarkta zamašenih arterij.
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebotreated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogreltreated group. 
Število bolnikov s primarnim opazovanim dogodkom (srčno-žilna smrt, MI, kap ali neodzivna ishemijo) je bilo 1.035 (16,5 %) v skupini zdravljeni s klopidogrelom in 1.187 (18,8 %) v skupini s placebom, to je 14 % zmanjšanje relativnega tveganja (95 % IZ od 6 % - 21 %, p=0,0005) za skupino, zdravljeno s klopidogrelom.
Other medicines and Clopidogrel Acino 
Kaj vsebuje zdravilo Klopidogrel Acino
As a precautionary measure, breast-feeding should not be continued during treatment with clopidogrel. 
Iz varnostnih razlogov naj se z dojenjem med zdravljenjem z zdravilom Clopidogrel Acino ne nadaljuje.
Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 
Pri bolnikih z akutnim koronarnim sindromom: - Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca): zdravljenje moramo začeti z enkratnim udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
Clopidogrel Acino 75 mg film-coated tablets Clopidogrel 
Klopidogrel Acino 75 mg filmsko obložene tablete Klopidogrel
If you are breastfeeding or planning to breast-feed, talk to your doctor before taking this medicine. 
Če dojite ali nameravate dojiti, se pred jemanjem tega zdravila posvetujte z zdravnikom.
Clopidogrel is a product, one of whose metabolites is an inhibitor of platelet aggregation. 
Klopidogrel je predzdravilo in eden njegovih presnovkov zavira agregacijo trombocitov.
Seventy-three percent (73%) of patients enrolled into the ACTIVE-A study were unable to take VKA due to physician assessment, inability to comply with INR (international normalised ratio) monitoring, 
Triinsedemdeset odstotkov (73 %) bolnikov, vključenih v študijo ACTIVE-A, je bilo neprimernih za prejemanje VKA po zdravnikovi oceni, nezmožnosti upoštevanja kontrol INR (internacionalnega normaliziranega razmerja), nagnjenosti k padcem ali poškodbe glave, ali specifičnega tveganja krvavitev; pri 26 % bolnikov je zdravnikova odločitev temeljila na tem, da bolnik ni želel jemati VKA.
You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease (disturbed blood flow in arms or legs caused by vascular 
Zdravilo Klopidogrel Acino vam je predpisano za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker: - imate stanje otrdelih arterij (znano tudi kot ateroskleroza), in - ste predhodno doživeli srčni napad, kap ali imeli stanje, ki je znano kot periferna arterijska bolezen (moten krvni pretok v rokah ali nogah, ki ga povzroči zapora žil) ali - ste doživeli hudo obliko bolečine v prsih, znano kot “nestabilna angina” ali “miokardni infarkt” (srčni napad).
Clopidogrel should not be used in children because of efficacy concerns (see section 5.1). 
• Pediatrična populacija Klopidogrel naj se pri otrocih ne uporablja iz razlogov, ki zadevajo učinkovitost (glejte
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion 
povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ali zmedenostjo
Do not stop the treatment unless your doctor tells you so. 
Če ste prenehali jemati zdravilo Klopidogrel Acino Ne prekinite zdravljenja razen, če tako odloči zdravnik.
4.1 Therapeutic indications Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial 
• bolnikih z miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo (od 7 dni do manj kot 6 mesecev) ali dokazano periferno arterijsko boleznijo.
Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time. 
Če bolnik izpusti odmerek: - če je zamuda manj kot 12 ur po pravem času: bolnik naj odmerek vzame takoj, potem pa
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2). 
Vendar pa se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih (glejte poglavje 2).
Haematoma 
Vrtoglavica
Other side effects include: 
Drugo sočasno zdravljenje:
• You should tell your doctor if a surgery (including dental) is planned. 
Ko jemljete zdravilo Klopidogrel Acino: • morate povedati zdravniku, če imate predvideno kakšno operacijo (vključno z
General disorders and administration site conditions 
Splošne težave in spremembe na mestu aplikacije mestu vboda
You have been prescribed Clopidogrel Acino to help prevent blood clots and reduce the risk of these severe events because: 
Klopidogrel je indiciran pri odraslih za preprečevanje aterotrombotičnih dogodkov pri:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2009 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z
Macrogol 6000 
z 0,6 %).
* Information related to clopidogrel with frequency “not known”. 
Podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov * Podatki se nanašajo na klopidogrel s pogostnostjo “neznani”.
This summary was last updated in June 2013. 
Ta povzetek je bil nazadnje posodobljen junija 2013.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again. 
Če bolečina ne popusti več kot 12 ur po zdravniškem pregledu, se ponovno posvetujte z zdravnikom.
For cats 9 weeks and older, two doses are given at an interval of 3 to 4 weeks. 
Mačkam, starim 9 tednov ali več, damo dva odmerka v presledku 3 do 4 tedne.
When exposed to any of these viruses and bacterium later in life, the cat will either not become infected or will have a much less serious infection. 
Če je mačka pozneje v življenju izpostavljena kateremu koli od teh virusov in bakteriji, se mačka ne bo okužila ali pa bo njena okužba blažja.
In the trial to observe side effects, there were no side effects in 94.2 % of cats for the first vaccination and no side effects observed for 99 % of cats for the second vaccination. 
V preskušanju, v katerem so opazovali neželene učinke, po prvem cepljenju ni bilo nobenih neželenih učinkov pri 94,2 % mačk, po drugem pa pri 99 % mačk.
The European Commission granted a marketing authorisation valid throughout the European Union, for Fevaxyn Pentofel on 5 February 1997. 
Evropska komisija je dovoljenje za promet z zdravilom Fevaxyn Pentofel, veljavno po vsej Evropski uniji, odobrila dne 5. februarja 1997.
In addition, studies in cats of various breeds were carried out to observe any side effects of Fevaxyn Pentofel after the first and second vaccinations. 
Poleg tega so pregledali podatke študij na mačkah različnih pasem, da bi odkrili kakršne koli neželene učinke zdravila Fevaxyn Pentofel po prvem in drugem cepljenju.
If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. 
Če vam je bil ta pripravek nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana zelo majhna količina.
The benefit-risk balance may be found in the scientific discussion of this EPAR. 
Razmerje med koristmi in tveganji najdete v znanstvene razprave tega Evropskega javnega poročila o oceni zdravila (EPAR).
Fevaxyn Pentofel contains small amounts of four inactivated viruses and one inactivated bacterium. 
Zdravilo Fevaxyn Pentofel vsebuje majhne količine štirih inaktiviranih virusov in ene inaktivirane bakterije.
Fevaxyn Pentofel is then given once every year. 
Zdravilo Fevaxyn Pentofel se daje enkrat letno.
When injected, this small exposure helps the cat's immune system to recognise and attack the viruses and bacterium. 
Z injiciranjem zdravila izpostavimo mačko tem majhnim količinam, kar imunskemu sistemu mačke pomaga prepoznavati in napadati viruse in bakterijo.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - rarely causing the loss of a finger. 
Nenamerno injiciranje lahko povzroči hude bolečine in otekline, zlasti če se zdravilo injicira v sklep ali prst - in lahko v izjemnih primerih privede do izgube prsta.
Fevaxyn Pentofel contains mineral oil. 
Zdravilo Fevaxyn Pentofel vsebuje mineralno olje.
In very rare cases there is an anaphylactic reaction (severe allergy) with oedema (fluid under the skin), pruritus, respiratory and cardiac distress, severe gastrointestinal signs or shock during the first hours after vaccination. 
V zelo redkih primerih se pojavi anafilaktična reakcija (huda alergija), ki jo spremljajo edem (tekočina pod kožo), pruritus, dihalna in srčna stiska, hude gastrointestinalne motnje ali šok, ki se lahko pojavijo v prvih urah po cepljenju.
Occasionally there is swelling, pain, pruritus (itching) or hair loss at the injection site. 
Včasih se pojavijo otekline, bolečine, pruritus (srbenje) ali izpadanje dlake na mestu injiciranja.
Other information about Fevaxyn Pentofel: 
Druge informacije o zdravilu Fevaxyn Pentofel:
The contents of the prefilled syringe are shaken and given by subcutaneous (under the skin) injection. 
Vsebino napolnjene brizge je treba pretresti in dati v obliki subkutane (podkožne) injekcije.
Some vaccinated cats may develop reactions to the vaccine, which include temporary fever, vomiting, anorexia (not eating), and/or depression, which usually disappear within 24 hours. 
Pri nekaterih cepljenih mačkah se lahko pojavijo reakcije na cepivo, ki vključujejo začasno zvišanje telesne temperature, bruhanje, anoreksijo (neješčnost) in/ali depresijo.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Fevaxyn Pentofel are greater than any risks to immunise healthy cats of 9 weeks or older against feline viruses. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila Fevaxyn Pentofel pri imunizaciji zdravih mačk, starih 9 tednov ali več, proti mačjim virusom večje od z njim povezanih tveganj.
Fevaxyn Pentofel is a vaccine for cats which is a solution for injection in a prefilled syringe. 
Zdravilo Fevaxyn Pentofel je cepivo za mačke v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi.
What benefit has Fevaxyn Pentofel shown during the studies? 
Kakšne koristi je zdravilo Fevaxyn Pentofel izkazalo med raziskavami?
They recommended that Fevaxyn Pentofel should be given a marketing authorisation. 
Odbor za zdravilo Fevaxyn Pentofel priporoča odobritev dovoljenja za promet.
The Package Leaflet should be taken to the doctor. 
K zdravniku nesite tudi Navodila za uporabo.
Why has Fevaxyn Pentofel been approved? 
Zakaj je bilo zdravilo Fevaxyn Pentofel odobreno?
An additional dose is recommended for kittens living in high-risk areas for feline leukaemia virus whose first dose was administered before 12 weeks of age. 
Pri mačkah, ki živijo v območjih z velikim tveganjem za prenos virusa mačje leukemije in pri katerih je bil prvi odmerek dan pred starostjo 12 tednov, se priporoča dodaten odmerek.
How has the effectiveness of Fevaxyn Pentofel been studied? 
Kako je bila učinkovitost zdravila Fevaxyn Pentofel raziskana?
Fevaxyn Pentofel contains the following inactivated viruses: feline panleukopenia virus, feline rhinotracheitis virus, feline calicivirus, feline leukaemia virus, and the inactivated bacterium feline Chlamydophila felis. 
Zdravilo Fevaxyn Pentofel vsebuje naslednje inaktivirane viruse: virus mačje panleukopenije, virus mačjega rinotraheitisa, mačji calicivirus, virus mačje leukemije in inaktivirano bakterijo mačje Chlamydophila felis.
Fevaxyn Pentofel is used to immunise healthy cats of 9 weeks or older against feline panleukopenia and feline leukaemia and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis. 
Zdravilo Fevaxyn Pentofel se uporablja za imunizacijo zdravih mačk, starih 9 tednov ali več, proti mačji panleukopeniji in mačji leukemiji ter proti boleznim dihal, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi in mačja Chlamydophila felis.
What are the side effects of Fevaxyn Pentofel? 
Kakšni so neželeni učinki zdravila Fevaxyn Pentofel?
How does Fevaxyn Pentofel work? 
Kako zdravilo Fevaxyn Pentofel deluje?
What is Fevaxyn Pentofel used for? 
Za kaj se zdravilo Fevaxyn Pentofel uporablja?
What is Fevaxyn Pentofel? 
Kaj je zdravilo Fevaxyn Pentofel?
Fevaxyn Pentofel has been studied against Feline Leukaemia, against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis, as well as against disease caused by feline panleukopenia virus. 
Zdravilo Fevaxyn Pentofel so preučevali proti mačji leukemiji, boleznim dihal, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi ter mačja Chlamydophila felis, in proti bolezni, ki jo povzroča virus mačje panleukopenije.
Fevaxyn Pentofel has been shown to be effective against Feline Leukaemia, against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis, as well as against disease caused by feline panleukopenia virus. 
Dokazali so, da je zdravilo Fevaxyn Pentofel učinkovito proti mačji leukemiji, boleznim dihal, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi ter mačja Chlamydophila felis, in proti bolezni, ki jo povzroča virus mačje panleukopenije.
Invented name Strength Pharmaceutical Form Route of administration 
Številka EU Zaščiteno ime Jakost Farmacevtska oblika
1 dose (0.5 ml) contains: 
1 odmerek (0,5 ml) vsebuje: davični toksoid*
≥ 60 IU 
10 mikrogramov
Diphtheria toxoid* ≥ 30 IU Tetanus toxoid* 
tetanusni toksoid*
Inactivated Bordetella pertussis strain** ≥ 4 IU Hepatitis B virus surface Antigen recombinant** (S protein)*** 10 micrograms * adsorbed on aluminium oxide hydrated Total: 0.26 milligrams Al ** adsorbed on aluminium phosphate Total: 0.37 milligrams Al3+ 
*adsorbiran na aluminijev hidroksid skupno: 0,26 miligrama Al3+
*** produced on genetically-engineered yeast cells (Saccharomyces cerevisiae) 
**adsorbiran na aluminijev fosfat skupno: 0,37 miligrama Al3+ ***pridobljen z genetskim inženiringom na celični kulturi kvasovk (Saccharomyces cerevisiae)
Packaging Content 
Ovojnina
This can happen. 
To se lahko zgodi.
Breathe in quickly and as deeply as you can. 
Vdihnite hitro in globoko kolikor morete.
Date of first authorisation: 19 September 2013 Date of latest renewal: 22 May 2018 
Datum prve odobritve: 19. september 2013 Datum zadnjega podaljšanja: 22. maj 2018
Hold breath Hold your breath for up to 5 seconds. 
Zadržite dih Zadržite dih do 5 sekund.
Health-related quality of life: 
Z zdravjem povezana kakovost življenja:
Supportive and symptomatic treatment is indicated. 
Indicirano je podporno in simptomatsko zdravljenje.
You have not received enough of your medicine. 
Niste prejeli dovolj zdravila.
In serious cases, patients should be hospitalised. 
V resnih primerih je treba bolnika sprejeti v bolnišnico.
Daily activities 
Vsakodnevne aktivnosti
Frequently Asked Questions 
Pogosta vprašanja
If you use this medicine once a day, it will help to reduce the effects of COPD on your everyday life. 
Če boste to zdravilo uporabljali enkrat na dan, vam bo pomagalo pri zmanjševanju vpliva KOPB na vaše vsakodnevno življenje.
Not all pack sizes may be available in your country. 
V vaši državi morda niso na voljo vse velikosti pakiranj.
It is not harmful. 
To vam ne bo škodovalo.
• voice alteration (hoarseness). 
• spremembe glasu (hripavost)
Patients should be instructed not to take more than one dose in a day. 
Bolnikom je treba naročiti, naj ne vzamejo več kot enega odmerka v istem dnevu.
A further 5% of the dose was found in the bile. 
Nadaljnjih 5 % odmerka so našli v žolču.
Patients should be instructed on how to administer the medicinal product correctly. 
Bolnike je treba poučiti, kako naj si pravilno aplicirajo zdravilo.
These patients should be monitored closely for potential adverse reactions. 
Te bolnike je treba skrbno opazovati glede morebitnih neželenih učinkov.
Some side effects may be serious: 
Nekateri neželeni učinki so lahko resni:
During inhalation you will hear a whirring noise. 
Med vdihovanjem boste slišali brneč zvok.
If you get any of these serious side effects, seek medical help immediately. 
Če pride do katerega od navedenih resnih neželenih učinkov, takoj poiščite zdravniško pomoč.
Needles and springs are made from stainless steel. 
Igle in vzmeti so iz nerjavečega jekla.
Elderly (age 75 years and over) You can use this medicine if you are aged 75 years and over at the same dose as for other adults. 
Starejši (stari 75 let ali več) Če ste stari 75 let ali več, lahko uporabljate to zdravilo v enakem odmerku kot drugi odrasli.
Week 26 
1. dan po 26 tednih
No difference between ethnic subgroups was identified. 
Razlik med pripadniki etničnih podskupin niso ugotovili.
The chances of the capsule breaking into small pieces will be increased if the capsule is pierced more than once. 
Možnost, da se kapsula zdrobi v manjše delce, je večja, če kapsulo nehote predrete več kot enkrat.
Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it. 
Bolnike, pri katerih ne pride do izboljšanja dihanja, je treba vprašati, ali zdravilo morda pogoltnejo namesto da bi ga inhalirali.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z manjševanjem tveganja).
Carcinogenicity was assessed in a two-year rat study and a six-month transgenic mouse study. 
Kancerogenost so ocenjevali v dvoletni študiji na podganah in v šestmesečni študiji na transgenskih miših.
However, this medicine may cause dizziness (see section 4). 
Lahko pa to zdravilo povzroča omotičnost (glejte poglavje 4).