FrancophonIA/ELRC3.0 huggingface dataset:
English: BiResp Spiromax is not likely to affect your ability to drive or to use tools or machines.
Slovenian: Ni verjetno, da bi zdravilo BiResp Spiromax vplivalo na sposobnost vožnje, uporabe orodij in upravljanja s stroji.
English: Adults (18 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening.
Slovenian: Odrasli (18 let in več): priporočen vzdrževalni odmerek je 2 vdiha na dan, bodisi 1 vdih zjutraj in 1 vdih zvečer ali pa 2 vdiha zjutraj oziroma 2 vdiha zvečer.
English: If any of the following happen to you, stop using BiResp Spiromax and talk to your doctor immediately:
Slovenian: Če se pri vas pojavi kaj od naslednjega, prenehajte uporabljati zdravilo BiResp Spiromax in se nemudoma posvetujte z zdravnikom:
English: If any of the above applies to you, or if you are not sure, talk to your doctor,pharmacist or nurse before using BiResp Spiromax.
Slovenian: Če kar koli od naštetega velja za vas, ali če niste prepričani, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden uporabite zdravilo BiResp Spiromax.
English: What BiResp Spiromax is and what it is used for
Slovenian: Kaj je zdravilo BiResp Spiromax in za kaj ga uporabljamo
English: The mean PIFR achieved by patients with asthma or COPD was over 60L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Slovenian: Povprečna PIFR), ki so jo dosegli bolniki z astmo ali KOPB, jepresegala 60 l/min, pri tej stopnji obe preiskovani napravi v pljuča dovedeta primerljivi količini zdravila.
English: There are no clinical study data on BiResp Spiromax available in COPD patients with a pre-bronchodilator FEV1 >50% predicted normal and with a post-bronchodilator FEV1 <70% predicted normal (see section 5.1)
Slovenian: Podatkov iz kliničnih študij za zdravilo BiResp Spiromax pri bolnikih s KOPD, ki imajo > 50 % predvidenega normalnega FEV1 pred bronhodilatatorjem in < 70 % predvidenega normalnega FEV1 po bronhodilatatorju, ni na voljo (glejte poglavje 5.1).
English: Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of
Slovenian: Izvedeni sta bili dve 12-tedenski pediatrični študiji, v katerih je 265 otrok, starih od 6 do 11 let, uporabljalo vzdrževalni odmerek budezonida/formoterola (2 vdiha po
English: If you use more BiResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice.
Slovenian: Če ste uporabili večji odmerek zdravila BiResp Spiromax, kot bi smeli, se za nasvet obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: BiResp Spiromax is an inhalation powder.
Slovenian: Zdravilo BiResp Spiromax je prašek za inhaliranje.
English: Contents of the pack and other information What BiResp Spiromax contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo BiResp Spiromax
English: If you use more BiResp Spiromax than you should
Slovenian: Če ste uporabili večji odmerek zdravila BiResp Spiromax, kot bi smeli
English: This medicinal product is not recommended for use in children and adolescents under the age of 18 years.
Slovenian: Uporabe zdravila se ne priporoča pri otrocih in mladostnikih, mlajših od 18 let.
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procinamide and terfanadine).
Slovenian: • zdravila proti hitremu ali neenakomernemu bitju srca (npr. kinidin, dizopiramid, prokainamid in terfenadin).
English: Linearity/non-linearity Systemic exposure for both budesonide and formoterol correlates in a linear fashion to administered dose.
Slovenian: Linearnost/nelinearnost Sistemska izpostavljenost za budezonid in formoterol linearno korelira z uporabljenim odmerkom.
English: Do not use BiResp Spiromax to treat these asthma symptoms.
Slovenian: Ne uporabljate zdravila BiResp Spiromax za odpravljanje teh simptomov astme.
English: The reliever inhalations of BiResp Spiromax should be taken in response to symptoms but are not intended for regular prophylactic use, e.g. before exercise.
Slovenian: Zdravilo BiResp Spiromax kot olajševalec se uporablja v primerih, ko se pojavijo simptomi, ne pa redno v profilaktične namene, na primer pred telesnim naporom.
English: Always keep your BiResp Spiromax with you and use it to relieve sudden attacks of breathlessness and wheezing.
Slovenian: Inhalator BiResp Spiromax imejte vedno pri sebi in ga uporabite za lajšanje nenadnih napadov zasoplosti in piskajočega dihanja.
English: For some patients a maintenance dose of 2 inhalations twice daily may be appropriate.
Slovenian: Za nekatere bolnike je primeren vzdrževalni odmerek 2 vdiha dvakrat dnevno.
English: BiResp Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only.
Slovenian: Zdravilo BiResp Spiromax 320 mikrogramov/9,0 mikrogramov je treba uporabljati le kot vzdrževalno zdravljenje.
English: Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice.
Slovenian: Bolniki, ki uporabljajo več kot 8 vdihov dnevno, morajo obiskati zdravnika.
English: Candida infections in the oropharynx, pneumonia (in COPD patients)
Slovenian: Pogosti okužbe s kandido v ustnih in žrelu, pljučnica (pri bolnikih s KOPB)
English: Use your BiResp Spiromax every day.
Slovenian: Zdravilo BiResp Spiromax uporabljajte vsak dan.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of BiResp Spiromax.
Slovenian: Ko dosežemo ustrezen nadzor simptomov astme, je treba razmisliti o postopnem zmanjšanju odmerka zdravila BiResp Spiromax.
English: Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure (see section 5.3).
Slovenian: Študije vpliva formoterola na sposobnost razmnoževanja pri živalih so pokazale nekoliko zmanjšano plodnost pri podganjih samcih pri veliki sistemski izpostavljenosti (glejte poglavje 5.3).
English: Each BiResp Spiromax inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Slovenian: En inhalator BiResp Spiromax vsebuje 120 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim ustnikom.
English: • If you get pregnant while using BiResp Spiromax, do NOT stop using BiResp Spiromax but talk to your doctor immediately.
Slovenian: • Če med zdravljenjem z zdravilom BiResp Spiromax zanosite, zdravila BiResp Spiromax NE nehajte uporabljati, se pa takoj posvetujte z zdravnikom.
English: BiResp Spiromax can be prescribed for asthma in two different ways.
Slovenian: Zdravnik lahko predpiše zdravilo BiResp Spiromax za zdravljenje astme na dva različna načina.
English: Also use BiResp Spiromax as a ‘reliever inhaler' to treat asthma symptoms when they occur.
Slovenian: Zdravilo BiResp Spiromax uporabite tudi kot »inhalator z olajševalcem« za odpravljanje simptomov astme, ko se pojavijo.
English: The spaces between the even numbers represent the odd number of remaining inhalations.
Slovenian: Razmaki med sodimi števili predstavljajo liha števila preostalih inhalacij.
English: Variations in blood pressure
Slovenian: • spremembe krvnega tlaka,
English: A fixed-dose combination of budesonide and formoterol fumarate dihydrate should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Slovenian: Kombinacijo budezonida in formoterolijevega fumarata dihidrata v fiksnih odmerkih predpisujte previdno pri bolnikih s tirotoksikozo, feokromocitomom, sladkorno boleznijo, nezdravljeno hipokaliemijo, hipertrofično obstruktivno kardiomiopatijo, idiopatsko subvalvularno aortno stenozo,
English: • Use BiResp Spiromax when you need to take extra inhalations or puffs to relieve asthma symptoms andto make it easier to breathe again.
Slovenian: • Poleg tega uporabljajte inhalator BiResp Spiromax tudi v primerih, ko potrebujete dodatne odmerke ali vpihe za lajšanje simptomov astme in za lažje dihanje.
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Slovenian: Te kombinacije se je treba izogibati, razen kadar koristi odtehtajo povečano tveganje za sistemske neželene učinke kortikosteroidov.
English: Taste disturbances
Slovenian: Motnje vida
English: • Disturbance of the heart's electrical system which does not cause symptoms (prolongation of the QTc interval).
Slovenian: • bolečina ali tiščanje v prsih (angina pektoris), • motnje električnega sistema srca, ki ne povzročajo simptomov (podaljšanje intervala QTc),
English: • Use BiResp Spiromax every day.
Slovenian: • Inhalator BiResp Spiromax uporabljajte vsak dan.
English: BiResp Spiromax maintenance therapy: BiResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Slovenian: Zdravilo BiResp Spiromax za vzdrževalno zdravljenje: Zdravilo BiResp Spiromax se uporablja za redno vzdrževalno zdravljenje, kot olajševalec pa se ločeno uporablja inhalator s hitrodelujočim bronhodilatatorjem.
English: However, do not use BiResp Spiromax just before exercise to stop asthma symptoms from happening.
Slovenian: Ne uporabljajte pa zdravila BiResp Spiromax neposredno pred telesno dejavnostjo, da bi preprečili pojav simptomov astme.
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Slovenian: če ste alergični na budezonid, formoterolijev fumarat dihidrat, ali katero koli sestavino tega zdravila
English: Mild irritation in the throat, coughing, hoarseness
Slovenian: Pogosti blago draženje grla, kašljanje, hripavost
English: • If you get asthma symptoms such as sudden attacks of breathlessness and wheezing, take 1 inhalation and wait a few minutes.
Slovenian: • Ob pojavu simptomov astme, kot so nenadni napadi zasoplosti in piskajočega dihanja, naredite
English: a) You may be prescribed two asthma inhalers: BiResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Slovenian: a) Lahko vam predpišejo inhalator BiResp Spiromax skupaj z ločenim »inhalatorjem z olajševalcem«, npr. salbutamolom.
English: A lower strength of BiResp Spiromax is available for the maintenance and reliever therapy regimen.
Slovenian: Nižje jakosti zdravila BiResp Spiromax so na voljo kot vzdrževalno in olajševalno zdravljenje.
English: Infections and infestations Common
Slovenian: Infekcijske in parazitske bolezni
English: Other medicines and BiResp Spiromax
Slovenian: Druga zdravila in zdravilo BiResp Spiromax
English: BiResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Slovenian: Zdravilo BiResp Spiromax je indicirano za redno zdravljenje astme v primerih, ko je primerna kombinacija zdravil (inhalacijski kortikosteroid in dolgodelujoči agonist adrenergičnih receptorjev β2):
English: Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of BiResp Spiromax.
Slovenian: Ko so simptomi astme dobro obvladani, bo vaš zdravnik morda predlagal, da odmerek zdravila BiResp Spiromax postopoma zmanjšate.
English: When used for asthma, your doctor will prescribe BiResp Spiromax together with a separate ‘reliever inhaler' such as salbutamol.
Slovenian: Za zdravljenje astme vam bo zdravnik predpisal inhalator BiResp Spiromax skupaj z ločenim inhalatorjem z olajševalcem, npr. salbutamolom.
English: • Blurred vision.
Slovenian: • zamegljen vid.
English: Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems, including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.
Slovenian: Simptomi slabšega delovanja nadledvične žleze so lahko utrujenost, šibkost, težave z želodcem, vključno z navzeo, bruhanjem, bolečino in drisko, potemnitev kože in hujšanje.
English: A total of 12076 asthma patients were included in 5 double-blind clinical studies (4447 were randomised to budesonide/formoterol maintenance and reliever therapy) for 6 or 12 months.
Slovenian: V pet dvojno-slepih kliničnih študij, ki so trajale od 6 do 12 mesecev, so vključili 12.076 bolnikov z astmo (4447 od teh je bilo randomiziranih v skupino z vzdrževalnim in olajševalnim zdravljenjem z budezonidom/formoterolom).
English: Patients take a daily maintenance dose of BiResp Spiromax and in addition take BiResp Spiromax as needed in response to symptoms.
Slovenian: Bolniki redno jemljejo dnevni vzdrževalni odmerek zdravila BiResp Spiromax, ob pojavu simptomov pa po potrebi dodatne odmerke zdravila BiResp Spiromax.
English: Since BiResp Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur.
Slovenian: Ker zdravilo BiResp Spiromax vsebuje tako budezonid kot formoterol, lahko pri bolnikih pričakujemo enak vzorec neželenih učinkov, kot so jih opažali pri posameznih učinkovinah.
English: In patients using potent CYP3A4 inhibitors, a fixed-dose combination of budesonide and formoterol fumarate dihydrate maintenance and reliever therapy is not recommended.
Slovenian: Pri bolnikih, ki jemljejo močne zaviralce CYP3A4, kombinacija budezonida in formoterolijevega fumarata dihidrata v fiksnih odmerkih kot vzdrževalno in olajševalno zdravljenje ni priporočeno.
English: • If you have been prescribed BiResp Spiromax as your only inhaler, read the section called (B) Using
Slovenian: • Če vam je zdravilo BiResp Spiromax zdravnik predpisal kot edini inhalator, preberite poglavje
English: • Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
Slovenian: • antipsihotična fenotiazinska zdravila (npr. klorpromazin in proklorperazin).
English: Do not use BiResp Spiromax 320/9 micrograms as a ‘reliever inhaler'.
Slovenian: Ne uporabljajte inhalatorja BiResp Spiromax 320/9 mikrogramov kot olajševalca.
English: BiResp Spiromax is not intended for the initial management of asthma.
Slovenian: Zdravilo BiResp Spiromax ni primerno za začetno zdravljenje astme.
English: µg bd + terbutaline 0.4 mg as needed Salmeterol/fluticasone 2 x 25/125 µg bd + terbutaline 0.4 mg as needed
Slovenian: 1103 125 0,23b budezonid/formoterolijev fumarat dihidrat 320/9 µg 2-krat na dan + terbutalin 0,4 mg po potrebi salmeterol/flutikazon 2×25/125 µg 2-krat na dan + terbutalin 0,4 mg po potrebi
English: Swensweg 5, 2031GA Haarlem The Netherlands
Slovenian: Swensweg 5, 2031 GA Haarlem Nizozemska
English: Method of administration Inhalation use.
Slovenian: Način uporabe za inhaliranje
English: BiResp Spiromax is indicated for use in adults 18 years of age and older only.
Slovenian: Zdravilo BiResp Spiromax je namenjeno izključno za uporabo pri odraslih osebah, starih 18 let in več.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja Občasni modrice
English: If you forget to use BiResp Spiromax
Slovenian: Če ste pozabili uporabiti zdravilo BiResp Spiromax
English: Bronchospasm
Slovenian: Redki bronhospazem
English: Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + as needed
Slovenian: Študija mesecev budezonid/formoterolijev fumarat dihidrat 160 µg /4,5 µg 2-krat na dan + po potrebi
English: BiResp Spiromax is indicated in adults 18 years of age and older only.
Slovenian: Zdravilo BiResp Spiromax je indicirano izključno pri odraslih, starih 18 let in več.
English: BiResp Spiromax maintenance and reliever therapy: BiResp Spiromax is taken as regular maintenance treatment and as needed in response to symptoms.
Slovenian: Zdravilo BiResp Spiromax za vzdrževalno in olajševalno zdravljenje: Zdravilo BiResp Spiromax se uporablja za vzdrževalno zdravljenje in hkrati kot olajševalec po potrebi, ko se pojavijo simptomi.
English: Patients should be advised to have their rescue inhaler available at all times, either BiResp Spiromax (for asthma patients using BiResp Spiromax as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for asthma patients using BiResp Spiromax as maintenance therapy only).
Slovenian: Bolnikom svetujte, naj imajo inhalator z olajševalcem vedno pri roki, bodisi BiResp Spiromax (za bolnike z astmo, ki uporabljajo zdravilo BiResp Spiromax za vzdrževalno in olajševalno zdravljenje),
English: 1 or 2 inhalations (actuations), twice a day, taken in the morning and in the evening.
Slovenian: 1 ali 2 vdiha (sprožitvi) dvakrat na dan, uporabi se zjutraj in zvečer.
English: Hospitalisation/emergency room treatment or treatment with oral steroids b
Slovenian: Opredeljeno kot bolnišnično zdravljenje, urgentno zdravljenje ali pa kot zdravljenje s peroralnimi steroidi.
English: BiResp Spiromax maintenance and reliever therapy should especially be considered for patients with:
Slovenian: Vzdrževalno in olajševalno zdravljenje z zdravilom BiResp Spiromax je primerno predvsem za bolnike:
English: Hypokalaemia
Slovenian: Redki hipokaliemija
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.
Slovenian: Ko je inhalator poln, kaže kazalnik 120 inhalacij in se konča z 0 (nič) inhalacijami, ko je prazen.
English: BiResp Spiromax is NOT indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Slovenian: Zdravilo BiResp Spiromax NI namenjeno za uporabo pri otrocih, starih 12 let in manj, ali mladostnikih, starih od 13 do 17 let.
English: If you stop using BiResp Spiromax
Slovenian: Če ste prenehali uporabljati zdravilo BiResp Spiromax
English: What BiResp Spiromax looks like and contents of the pack
Slovenian: Izgled zdravila BiResp Spiromax in vsebina pakiranja
English: Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction
Slovenian: Bolezni imunskega sistema Redki takojšnje in zapoznele preobčutljivostne reakcije npr. eksantem, urtikarija, pruritus, dermatitis,
English: (B) Using BiResp Spiromax as your only asthma inhaler
Slovenian: (B) Uporaba zdravila BiResp Spiromax kot edinega inhalatorja za astmo
English: Patients should be advised to always have BiResp Spiromax available for rescue use.
Slovenian: Bolnikom je treba svetovati, da naj imajo zdravilo BiResp Spiromax vedno na razpolago za hitro obvladanje simptomov.
English: Lactose monohydrate.
Slovenian: Zelo redki hiperglikemija
English: Patients should be reminded to take their BiResp Spiromax maintenance dose as prescribed, even when asymptomatic.
Slovenian: Bolnike je treba opozoriti, naj uporabljajo vzdrževalni odmerek zdravila BiResp Spiromax skladno z navodili zdravnika, tudi če nimajo simptomov.
English: If either of these symptoms occur, stop using BiResp Spiromax straightaway and use your 'reliever inhaler' if you have one.
Slovenian: Če se pojavi kateri od teh simptomov, takoj nehajte uporabljati inhalator BiResp Spiromax in uporabite svoj
English: In animal studies formoterol has caused adverse reactions in reproduction studies at very high systemic exposure levels (see section 5.3).
Slovenian: V študijah vpliva na sposobnost razmnoževanja pri živalih je formoterol pri zelo veliki sistemski izpostavljenosti zdravilu povzročil nekatere neželene učinke (glejte poglavje 5.3).
English: In pharmacokinetic studies with and without a charcoal blockage, BiResp Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Slovenian: da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno kombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
English: Prolongation of QTc-interval
Slovenian: Zelo redki angina pektoris podaljšanje intervala QTc
English: Only use BiResp Spiromax in this way if your doctor has told you to. Use your BiResp Spiromax every day.
Slovenian: Zdravilo BiResp Spiromax uporabljajte na ta način le, če vam je tako naročil zdravnik.
English: BiResp Spiromax contains lactose
Slovenian: Zdravilo BiResp Spiromax vsebuje laktozo.
English: Patients should take 1 additional inhalation as needed in response to symptoms.
Slovenian: Ob pojavu simptomov naj bolniki po potrebi naredijo še 1 dodaten vdih.
English: b) You may be prescribed BiResp Spiromax as your only asthma inhaler.
Slovenian: b) Lahko vam predpišejo inhalator BiResp Spiromax kot edini inhalator za zdravljenje astme.
English: Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
Slovenian: supraventrikularna tahikardija, ekstrasistole
English: BiResp Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Slovenian: Mehanizem delovanja in farmakodinamični učinki Zdravilo BiResp Spiromax vsebuje učinkovini formoterol in budezonid, ki imata različna mehanizma delovanja, njuni učinki pri zmanjšanju pogostnosti poslabšanj astme pa so aditivni.
English: • The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full and ending with 0 (zero) inhalations when it is empty.
Slovenian: Ko je inhalator poln, kaže kazalnik 60 inhalacij in se konča z 0 (nič) inhalacijami, ko je prazen.
English: BiResp Spiromax is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
Slovenian: Zdravljenje z zdravilom BiResp Spiromax ni ustrezno pri odraslih bolnikih z blago obliko astme, ki ni ustrezno nadzorovana z inhalacijskim kortikosteroidi in inhalacijskimi kratkodelujočimi agonisti adrenergičnih adrenoreceptorjev β2, ki se uporabljajo po potrebi.
English: How to use BiResp Spiromax
Slovenian: Kako uporabljati zdravilo BiResp Spiromax
English: Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Slovenian: Cushingov sindrom, Cushingoidne značilnosti, supresijo nadledvične žleze, upočasnitev rasti pri otrocih in mladostnikih, zmanjšanje kostne mineralne gostote, katarakto in glavkom.
English: BiResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
Slovenian: tem primeru je treba zdravljenje z zdravilom BiResp Spiromax takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja (glejte poglavje 4.4).
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Slovenian: Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
English: Adults (18 years and older): • 1 inhalation twice a day, taken in the morning and in the evening.
Slovenian: Odrasli (18 let in več) 1 vdih (sprožitev) dvakrat na dan, uporabi se zjutraj in zvečer.
English: Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using BiResp Spiromax due to the lactose excipient.
Slovenian: Bolnikom svetujte tudi, naj si po inhaliranju sperejo usta z vodo (glejte poglavje 4.4).
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Slovenian: Občasni agresija, psihomotorična hiperaktivnost,