FrancophonIA/ELRC3.0 huggingface dataset:
English: PROTELOS also decreased the number of patients with a body height loss of at least 1 cm as compared to placebo.
Slovenian: PROTELOS je v primerjavi s placebom zmanjšal tudi število bolnic z izgubo telesne višine za najmanj 1 cm.
English: If PROTELOS is used inadvertently during pregnancy, treatment must be stopped.
Slovenian: Če bolnica nehote jemlje PROTELOS med nosečnostjo, mora jemanje prekiniti.
English: Adverse reactions, defined as adverse events considered at least possibly attributable to strontium ranelate treatment in phase III studies are listed below using the following convention (frequencies versus placebo): very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki, opredeljeni kot neželeni učinki, ki jih je vsaj mogoče pripisati zdravljenju s stroncijevim ranelatom v študijah III. faze, so našteti po naslednjem pravilu (pogostnost v primerjavi s placebom): zelo pogosti (> 1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1.000, < 1/100), redki (> 1/10.000, < 1/1.000), zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: PROTELOS, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.
Slovenian: PROTELOS, ki vsebuje učinkovino stroncijev ranelat, spada v skupino zdravil za zdravljenje bolnikov z boleznimi kosti.
English: Table 2: Incidence of patients with hip fracture and relative risk reduction in patients with BMD ≤ -2.4 SD (NHANES III) and age ≥ 74 years
Slovenian: Preglednica 2: Pojavnost zlomov kolka in zmanjšanje relativnega tveganja pri bolnicah z mineralno kostno gostoto ≤2,4 SD (NHANES III) in starostjo ≥ 74 let
English: PROTELOS can interact with milk and milk products, so it is important that you mix PROTELOS only with water to be sure it works properly.
Slovenian: PROTELOS lahko medsebojno deluje z mlekom in mlečnimi izdelki, zato je za pravilno delovanje pomembno, da
English: How to take protelos
Slovenian: Kako jemati zdravilo PROTELOS
English: The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTELOS should be administered in-between meals.
Slovenian: Absorpcija stroncijevega ranelata se zmanjša ob hrani ter mleku in mlečnih izdelkih, zato je treba PROTELOS jemati v času med dvema obrokoma.
English: PROTELOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Slovenian: Pomožna snov PROTELOS vsebuje vir fenilalanina, ki je lahko škodljiv za bolnike s fenilketonurijo.
English: Common:
Slovenian: Pogostid:
English: Statistically significant increases in BMD were observed as early as 6 months following initiation ofPROTELOS treatment versus placebo.
Slovenian: Statistično značilno povečanje mineralne kostne gostote v primerjavi s placebom je bilo opaženo že v 6 mesecih po začetku zdravljenja z zdravilom PROTELOS.
English: PROTELOS contains aspartame:
Slovenian: Zdravilo PROTELOS vsebuje aspartam.
English: Driving and using machines: Protelos is unlikely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi PROTELOS vplival na vašo sposobnost upravljanja vozil in strojev.
English: - If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS.
Slovenian: - Če jemljete antacide (zdravila proti zgagi), jih vzemite najmanj 2 uri po jemanju zdravila PROTELOS.
English: The following adverse reactions have been reported during clinical studies and/or post marketing use with Strontium ranelate.
Slovenian: Tabelarični seznam neželenih učinkov O naslednjih neželenih učinkih so poročali v kliničnih študijah in/ali postmarketinški uporabi stroncijevega ranelata.
English: The efficacy of PROTELOS was demonstrated in men with osteoporosis in a 2-year, doubleblind,placebo-controlled study with a main analysis after one year in 243 patients (Intention to treatpopulation, 161 patients received strontium ranelate) at high risk of fracture (mean age 72,7 years; mean lumbar BMD T-score value of -2.6; 28% of prevalent vertebral fracture).
Slovenian: Učinkovitost zdravila PROTELOS je bila pri moških z osteoporozo dokazana v dvojno slepi, s placebom nadzorovani študiji, ki je trajala 2 leti, z glavno analizo po enem letu pri 243 bolnikov (ITT - populacija bolnikov, ki so jih nameravali zdraviti, 161 bolnikov je prejemalo stroncijev ranelat) s povečanim tveganjem za zlome (srednja starost 72,7 let; vrednost T srednje mineralne kostne gostote v ledveni hrbtenici -2,6; obstoječi zlomi vretenc pri 28 %).
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
Slovenian: Poročali so o morebitno življenje ogrožajočih kožnih izpuščajih (Stevens-Johnsonovem sindromu, toksični epidermalni nekrolizi) (glejte poglavje 2).
English: This is especially common in women after the menopause Many people with osteoporosis have no symptoms and you may not even know that you have it.
Slovenian: Mnogi bolniki z osteoporozo nimajo simptomov in mogoče je, da sploh ne veste, da bolezen že imate.
English: Food, milk and milk products reduce the absorption of strontium ranelate.
Slovenian: Zdravilo PROTELOS skupaj s hrano in pijačo Hrana, mleko in mlečni izdelki zmanjšujejo absorpcijo stroncijevega ranelata.
English: In this group, over 3 years of treatment, PROTELOS reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Slovenian: Pri takšnih bolnicah je v 3 letih zdravljenja PROTELOS zmanjšal tveganje za zlome kolka za 36 % v primerjavi s placebom (preglednica 2).
English: България Сервие Медикал ЕООД
Slovenian: Сервие Медикал ЕООД Тел.
English: Therefore, administration of PROTELOS and such products should be separated by at least two hours (see section 5.2).
Slovenian: Zato je priporočljivo, da bolniki jemljejo PROTELOS najmanj dve uri po njihovem zaužitju (glejte poglavje 5.2).
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration
Slovenian: Vnos stroncijevega ranelata s kalcijem ali hrano zmanjšuje biološko uporabnost stroncija za približno 60 do 70 % v primerjavi z jemanjem 3 ure po obroku.
English: However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists
Slovenian: Vendar se zaradi osteoporoze poveča tveganje, da boste doživeli zlom kosti, zlasti v hrbtenici, kolku in zapestju.
English: Τηλ: +357 22741741
Slovenian: Χ.Α.Παπαέλληνας & Σία Λτδ Τηλ: +357 22741741
English: Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, dry mouth, pins and needles, dizziness, vertigo, difficulty in sleeping, inflammation of the liver (hepatitis), oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/or joint pain, muscle cramps, hair loss, reduction in production of blood cells in the bone marrow, itching, hives, blistering, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling unwell, feeling confused, bronchial hyperreactivity (symptoms include wheezing, shortness of breath and cough).
Slovenian: Bruhanje, bolečine v trebuhu, refluks, prebavne težave, zaprtje, vetrovi, suha usta, mravljinčenje in zbadanje, omotica, vrtoglavica, težave s spanjem, vnetje jeter (hepatitis), razdraženje ust (kot so ustne razjede ali vnetje dlesni), bolečine v kosteh, mišicah in/ali sklepih, mišični krči, izpadanje las,
English: In pooled placebo-controlled studies of post-menopausal osteoporotic patients, strontium ranelate treated patients (N=3803, 11270 patient years of treatment) compared to placebo (N=3769, 11250 patient years of treatment)
Slovenian: c redkeje poročane v azijskih državah d v združenih s placebom nadzorovanih študijah pri bolnicah z osteoporozo po menopavzi, ki so se zdravile s stroncijevim ranelatom (n = 3.803, 11.270 bolnikov-let zdravljenja) v primerjavi s placebom (n = 3.769, 11.250 bolnikov-let zdravljenja)
English: EU/1/04/288/006
Slovenian: EU/1/04/288/006 100 vrečk
English: If you take too many sachets of PROTELOS, tell your doctor or pharmacist.
Slovenian: Če ste vzeli večji odmerek zdravila PROTELOS, kot bi smeli Če ste vzeli preveč vrečk zdravila PROTELOS, obvestite svojega zdravnika ali farmacevta.
English: PROTELOS 2 g granules for oral suspension Strontium ranelate
Slovenian: PROTELOS 2 g zrnca za peroralno suspenzijo stroncijev ranelat
English: DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Slovenian: Sindrom DRESS se v začetku pojavi v obliki gripi podobnih simptomov in izpuščaja na obrazu, nato v obliki razširjenega izpuščaja z visoko telesno temperaturo, zvišanih vrednosti jetrnih encimov,
English: Pregnancy and breast-feeding:
Slovenian: Nosečnost in dojenje
English: An a-posteriori analysis was performed on a subgroup of patients from the TROPOS study of particular medical interest and at high-risk of fracture [defined by a femoral neck BMD T-score ≤3 SD (manufacturer's range corresponding to -2.4 SD using NHANES III) and an age ≥ 74 years (n=1,977, i.e. 40% of the TROPOS study population)].
Slovenian: Analizo a posteriori so izvedli tudi pri podskupini bolnic iz študije TROPOS, ki so bile zlasti medicinsko zanimive in imele veliko tveganje za zlome [opredeljeno kot MKG vratu stegnenice vrednost T ≤ -3 SD (izdelovalčev razpon je ustrezal -2,4 SD po merilih NHANES III - National
English: It is recommended that you take PROTELOS at bedtime, preferably at least 2 hours after dinner.
Slovenian: Priporočeni odmerek je ena vrečka po 2 g na dan. Priporočljivo je, da PROTELOS jemljete pred spanjem, najbolje vsaj 2 uri po večerji.
English: Stevens-Johnson syndrome and toxic epidermal necrolysis appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Slovenian: Stevens-Johnsonov sindrom in toksična epidermalna nekroliza se sprva pojavita v obliki rdečkastih,
English: If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of PROTELOS, you must not be re-started on PROTELOS at any time If you develop a rash or these skin symptoms, stop taking PROTELOS, seek urgent advice from a doctor and tell him that you are taking this medicine.
Slovenian: Če na koži opazite izpuščaj ali opisane simptome, prenehajte z jemanjem zdravila PROTELOS in nemudoma poiščite zdravniško pomoč ter zdravniku povejte, da jemljete to zdravilo.
English: Psychiatric disorders Frequency unknown:a Confusional state Insomnia Nervous system disorders Common: Headache Disturbances in consciousness Memory loss Uncommon: Seizures Frequency unknown:a Paraesthesia Dizziness Vertigo Cardiac disorders Commond: Myocardial infarction Vascular disorders Common: Venous thromboembolism (VTE) Respiratory, thoracic and mediastinal disorders Frequency unknown:a Bronchial hyperreactivity Gastrointestinal disorders Common: Nausea Diarrhoea Loose stools Frequency unknown:a Vomiting
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Neznana pogostnost:a hiperaktivnost bronhijev Bolezni prebavil Pogosti: slabost diareja mehko blato Neznana pogostnost:a bruhanje bolečine v trebuhu razdraženje ustne sluznice (stomatitis in/ali razjede v ustih) gastroezofagealni refluks dispepsija zaprtje flatulenca suha usta
English: - in postmenopausal women,
Slovenian: Zlasti pogosto se to dogaja pri ženskah v obdobju po menopavzi.
English: Physico-chemical data suggest excretion of Strontium ranelate in human milk.. PROTELOS should not be used during breast-feeding.
Slovenian: Fizikalnokemijski podatki nakazujejo izločanje stroncijevega ranelata v materino mleko.
English: Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2).
Slovenian: Za bolnike z blago do zmerno ledvično okvaro (očistek kreatinina 30 do 70 ml/min) odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Tel: +46 (8) 52 25 08 00 United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
Slovenian: United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase of myocardial infarction has been observed in PROTELOS treated patients as compared to placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI = [1.07 ; 2.38]).
Slovenian: PROTELOS v primerjavi s placebom (1,7 % v primerjavi z 1,1 %), in relativnim tveganjem 1,6 (95% IZ = [1,07 ; 2,38].
English: - if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo PROTELOS Ne jemljite zdravila PROTELOS: - če ste alergični na stroncijev ranelat ali katero koli sestavino tega zdravila (navedeno v poglavju
English: However, it is recommended to drink the suspension immediately after preparation (see section 3) Do not throw away any medicines via wastewater or household waste.
Slovenian: Vseeno je suspenzijo priporočljivo popiti takoj po pripravi (glejte 3. poglavje).
English: In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that PROTELOS reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
Slovenian: pokazala, da je PROTELOS v 3-letnem zdravljenju zmanjšal relativno tveganje za pojav novih zlomov vretenc za 32 % (ob stroncijevem ranelatu je bila pojavnost 19,1 % v primerjavi s 26,5 % ob placebu).
English: Aspartame (E951)
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi aspartam (E951).
English: Abdominal pain Oral mucosal irritation (stomatitis and/or mouth ulceration) Gastrooesophageal reflux Dyspepsia Constipation Flatulence Dry mouth Hepatobiliary disorders Frequency unknown:a Serum transaminase increased (in association with hypersensitivity skin reactions) Hepatitis Skin and subcutaneous tissue disorders Common: Dermatitis Eczema Rare: DRESS (see section 4.4) Very rare: Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome and toxic epidermal necrolysisc (see section 4.4) Frequency unknown:a Hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema) Alopecia Musculoskeletal and connective tissue disorders Frequency unknown:a Musculoskeletal pain (muscle spasm, myalgia, bone pain, arthralgia and pain in extremity) General disorders and administration site conditions Frequency unknown:a Peripheral oedema Pyrexia (in association with hypersensitivity skin reactions) Malaise Blood and Lymphatic disorders Frequency unknown:a Bone marrow failure Eosinophilia (in association with hypersensitivity skin reactions) Lymphadenopathy (in association with hypersensitivity skin reactions) Investigations Common: Blood Creatine phosphokinase (CPK) increasedb a
Slovenian: Redki: sindrom DRESS (glejte poglavje 4.4) Zelo redki: hude neželene kožne reakcije (SCARs - severe cutaneous adverse reactions): Stevens-Johnsonov sindrom in toksična epidermalna nekrolizac (glejte poglavje 4.4) Neznana pogostnost:a preobčutljivostne kožne reakcije (izpuščaj, srbenje, koprivnica,
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), PROTELOS reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Slovenian: toda z vsaj enim dodatnim dejavnikom tveganja zanje (n = 176), je skupna analiza a posteriori pokazala, da je PROTELOS zmanjšal tveganje prvega zloma vretenc za 72 % v 3 letih (pojavnost zlomov vretenc 3,6 % ob stroncijevem ranelatu v primerjavi z 12,0 % ob placebu).
English: In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, PROTELOS is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2).
Slovenian: zdravilo PROTELOS ni priporočeno pri bolnikih z očistkom kreatinina pod 30 ml/min (glejte poglavje 5.2).
English: In addition to their treatment (2 g/day strontium ranelate or placebo), the patients received adapted calcium and vitamin D supplements throughout both studies.
Slovenian: Poleg zdravljenja s stroncijevim ranelatom po 2 g na dan ali placebom so bolnice ves čas obeh študij jemale prilagojene pripravke kalcija in vitamina D. V 3-letnem zdravljenju v študiji SOTI je PROTELOS zmanjšal relativno tveganje novih zlomov vretenc za 41 % (preglednica 1).
English: Cardiac ischaemic events
Slovenian: Pogosti: dermatitis ekcem
English: NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension Strontium ranelate
Slovenian: Navodilo za uporabo PROTELOS 2 g zrnca za peroralno suspenzijo stroncijev ranelat
English: • Risk Management Plan (RMP)
Slovenian: venske trombembolije (VTE)
English: Uncommon: Seizures.
Slovenian: Neznana pogostnost:
English: Hirobriz Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Slovenian: Uporaba zdravila Hirobriz Breezhaler je v času nosečnosti upravičena le v primeru, da pričakovane koristi presegajo možna tveganja.
English: Do not use Hirobriz Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Hirobriz Breezhaler - če ste alergični na indakaterol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: An increase in the daily dose of Hirobriz Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Slovenian: Zviševanje dnevnega odmerka zdravila Hirobriz Breezhaler preko najvišjega odmerka 300 mikrogramov ni primerno.
English: Hirobriz Breezhaler capsules must always be stored in the blister, and only removed immediately before use.
Slovenian: Kapsule Hirobriz Breezhaler je treba vedno shranjevati v pretisnem omotu in jih iz njega vzeti šele tik pred uporabo.
English: If you use more Hirobriz Breezhaler than you should If you have inhaled too much Hirobriz Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit.
Slovenian: Če ste uporabili večji odmerek zdravila Hirobriz Breezhaler, kot bi smeli Če ste vdihnili preveč zdravila Hirobriz Breezhaler ali če kdo drug uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno medicinsko pomoč.
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Hirobriz Breezhaler (i.e. medicines such as salmeterol and formoterol).
Slovenian: Še posebno pomembno je, da zdravniku poveste, če: zaradi težav z dihanjem uporabljate zdravila, ki so podobna zdravilu Hirobriz Breezhaler (na primer zdravila, kot sta salmeterol in formoterol).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Hirobriz Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Hirobriz Breezhaler za vse podskupine pediatrične populacije pri kronični obstruktivni pljučni bolezni (KOPB) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: COPD is a long-term disease and you should use Hirobriz Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Slovenian: KOPB je dolgotrajna bolezen in zdravilo Hirobriz Breezhaler morate uporabljati vsak dan, ne le takrat, ko težko dihate ali imate katerega od drugih simptomov KOPB.
English: The 24-hour bronchodilator effect of Hirobriz Breezhaler was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (tachyphylaxis).
Slovenian: 24-urni brohodilatatorni učinek zdravila Hirobriz Breezhaler se je ohranjal od prvega odmerka skozi celotno enoletno obdobje zdravljenja brez znakov zmanjševanja učinkovitosti (tahifilaksije).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Hirobriz Breezhaler therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Hirobriz Breezhaler, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Hirobriz Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended therapeutic dose.
Slovenian: Povečanje izpostavljenosti zaradi interakcij ni zaskrbljujoče, in sicer zaradi izkušenj glede varnosti pri uporabi zdravila Hirobriz Breezhaler v kliničnih študijah s trajanjem do enega leta v odmerkih, ki so dosegali tudi dvakratni priporočeni terapevtski odmerek.
English: Hirobriz Breezhaler should be administered at the same time of the day each day.
Slovenian: Zdravilo Hirobriz Breezhaler je treba jemati vsak dan ob istem času.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Hirobriz Breezhaler.
Slovenian: Sočasna uporaba drugih simpatikomimetičnih zdravil (samih ali v sklopu kombinacije zdravil) lahko okrepi neželene učinke zdravila Hirobriz Breezhaler.
English: If you have questions about how long to continue your treatment with Hirobriz Breezhaler, talk to your doctor or pharmacist.
Slovenian: Če vas zanima, kako dolgo je treba nadaljevati z uporabo zdravila Hirobriz Breezhaler, se pogovorite s svojim zdravnikom ali farmacevtom.
English: In addition, patients treated with Hirobriz Breezhaler required significantly less rescue medication, had more days when no rescue medication was needed compared to placebo and had a significantly improved percentage of days with no daytime symptoms.
Slovenian: Poleg tega so bolniki, ki so uporabljali zdravilo Hirobriz Breezhaler, potrebovali bistveno manj nadomestnih zdravil in v primerjavi s tistimi, ki so uporabljali placebo, preživeli so več dni, ko niso potrebovali hitrih olajševalcev, pri njih se je bistveno povečal delež dni, ko preko dneva niso imeli simptomov.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Hirobriz Breezhaler at the recommended doses than on placebo.
Slovenian: V kliničnih študijah so bile klinično opazne spremembe v koncentraciji glukoze v krvi večinoma za 1-2 % bolj pogoste pri bolnikih, ki so jemali zdravilo Hirobriz Breezhaler v priporočenih odmerkih, kot pri tistih, ki so jemali placebo.
English: You should not use Hirobriz Breezhaler unless your doctor tells you so.
Slovenian: Zdravila Hirobriz Breezhaler ne smete uporabljati, razen če vam tako naroči zdravnik.
English: The capsules must be administered only using the Hirobriz Breezhaler inhaler (see section 6.6).
Slovenian: Kapsule so namenjene samo uporabi z inhalatorjem Hirobriz Breezhaler (glejte poglavje 6.6).