FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic data following administration of single doses of 1 mg budesonide to fasted healthy subjects show a median lag time of 0.17 hours (range 0.00 - 0.33 hours) and a median time to peak plasma concentration of 1.00 hour (range 0.50 - 2.00 hours).
Slovenian: Farmakokinetični podatki po dajanju enkratnih odmerkov 1 mg budezonida teščim zdravim osebam kažejo mediano zakasnitev 0,17 ure (razpon 0,00
English: For information about the observed adverse reactions, see section 4.8.
Slovenian: Za podatke o opaženih neželenih učinkih glejte poglavje 4.8. 5.2 Farmakokinetične lastnosti
English: What Jorveza contains - The active substance is budesonide.
Slovenian: Kaj vsebuje zdravilo Jorveza - Učinkovina je budezonid.
English: Marketing Authorisation Holder and Manufacturer Dr. Falk Pharma GmbH
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Dr. Falk Pharma GmbH
English: A slightly increased number of basophilic hepatic foci were observed in chronic rat studies with budesonide, and in carcinogenicity studies, an increased incidence of primary hepatocellular neoplasms, astrocytomas (in male rats) and mammary tumours (female rats) were observed.
Slovenian: V dolgoročnih študijah z budezonidom pri podganah so opazili rahlo povečanje števila bazofilnih žarišč v jetrih, v študijah kancerogenosti pa so opazili povečano incidenco primarnih hepatocelularnih neoplazem,
English: Esophageal candidiasis Oral and/or oropharyngeal candidiasis
Slovenian: Infekcijske in parazitske bolezni ezofagealna kandidiaza oralna in/ali orofaringealna kandidiaza
English: No budesonide, but only budesonide metabolites were detected in urine.
Slovenian: V urinu ni bilo zaznati budezonida, temveč le presnovke budezonida.
English: − clarithromycin, an antibiotic medicine used to treat infections
Slovenian: - klaritromicin, antibiotik za zdravljenje okužb, - ritonavir in kobicistat (za zdravljenje okužb s HIV),
English: Driving and using machines Jorveza is not expected to affect your ability to drive or use machines.
Slovenian: Zdravilo Jorveza naj ne bi imelo vpliva na sposobnost upravljanja vozil in strojev.
English: − increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disk) in adolescents
Slovenian: − nemirnost s povečano telesno aktivnostjo, tesnobnost, agresija; - zvišan tlak v možganih z morebitnim zvišanjem tlaka v očesu (otekanje papile vidnega živca) pri mladostnikih; − zamegljen vid;
English: In case your kidney problems are severe, you should not take Jorveza.
Slovenian: Če imate hude težave z ledvicami, ne smete uporabljati zdravila Jorveza.
English: − cardiac glycosides such as digoxin (medicines used to treat heart conditions)
Slovenian: - srčni glikozidi, kot je digoksin (zdravila za zdravljenje srčnih bolezni), - diuretiki (za odstranjevanje presežka tekočine v telesu).
English: − fungal infections in the mouth and throat (symptoms can be white spots)
Slovenian: - glavobol; - glivične okužbe v ustih in v žrelu (simptomi so lahko bele pike); - visok krvni tlak;
English: Speak to your doctor if you want to interrupt or end your treatment early.
Slovenian: Če želite prekiniti ali predčasno končati svoje zdravljenje, se posvetujte z zdravnikom.
English: − muscle and joint pain, muscle weakness, muscle twitching
Slovenian: − bolečine v mišicah in sklepih, mišična šibkost, trzanje mišic;
English: Do not use any oral solutions, sprays or chewable tablets for at least 30 minutes before or after administration of the orodispersible tablet.
Slovenian: Vsaj 30 minut pred uporabo orodisperzibilne tablete in 30 minut po tem ne uporabljajte nikakršne peroralne raztopine, pršil ali žvečljivih tablet.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Dr. Falk Pharma GmbH
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Dr. Falk Pharma GmbH
English: Upper abdominal pain, gastroesophageal reflux disease, lip edema, nausea, oral paraesthesia
Slovenian: gastroezofagealna refluksna bolezen, edem ustnic, navzea, oralna parestezija
English: Tell your doctors that you are taking Jorveza before you have any tests.
Slovenian: Pred izvedbo preiskav zdravnikom povejte, da jemljete zdravilo Jorveza.
English: Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation.
Slovenian: Kaj je zdravilo Jorveza in za kaj ga uporabljamo Zdravilo Jorveza vsebuje učinkovino budezonid, kortikosteroidno zdravilo, ki zmanjša vnetje.
English: NAME OF THE MEDICINAL PRODUCT Jorveza 1 mg orodispersible tablets budesonide
Slovenian: IME ZDRAVILA Jorveza 1 mg orodisperzibilne tablete budezonid
English: Do not eat, drink, brush your teeth or rinse your mouth for at least 30 minutes after you have taken the orodispersible tablet.
Slovenian: Ko ste vzeli orodisperzibilno tableto, vsaj 30 minut ne jejte, pijte oziroma si umivajte zob ali izpirajte ust.
English: Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives.
Slovenian: Pri ženskah, ki so hkrati jemale tudi estrogene ali peroralne kontraceptive, so poročali o zvišanih plazemskih koncentracijah in o okrepljenih učinkih glukokortikosteroidov.
English: − increased risk of blood clots, inflammation of the blood vessels (which can happen when the medicine is stopped after long-term use)
Slovenian: - povečano tveganje za krvne strdke, vnetje krvnih žil (kar se lahko zgodi, če zdravilo prenehate jemati po dolgotrajni uporabi); − prebavne motnje, dispepsija, zaprtje, razjede v želodcu ali tankemu črevesu;
English: These tumours are probably due to the specific steroid receptor action, increased metabolic burden and anabolic effects on the liver, effects which are also known from other glucocorticosteroids in rat studies and therefore represent a class effect in this species.
Slovenian: Ti tumorji so najverjetneje posledica specifičnega delovanja na steroidne receptorje, povečane presnovne obremenitve jeter in anabolnih učinkov na jetra.
English: The clinical relevance of these findings to man has not been established (see section 4.6).
Slovenian: Poročali so, da nekateri glukokortikoidi povzročajo tudi nastanek volčjega žrela pri živalih, vendar klinični pomen omenjenih izsledkov za človeka še ni bil ugotovljen (glejte poglavje 4.6).
English: Do not chew or swallow the undissolved orodispersible tablet.
Slovenian: Orodisperzibilne tablete ne smete žvečiti ali pogoltniti neraztopljene.
English: In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development (see section 5.3).
Slovenian: Pri brejih živalih so pokazali, da tako kot drugi glukokortikosteroidi tudi budezonid povzroča motnje v razvoju ploda (glejte poglavje 5.3), vendar pomembnost tega izsledka za ljudi še ni bila ugotovljena.
English: Jorveza contains sodium
Slovenian: Zdravilo Jorveza vsebuje natrij
English: What Jorveza looks like and contents of the pack The orodispersible tablets are white, round, biplane tablets.
Slovenian: Orodisperzibilne tablete so bele, okrogle, ploščate tablete.
English: (osteonecrosis)
Slovenian: osteoporoza, osteonekroza
English: The systemic exposure of budesonide is considerably increased in patients with severely impaired hepatic function.
Slovenian: Pri bolnikih s hudo okvarjenim delovanjem jeter je močno povečana sistemska izpostavljenost budezonidu.
English: Cushing's syndrome, adrenal suppression, growth retardation in children Metabolism and nutrition disorders Hypokalaemia, hyperglycaemia Psychiatric disorders
Slovenian: Cushingov sindrom, zmanjšano delovanje nadledvične žleze, zastoj rasti pri otrocih
English: Fungal infections in the mouth, pharynx and the oesophagus were the most frequently observed adverse reactions in clinical studies with Jorveza.
Slovenian: V kliničnih študijah z zdravilom Jorveza so bile najpogosteje opažen neželeni učinek glivične okužbe ust,
English: Do NOT take any liquid with the orodispersible tablet.
Slovenian: Orodisperzibilne tablete NE smete vzeti s tekočino.
English: Glucocorticosteroids may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis and reduce the stress response.
Slovenian: Glukokortikosteroidi lahko povzročijo zavoro osi hipotalamus-hipofiza-nadledvična žleza
English: Very common: may affect more than 1 in 10 people − fungal infections in the gullet (which can cause pain or discomfort when swallowing)
Slovenian: − glivične okužbe požiralnika (ki lahko povzroči bolečino ali neprijeten občutek pri požiranju).
English: Allergic exanthema, petechiae, delayed wound healing, contact dermatitis, ecchymosis
Slovenian: kontaktni dermatitis, ekhimoza
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI škatla
English: The dissolved material should be swallowed with saliva little by little while the orodispersible tablet disintegrates.
Slovenian: Medtem ko orodisperzibilna tableta razpada, je treba raztopljeni material postopno požirati s slino.
English: − increased pressure in your eye (which can cause glaucoma) or eye problems such as clouding of the lens (cataracts) or if somebody in your family has glaucoma
Slovenian: - razjede v želodcu ali začetnem delu tankega črevesja (peptični ulkus), - zvišan tlak v očesu (kar lahko povzroči glavkom) ali težave z očmi, kot je zamotnitev leče
English: Hypertension
Slovenian: Saluretiki
English: Jorveza 1 mg orodispersible tablets budesonide
Slovenian: Navodilo za uporabo Jorveza 1 mg orodisperzibilne tablete budezonid
English: Contact a doctor if you are in doubt.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom.
English: Disodium hydrogen citrate Docusate sodium Macrogol 6000
Slovenian: 6.1 Seznam pomožnih snovi dinatrijev hidrogencitrat natrijev dokusat makrogol 6000 magnezijev stearat manitol brezvodni mononatrijev citrat povidon K25 natrijev hidrogenkarbonat sukraloza
English: How to store Jorveza
Slovenian: Shranjevanje zdravila Jorveza
English: Fax: +49 (0)761 1514-321
Slovenian: Nemčija tel.: +49 (0)761 1514-0 faks: +49 (0)761 1514-321 e-pošta: zentrale@drfalkpharma.de
English: Budesonide is excreted in human milk (data on excretion after inhalative use is available).
Slovenian: Budezonid se izloča v materino mleko (na voljo so podatki o izločanju pri inhalacijski uporabi), vendar po peroralni uporabi terapevtskih odmerkov zdravila Jorveza pri dojenih otrocih pričakujemo le manjše učinke.
English: Swallow the dissolved material with saliva little by little, as the orodispersible tablet breaks up.
Slovenian: Medtem ko orodisperzibilna tableta razpada, raztopljeni material postopno požirajte s slino.
English: Blood cortisol decreased
Slovenian: Preiskave znižanje ravni kortizola v krvi
English: Muscle and joint pain, muscle weakness and twitching, osteoporosis, osteonecrosis
Slovenian: Pri bolnikih s tuberkulozo, hipertenzijo, sladkorno boleznijo, osteoporozo, peptičnim ulkusom,
English: Dyspepsia, duodenal or gastric ulcers, pancreatitis, constipation
Slovenian: Bolezni prebavil dispepsija, razjeda dvanajstnika ali želodca, pankreatitis, zaprtje
English: Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Jorveza.
Slovenian: Če zdravljenje z zdravilom Jorveza ni res nujno, se morate njegovi uporabi v času nosečnosti izogibati, saj je na voljo le malo podatkov o izidu nosečnosti pri človeku po peroralni uporabi budezonida.
English: The following known adverse reactions of the therapeutic class (corticosteroids, budesonide) could also occur with Jorveza (frequency = not known).
Slovenian: (kortikosteroidi, budezonid) (pogostnost = neznana).
English: Sodium hydrogen carbonate Sucralose
Slovenian: Žilne bolezni hipertenzija
English: Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja o ā
English: - if you have cancer.
Slovenian: - če imate raka.
English: EXP After first opening, use within 30 days.
Slovenian: EXP Po prvem odprtju porabite v 30 dneh.
English: That parents and caregivers should always ensure that the child has a source of sugar.
Slovenian: Da morajo starši in skrbniki vedno zagotoviti, da ima otrok vir sladkorja.
English: • Long-term toxicity in patients undergoing developmental changes
Slovenian: • dolgotrajno toksičnost pri bolnikih, ki so podvrženi razvojnim spremembam,
English: - if you have finished growing (the bone growth plates are closed).
Slovenian: - če ste nehali rasti (rastne plošče kosti so zaprte).
English: Date of latest renewal: 03 August 2017
Slovenian: Datum zadnjega podaljšanja: 03. avgust 2017
English: Efficacy is dose dependent.
Slovenian: Učinkovitost je odvisna od odmerka.
English: Treatment success should be evaluated based on height velocities.
Slovenian: Uspeh zdravljenja je treba ovrednotiti na osnovi hitrosti rasti.
English: These studies did not indicate direct or indirect harmful effects with respect to fertility and pregnancy, but due to the different route of application the relevance of these findings is unclear.
Slovenian: Te študije niso pokazale neposrednih ali posrednih škodljivih učinkov na plodnost in nosečnost, vendar pa zaradi drugačne poti uporabe ustreznost teh ugotovitev ni jasna.
English: Store in a refrigerator (2C - 8°C).
Slovenian: Shranjujte v hladilniku (2 C - 8 °C).
English: GR-17456 Αθήνα Ελλάδα
Slovenian: GR-17456 Αθήνα
English: Worsened scoliosis (caused by rapid growth)
Slovenian: Poslabšanje skolioze (zaradi hitre rasti)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/402/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/402/001
English: This medicinal product should not be used during pregnancy unless clearly necessary.
Slovenian: Tega zdravila ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: Some patients required hospitalization.
Slovenian: Nekateri bolniki so potrebovali zdravljenje v bolnišnici.
English: Upon re-administration, symptoms did not re-occur in all patients.
Slovenian: Po ponovni uvedbi zdravljenja se simptomi niso ponovili pri vseh bolnikih.
English: The safety and efficacy of mecasermin in children below age of 2 have not been established (see section 5.1).
Slovenian: Varnost in učinkovitost mekazermina pri otrocih, mlajših od 2 let, nista bili dokazani (glejte poglavje 5.1).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2007
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 03. avgust 2007
English: You are now ready to inject (see Figure 7).
Slovenian: Sedaj ste pripravljeni na injiciranje (glejte sliko 7).
English: It is important that you have a well-balanced diet including protein and fat such as meat and cheese in addition to sugarcontaining foods.
Slovenian: Pomembno je, da imate dobro uravnoteženo prehrano, ki poleg hranil s sladkorjem vključuje tudi beljakovine in maščobe, npr. meso in sir.
English: Long-term overdose may result in enlargement of certain body parts (e.g., hands, feet, parts of the face) or excessive growth of the whole body.
Slovenian: Zaradi dolgotrajnega prevelikega odmerjanja se lahko povečajo nekateri deli telesa (npr. roke, noge, deli obraza) ali pojavi prekomerna rast celega telesa.
English: Systemic/local hypersensitivity
Slovenian: Sistemska/lokalna preobčutljivost
English: • basal IGF-1 levels below the 2.5th percentile for age and gender and
Slovenian: • osnovna raven IGF-1, manjša od 2,5. percentila, glede na starost in spol in
English: • GH sufficiency.
Slovenian: • zadostna količina GH.
English: Injecting the dose:
Slovenian: Injiciranje odmerka:
English: This condition is called primary IGF-1 deficiency.
Slovenian: To stanje imenujemo primarno pomanjkanje IGF-1.
English: Use syringes and needles only once.
Slovenian: Brizgo in iglo uporabite le enkrat.
English: To perform one long-term safety study where mecasermin treatment is initiated in early phase of childhood and continued to adulthood in order to investigate:
Slovenian: Izvajanje dolgoročne varnostne študije, kjer se je zdravljenje z mekazerminom začelo v zgodnjem otroštvu in se nadaljuje v odraslem obdobju, da bi bilo mogoče raziskati:
English: Uncommon: Depression, nervousness
Slovenian: Občasni: depresija, živčnost
English: - in premature babies or neonates because it contains benzyl alcohol.
Slovenian: - pri nedonošenčkih ali novorojenčkih, ker zdravilo vsebuje benzilalkohol.
English: Check the liquid to make sure it is clear and colourless.
Slovenian: Preverite tekočino in se prepričajte, da je bistra in brezbarvna.
English: This medicine has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v “izjemnih okoliščinah”.
English: Among all subjects included for safety evaluation (n=92), 83% of the subjects reported at least one adverse event during the course of the studies.
Slovenian: Med vsemi osebami, vključenimi v vrednotenje varnosti (n=92), so pri 83 % oseb poročali o pojavu vsaj enega neželenega učinka med potekom študij.
English: Never inject it into a vein or muscle.
Slovenian: Zdravila ne smete nikoli injicirati v žilo ali mišico.
English: Sleep apnea can cause excessive daytime sleepiness.
Slovenian: Apneja v spanju lahko povzroči prekomerno zaspanost podnevi.
English: All cases were mild or moderate in severity and none was serious.
Slovenian: Vsi primeri so bili blagi ali zmerni.
English: • INCRELEX should not be administered if the patient is unable to eat for any reason.
Slovenian: • Zdravila INCRELEX ni dovoljeno dajati, če bolnik zaradi kakršnegakoli razloga ne more jesti.
English: Lonza AG Lonzastrasse CH-3930 Visp Switzerland
Slovenian: Lonza AG Lonzastrasse CH-3930 Visp Švica
English: Beaufour Ipsen Industrie Rue d'Ethe Virton 28100 Dreux France
Slovenian: Beaufour Ipsen Industrie Rue d'Ethe Virton 28100 Dreux Francija
English: Do not use INCRELEX - if you are allergic to mecasermin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila INCRELEX - če ste alergični na mekazermin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (not known).
Slovenian: Ker so bila ta poročila pridobljena spontano iz populacije bolnikov neznane velikosti, njihove pogostnosti ni mogoče zanesljivo oceniti (neznana pogostnost).
English: - It is used to treat children and adolescents from 2 to 18 years old who are very short for their age because their bodies do not make enough IGF-1.
Slovenian: - Uporabljamo ga za zdravljenje otrok in mladostnikov, starih od 2 do 18 let, ki so za svojo starost zelo nizke rasti, ker njihova telesa ne proizvajajo dovolj IGF-1.
English: Mecasermin should not be used for growth promotion in patients with closed epiphyses.
Slovenian: Mekazermina se ne sme uporabljati za pospeševanje rasti pri bolnikih z zaprtimi epifizami.
English: Race No information is available.
Slovenian: Rasa Podatki niso na voljo.
English: Baseline characteristics for the 81 patients evaluated in the primary and secondary efficacy analyses from the combined studies were (mean ± SD): chronological age (years): 6.8  3.8; age range (years): 1.7 to 17.5; height (cm): 84.1  15.8; height standard deviation score (SDS): -6.9  1.8; height velocity (cm/yr): 2.6  1.7; height velocity SDS: -3.4  1.6; IGF-1 (ng/ml): 24.5  27.9; IGF-1 SDS: -4.2  2.0; and bone age (years): 3.8  2.8.
Slovenian: Izhodiščne lastnosti 81 bolnikov, ki so jih vrednotili pri primarnih in sekundarnih analizah učinkovitosti kombiniranih študij, so bile (povprečna vrednost ± SD): kronološka starost (leta): 6,8  3,8; starostni razpon (leta): 1,7 do 17,5; telesna višina (cm): 84,1  15,8; vrednost standardnega odklona (Standard deviation score - SDS) telesne višine: -6,9  1,8; hitrost rasti (cm/leto): 2,6  1,7; SDS hitrosti rasti: -3,4  1,6; IGF-1 (ng/ml): 24,5  27,9; SDS IGF-1: -4,2  2,0; in zrelost kosti (leta): 3,8  2,8.
English: There was no death during the studies.
Slovenian: V času študij smrtnih primerov ni bilo.
English: Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced (see section 4.4).
Slovenian: Odmerke insulina in/ali drugih hipoglikemičnih zdravil bo morda treba zmanjšati (glejte poglavje 4.4).
English: Severe Primary IGFD is defined by:
Slovenian: Hudo primarno pomanjkanje IGF je definirano kot:
English: • height standard deviation score  -3.0 and
Slovenian: • vrednost standardnega odklona (SDS) telesne višine  -3,0 in
English: In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test.
Slovenian: V nekaterih primerih, kadar je to potrebno, si lahko zdravnik pri diagnosticiranju pomaga z izvedbo testa IGF-1.
English: Figure 1: Wipe top with alcohol
Slovenian: Slika 1: Vrh obrišite z alkoholom
English: Ελλάδα, Κύπρος, Malta Ipsen EΠΕ
Slovenian: Ελλάδα, Κύπρος, Malta
English: For further information ask the doctor.
Slovenian: Za nadaljnje informacije se obrnite na zdravnika.
English: Table 1 contains very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000, < 1/100) adverse reactions which occurred in clinical trials.
Slovenian: V preglednici 1 so navedeni zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100) neželeni učinki, ki so se pojavili med kliničnimi preskušanji.
English: • Physician information about INCRELEX (information card, dosing guide, and a dose calculator)
Slovenian: • Informacije za zdravnika o zdravilu INCRELEX (informacijsko kartico, navodilo za odmerjanje in kalkulator odmerkov)
English: Table 2: Annual Height Results by Number of Years Treated with INCRELEX Pre-Tx Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8
Slovenian: Preglednica 2: Letni rezultati telesne višine glede na število let zdravljenja z zdravilom INCRELEX Pre-Tx Leto 1 Leto 2 Leto 3 Leto 4 Leto 5 Leto 6 Leto 7 Leto 8
English: Mecasermin is not a substitute for GH treatment.
Slovenian: Mekazermin ni nadomestilo za zdravljenje z GH.
English: Annual results for height velocity, height velocity SDS, and height SDS until year 8 are shown in Table 2.
Slovenian: Letni rezultati o hitrost rasti, SDS hitrosti rasti in SDS telesne višine do 8. leta so prikazani v preglednici 2.
English: IGF-1 has mitogenic activity that leads to an increased number of cells in the body.
Slovenian: IGF-1 deluje mitogeno, kar vodi k povečanju števila celic v telesu.
English: Lightly pinch the skin.
Slovenian: Kožo rahlo stisnite v gubo.
English: The dose should be individualised for each patient.
Slovenian: Odmerek je treba prilagoditi vsakemu bolniku posebej.
English: Frequency not known (frequency cannot be estimated from the available data) Serious allergic reactions (anaphylaxis)
Slovenian: Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Resne alergijske reakcije (anafilaksija)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni “brez natrija”.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Slovenian: Neželeni učinki, ki jih v kliničnih študijah niso opazili, v študijah na živalih pa so jih opazili pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti, in bi lahko bili klinično pomembni, so naslednji:
English: Do not rub the area (see Figure B).
Slovenian: Mesta ne drgnite (glejte sliko B).
English: If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced.
Slovenian: Če se pri uporabi priporočenih odmerkov kljub zadostnemu vnosu hrane pojavi hipoglikemija, je treba odmerek zmanjšati.
English: Δημητρίου 63
Slovenian: Δημητρίου 63 Άλιμος
English: Your doctor can check to see if intracranial hypertension is present.
Slovenian: Zdravnik bo med pregledom preveril, če se je pojavila intrakranialna hipertenzija.