FrancophonIA/ELRC3.0 huggingface dataset:
English: Irritation or swelling of the conjunctiva (thin membrane covering the front part of the eye), eye allergy, tear disorder, eye discharge, inflammation of the iris (coloured part of the eye) or eyelid, deposits in the eye, bacterial infection or inflammation of the cornea (transparent front part of the eye), abrasion to the outer layer of the cornea, whitish patches on the cornea, cyst in the eyelid, itching in the eyelid, painful rash around the eye caused by the herpes zoster virus.
Slovenian: Draženje ali oteklina veznice (tanka membrana, ki prekriva sprednji del očesa), očesna alergija, motnje solzenja, izločanje iz oči, vnetje šarenice (obarvani del očesa) ali veke, depoziti v očesu, bakterijska okužba ali vnetje roženice (prosojni sprednji del očesa), abrazija zunanje plasti roženice, belkasti madeži na roženici, cista na veki, srbenje veke, boleč izpuščaj okoli očesa, ki ga povzroča virus herpes zoster.
English: The mean change from baseline in the 100-point OSDI score was -13.6 with IKERVIS and -14.1 with vehicle at Month 6 (p=0.858).
Slovenian: Povprečno izboljšanje od izhodišča v 100-točkovnem rezultatu OSDI je bilo -13.6 z zdravilom IKERVIS in -14,1 z vehiklom v 6. mesecu (p = 0,858).
English: SantenPharma AB Tlf: +45 78737843
Slovenian: Danmark SantenPharma AB Tlf: +45 78737843
English: Excipient IKERVIS contains cetalkonium chloride which may cause eye irritation.
Slovenian: Pomožna snov Zdravilo IKERVIS vsebuje cetalkonijev klorid, ki lahko draži oči.
English: In the 12 month, double-masked, vehicle controlled, pivotal clinical trial (SANSIKA study), 246 Dry Eye Disease (DED) patients with severe keratitis (defined as a corneal fluorescein staining (CFS) score of 4 on the modified Oxford scale) were randomised to one drop of IKERVIS or vehicle daily at bedtime for 6 months.
Slovenian: V 12-mesečnem, dvojno slepem, z vehiklom nadzorovanem osrednjem kliničnem preskušanju (študija SANSIKA) je bilo 246 bolnikov s sindromom suhega očesa s hudim keratitisom, (opredeljen kot obarvanje roženice s fluoresceinom (CFS - corneal fluorescein staining) z rezultatom 4 na prilagojeni lestvici Oxford) randomiziranih v skupino z eno kapljico zdravila IKERVIS ali vehikla enkrat na dan pred spanjem za 6 mesecev.
English: It is used in those patients who have dry eye disease, which has not improved despite treatment with tear substitutes (artificial tears).
Slovenian: Uporablja se za bolnike s sindromom suhega očesa, ki se kljub zdravljenju z umetnimi solzami ne izboljša.
English: If you are breast feeding talk to your doctor before using this medicine.
Slovenian: Če dojite, se morate posvetovati z zdravnikom, preden začnete uporabljati to zdravilo.
English: In the 6 month, double-masked, vehicle controlled, supportive clinical trial (SICCANOVE study), 492 DED patients with moderate to severe keratitis (defined as a CFS score of 2 to 4) were also randomised to IKERVIS or vehicle daily at bedtime for 6 months.
Slovenian: V 6-mesečnem so v dvojno slepem, z vehiklom nadzorovanem podpornem kliničnem preskušanju (študija SICCANOVE) s 492 bolniki s sindromom suhega očesa z zmernim do hudim keratitisom (opredeljenim kot rezultat 2 do 4 po CFS) je bilo tudi randomiziranih v skupino z zdravilom IKERVIS ali vehiklom enkrat na dan pred spanjem za 6 mesecev.
English: Excipients: medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (to adjust pH) and water for injections.
Slovenian: Pomožne snovi: srednjeverižni trigliceridi, cetalkonijev klorid, glicerol, tiloksapol, poloksamer 188, natrijev hidroksid (za uravnavanje pH) in voda za injekcije Za več informacij glejte navodilo za uporabo.
English: The primary objective of the study was to assess the duration of the improvement following IKERVIS treatment discontinuation once the patient was improved with respect to the baseline of the SANSIKA study (i.e. at least 2 grade improvement on the modified Oxford scale).
Slovenian: po izboljšanju stanja bolnika, ob upoštevanju izhodišča študije SANSIKA (tj. vsaj 2-stopenjsko izboljšanje na prilagojeni lestvici Oxford).
English: Contact lenses should be removed before instillation of the eye drops at bedtime and may be reinserted at wake-up time.
Slovenian: Pred vkapanjem kapljic za oko pred spanjem je treba odstraniti kontaktne leče in jih ponovno vstaviti po zbujanju.
English: • Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Slovenian: • Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice
English: No interaction studies have been performed with IKERVIS.
Slovenian: Študij medsebojnega delovanja z zdravilom IKERVIS niso izvedli.
English: IKERVIS is a milky white eye drops emulsion.
Slovenian: Zdravilo IKERVIS je mlečno-bela emulzija kapljic za oko.
English: There is limited experience with IKERVIS in the treatment of patients with glaucoma.
Slovenian: Izkušnje z zdravilom IKERVIS pri zdravljenju bolnikov z glavkomom so omejene.
English: Patients spent more time on CFS grade 2 (Median 12.7 weeks/year) and grade 1 (Median 6.6 weeks/year) than CFS grade 3 (Median 2.4 weeks/year), CFS grades 4 and 5 (Median time 0 week/year).
Slovenian: Bolniki so imeli dlje časa 2. stopnjo po CFS (mediana 12,7 tednov/leto) in 1. stopnjo
English: • Gently shake the single dose container prior to use
Slovenian: • Pred uporabo nežno stresite enoodmerni vsebnik.
English: Eye drops, emulsion.
Slovenian: kapljice za oko, emulzija
English: time to relapse (back to CFS grade 4) was ≤224 days and ≤175 days in patients previously treated 12
Slovenian: Na podlagi prvega kvartila (mediane ni bilo možno oceniti zaradi majhnega števila recidivov) je bil čas do recidiva (nazaj do stopnje 4 po CFS) ≤ 224 dni za bolnike, predhodno zdravljene z zdravilom IKERVIS 12 mesecev, in ≤ 175 dni za bolnike, predhodno zdravljene z zdravilom IKERVIS 6 mesecev.
English: Santen Oy Tel: +370 37 366628
Slovenian: Tel: +370 37 366628
English: Santen Oy Tel: +371 677 917 80
Slovenian: Tel: +371 677 917 80
English: The proportion of IKERVIS-treated patients with a 3-grade improvement in CFS score at Month 6 (from 4 to 1) was 28.8%, compared to 9.6% of vehicle-treated subjects, but this was a post-hoc analysis, which limits the robustness of this outcome.
Slovenian: 28,8 % v primerjavi z 9,6 % oseb, zdravljenih z vehiklom, vendar je bila to analiza post-hoc, ki omejuje robustnost izida.
English: Santen Oy Tel: +421 (01) 23 332 5519
Slovenian: Tel: +421 (01) 23 332 5519
English: Santen Oy Tel.: +36 (06) 16777305
Slovenian: Tel.: +36 (06) 16777305
English: Santen Oy Puh/Tel: +358 (0) 974790211
Slovenian: Puh/Tel: +358 (0) 974790211
English: Santen Oy Tel: +372 5067559
Slovenian: Tel: +372 5067559
English: Therefore, you should remove your contact lenses at bedtime before using IKERVIS; you can reinsert them when you wake up.
Slovenian: Zato morate pred spanjem pred uporabo zdravila IKERVIS odstraniti kontakte leče, ki jih lahko ponovno vstavite, ko zjutraj vstanete.
English: Santen Oy Tel: +420 234 102 170
Slovenian: Tel: +420 234 102 170
English: Santen Oy Tel: + 351 308 805 912
Slovenian: Tel: +351 308 805 912
English: - if you are taking any medicines to treat glaucoma.
Slovenian: - če jemljete zdravila za zdravljenje glavkoma.
English: IKERVIS 1 mg/mL eye drops, emulsion
Slovenian: IKERVIS 1 mg/ml kapljice za oko, emulzija
English: Santen Oy Tél/Tel : +32 (0) 24019172
Slovenian: Tél/Tel : +32 (0) 24019172
English: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) Bolečina ob vkapanju kapljic v oko.
English: Do not use this medicine after the expiry date which is stated on the outer carton, the aluminium pouch and on the single-dose containers after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli,
English: Talk to your doctor or pharmacist before using IKERVIS - if you have previously had an eye infection by the herpes virus that might have damaged the transparent front part of the eye (cornea).
Slovenian: - če ste imeli predhodno okužbo očesa z virusom herpesa, ki je morda poškodovala prosojni sprednji del očesa (roženico).
English: Concomitant therapy
Slovenian: Sočasno zdravljenje
English: Santen Oy Tel.: +48 (0) 221168608
Slovenian: Tel.: +48 (0) 221168608
English: 1 mL of emulsion contains 1 mg of ciclosporin.
Slovenian: 1 ml emulzije vsebuje 1 mg ciklosporina.
English: Cases of infections have been reported uncommonly in association with the use of IKERVIS.
Slovenian: Občasno so v povezavi z zdravilom IKERVIS poročali o primerih okužb.
English: • Gently squeeze one drop of the medicine onto your eye. Make sure you do not touch your eye with the tip of the single-dose container.
Slovenian: • Nežno vkapajte eno kapljico zdravila v oko.
English: Poloxamer 188
Slovenian: Niittyhaankatu 20
English: IKERVIS 1 mg/mL eye drops, emulsion ciclosporin
Slovenian: IKERVIS 1 mg/ml kapljice za oko, emulzija ciklosporin
English: One millilitre of IKERVIS contains 1 mg of ciclosporin.
Slovenian: En mililiter zdravila IKERVIS vsebuje 1 mg ciklosporina.
English: 5 single-dose containers.
Slovenian: 5 enoodmernih vsebnikov
English: Infections and infestations
Slovenian: voda za injekcije
English: Santen Oy Τηλ: + 358 (0) 3 284 8111
Slovenian: Τηλ: +358 (0) 3 284 8111
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS POUCH LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: One mL of emulsion contains 1 mg of ciclosporin.
Slovenian: En mililiter emulzije vsebuje 1 mg ciklosporina (ciclosporin).
English: Santen Oy Tel: + 353 (0) 16950008
Slovenian: Tel: +353 (0) 16950008
English: Uncommon Conjunctival oedema, lacrimal disorder, eye discharge, eye pruritus, conjunctival irritation, conjunctivitis, foreign body sensation in eyes, deposit eye, keratitis, blepharitis, corneal decompensation, chalazion, corneal infiltrates, corneal scar, eyelid pruritus, iridocyclitis.
Slovenian: Očesne bolezni pogosti eritem veke, večje solzenje, očesna hiperemija, zamegljeni vid, edem veke, hierpemija veznice, draženje očesa, bolečina v očesu občasni edem veznice, motnje solzenja, izcedek iz očesa, očesni pruritus, draženje veznice, konjunktivitis, občutek tujka v očesu, depozit v očesu, keratitis, blefaritis, roženična dekompenzacija, halacij, roženični infiltrati, roženične brazgotine, pruritus veke, iridociklitis
English: IKERVIS contains the active ingredient, ciclosporin.
Slovenian: Kaj vsebuje zdravilo IKERVIS - Zdravilna učinkovina je ciklosporin.
English: Method of administration Ocular use.
Slovenian: Način uporabe okularna uporaba
English: Milky white emulsion.
Slovenian: kapljice za oko, emulzija mlečno-bela emulzija
English: Uncommon Instillation site reaction, instillation site discomfort, instillation site pruritus, instillation site foreign body sensation.
Slovenian: pruritus na mestu vkapanja, občutek tujka na mestu vkapanja
English: Talk to a doctor if you do not feel better or if you feel worse.
Slovenian: Če se znaki vaše bolezni poslabšajo ali ne izboljšajo, se posvetujte z zdravnikom.
English: Package leaflet: Information for the patient IKERVIS 1 mg/mL, eye drops, emulsion ciclosporin
Slovenian: Navodilo za uporabo IKERVIS 1 mg/ml kapljice za oko, emulzija ciklosporin (ciclosporin)
English: Only use IKERVIS for dropping in your eye(s).
Slovenian: Opozorila in previdnostni ukrepi Zdravilo IKERVIS uporabljajte le za vkapanje v oko ali očesi.
English: How to store IKERVIS
Slovenian: Shranjevanje zdravila IKERVIS
English: Santen Oy Sími: + 358 (0) 3 284 8111
Slovenian: Sími: +358 (0) 3 284 8111
English: A topical overdose is not likely to occur after ocular administration.
Slovenian: Po dajanju v oko ni verjetno, da bi prišlo do lokalnega prevelikega odmerjanja.
English: Adults
Slovenian: Odmerjanje Odrasli
English: Your vision may be blurred immediately after using IKERVIS eye drops.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Tik po uporabi zdravila IKERVIS kapljic za oko se vam lahko zamegli vid.
English: • Take one single-dose container from the aluminium pouch.
Slovenian: • Iz aluminijastega mošnjička vzemite 1 enoodmerni vsebnik.
English: A small but statistically significant difference in CFS improvement was observed between the treatment groups at Month 6 in favour of IKERVIS (mean change from baseline in CFS -1.05 with IKERVIS and -0.82 with vehicle, p=0.009).
Slovenian: (povprečna sprememba CFS od izhodišča -1,05 za zdravilo IKERVIS in -0,82 za vehikel, p = 0,009).
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) Občasni neželeni učinki, povezani z očesom:
English: Remove contact lenses before use.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Pred uporabo odstranite kontaktne leče.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Kako uporabljati zdravilo IKERVIS Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
English: Common Instillation site irritation, instillation site erythema, instillation site lacrimation.
Slovenian: solzenje na mestu vkapanja občasni reakcija na mestu vkapanja, nelagodje na mestu vkapanja,
English: Medium-chain triglycerides Cetalkonium chloride Glycerol
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi srednjeverižni trigliceridi cetalkonijev klorid glicerol tiloksapol poloksamer 188 natrijev hidroksid (za uravnavanje pH)
English: Irritation, redness, and increase in tears when the drops are put into the eye, redness of the eyelid, watery eyes, eye redness, blurred vision.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) Draženje, rdečina in večje solzenje pri vkapanju kapljic v oko, rdečina veke, solznate oči, rdečina očesa, zamegljen vid. Oteklost veke, rdečina veznice (tanka membrana, ki prekriva sprednji del očesa), draženje očesa, bolečina v očesu.
English: • Risk Management Plan ( RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: This dose might be repeated if needed up to 4.8 mL.
Slovenian: Ta odmerek se sme po potrebi ponoviti do 4,8 ml.
English: Not known Cannot be estimated from available data
Slovenian: Neznani - ni mogoče oceniti iz razpoložljivih podatkov
English: No interaction studies have been performed.
Slovenian: Študije interakcij niso bile izvedene.
English: Animal studies do not indicate harmful effects on fertility .
Slovenian: Študije na živalih ne kažejo škodljivih učinkov na plodnost.
English: Emergency equipment and personnel trained in its use must be readily available.
Slovenian: Oprema nujne pomoči in osebje, ki je usposobljeno za njeno uporabo, mora biti vedno na voljo.
English: However you must stop breastfeeding for two to three hours after your ultrasound examination.
Slovenian: Vendar morate prenehati z dojenjem dve do tri ure po ultrazvočni preiskavi.
English: From a microbiological point of view, the medicinal product should be used immediately.
Slovenian: Z mikrobiološkega stališča moramo pripravek uporabiti takoj.
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovenian: Posvetujte se s farmacevtom, kako zavreči zdravila, ki ga ne uporabljate več.
English: In the case of overdose the doctor will take appropriate action.
Slovenian: V primeru prevelikega odmerjanja bo zdravnik ustrezno ukrepal.
English: Technical recommendation
Slovenian: Tehnična priporočila
English: The mean terminal half-life was 12 minutes (range 2 to 33 minutes).
Slovenian: Povprečni končni razpolovni čas je 12 minut (območje 2 do 33 minut).
English: Although these biological side effects have not been reported in humans, the use of a low mechanical index is recommended.
Slovenian: Čeprav ti neželeni učinki niso bili zapaženi pri ljudeh, se priporoča uporabo nizkega mehanskega indeksa.
English: Any unused liquid remaining at the end of an examination must be discarded.
Slovenian: Vso tekočino, ki preostane na koncu pregleda, je treba zavreči.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovenian: Omogoča namreč stalno spremljanja razmerja med koristmi in tveganjem zdravila.
English: Do not throw away any medicines via wastewater.
Slovenian: Ne zavrzite nobenega zdravila v odpadno vodo.
English: The recommended dose is 2 or 2.4 mL per patient.
Slovenian: Priporočeni odmerek znaša 2 ali 2,4 ml na bolnika.
English: • Vascular Doppler imaging: 2.4 mL.
Slovenian: • vaskularno dopplersko slikanje: 2,4 ml.
English: Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified.
Slovenian: Ker do danes ni poročil o primerih prevelikega odmerjanja, niso znani znaki niti simptomi prevelikega odmerjanja.
English: In all these patients there was a high underlying risk for major cardiac complications, which could have led to the fatal outcome.
Slovenian: Pri vseh teh bolnikih je bila velika verjetnost resnih srčnih zapletov, ki bi lahko pripeljali do smrtnega izida.
English: Date of latest renewal: 24 April 2006
Slovenian: Datum zadnjega podaljšanja: 2. maj 2014
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden prejmete zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Z neuporabljenem zdravilom ali odpadnim materialom je treba postopati v skladu z lokalnimi predpisi.
English: In the event of overdose occurring, the patient should be observed and treated symptomatically.
Slovenian: V primeru prevelikega odmerka je treba bolnika opazovati in zdraviti simptomatsko.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Slovenian: Če ste noseči ali če dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden prejmete to zdravilo.
English: NL - 1077 ZX Amsterdam The Netherlands
Slovenian: NL - 1077 ZX Amsterdam Nizozemska
English: Elderly Patients
Slovenian: Starejši bolniki
English: Via Ribes 5, Bioindustry Park Colleretto Giacosa - 10010 (TO) Italy
Slovenian: Via Ribes 5, Bioindustry Park Colleretto Giacosa - 10010 (TO) Italija
English: As a precautionary measure, it is preferable to avoid the use of SonoVue during pregnancy.
Slovenian: Iz previdnostnih ukrepov, je bolje, da se izognemo uporabi zdravila SonoVue med nosečnostjo.
English: The dose recommendations for intravenous administration also apply to elderly patients.
Slovenian: Priporočeni odmerki za intravensko uporabo so primerni tudi za starejše bolnike.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2001
Slovenian: DATUM PRIDOBITVE / PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve:26/03/2001
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < /100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data)
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostosti, po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/ 1.000 do < 1/100 ), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: However, some patients may experience serious side effects and may require treatment.
Slovenian: Vendar pa se pri nekaterih bolnikih lahko pojavijo resni neželeni učinki, ki lahko zahtevajo zdravljenje.
English: The presence or absence of vesicoureteral reflux with SonoVue ultrasound was compared to the radiographic reference standard.
Slovenian: Prisotnost ali odsotnost vezikoureternega refluksa s SonoVue ultrazvokom so primerjali z radiografskim referenčnim standardom.
English: The recommended doses of SonoVue in adults are:
Slovenian: Priporočeni odmerki zdravila SonoVue pri odraslih so:
English: The medicinal product does not require any special storage conditions.
Slovenian: Zdravilo ne zahteva nobenih posebnih pogojev shranjevanja.
English: MARKETING AUTHORISATION NUMBERS EU/1/01/177/002
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/01/177/002
English: This leaflet was last revised on
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3 Preclinical safety data).
Slovenian: Študije na živalih ne kažejo na škodljive vplive za nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3 Predklinični podatki o varnosti).
English: For the limitation in the interpretation of a negative urosonography, see section 4.4. and 5.1.
Slovenian: Za omejitve v interpretaciji negativnih primerov ultrazvočne cistografije glejte poglavji 4.4 in 5.1.
English: No clinical data on exposed pregnancies are available.
Slovenian: Kliničnih podatkov o nosečnicah, ki so bile izpostavljene zdravilu, ni.
English: Before use examine the product to ensure that the container and closure have not been damaged.
Slovenian: Pred uporabo preglejte zdravilo, da preverite, da vsebnik in zaporka nista poškodovana.
English: More than 80% of the administered sulphur hexafluoride was recovered in exhaled air within 2 minutes after injection and almost 100% after 15 minutes.
Slovenian: Več kot 80% injiciranega žveplovega heksafluorida se je pojavilo v izdihanem zraku po 2 minutah po aplikaciji in skoraj 100% po 15 minutah.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA IZVEN DOSEGA IN POGLEDA OTROK
English: Other concomitant diseases
Slovenian: Druge občasne bolezni
English: Intravesical local tolerance for SonoVue was also assessed.
Slovenian: Ocenjena je bila tudi intravezikalna lokalna toleranca za zdravilo SonoVue.
English: Pharmacotherapeutic group: Ultrasound contrast media ATC code: VO8DA05.
Slovenian: Farmakoterapevtska skupina: ultrazvočna kontrastna sredstva Oznaka ATC: VO8DA05
English: • Obligation to conduct post-authorisation measures
Slovenian: • Obveza izvajanja ukrepov po pridobitvi dovoljenja za promet
English: In patients with diffuse interstitial pulmonary fibrosis, the percent of dose recovered in expired air averaged 100% and the terminal half-life was similar to that measured in healthy volunteers.
Slovenian: Pri bolnikih z difuzno intersticijsko pljučno fibrozo je bil odstotek odmerka v izdihanem zraku povprečno 100% in končni razpolovni čas podoben kot pri zdravih prostovoljcih.
English: Caecal lesions observed in some repeat-dose studies with rats, but not in monkeys, are not relevant for humans under normal conditions of administration.
Slovenian: Lezije cekuma, o katerih so poročali v nekaterih študijah pri ponavljajočih se odmerkih pri podganah, toda ne pri opicah, nimajo pomena za človeka pri predpisanih pogojih uporabe.