FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are also taking tobramycin or another aminoglycoside antibiotic by injection, it may increase the risk of side effects and your doctor will monitor for these as appropriate.
Slovenian: Če uporabljate tobramicin ali druge aminoglikozidne antibiotike v obliki injekcij, lahko to poveča tveganje neželenih učinkov, kar bo zdravnik ustrezno spremljal.
English: If you forget to use Vantobra
Slovenian: Če ste pozabili uporabiti zdravilo Vantobra
English: There are no data in this population to support a recommendation for or against dose adjustment with Vantobra.
Slovenian: Pri tej populaciji ni dovolj podatkov o uporabi zdravila, zato se priporočil za ali proti prilagajanju odmerkov zdravila Vantobra ne more podati.
English: If you experience any of these, stop using Vantobra and tell your doctor straight away.
Slovenian: Če se kar koli pojavi pri vas, prenehajte uporabljati zdravilo Vantobra in to takoj povejte zdravniku.
English: In patients with a predisposing risk due to previous prolonged systemic aminoglycoside therapy it may be necessary to consider audiological assessment before initiating Vantobra therapy.
Slovenian: Pri bolnikih z nagnjenostjo k slušni disfunkciji zaradi predhodne dolgotrajne sistemske terapije z aminoglikozidom je treba pred uvedbo zdravila Vantobra razmisliti o pregledu sluha.
English: Paediatric population There is no relevant use of Vantobra in children below 6 years of age.
Slovenian: Zdravilo Vantobra ni primerno za uporabo pri otrocih, mlajših od 6 let.
English: It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Slovenian: V koncentracijah, ki so enake ali nekoliko višje od inhibitornih, deluje baktericidno.
English: The drug delivery rate of Vantobra with the Tolero nebuliser is independent of the breathing pattern applied i.e. adult or child in contrast to the PARI LC PLUS nebuliser.
Slovenian: Hitrost dostave zdravila Vantobra ni odvisna od uporabljenega vzorca dihanja, tj. odrasli v primerjavi z otrokom, v nasprotju z nebulatorjem s kompresorjem PARI LC PLUS.
English: These medicines may harm the kidneys; o platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Slovenian: o zdravila, ki vsebujejo platino, kot sta karboplatin in cisplatin (za zdravljenje nekaterih vrst raka).
English: This necessitates sputum concentrations following treatment with aerosolised tobramycin to be ten to twentyfive-fold above the Minimum Inhibitory Concentration (MIC) for both P. aeruginosa growth suppression and control of bactericidal activity.
Slovenian: Zato morajo biti koncentracije tobramicina v obliki aerosola v izpljunku vsaj deset- do petindvajsetkrat višje od minimalne inhibitorne koncentracije (MIK), da povzročijo supresijo rasti bakterij P. aeruginosa in za obvladovanje baktericidne aktivnosti.
English: No studies have been performed on patients with hepatic impairment.
Slovenian: Pri bolnikih z jetrno insuficienco niso opravili študij.
English: • fungal infections of the mouth or throat, such as thrush
Slovenian: • glivične okužbe ust ali žrela, kot je ustni oprh (gobice)
English: If your underlying lung disease seems to become worse while you are using Vantobra, tell your doctor straight away.
Slovenian: Če vam zdi, da se je osnovna bolezen pljuč med uporabo zdravila Vantobra poslabšala, to takoj povejte zdravniku.
English: NAME OF THE MARKETING AUTHORISATION HOLDER PARI Pharma GmbH
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM PARI Pharma GmbH
English: Following intravenous administration, systemically absorbed tobramycin is eliminated by glomerular filtration.
Slovenian: Sistemsko absorbirani tobramicin se po intravenski uporabi izloča predvsem z glomerulno filtracijo.
English: Very rare (may affect up to 1 in 10,000 people)
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov)
English: Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
Slovenian: Vestibularna toksičnost se lahko kaže kot vrtoglavica, ataksija ali omotičnost.
English: PHARMACEUTICAL FORM AND CONTENTS Package contains 56 ampoules with nebuliser solution in 7 sachets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Pakiranje vsebuje 56 ampul z raztopino za nebulator v 7 vrečicah.
English: FEV1 should be measured before and after nebulisation.
Slovenian: Pred dajanjem zdravila z nebulatorjem in po njem je treba izmeriti FEV1.
English: There are no adequate data from the use of tobramycin administered by inhalation in pregnant women.
Slovenian: Ni ustreznih podatkov o uporabi tobramicina za inhaliranje pri nosečnicah.
English: If a patient reports tinnitus or hearing loss during aminoglycoside therapy, the physician should consider referring them for audiological assessment.
Slovenian: Če bolnik v času zdravljenja z aminoglikozidi poroča o tinitusu ali izgubi sluha, mora zdravnik razmisliti o napotitvi bolnika na preiskavo sluha.
English: Physicians should consider the potential for aminoglycosides to cause vestibular and cochlear toxicity and carry out appropriate assessments of auditory function during Vantobra therapy.
Slovenian: Zdravniki morajo upoštevati, da lahko aminoglikozidi povzročijo vestibularno in kohlearno toksičnost in med zdravljenjem z zdravilom Vantobra ustrezno ocenjevati slušno funkcijo.
English: If you stop using Vantobra
Slovenian: Če ste prenehali uporabljati zdravilo Vantobra
English: Such compounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue (see section 4.4).
Slovenian: Ta zdravila spreminjajo koncentracije antibiotikov v serumu in tkivih in tako lahko povečajo toksično delovanje aminoglikozidov (glejte poglavje 4.4).
English: Table 2: Comparative performance data for the clinical test and reference batches: Vantobra /Tolero nebuliser handset
Slovenian: Preglednica 2: Primerjalni podatki o učinku iz kliničnih testov in referenčnih serij: Zravilo Vantobra/pršilnik nebulatorja Tolero in TOBI/PARI LC PLUS
English: There was no difference in the safety profile between pediatric and adult patient population treated with Vantobra.
Slovenian: Med pediatrično populacijo in odraslimi bolniki, zdravljenimi z zdravilom Vantobra, ni bilo razlik v varnostnem profilu.
English: Do not use this medicine after the expiry date which is stated on the ampoule or the sachet or box after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ampuli ali vrečici ali škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: When they are given by injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness and kidney problems.
Slovenian: Kadar se tobramicin in drugi aminoglikozidni antibiotiki, uporabljajo v obliki injekcije lahko škodujejo nerojenemu otroku, tako da na primer povzročijo gluhost ali težave z ledvicami.
English: Established susceptibility breakpoints for parenteral administration of tobramycin are inappropriate in the aerosolised administration of the medicinal product.
Slovenian: Ugotovljene mejne vrednosti za občutljivost bakterij pri parenteralnem vnosu tobramicina ne ustrezajo vnosu zdravila v obliki aerosola.
English: • Nebulisation should take place in a well ventilated room.
Slovenian: • Inhalacijo z nebulatorjem je treba opraviti v prostoru z dobrim zračenjem.
English: In the absence of conventional susceptibility breakpoints for the nebulised route of administration, caution must be exercised in defining organisms as susceptible or insusceptible to nebulised tobramycin.
Slovenian: Ker pri poti uporabe zdravila s pomočjo nebulatorja ni na voljo običajnih mejnih vrednosti za občutljivost bakterij, je potrebna previdnost pri opredelitvi, kateri organizmi so občutljivi oziroma neobčutljivi na tobramicin, ki se uporablja s pomočjo nebulatorja.
English: The use of an alternative untested nebuliser system may alter the pulmonary deposition of the active substance.
Slovenian: Uporaba drugega, netestiranega nebulatorskega sistema lahko spremeni odlaganje učinkovine v pljučih.
English: Adverse drug reactions reported for tobramycin nebuliser solution are listed in Table 1.
Slovenian: Neželeni učinki o katerih so poročali za raztopino tobramicina za nebulator, so navedeni v preglednici 1.
English: Inhalation of nebulised tobramycin solutions may induce a cough reflex.
Slovenian: Inhaliranje raztopin tobramicina z nebulatorjem lahko izzove refleks kašlja.
English: • Remove one ampoule of Vantobra from the aluminium foil sachet just before inhalation.
Slovenian: • Iz vrečice iz aluminijaste folije vzemite eno ampulo zdravila Vantobra tik pred inhaliranjem.
English: Occasionally, patients with a history of prolonged previous or concomitant use of intravenous aminoglycosides may experience hearing loss.
Slovenian: Občasno so pri bolnikih s podaljšano predhodno ali sočasno uporabo intravenskih aminoglikozidov v anamnezi poročali o izgubi sluha.
English: In clinical studies with TOBI, most patients with P. aeruginosa isolates with tobramycin MICs < 128 µg/ml at baseline showed improved lung function following treatment with TOBI.
Slovenian: V kliničnih študijah z zdravilom TOBI se je pri večini bolnikov z izolati P. aeruginosa z MIK za tobramicin < 128 µg/ml na začetku zdravljenja pljučna funkcija po zdravljenju z zdravilom TOBI izboljšala.
English: Finger prick blood sampling is not recommended due to the risk of contamination of the sample.
Slovenian: Zaradi tveganja za kontaminacijo vzorca odvzem krvi iz prsta ni priporočljiv.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: In the event of accidental ingestion of Vantobra, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
Slovenian: V primeru nehotenega zaužitja zdravila Vantobra je toksično delovanje le malo verjetno, saj se tobramicin slabo absorbira iz nepoškodovanih prebavil.
English: If Vantobra is used during pregnancy, or if the patient becomes pregnant while taking Vantobra, she should be informed of the potential hazard to the foetus.
Slovenian: Vantobra med nosečnostjo ali zanosijo v času, ko uporabljajo zdravilo Vantobra, je treba opozoriti na možno nevarnost za plod.
English: If you are taking one or more of the above medicines, talk to your doctor before you use Vantobra.
Slovenian: Če jemljete eno ali več navedenih zdravil, se morate pred začetkom uporabe zdravila Vantobra posvetovati z zdravnikom.
English: In controlled clinical trials with Vantobra the most frequent adverse reactions in cystic fibrosis patients with P. aeruginosa infection were cough and dysphonia.
Slovenian: V kontroliranih preskušanjih z zdravilom Vantobra sta bila najpogostejša neželena učinka pri bolnikih s cistično fibrozo z okužbo z bakterijo P. aeruginosa kašelj in disfonija.
English: Unabsorbed tobramycin following administration by inhalation is probably eliminated primarily in expectorated sputum.
Slovenian: Neabsorbirani tobramicin se po inhaliranju verjetno izloča predvsem v izkašljanih izpljunkih.
English: • The nebuliser handset must be kept horizontally during operation.
Slovenian: • Nebulator mora biti med uporabo vodoravno.
English: Empty the contents of one ampoule into the medication reservoir of the nebuliser handset.
Slovenian: Celo vsebino ene ampule izpraznite neposredno v vsebnik za zdravilo nebulatorja.
English: One ampoule contains 170 mg of tobramycin as a single dose.
Slovenian: Ena ampula vsebuje 170 mg tobramicina kot enkratni odmerek.
English: - If you have any further questions, ask your doctor, or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered.
Slovenian: Če je očitno, da je prišlo do kliničnega poslabšanja stanja pljuč, je treba razmisliti o uvedbi dodatnega zdravila oziroma o zamenjavi z drugim zdravilom, ki deluje proti bakteriji Pseudomonas aeruginosa.
English: Auditory toxicity, as measured by complaints of hearing loss or by audiometric evaluations, was observed with parenteral aminoglycosides and may be considered also for the inhalation route of administration.
Slovenian: Pri uporabi parenteralnih aminoglikozidov so opazili toksično delovanje na sluh, izmerjeno kot pritožbe o izgubi sluha ali z avdiometričnimi ocenami, zato je treba nanje pomisliti tudi pri inhalacijskemu načinu uporabe.
English: If this applies to you, tell your doctor before using Vantobra.
Slovenian: Če kaj od navedenega velja za vas, povejte zdravniku, preden uporabite zdravilo Vantobra.
English: Adequate data do not exist for the use of inhaled tobramycin in patients after organ transplantation.
Slovenian: Bolniki po presaditvi organa O uporabi tobramicina za inhaliranje pri bolnikih po presaditvi organa ni na voljo zadostnih podatkov.
English: • kidney problems;
Slovenian: • težave z ledvicami
English: Vantobra is available together with a Tolero nebuliser handset.
Slovenian: Zdravilo Vantobra je na voljo skupaj z nebulatorjem Tolero.
English: The Tolero nebuliser handset can be operated either with an eBase controller or with the eFlow rapid control unit.
Slovenian: Nebulator se lahko uporablja s krmilnikom eBase ali eFlow rapid.
English: • Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the medicine.
Slovenian: • Za vsak cikel zdravljenja (28-dnevno zdravljenje) uporabite nov nebulator Tolero, priložen zdravilu.
English: How to use Vantobra
Slovenian: Kako uporabljati zdravilo Vantobra
English: Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the medicine.
Slovenian: Za vsak cikel zdravljenja (28-dnevno zdravljenje) uporabite nov nebulator Tolero, priložen zdravilu.
English: • Assemble the Tolero nebuliser handset as illustrated in the Instructions for Use of the handset device.
Slovenian: • Nebulator Tolero sestavite, kot je prikazano v navodilih za uporabo nebulatorja.
English: Tobramycin is excreted in human breast milk after systemic administration.
Slovenian: Tobramicin se po sistemski uporabi izloča v materino mleko.
English: No effect on male or female fertility was observed in animal studies after subcutaneous administration (see section 5.3).
Slovenian: V študijah na živalih po subkutani uporabi zdravila niso opažali vpliva na plodnost samic ali samcev (glejte poglavje 5.3).
English: The systemic exposure to tobramycin after inhalation of Vantobra is expected to emerge primarily from the inhaled portion of the medicinal product as tobramycin is not absorbed to any appreciable extent when administered via the oral route.
Slovenian: Predvideva se, da je po inhalaciji zdravila Vantobra njegova sistemska izpostavljenost predvsem posledica inhaliranega dela zdravila, saj se tobramicin pri peroralnem vnosu ne absorbira v znatnejši meri.
English: Vantobra has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Vantobra nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja strojev.
English: Vantobra solution is a sterile, aqueous preparation for single use only.
Slovenian: Raztopina zdravila Vantobra je sterilen, vodni pripravek za enkratno uporabo.
English: Talk to your doctor if you are concerned about this.
Slovenian: Če vas to skrbi, se pogovorite z zdravnikom.
English: Caution should be exercised when prescribing Vantobra to patients with known or suspected renal dysfunction.
Slovenian: Pri predpisovanju zdravila Vantobra bolnikom z ugotovljeno ledvično disfunkcijo ali s sumom nanjo je potrebna previdnost.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read both the package leaflet of Vantobra and the Instructions for Use of the Tolero nebuliser handset before use.
Slovenian: Pred uporabo preberite priloženo navodilo za zdravilo Vantobra in navodila za uporabo nebulatorja Tolero!
English: Administration by inhalation results in low systemic bioavailability of tobramycin.
Slovenian: Pri inhalacijski uporabi je biološka razpoložljivost tobramicina majhna.
English: If you are breast feeding, you should talk to your doctor before using this medicine.
Slovenian: Če dojite, se morate posvetovati z zdravnikom, preden začnete jemati to zdravilo.
English: • diarrhoea, pain in and around the stomach
Slovenian: • driska, bolečine v želodcu in okoli njega • rdeče pustule, papule na koži
English: • increased cough
Slovenian: • pogostejše kašljanje
English: • Read the Instructions for Use provided with the handset device before use.
Slovenian: • Pred uporabo preberite priložena navodila za uporabo nebulatorja.
English: In clinical studies patients using inhaled tobramycin continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides.
Slovenian: V kliničnih študijah so bolniki, ki so inhalirali tobramicin, še naprej uporabljali dornazo alfa,
English: The elimination of tobramycin administered by the inhalation route has not been studied.
Slovenian: Izločanja tobramicina po inhaliranju niso preučili.
English: • sleepiness
Slovenian: • zaspanost
English: • The other ingredient(s) (excipient(s)) are: sodium chloride, calcium chloride, magnesium sulphate, water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Slovenian: - Druge sestavine zdravila (pomožne snovi) so: natrijev klorid, kalcijev klorid, magnezijev sulfat, voda za injekcije, žveplova kislina in natrijev hidroksid za uravnavanje pH.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema zelo redki limfadenopatija
English: Excipients: sodium chloride, calcium chloride, magnesium sulphate, water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Slovenian: Pomožne snovi: natrijev klorid, kalcijev klorid, magnezijev sulfat, voda za injekcije, žveplova kislina in natrijev hidroksid za uravnavanje pH.
English: Pulmonary function test decreased
Slovenian: Preiskave redki zmanjšanje vrednosti testov pljučne funkcije
English: Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).
Slovenian: 4.1 Terapevtske indikacije Zdravilo Vantobra je indicirano za obvladovanje kronične okužbe pljuč z bakterijo Pseudomonas aeruginosa pri bolnikih, starih 6 let in več, ki imajo cistično fibrozo (CF).
English: What Vantobra is used for
Slovenian: Za kaj se uporablja zdravilo Vantobra
English: Bronchospasm can occur with inhalation of medicinal products and has been reported with the use of nebulised tobramycin.
Slovenian: Pri inhalaciji zdravil lahko pride do bronhospazma, o katerem so poročali tudi pri uporabi tobramicina za inhaliranje z nebulatorjem v kliničnih študijah.
English: How Vantobra works
Slovenian: Kako deluje zdravilo Vantobra
English: What Vantobra is and what it is used for
Slovenian: Kaj je zdravilo Vantobra in za kaj ga uporabljamo Kaj je zdravilo Vantobra
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje bakterijskih infekcij, aminoglikozidni antibiotiki, oznaka ATC: J01GB01
English: Magnesium sulphate Sulphuric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid kalcijev klorid magnezijev sulfat žveplova kislina (za uravnavanje pH ) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: No recommendation for or against dose adjustment can be made for patients after organ transplantation.
Slovenian: Za bolnike po presaditvi organa ni mogoče podati priporočil glede prilagajanja odmerkov ali takega prilagajanja odsvetovati.
English: • coughing up blood, producing more sputum than normally, chest discomfort, asthma, fever
Slovenian: • izkašljevanje krvi, nastajanje več izpljunkov kot običajno, nelagodje v prsnem košu, astma, zvišana telesna temperatura • motnje v okušanju, siljenje na bruhanje (navzea), razjede v ustih, bruhanje, izguba apetita
English: You should not take the following medicines while you are using Vantobra:
Slovenian: Kadar jemljete zdravilo Vantobra, ne smete jemati naslednjih zdravil:
English: The most prevalent aminoglycoside resistance mechanism seen in P. aeruginosa isolated from chronically infected CF patients is impermeability, defined by a general lack of susceptibility to all aminoglycosides.
Slovenian: Najbolj prevladujoč mehanizem odpornosti na aminoglikozid, ki so ga opazili pri P. aeruginosa, izoliranih pri bolnikih s kronično okužbo s cistično fibrozo, je neprepustnost,
English: The contents of one ampoule should be emptied into the medication reservoir of the Tolero nebuliser handset and administered by inhalation until no medicine is left in the reservoir.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Vsebino ene ampule je potrebno izliti v vsebnik za zdravilo nebulatorja Tolero in inhalirati, dokler v vsebniku ni več zdravila.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Drugi neželeni učinki lahko vključujejo: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: There was no evidence of nephrotoxicity during clinical trials with inhaled tobramycin and Vantobra.
Slovenian: V kliničnih študijah s tobramicinom za inhaliranje in zdravilom Vantobra niso opažali nefrotoksičnosti.
English: Vantobra is administered by inhalation using the Tolero nebuliser handset provided in the pack.
Slovenian: Zdravilo Vantobra se inhalira s pomočjo nebulatorja Tolero, priloženega pakiranju.
English: Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of Vantobra is not recommended with other medicinal products with nephrotoxic or ototoxic potential, such as:
Slovenian: Glede na profil interakcij tobramicina pri intravenski uporabi in uporabi v obliki aerosola, sočasna in/ali zaporedna uporaba zdravila Vantobra z drugimi zdravili, ki imajo nefrotoksičen ali ototoksičen potencial, ni priporočena: - amfotericin B, cefalotin, ciklosporin, takrolimus, polimiksini (tveganje za povečano nefrotoksičnost); - zdravila, ki vsebujejo platino (tveganje za povečano nefrotoksičnost in ototoksičnost);
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE Številka serije
English: • One box with the medicinal product: 56 ampoules with nebuliser solution in 7 sachets.
Slovenian: • Eno škatlo z zdravilom: 56 ampul z inhalacijsko raztopino za nebulator v 7 vrečicah.
English: Tobramycin did not impair fertility in male or female rats at subcutaneous doses up to 100 mg/kg/day.
Slovenian: Tobramicin pri podganjih samcih ali samicah pri subkutanih odmerkih do
English: Clinical experience with tobramycin nebuliser solutions reports dysphonia and tinnitus in patients treated with tobramycin.
Slovenian: V kliničnih izkušnjah z raztopino tobramicina za nebulator pri bolnikih, zdravljenih s tobramicinom,
English: Urea and creatinine levels should be reassessed after every 6 complete cycles of Vantobra therapy (180 days of nebulised aminoglycoside therapy).
Slovenian: 6 zaključenih ciklih zdravljenja z zdravilom Vantobra (180 dni zdravljenja z aminoglikozidom za inhaliranje z nebulatorjem) je treba ponovno preveriti koncentraciji sečnine in kreatinina.