FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhalation of nebulised tobramycin produces high sputum concentrations and low plasma levels.
Croatian: Inhalacija nebuliziranog tobramicina dovodi do visokih koncentracija u sputumu , a niskih u plazmi.
English: Stability after opening of the sachet: 4 weeks when stored below 25 °C
Croatian: Stabilnost nakon otvaranja vrećice: 4 tjedna ako se čuva na temperaturi ispod 25°C 6.4 Posebne mjere pri čuvanju lijeka
English: For comparative aerosol data please refer to Table 2 in section 5.1
Croatian: Za usporedne podatke o aerosolu pogledajte tablicu 2 u dijelu 5.1.
English: If Vantobra is swallowed, it is unlikely to cause severe problems as tobramycin is poorly absorbed from the stomach, but you should still tell your doctor as soon as possible.
Croatian: Ako progutate lijek Vantobra, nije vjerojatno da će doći do značajnih poteškoća jer se tobramicin jako slabo apsorbira iz želuca, ali svejedno trebate što prije obavijestiti svog liječnika.
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.
Croatian: Uslijed toga je potrebno da koncentracije u sputumu nakon liječenja tobramicinom u obliku aerosola budu od deset do dvadeset pet puta iznad minimalne inhibicijske koncentracije (MIK) i za supresiju rasta P. aeruginosa i za kontrolu baktericidne aktivnosti.
English: Where patients are receiving several inhaled medicinal products and chest physiotherapy, it is recommended that Vantobra is used last.
Croatian: Ako bolesnici primaju nekoliko različitih inhalacijskih lijekova i respiratornu fizioterapiju, preporučuje se da se lijek Vantobra primjenjuje posljednji.
English: If a patient reports tinnitus or hearing loss during aminoglycoside therapy, the physician should consider referring them for audiological assessment.
Croatian: Ako bolesnik prijavi tinitus ili gubitak sluha tijekom terapije aminoglikozidima, liječnik mora razmotriti upućivanje na audiološku obradu.
English: If your underlying lung disease seems to become worse while you are using Vantobra, tell your doctor straight away.
Croatian: Ako se vaša osnovna bolest pluća pogorša dok koristite lijek Vantobra, odmah obavijestite svog liječnika.
English: These medicines may harm the kidneys or hearing.
Croatian: Ovi lijekovi mogu dovesti do oštećenja bubrega ili sluha.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Aminoglycoside antibacterials.
Croatian: Farmakoterapijska skupina: antibakterijski lijekovi za sustavnu primjenu, aminoglikozidi.
English: Please also refer to nephrotoxicity information in section 4.4 and excretion information in section
Croatian: Pogledajte informacije o nefrotoksičnosti u dijelu 4.4 i informacije o eliminaciji u dijelu 5.2.
English: amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity);
Croatian: - amfotericin B, cefalotin, ciklosporin, takrolimus, polimiksini (rizik od povećane nefrotoksičnosti);
English: A clear to slightly yellow solution.
Croatian: Bistra do blago žuta otopina.
English: • chest pain or general pain
Croatian: • osip • bol u prsnom košu ili opća bol
English: Caution should be exercised when prescribing Vantobra to patients with known or suspected renal dysfunction.
Croatian: Potreban je oprez kod propisivanja lijeka Vantobra bolesnicima s potvrđenom ili suspektnom bubrežnom disfunkcijom.
English: Vantobra is used in patients with cystic fibrosis aged 6 years and older to treat lung infections caused by bacteria named Pseudomonas aeruginosa.
Croatian: Vantobra se koristi u bolesnika s cističnom fibrozom u dobi od 6 i više godina za liječenje plućnih infekcija uzrokovanih bakterijom koja se zove Pseudomonas aeruginosa.
English: It is not known whether inhaling this medicine while you are pregnant causes side effects.
Croatian: Nije poznato može li inhalacija ovog lijeka u trudnoći uzrokovati nuspojave.
English: If you are taking one or more of the above medicines, talk to your doctor before you use Vantobra.
Croatian: Ako uzimate jedan ili više od gore navedenih lijekova, razgovarajte sa svojim liječnikom prije nego primjenite Vantobra.
English: Vantobra is a clear to slightly yellow coloured solution which can vary to a darker yellow.
Croatian: Lijek Vantobra je bistra do blago žućkasta otopina čija boja može varirati do tamnije žute.
English: The serum concentration of tobramycin should only be monitored using validated methods.
Croatian: Koncentracija tobramicina u serumu smije se pratiti samo pomoću validiranih metoda.
English: Parenteral aminoglycosides have been associated with hypersensitivity, ototoxicity and nephrotoxicity (see section 4.4).
Croatian: Aminoglikozidi koji se daju parenteralno povezani su s preosjetljivošću, ototoksičnošću i nefrotoksičnošću (vidjeti dio 4.4).
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.
Croatian: Brzina isporuke lijeka Vantobra s Tolero nebulizatorom ne ovisi o načinu disanja, npr. odrasla osoba ili dijete, u odnosu na nebulizator PARI LC PLUS.
English: Sputum of cystic fibrosis patients exhibits an inhibitory action on the local biological activity of nebulised aminoglycosides.
Croatian: Sputum bolesnika koji boluju od cistične fibroze pokazuje inhibitorno djelovanje na lokalnu biološku aktivnost nebuliziranih aminoglikozida.
English: • Use Vantobra only with the Tolero nebuliser handset shown in the picture below to make sure you inhale the correct dose.
Croatian: • Koristite lijek Vantobra isključivo s ručnim nebulizatorom Tolero koji je prikazan na slici ispod kako biste inhalirali točnu dozu.
English: What you need to know before you use Vantobra
Croatian: Što morate znati prije nego počnete primjenjivati Vantobra
English: Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius.
Croatian: Mehanizam djelovanja Tobramicin je aminoglikozidni antibiotik dobiven iz Streptomyces tenebrarius.
English: If you experience any of these, stop using Vantobra and tell your doctor straight away.
Croatian: Ako primijetite bilo što od navedenog, prekinite koristiti lijek Vantobra i odmah obavijestite svog liječnika.
English: If oto- or nephrotoxicity occurs in a patient receiving Vantobra, tobramycin therapy should be discontinued until serum concentration falls below 2 µg/ml.
Croatian: Ako u bolesnika koji prima lijek Vantobra dođe do pojave ototoksičnosti ili nefrotoksičnosti, potrebno je prekinuti terapiju tobramicinom dok koncentracija u serumu ne padne ispod 2 μg/ml.
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.
Croatian: U nedostatku konvencionalnih graničnih koncentracija osjetljivosti kod primjene nebulizacijom, moraju se primijeniti mjere opreza kod definiranja organizma kao osjetljivog ili neosjetljivog na nebulizirani tobramicin.
English: Do not use this medicine if you notice that it has become cloudy, or if there are particles in the solution.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je otopina zamućena ili da sadržava krute čestice.
English: Adequate data do not exist for the use of inhaled tobramycin in patients after organ transplantation.
Croatian: Ne postoje primjereni podaci za primjenu inhaliranog tobramicina u bolesnika nakon presađivanja organa.
English: • red pustules, papules on the skin
Croatian: • crveni bolni čvorići (papule), gnojni prištići (pustule) na koži
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.
Croatian: Ako se lijek Vantobra primjenjuje tijekom trudnoće ili trudnoća nastupi za vrijeme uzimanja lijeka Vantobra, bolesnicu se mora obavijestiti o mogućim rizicima za plod.
English: P. aeruginosa isolated from CF patients has also been shown to exhibit adaptive aminoglycoside resistance that is characterised by a reversion to susceptibility when the antibiotic is removed.
Croatian: Izolati P. aeruginosa u bolesnika s CF-om pokazuju i adaptivnu rezistenciju na aminoglikozide koju karakterizira ponovna osjetljivost nakon ukidanja antibiotika.
English: Inhalation of nebulised tobramycin solutions may induce a cough reflex.
Croatian: Inhalacija nebuliziranih otopina tobramicina može potaknuti refleks kašlja.
English: Patients with known or suspected auditory or renal dysfunction should be monitored for serum tobramycin concentrations.
Croatian: U bolesnika s potvrđenom ili suspektnom auditivnom ili bubrežnom disfunkcijom potrebno je pratiti koncentracije tobramicina u serumu.
English: Empty the contents of one ampoule into the medication reservoir of the nebuliser handset.
Croatian: Ispraznite sadržaj jedne ampule u spremnik za lijek na ručnom nebulizatoru.
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.
Croatian: Kada se daju injekcijom, tobramicin i drugi aminoglikozidni antibiotici mogu naškoditi nerođenom djetetu, izazivajući gluhoću ili poteškoće s bubrezima.
English: However, seven of 13 patients (54%) in the placebo-controlled trials who acquired isolates with MICs of 128 µg/ml while using TOBI had improvement in pulmonary function.
Croatian: Međutim, u placebom kontroliranim ispitivanjima sedam od 13 bolesnika (54 %) kod kojih su izolati dosegli vrijednosti MIK ≥ 128 µg/ml prilikom primjene TOBI pokazalo je poboljšanje plućne funkcije.
English: - If you have any further questions, ask your doctor, or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
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.
Croatian: U kliničkim ispitivanjima s TOBI, većina bolesnika s izolatima P. aeruginosa s vrijednostima MIK za tobramicin < 128 μg/ml na početku pokazala je poboljšanje plućne funkcije nakon liječenja s TOBI.
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.
Croatian: Auditivna toksičnost, zabilježena kao pritužba na gubitak sluha ili tijekom audiometrijskog ispitivanja, uočena kod parenteralne primjene aminoglikozida, može se uzeti u obzir i kod inhalacijskog puta primjene.
English: Tobramycin is excreted in human breast milk after systemic administration.
Croatian: Tobramicin se izlučuje u majčino mlijeko nakon sistemske primjene.
English: Vantobra solution is a sterile, aqueous preparation for single use only.
Croatian: Otopina lijeka Vantobra je sterilni vodeni pripravak samo za jednokratnu primjenu.
English: After administering a single dose of Vantobra 170 mg to healthy volunteers Cmax of 1.1 + 0.4 µg/ml were reached after a tmax of approximately 4 hours.
Croatian: Nakon primjene pojedinačne doze lijeka Vantobra 170 mg u zdravih dobrovoljaca, vrijednosti Cmax od 1,1 ± 0,4 µg/ml dosegnute su u vremenu tmax od otprilike četiri sata.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH
English: Inhaling medicines can cause chest tightness due to narrowing of the airways, and this can happen with Vantobra.
Croatian: Inhalacija lijekova može uzrokovati stezanje u prsnom košu zbog sužavanja dišnih putova, i ovo se može dogoditi i prilikom uporabe lijeka Vantobra.
English: The treatment with Vantobra in patients with active, severe haemoptysis should be initiated only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Croatian: Liječenje lijekom Vantobra smije se započeti u bolesnika s teškom aktivnom hemoptizom samo ako se smatra da korist od liječenja premašuje rizik od izazivanja daljnjeg krvarenja.
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.
Croatian: - Drugi sastojak(ci) (pomoćna(e) tvar(i)) je(su): natrijev klorid, kalcijev klorid, magnezijev sulfat, voda za injekcije, sulfatna kiselina i natrijev hidroksid za podešavanje pH vrijednosti.
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.
Croatian: Ako uz inhalacije uzimate tobramicin ili neki drugi aminoglikozidni antibiotik putem injekcije, rizik od nuspojava može biti povećan, što će Vaš liječnik po potrebi nadzirati.
English: If there is evidence of therapy-induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of Vantobra outweighs the risks to the patient.
Croatian: Ako se utvrdi postojanje bronhospazma izazvanog terapijom, liječnik mora pažljivo procijeniti premašuju li koristi nastavka primjene lijeka Vantobra rizike kojima je izložen bolesnik.
English: • voice alteration (hoarseness)
Croatian: • nedostatak zraka • promjena glasa (promuklost)
English: At the end of a 4-weeks dosing cycle of Vantobra (170 mg/1.7 ml twice daily) in cystic fibrosis patients, maximum tobramycin plasma concentrations (Cmax) of 1.27 ± 0.81 µg/ml were reached at approximately one hour after inhalation.
Croatian: Vantobra (170 mg/1,7 ml - dva puta dnevno), najviša koncentracija tobramicina u plazmi (Cmax) u vrijednosti od 1,27 ± 0,81 µg/ml dosegnuta je otprilike jedan sat nakon inhalacije.
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.
Croatian: Očekuje se da će sistemska izloženost tobramicinu nakon inhalacije lijeka Vantobra biti primarno iz inhaliranog dijela lijeka, budući da se tobramicin ne apsorbira u značajnoj mjeri nakon peroralne primjene.
English: Very rare (may affect up to 1 in 10,000 people)
Croatian: Vrlo rijetko (može se javiti u najviše 1 na 10 000 osoba)
English: If you forget to use Vantobra
Croatian: Ako ste zaboravili primijeniti Vantobra
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.
Croatian: Prevladavajući mehanizam rezistencije na aminoglikozide sojeva P. aeruginosa izoliranih u bolesnika s CF-om i kroničnom infekcijom je nepropusnost, definirana općenitim nedostatkom osjetljivosti na sve aminoglikozide.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE AMPULA
English: Aerosol characteristics
Croatian: Svojstva aerosola
English: According to current clinical practice baseline renal function should be assessed.
Croatian: U skladu s postojećom kliničkom praksom, potrebno je provjeriti početnu funkciju bubrega.
English: Acute toxicity should be treated with immediate withdrawal of Vantobra and baseline tests of renal function should be undertaken.
Croatian: Akutna toksičnost mora se liječiti trenutačnim prekidom primjene lijeka Vantobra te se moraju napraviti osnovni testovi funkcije bubrega.
English: If you are breast feeding, you should talk to your doctor before using this medicine.
Croatian: Ako dojite, trebali biste se posavjetovati sa svojim liječnikom prije primjene ovog lijeka.
English: This includes monitoring of serum concentrations of tobramycin.
Croatian: To uključuje praćenje koncentracija tobramicina u serumu.
English: Vantobra is a clear to slightly yellow solution, but some variability in colour may be observed, which does not indicate loss of activity if the product is stored as recommended.
Croatian: Lijek Vantobra je bistra do blago žućkasta otopina čija boja može varirati, što ne ukazuje na gubitak djelovanja ako je lijek skladišten u skladu s uputama.
English: In open label studies and post-marketing experience, some patients with a history of prolonged previous or concomitant use of intravenous aminoglycosides have experienced hearing loss.
Croatian: U otvorenim ispitivanjima i iskustvima nakon stavljanja lijeka na tržište, u nekih bolesnika koji su ranije dugotrajno ili istodobno primali intravenske aminoglikozide zabilježen je gubitak sluha.
English: PHARMACEUTICAL FORM AND CONTENTS Package contains
Croatian: OBLIK I SADRŽAJ Sadržaj pakiranja
English: Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
Croatian: Vestibularna toksičnost može se manifestirati kao vrtoglavica, ataksija ili omaglica.
English: It belongs to a class of antibiotic medicines called aminoglycosides.
Croatian: Pripada skupini antibiotika koja se naziva aminoglikozidi.
English: What Vantobra is and what it is used for
Croatian: Što je Vantobra i za što se koristi
English: Other information
Croatian: Ostali podaci
English: Unabsorbed tobramycin following administration by inhalation is probably eliminated primarily in expectorated sputum.
Croatian: Neapsorbirani tobramicin se, nakon primjene inhalacijom, vjerojatno primarno eliminira u iskašljanom sputumu.
English: Ear pain Ear disorder
Croatian: • bol u uhu, poremećaj uha
English: If you stop using Vantobra
Croatian: Ako prestanete primjenjivati Vantobra
English: These medicines may harm the kidneys; o platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Croatian: o spojevi s platinom kao što su karboplatin i cisplatin (za liječenje nekih oblika raka).
English: • Assemble the Tolero nebuliser handset as illustrated in the Instructions for Use of the handset device.
Croatian: • Sastavite ručni nebulizator Tolero kako je prikazano u uputama za uporabu ručnog uređaja.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
English: NAME OF THE MARKETING AUTHORISATION HOLDER PARI Pharma GmbH
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET PARI Pharma GmbH
English: Table 2: Comparative performance data for the clinical test and reference batches: Vantobra /Tolero nebuliser handset
Croatian: Tablica 2: Usporedni podaci o funkcionalnosti za klinička ispitivanja i referentne serije: Vantobra/Tolero ručni nebulizator1 i TOBI/PARI LC PLUS2.
English: INFORMATION IN BRAILLE Vantobra 170 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vantobra 170 mg
English: Adverse drug reactions are listed according to system organ classes in MedDRA.
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava.
English: • One box with a Tolero nebuliser handset.
Croatian: • Jedna kutija s ručnim nebulizatorom Tolero.
English: Bronchospasm can occur with inhalation of medicinal products and has been reported with the use of nebulised tobramycin.
Croatian: Bronhospazam Tijekom inhalacije lijekova može nastupiti bronhospazam, a zabilježen je i prilikom primjene nebuliziranog tobramicina.
English: Administration by inhalation results in low systemic bioavailability of tobramycin.
Croatian: Primjena inhalacijom ima za posljedicu malu sistemsku bioraspoloživost tobramicina.
English: Do not use this medicine after the expiry date which is stated on the ampoule or the sachet or box after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na ampuli, vrećici ili kutiji iza oznake „Rok valjanosti”.
English: Vantobra is supplied in polyethylene (PE) ampoules that are packed in sealed aluminium foil sachets (8 ampoules per sachet).
Croatian: Lijek Vantobra isporučuje se u polietilenskim ampulama (PE) zapakiranim u zatvorene aluminijske vrećice
English: • taste disturbances, feeling sick (nausea), mouth ulcers, being sick (vomiting), loss of appetite
Croatian: • promjena osjeta okusa, mučnina, ranice u ustima, povraćanje, gubitak apetita
English: In controlled clinical trials with Vantobra the most frequent adverse reactions in cystic fibrosis patients with P. aeruginosa infection were cough and dysphonia.
Croatian: Najčešće zabilježene nuspojave u kontroliranim kliničkim ispitivanjima lijeka Vantobra u bolesnika s cističnom fibrozom i infekcijom P. aeruginosa bile su kašalj i disfonija.
English: Established susceptibility breakpoints for parenteral administration of tobramycin are inappropriate in the aerosolised administration of the medicinal product.
Croatian: Ustanovljene granične koncentracije osjetljivosti za parenteralnu primjenu tobramicina ne odgovaraju onima kod primjene lijeka aerosolom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose ampoule of 1.7 ml contains 170 mg tobramycin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna jednodozna ampula od 1,7 ml sadrži 170 mg tobramicina.
English: You should not mix or dilute Vantobra with any other medicine in your Tolero nebuliser handset which is provided together with Vantobra.
Croatian: Ne smijete miješati ili razrjeđivati lijek Vantobra s bilo kojim drugim lijekom u Vašem ručnom nebulizatoru
English: Once opened an ampoule should be used immediately, and any remaining product should be discarded.
Croatian: Ampula se treba iskoristiti odmah nakon otvaranja, te se sav preostali sadržaj mora baciti.
English: In the event of inadvertent administration of Vantobra by the intravenous route, signs and symptoms of parenteral tobramycin overdose may occur, including dizziness, tinnitus, vertigo, loss of hearing acuity, respiratory distress and/or neuromuscular blockage and renal impairment.
Croatian: U slučaju nenamjerne intravenske primjene lijeka Vantobra mogu nastupiti znakovi i simptomi predoziranja kao nakon parenteralne primjene tobramicina, kao što su omaglica, tinitus, vrtoglavica, gubitak sluha,
English: Patients with a P. aeruginosa isolate with MIC 128 µg/ml at baseline are less likely to show a clinical response.
Croatian: Bolesnici s izolatima P. aeruginosa kod kojih je na početku liječenja MIK ≥ 128 µg/ml imaju manje izgleda za klinički odgovor.
English: The first dose of Vantobra should be used under supervision of a physician, after taking a bronchodilator if this is part of the current regimen for the patient.
Croatian: Prva doza lijeka Vantobra mora se primijeniti pod nadzorom liječnika i to nakon uzimanja bronhodilatatora,
English: If this applies to you, tell your doctor before using Vantobra.
Croatian: Ako se ovo odnosi na Vas, obavijestite svog liječnika prije primjene lijeka Vantobra.
English: Monitoring of serum tobramycin concentrations
Croatian: Praćenje koncentracija tobramicina u serumu
English: PHARMACEUTICAL FORM Nebuliser solution.
Croatian: OBLIK Otopina za nebulizator.
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.
Croatian: Liječnici moraju uzeti u obzir mogućnost vestibularne i kohlearne toksičnosti aminoglikozida te provoditi primjerena ispitivanja sluha tijekom terapije lijekom Vantobra.
English: There are no adequate data from the use of tobramycin administered by inhalation in pregnant women.
Croatian: Nema odgovarajućih podataka o uporabi tobramicina inhalacijom u trudnica.
English: No reproduction toxicology studies have been conducted with tobramycin administered by inhalation.
Croatian: Nisu provedena ispitivanja reproduktivne toksičnosti tobramicina primijenjenog inhalacijski.
English: Geometric Standard Deviation ±SD 1.5 ± 0.0 Nebulisation Time [min]
Croatian: Geometrijska standardna devijacija ±SD 1,5 ± 0,0 Vrijeme nebulizacije [min] *Podaci dobiveni simulacijom disanja i mjerenjima kaskadnim impaktorom.