FrancophonIA/ELRC3.0 huggingface dataset:
English: • unusual difficulty in breathing with wheezing or coughing, chest tightness
Slovenian: • neobičajno oteženo dihanje s piskanjem ali kašljem in z občutkom stiskanja v prsih,
English: Mylan Finland Oy Puh/Tel: +358 20 720 9555
Slovenian: Puh/Tel: +358 20 720 9555
English: TOBI Podhaler contains a medicine called tobramycin which is an antibiotic.
Slovenian: Zdravilo TOBI Podhaler vsebuje zdravilno učinkovino, imenovano tobramicin, ki je antibiotik in sodi v skupino aminoglikozidov.
English: Each hard capsule contains 28 mg tobramycin.
Slovenian: Ena trda kapsula vsebuje 28 mg tobramicina.
English: • Just before use, remove the inhaler from its case by holding the base and twisting off the top of the case in an anti-clockwise direction.
Slovenian: • Inhalator tik pred uporabo vzemite iz etuija, in sicer tako, da držite spodnji del in odvijete pokrov etuija v nasprotni smeri urinega kazalca.
English: See sections 4.4 and 5.1 regarding data in different age groups.
Slovenian: Za podatke po različnih starostnih skupinah glejte poglavji 4.4 in 5.1.
English: Non-clinical data reveal that the main hazard for humans, based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction, consists of renal toxicity and ototoxicity.
Slovenian: Predklinični podatki na osnovi študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in vpliva na sposobnost razmnoževanja so pokazali, da poglavitno tveganje za človeka predstavljata nefrotoksičnost in ototoksičnost zdravila.
English: Inhale the capsule - 1st breath:
Slovenian: Inhalirajte vsebino kapsule - prvi vdih:
English: If there is evidence of therapy-induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of TOBI Podhaler outweigh the risks to the patient.
Slovenian: Če obstajajo podatki, da je pri bolniku že prišlo do bronhospazma zaradi uporabe zdravil, mora zdravnik skrbno pretehtati, ali koristi trajne uporabe zdravila presegajo tveganje pri bolniku.
English: Use capsule immediately after removal from blister.
Slovenian: Kapsule uporabite takoj, ko jih vzamete iz pretisnega omota.
English: • 1 inhaler (the Podhaler device) and its storage case.
Slovenian: • 1 inhalator (inhalator Podhaler) z etuijem,
English: • When you start a new weekly pack of capsules, use the new Podhaler device that is supplied in the pack.
Slovenian: • Ko odprete novo tedensko pakiranje kapsul, začnite uporabljati tudi nov inhalator Podhaler, ki je priložen pakiranju.
English: Other medicines and TOBI Podhaler
Slovenian: Druga zdravila in zdravilo TOBI Podhaler
English: If you are taking one or more of the above medicines, discuss with your doctor before you take TOBI Podhaler.
Slovenian: Če jemljete eno ali več navedenih zdravil, se morate pred začetkom jemanja zdravila TOBI Podhaler pogovoriti z zdravnikom.
English: Then breathe out normally, away from the inhaler.
Slovenian: Nato normalno izdihnite v smeri stran od inhalatorja.
English: The maximum tolerated daily dose of TOBI Podhaler has not been established.
Slovenian: Najvišjega dnevnega odmerka zdravila TOBI Podhaler, ki ga bolniki še prenašajo, niso ugotavljali.
English: If this applies to you, tell your doctor without taking TOBI Podhaler.
Slovenian: Če navedeno velja za vas, povejte to zdravniku in ne jemljite zdravila TOBI Podhaler.
English: monthly multipack
Slovenian: mesečno pakiranje
English: If you are breast feeding, you should talk to your doctor before taking this medicine.
Slovenian: Če dojite, se morate posvetovati z zdravnikom, preden začnete jemati to zdravilo.
English: Based on clinical trial data the inhalation powder TOBI Podhaler was associated with a higher reported rate of cough compared with tobramycin nebuliser solution (TOBI).
Slovenian: Po podatkih klinične študije je bil prašek za inhaliranje TOBI Podhaler povezan s pogostejšim poročanjem o kašlju v primerjavi z raztopino tobramicina za nebulator (zdravilo TOBI).
English: In patients with a predisposing risk due to previous prolonged, systemic aminoglycoside therapy it may be necessary to consider renal and audiological assessment before initiating TOBI Podhaler therapy.
Slovenian: Pri bolnikih, ki so zaradi predhodnega dolgotrajnega sistemskega zdravljenja z aminoglikozidi bolj nagnjeni k ledvičnim in ušesnim boleznim, je treba pred uvedbo zdravila TOBI Podhaler razmisliti o morebitnem pregledu ledvic in sluha.
English: Tobramycin is excreted in human breast milk after systemic administration.
Slovenian: Tobramicin se po sistemski aplikaciji izloča v materino mleko.
English: In a second open-label, multicentre study, patients received treatment with either TOBI Podhaler (112 mg) or tobramycin 300 mg/5 ml nebuliser solution (TOBI), administered twice daily for three cycles.
Slovenian: V drugi odprti multicentrični študiji so bolniki prejemali bodisi zdravilo TOBI Podhaler (112 mg) ali raztopino tobramicina za nebulator 300 mg/5 ml (zdravilo TOBI), in sicer dvakrat dnevno v treh ciklusih.
English: • Hold the inhaler with the mouthpiece pointing down
Slovenian: •Držite inhalator z ustnikom navzdol.
English: If you forget to take TOBI Podhaler
Slovenian: Če ste pozabili vzeti zdravilo TOBI Podhaler
English: 56 inhalation powder, hard capsules and 1 inhaler (weekly pack) 224 (4 x 56) inhalation powder, hard capsules and 5 inhalers (monthly multipack) 448 (8 x 56) inhalation powder, hard capsules and 10 inhalers (2 x monthly multipack wrapped in foil)
Slovenian: 56 trdih kapsul s praškom za inhaliranje in 1 inhalator (tedensko pakiranje) 224 (4 x 56) trdih kapsul s praškom za inhaliranje in 5 inhalatorjev (mesečno pakiranje) 448 (8 x 56) trdih kapsul s praškom za inhaliranje in 10 inhalatorjev (2 x mesečno skupno pakiranje,
English: The improvement in percent predicted FEV1 was numerically greater in the TOBI Podhaler treatment group and was statistically non-inferior to TOBI nebuliser solution.
Slovenian: Povečanje odstotka napovedane vrednosti FEV1 je bilo številčno večje v skupini z zdravilom TOBI Podhaler in zdravilo TOBI Podhaler statistično ni bilo slabše od raztopine za nebulator TOBI (dokazana neinferiornost).
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: How to store TOBI Podhaler Contents of the pack and other information Instructions for use with the Podhaler device (overleaf)
Slovenian: Shranjevanje zdravila TOBI Podhaler Vsebina pakiranja in dodatne informacije Navodila za uporabo inhalatorja Podhaler (na zadnji strani)
English: Patients who use TOBI Podhaler during pregnancy, or become pregnant while taking TOBI Podhaler, should be informed of the potential hazard to the foetus.
Slovenian: Podhaler med nosečnostjo ali zanosijo v času, ko uporabljajo zdravilo TOBI Podhaler, je treba opozoriti na potencialno nevarnost za plod.
English: • Hold the body of the inhaler and unscrew the mouthpiece in an anti-clockwise direction.
Slovenian: • Držite telo inhalatorja in odvijte z njega ustnik v nasprotni smeri urinega kazalca.
English: The use of TOBI Podhaler in patients with clinically significant haemoptysis should be undertaken or continued only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage.
Slovenian: Pri bolnikih s klinično pomembno hemoptizo je zdravilo TOBI Podhaler smiselno uporabljati oziroma nadaljevati z njegovo uporabo samo v primeru, da koristi zdravljenja presegajo tveganje za povzročanje nadaljnjih krvavitev.
English: Inhalation powder, hard capsules Multipack: 448 capsules (2 packs of 224 + 5 inhalers)
Slovenian: prašek za inhaliranje, trde kapsule Skupno pakiranje: 448 kapsul (2 pakiranji po 224 kapsul + 5 inhalatorjev)
English: In patients with any evidence of auditory dysfunction, or those with a predisposing risk, it may be necessary to consider audiological assessment before initiating TOBI Podhaler therapy.
Slovenian: Pri bolnikih s kakršnimikoli znaki slušne disfunkcije ali s povečanim tveganjem oziroma z nagnjenostjo k slušni disfunkciji je pred uvedbo zdravila TOBI Podhaler treba razmisliti o pregledu sluha.
English: If it is empty, discard the capsule.
Slovenian: Če je prazna, jo zavrzite.
English: Mylan Italia SRL Tel: +39 0261246921
Slovenian: Tel: +39 0261246921
English: What TOBI Podhaler is and what it is used for What TOBI Podhaler is
Slovenian: Kaj je zdravilo TOBI Podhaler in za kaj ga uporabljamo Kaj je TOBI Podhaler
English: Patientreported convenience and overall treatment satisfaction (as collected through a patient-reported outcomes questionnaire) were consistently higher with TOBI Podhaler compared with tobramycin nebuliser solution in each cycle.
Slovenian: Bolniki so dosledno pri vsakem ciklusu poročali o večji prikladnosti zdravljenja in izražali večje splošno zadovoljstvo z zdravljenjem (kar so ugotavljali s pomočjo vprašalnika o izidih zdravljenja, na katerega so odgovarjali bolniki) pri uporabi zdravila TOBI Podhaler v primerjavi z uporabo raztopine tobramicina za nebulator.
English: What TOBI Podhaler looks like and contents of the pack
Slovenian: Izgled zdravila TOBI Podhaler in vsebina pakiranja
English: If the capsule does not look pierced:
Slovenian: • Če je kapsula še vedno polna in ni videti predrta,
English: 224 (4 x 56) capsules and 5 inhalers (monthly multipack) 448 (8 x 56) capsules and 10 inhalers (2 x monthly multipack wrapped in foil) Not all pack sizes may be marketed.
Slovenian: 224 (4 x 56) kapsul in 5 inhalatorjev (mesečno pakiranje) 448 (8 x 56) kapsul in 10 inhalatorjev (2 x mesečno pakiranje, zavito v folijo)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL COMPRISING 2 MONTHLY PACKS, EACH CONTAINING 4 WEEKLY PACKS) (INCLUDING BLUE BOX)
Slovenian: NALEPKA NA OVITKU SKUPNEGA PAKIRANJA, ZAVITEGA V FOLIJO, KI OBSEGA 2 MESEČNI PAKIRANJI, OD KATERIH VSAKO VSEBUJE 4 TEDENSKA PAKIRANJA (VKLJUČNO Z "BLUE BOX" PODATKI)
English: The most commonly reported adverse reactions in the main safety, active-controlled clinical study with TOBI Podhaler versus tobramycin nebuliser solution in cystic fibrosis patients with P. aeruginosa infection were cough, productive cough, pyrexia, dyspnoea, oropharyngeal pain, dysphonia and haemoptysis.
Slovenian: Povzetek varnostnih lastnosti zdravila V glavni, aktivno kontrolirani klinični študiji za oceno varnosti zdravila TOBI Podhaler v primerjavi z raztopino tobramicina za nebulator pri bolnikih, ki so imeli cistično fibrozo in okužbo z bakterijo P. aeruginosa, so med neželenimi učinki zdravila najbolj pogosto poročali o kašlju, produktivnem kašlju, zvišani telesni temperaturi, dispneji, bolečinah v ustih in žrelu, hripavosti in hemoptizi.
English: Continue taking TOBI Podhaler as your doctor tells you.
Slovenian: Zdravilo TOBI Podhaler jemljite tako dolgo, kot vam svetuje zdravnik.
English: • Blocked nose
Slovenian: • zamašen nos • krvavitev iz nosu
English: MIC increases observed were in large part reversible during offtreatment periods.
Slovenian: Zvišanje MIK je večinoma izzvenelo v vmesnih obdobjih brez zdravljenja.
English: If any of these apply to you, tell your doctor before taking TOBI Podhaler.
Slovenian: Če kaj od navedenega velja za vas, povejte zdravniku, preden vzamete zdravilo TOBI Podhaler.
English: The systemic exposure to tobramycin after inhalation of TOBI Podhaler is expected to be 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: Domnevajo, da je po inhalaciji zdravila TOBI Podhaler njegova sistemska izpostavljenost predvsem posledica inhaliranega dela zdravila, saj se tobramicin pri peroralnem vnosu ne absorbira v znatnejši meri.
English: In clinical studies, some patients on TOBI Podhaler therapy showed an increase in aminoglycoside minimum inhibitory concentrations (MIC) for P. aeruginosa isolates tested.
Slovenian: V kliničnih študijah je pri nekaterih bolnikih, ki so prejemali zdravilo TOBI Podhaler, prišlo do zvišanja minimalne inhibitorne koncentracije (MIK) za testirane izolate bakterije P. aeruginosa.
English: In comparison, after inhalation of a single dose of tobramycin 300 mg/5 ml nebuliser solution (TOBI), Cmax was 1.04 ± 0.58 µg/ml and median Tmax was one hour.
Slovenian: Za primerjavo je bila Cmax po inhalaciji enkratnega odmerka tobramicina 300 mg/5 ml raztopine za nebulator (zdravilo TOBI) 1,04 ± 0,58 µg/ml in srednja vrednost Tmax ena ura.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONTHLY INTERMEDIATE CARTON OF MULTIPACK COMPRISING 2 MONTHLY PACKS, EACH CONTAINING 4 WEEKLY PACKS) (WITHOUT BLUE BOX)
Slovenian: MESEČNA VMESNA ŠKATLA SKUPNEGA PAKIRANJA, KI OBSEGA 2 MESEČNI PAKIRANJI, OD KATERIH VSAKO VSEBUJE 4 TEDENSKA PAKIRANJA (BREZ "BLUE BOX" PODATKOV)
English: If there is evidence of continued therapy-induced cough with TOBI Podhaler, the physician should consider whether an approved tobramycin nebuliser solution should be used as an alternative treatment.
Slovenian: Če se kašelj stalno pojavlja tudi ob dolgotrajnejši uporabi zdravila TOBI Podhaler, mora zdravnik razmisliti o nadomestni uporabi odobrene inhalacijske raztopine tobramicina za nebulator.
English: Repeat, starting at step 5, for the remaining three capsules of the dose.
Slovenian: Za preostale tri kapsule, ki so del odmerka, ponovite postopek od koraka št. 5 naprej.
English: • When you are ready, take your 2nd breath by repeating
Slovenian: • Ko boste pripravljeni, začnite z drugim vdihom in ponovite korak št. 8 z isto kapsulo.
English: Inhalation powder, hard capsules Multipack: 224 capsules (4 packs of 56 + 1 inhaler) + reserve inhaler
Slovenian: prašek za inhaliranje, trde kapsule Skupno pakiranje: 224 kapsul (4 pakiranja po 56 kapsul + 1 inhalator) + rezervni inhalator.
English: Concomitant use of TOBI Podhaler with diuretic compounds (such as ethacrynic acid, furosemide, urea or intravenous mannitol) is not recommended.
Slovenian: Sočasna uporaba zdravila TOBI Podhaler z diuretičnimi sredstvi (kot so etakrinska kislina, furosemid,
English: Treatment with TOBI Podhaler should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment with TOBI Podhaler.
Slovenian: Trajanje zdravljenja S cikličnim zdravljenjem z zdravilom TOBI Podhaler je treba nadaljevati, dokler je zdravljenje s zdravilom TOBI Podhaler po zdravnikovi presoji klinično koristno za bolnika.
English: Treatment with both TOBI Podhaler and tobramycin 300 mg/5 ml nebuliser solution (TOBI) resulted in relative increases from baseline to day 28 of the third treatment cycle in percent predicted FEV1 of 5.8% and 4.7%, respectively.
Slovenian: Do 28. dne tretjega ciklusa zdravljenja je tako z zdravilom TOBI Podhaler kot z raztopino tobramicina za nebulator 300 mg/5 ml (zdravilo TOBI) prišlo do relativnega povečanja odstotka napovedane vrednosti FEV1 za 5,8 % oziroma 4,7 % od izhodišča.
English: • Take a few normal breaths away from the inhaler.
Slovenian: • Nekajkrat normalno vdihnite in izdihnite v smeri stran od inhalatorja.
English: See also section 5.1 for the profile of response of TOBI Podhaler compared to tobramycin nebuliser solution.
Slovenian: Glejte tudi različne odzive na zdravilo TOBI Podhaler v primerjavi z odzivi na raztopino tobramicina za nebulator v poglavju 5.1.
English: • if you are allergic to tobramycin, to any type of aminoglycoside antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo TOBI Podhaler Ne jemljite zdravila TOBI Podhaler če ste alergični na tobramicin, na katero koli vrsto aminglikozidnih antibiotikov ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Strains of Pseudomonas can become resistant to treatment with an antibiotic over time.
Slovenian: Sevi bakterije Pseudomonas lahko sčasoma postanejo odporni na zdravljenje z antibiotikom, kar pomeni, da lahko zdravilo TOBI Podhaler sčasoma začne delovati slabše, kot bi moralo.
English: BGP Products SIA Tālr: +371 676 055 80
Slovenian: Tālr: +371 676 055 80
English: Haemodialysis may be helpful in removing tobramycin from the body.
Slovenian: Pri odstranjevanju tobramicina iz telesa je lahko koristna hemodializa.
English: Each weekly carton contains 7 blisters (capsule cards) of 8 capsules each, and a Podhaler device in its storage case.
Slovenian: Vsaka škatla za tedensko pakiranje vsebuje 7 pretisnih omotov (tablic s kapsulami), od katerih vsak vsebuje 8 kapsul, in inhalator Podhaler v etuiju.
English: If a patient reports tinnitus or hearing loss during TOBI Podhaler therapy the physician should consider referring them for audiological assessment.
Slovenian: Če bolnik v času zdravljenja z zdravilom TOBI Podhaler toži o tinitusu ali slabšanju suha, mora zdravnik razmisliti o napotitvi bolnika na preiskavo sluha.
English: Each weekly carton contains 56 x 28 mg capsules (7 blisters with 8 capsules per blister), and a Podhaler device in its storage case.
Slovenian: Vsaka škatla za tedensko pakiranje vsebuje 56 kapsul z vsebnostjo 28 mg (7 pretisnih omotov s po 8 kapsulami na pretisni omot) in inhalator Podhaler v etuiju.
English: Sputum concentrations
Slovenian: Koncentracije v izpljunku
English: Fully exhale away from the inhaler.
Slovenian: Globoko izdihnite v smeri stran od inhalatorja.
English: Adult patients tended to discontinue more frequently for tolerability reasons with TOBI Podhaler than with the nebuliser solution.
Slovenian: Odrasli bolniki so zaradi neprenašanja zdravila nekoliko pogosteje prekinili zdravljenje z zdravilom TOBI Podhaler kot z raztopino za nebulator.
English: The apparent terminal half-life of tobramycin in serum after inhalation of a 112 mg single dose of TOBI Podhaler was approximately 3 hours in cystic fibrosis patients and consistent with the half-life of tobramycin after inhalation of tobramycin 300 mg/5 ml nebuliser solution (TOBI).
Slovenian: Pri bolnikih s cistično fibrozo je po inhalaciji enkratnega odmerka 112 mg zdravila TOBI Podhaler navidezni končni razpolovni čas izločanja iz seruma približno 3 ure, kar se ujema z razpolovnim časom po inhalaciji tobramicina 300 mg/5 ml raztopine za nebulator (zdravilo TOBI).
English: • Replace the mouthpiece and repeat steps 8,9 and 10.
Slovenian: • Ponovno namestite ustnik in ponovite korake št. 8, 9 in
English: • Never wash the Podhaler device with water.
Slovenian: • Inhalatorja Podhaler nikoli ne umivajte z vodo.
English: Musculoskeletal, connective tissue and bone disorders
Slovenian: Bolezni mišično-skeletnega sistema, vezivnega tkiva in kosti mišičnoskeletna bolečina v prsih pogosti
English: Do not push the capsules through the foil.
Slovenian: Kapsule ne potiskajte skozi zaščitno folijo.
English: Clear colourless capsules containing a white to almost white powder, with “NVR AVCI” printed in blue on one part of the capsule and Novartis logo printed in blue on the other part of the capsule.
Slovenian: Na enem delu kapsule je natisnjena modra oznaka "NVR AVCI", na drugem pa moder logotip Novartis.
English: • Peel back the foil from the capsule card to reveal one capsule only.
Slovenian: • Potegnite zaščitno folijo s tablice s kapsulami, tako da odkrijete samo eno kapsulo.
English: • 4 capsules in the evening to be inhaled using the Podhaler device.
Slovenian: • zvečer inhalirajte vsebino 4 kapsul s pomočjo inhalatorja Podhaler,
English: Table 1 Adverse reactions Adverse reactions
Slovenian: Preglednica 1 Neželeni učinki Neželeni učinki
English: Inhalation powder, hard capsules
Slovenian: prašek za inhaliranje, trde kapsule
English: • Only use the inhaler contained in this pack.
Slovenian: • Uporabljajte samo inhalator, ki je priložen pakiranju.
English: No studies have been performed on patients with hepatic impairment.
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter niso opravili nobene študije.
English: • The other ingredients are DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), calcium chloride, sulfuric acid (for pH adjustment).
Slovenian: • Druge sestavine zdravila so 1,2-distearoil-sn-glicero-3-fosfoholin (DSPC), kalcijev klorid in žveplova kisina (za uravnavanje pH).
English: • Discoloration of the substance you cough up (sputum)
Slovenian: • obarvanost izkašljane vsebine (izmečka)
English: Holding the body of the inhaler, unscrew and remove the mouthpiece from the inhaler body.
Slovenian: Medtem ko držite telo inhalatorja, odvijte in odstranite z njega ustnik.
English: • Other medicines with diuretic properties such as urea or intravenous mannitol
Slovenian: • furosemida ali etakrinske kisline, ki sta diuretika, • drugih zdravil, ki delujejo diuretično, kot sta urea ali intravenski manitol,
English: When they are given by an injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness.
Slovenian: Tobramicin in drugi aminoglikozidni antibiotiki, ki si jih ženska injicira, lahko škodujejo nerojenemu otroku, tako da na primer povzročijo gluhost.
English: • It is not harmful if these pieces are swallowed or inhaled.
Slovenian: • Če te delce pogoltnete ali vdihnete, vam to ne bo škodovalo.
English: These medicines may harm the kidneys or hearing.
Slovenian: Navedena zdravila lahko škodujejo ledvicam ali sluhu.
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Slovenian: Antibiotično zdravljenje je lahko povezano s tveganji, kot sta razvoj rezistence na antibiotike pri bakteriji P. aeruginosa in superinfekcija z drugimi patogeni.
English: No interaction studies have been performed with TOBI Podhaler.
Slovenian: Študij medsebojnega delovanja zdravil z zdravilom TOBI Podhaler niso izvedli.
English: • Sore throat
Slovenian: • vneto žrelo oziroma grlo
English: • Please read the instructions at the end of this leaflet for more information about how to use the inhaler.
Slovenian: • Več o uporabi inhalatorja boste našli v navodilih na koncu tega Navodila za uporabo.
English: However, no association was observed in either clinical study between the incidence of bronchospasm and cough events.
Slovenian: V obeh kliničnih študijah so najbolj pogosto poročali o kašlju kot neželenem učinku, vendar v nobeni od kliničnih študij niso opažali povezave med pojavljanjem bronhospazma in napada kašlja.
English: However, aminoglycosides can cause foetal harm (e.g. congenital deafness) when high systemic concentrations are achieved in a pregnant woman.
Slovenian: Študije tobramicina na živalih ne kažejo teratogenega delovanja (glejte poglavje 5.3), vendar aminoglikozidi lahko škodujejo plodu (lahko na primer povzročijo prirojeno gluhost), kadar pri nosečnici dosegajo visoke sistemske koncentracije.
English: However, subcutaneous administration of tobramycin during organogenesis was not teratogenic nor embryotoxic.
Slovenian: Študij vpliva s tobramicinom za inhaliranje na sposobnost razmnoževanja niso izvajali, vendar subkutana aplikacija tobramicina v času organogeneze ni delovala niti teratogeno niti embriotoksično.
English: After inhalation of a 112 mg single dose (4 x 28 mg capsules) of TOBI Podhaler in cystic fibrosis patients, the maximum serum concentration (Cmax) of tobramycin was 1.02 ± 0.53 μg/ml (mean ± SD) and the median time to reach the peak concentration (Tmax) was one hour.
Slovenian: Koncentracije v serumu Po inhalaciji enkratnega odmerka 112 mg zdravila TOBI Podhaler (štiri 28-miligramske kapsule) pri bolnikih s cistično fibrozo, je bila najvišja koncentracija tobramicina v serumu (Cmax) 1,02 ± 0,53 μg/ml (povprečje ± standardna deviacija), srednja vrednost časa, v katerem je prišlo do najvišje koncentracije (Tmax) pa je bila ena ura.
English: Such coumpounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Slovenian: Ta sredstva spreminjajo koncentracije antibiotikov v serumu in tkivih in tako lahko povečajo toksično delovanje aminoglikozidov.
English: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Calcium chloride
Slovenian: 1,2-distearoil-sn-glicero-3-fosfoholin (DSCP) kalcijev klorid žveplova kisina (za uravnavanje pH)