FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): slabost s siljenjem na bruhanje, zardevanje obraza, vročinski oblivi (nenaden občutek vročine v zgornjem delu telesa), prebavne težave, spremenjeno zaznavanje barv, zamegljen vid, motnje vida, zamašen nos in omotica
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Slovenian: V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so spontano poročali o primerih okvar vida (glejte poglavje 4.8).
English: Sildenafil ratiopharm 100 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Slovenian: Sildenafil ratiopharm 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 100 mg sildenafila.
English: Taking Sildenafil ratiopharm together with some medicines may lead to problems.
Slovenian: Jemanje zdravila Sildenafil ratiopharm skupaj z nekaterimi drugimi zdravili lahko povzroči težave, zato obvestite zdravnika, če jemljete katero od naslednjih zdravil:
English: No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
Slovenian: V študijah vpliva na sposobnost razmnoževanja na podganah in kuncih po peroralnem dajanju sildenafila niso ugotovili pomembnih neželenih učinkov.
English: Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes/red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): bruhanje, kožni izpuščaj, draženje oči, pordelost oči/rdeče oči, bolečine v očeh, svetlobni bliski, občutek svetlosti pri gledanju, občutljivost na svetlobo, solzne oči, razbijanje srca, zvišan srčni utrip, visok krvni tlak, nizek krvni tlak, bolečine v mišicah, občutek zaspanosti, zmanjšana občutljivost na dotik, vrtoglavica, zvenenje v ušesih, suha usta, zamašeni sinusi (obnosne votline), vnetje sluznice nosu (vključno z izcedkom iz nosu, kihanjem in zamašenim nosom), bolečina v zgornjem delu trebuha, gastroezofagealna refluksna bolezen (simptomi vključujejo zgago), prisotnost krvi v urinu, bolečine v rokah ali nogah, krvavitev iz nosu, občutek vročine in občutek utrujenosti
English: How to take Sildenafil ratiopharm
Slovenian: Kako jemati zdravilo Sildenafil ratiopharm
English: Sildenafil ratiopharm 25 mg film-coated tablets Pack sizes of 1, 2, 4, 8, or 12 film-coated tablets.
Slovenian: Sildenafil ratiopharm 25 mg filmsko obložene tablete Pakiranja po 1, 2, 4, 8 ali 12 filmsko obloženih tablet.
English: INFORMATION IN BRAILLE Sildenafil ratiopharm 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Sildenafil ratiopharm 50 mg
English: Sildenafil ratiopharm 50 mg film-coated tablets Pack sizes of 1, 2, 4, 8, 12 or 24 film-coated tablets.
Slovenian: Sildenafil ratiopharm 50 mg filmsko obložene tablete Pakiranja po 1, 2, 4, 8, 12 ali 24 filmsko obloženih tablet.
English: - Chest pains - this occurs uncommonly.
Slovenian: Bolečine v prsnem košu - to se zgodi občasno.
English: Sildenafil ratiopharm 25 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Slovenian: Sildenafil ratiopharm 25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 25 mg sildenafila.
English: Tell your doctor or pharmacist if you are already taking riociguat.
Slovenian: Če niste prepričani, se posvetujte z zdravnikom ali farmacevtom; če jemljete riociguat.
English: Cerebrovascular accident,
Slovenian: obarvanje beločnice
English: (≥ 1/10,000 and
Slovenian: Redki (≥ 1/10000 in
English: Sildenafil ratiopharm 50 mg film-coated tablets Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Slovenian: Sildenafil ratiopharm 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 50 mg sildenafila.
English: Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Slovenian: Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 25 mg sildenafila.
English: Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Slovenian: Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 100 mg sildenafila.
English: - if you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Slovenian: če imate nizek krvni tlak; če imate hude težave z jetri; če imate nekatere redke dedne očesne bolezni (kot je pigmentozni retinitis); če ste kadar koli izgubili vid zaradi očesne bolezni, imenovane »očesna kap« (nearteritična anteriorna ishemična optična nevropatija - NAION).
English: Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Slovenian: Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 50 mg sildenafila.
English: Chest pain, Fatigue, Feeling hot
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečine v prsnem košu, utrujenost, občutek vročine razdražljivost
English: If you are taking riociguat or are unsure tell your doctor.
Slovenian: Če že jemljete riociguat, to povejte zdravniku ali farmacevtu.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija, bolečine v okončinah
English: Gastro oesophagael reflux disease, Vomiting, Abdominal pain upper,
Slovenian: Bolezni prebavil navzea, dispepsija gastroezofagealna refluksna bolezen, bruhanje, bolečine v zgornjem delu trebuha, suha usta hipestezija ust
English: Other medicines and Sildenafil ratiopharm
Slovenian: Shranjevanje zdravila Sildenafil ratiopharm
English: What Sildenafil ratiopharm is
Slovenian: Kaj je zdravilo Sildenafil ratiopharm
English: Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8, 12, 24 or 48 film-coated tablets in blisters.
Slovenian: Zdravilo Sildenafil ratiopharm je na voljo v pakiranjih po 1, 2, 4, 8, 12, 24 ali 48 filmsko obloženih tablet v pretisnih omotih.
English: Sildenafil ratiopharm 100 mg film-coated tablets
Slovenian: Sildenafil ratiopharm 100 mg filmsko obložene tablete
English: Sildenafil ratiopharm 25 mg film-coated tablets
Slovenian: Sildenafil ratiopharm 25 mg filmsko obložene tablete sildenafil
English: Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min), a 25 mg dose should be considered.
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je očistek sildenafila zmanjšan, zato je priporočljivi začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je to potrebno.
English: Sildenafil ratiopharm 50 mg film-coated tablets
Slovenian: Sildenafil ratiopharm 50 mg filmsko obložene tablete
English: Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma,
Slovenian: Bolezni živčevja glavobol omotica zaspanost, hipestezija cerebrovaskularni insul, tranzitorni ishemični napad, konvulzije,* ponavljajoče konvulzije,* sinkopa
English: Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8 or 12 film-coated tablets in blisters.
Slovenian: Zdravilo Sildenafil ratiopharm je na voljo v pakiranjih po 1, 2, 4, 8 ali 12 filmsko obloženih tablet v pretisnih omotih.
English: Sildenafil ratiopharm are supplied in packs of 1, 2, 4, 8, 12 or 24 film-coated tablets in blisters.
Slovenian: Zdravilo Sildenafil ratiopharm je na voljo v pakiranjih po 1, 2, 4, 8, 12 ali 24 filmsko obloženih tablet v pretisnih omotih.
English: Penile haemorrhage, Priapism*, Haematospermia, Erection increased
Slovenian: Motnje reprodukcije in dojk krvavitev iz penisa, priapizem,* hematospermija, dolgotrajna erekcija
English: Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Slovenian: Pri bolnikih z okvaro jeter (npr. ciroza) je očistek sildenafila zmanjšan, zato je priporočljivi začetni odmerek 25 mg. Glede na učinkovitost in prenašanje se odmerek lahko postopoma zveča na 50 mg do 100 mg, če je to potrebno.
English: Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction, ATC code: G04BE03
Slovenian: Farmakoterapevtska skupina: zdravila za bolezni sečil, zdravila za zdravljenje erektilne disfunkcije.
English: Asthenopia, Vitreous floaters, Iris disorder, Mydriasis,
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica, tinitus oglušelost
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 25 mg sildenafila.
English: Haematuria
Slovenian: Odmerjanje
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 100 mg sildenafila.
English: Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Slovenian: Zato je njegova hkratna uporaba z donorji dušikovega oksida ali nitrati v kakršni koli obliki kontraindicirana (glejte poglavje 4.3).
English: NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 100 mg film-coated tablets Sildenafil
Slovenian: Sildenafil ratiopharm 100 mg filmsko obložene tablete sildenafil
English: Teva Pharma Belgium N.V./S.A./AG
Slovenian: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 3 820 73 73
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje sildenafilijev citrat, ki ustreza 50 mg sildenafila.
English: NAME OF THE MEDICINAL PRODUCT Sildenafil ratiopharm 50 mg film-coated tablets Sildenafil
Slovenian: Sildenafil ratiopharm 50 mg filmsko obložene tablete sildenafil
English: Elderly patients (≥65 years)
Slovenian: Posebne populacije Starejši bolniki (≥ 65 let)
English: D-82319 Starnberg Germany
Slovenian: D-82319 Starnberg
English: 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja niso izvedli.
English: This damages the bacteria and eventually kills them.
Slovenian: To bakterijo poškoduje in nato ubije.
English: Geometric Standard Deviation ±SD 1.5 ± 0.0
Slovenian: Geometrična standardna deviacija ± SD 1,5 ± 0,0
English: The medicine is not intended for use in children under 6 years of age.
Slovenian: To zdravilo ni namenjeno za uporabo pri otrocih, starih manj kot 6 let.
English: Distribution Less than 10% of tobramycin is bound to plasma proteins.
Slovenian: Porazdelitev Manj kot 10 % tobramicina se veže na beljakovine plazme.
English: If the infection is not properly treated, it continues to damage the lungs, causing
Slovenian: Če se okužba ne zdravi ustrezno, še naprej kvari pljuča in tako
English: • Keep the rest of the medicine refrigerated in the original carton.
Slovenian: • Preostalo zdravilo shranjujte v hladilniku v originalni škatli.
English: Opened ampoule should never be stored for re-use.
Slovenian: Odprtih ampul ni dovoljeno shranjevati za ponovno uporabo.
English: If you don't have a refrigerator available (such as when you are transporting your medicine) you can store the carton with the medicine (pouches opened or unopened) below 25°C for up to 4 weeks.
Slovenian: Če hladilnik ni na voljo (na primer med transportom zdravila), lahko škatlo z zdravilom (odprte ali neodprte vrečice) do 4 tedne shranjujete pri temperaturi do 25 °C.
English: It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death.
Slovenian: Deluje predvsem tako, da ovira sintezo proteinov, kar spremeni prepustnost celične membrane in povzroči progresiven razkroj celične ovojnice in končno smrt celice.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 12 months following authorisation.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 12 mesecih po pridobitvi dovoljenja za promet.
English: A package is sufficient for one treatment cycle of 28 days.
Slovenian: Pakiranje zadošča za en 28-denvni cikel zdravljenja.
English: • If you need to interrupt your treatment for any reason, press and hold the On/Off button for one full second.
Slovenian: • Če morate zdravljenje zaradi katerega koli razloga prekiniti, celo sekundo pritiskajte na gumb za vklop/izklop.
English: Tell your doctor or a pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, tudi če
English: Any unused medicinal product or waste material should be disposed off in accordance with local
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: These may still occur while using Vantobra, but should not be as frequent or worse than before.
Slovenian: Ti se lahko med uporabo zdravila Vantobra še vedno pojavljajo, vendar ne tako pogosto in v tako hudi obliki kot prej.
English: • It is best to have an interval as close as possible to 12 hours between doses, but this interval must be at
Slovenian: • Najbolje je, da je interval, ki mine med dvema odmerkoma, čim bližje 12 uram, vendar pa mora biti
English: The dose of Vantobra is the same for all patients within the approved age range, regardless of age or weight.
Slovenian: Odmerek zdravila Vantobra je v odobrenem starostnem okviru enak za vse bolnike, ne glede na starost ali telesno maso.
English: Ampoules are packed in pouches, one pouch contains 8 ampoules which correspond with 4 days of
Slovenian: Ampule so pakirane v vrečice, ena vrečica vsebuje 8 ampul,, kar ustreza štirim dnevom zdravljenja.
English: • Hold the ampoule upright and tap lightly before twisting off the head part to avoid spilling.
Slovenian: • Ampulo držite pokonci in po njej rahlo potapkajte, preden ji odtrgate glavo; pazite, da ne polijete.
English: The dose interval should be as close as possible to 12 hours and not less than 6 hours.
Slovenian: Interval odmerjanja naj bo kar najbližje 12 uram in ne manj kot
English: The respective controller can be prescribed by your physician or purchased separately.
Slovenian: Zadevni krmilnik vam je predpisal zdravnilk ali ste ga kupili posebej.
English: 4.7 Effects on ability to drive and use machines Vantobra has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Vantobra nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja s stroji.
English: Limited data from one controlled clinical study over one treatment cycle indicate that the improvement in lung function was maintained above baseline during the 28-day off-treatment period.
Slovenian: Malo podatkov, ki so na voljo iz ene kontrolirane klinične študije za en cikel zdravljenja, kažejo, da se je izboljšanje pljučne funkcije ohranilo nad vrednostjo na začetku zdravljenja v 28-dnevnem obdobju brez
English: Vantobra/Tolero TOBI/PARI LC PLUS
Slovenian: Zravilo VANTOBRA/pršilnik nebulatorja Tolero in TOBI/PARI LC PLUS Vantobra/Tolero TOBI/PARI LC PLUS
English: CFU reduction as an indicator for suppression of P. aeruginosa was comparable for Vantobra and the reference product.
Slovenian: Zmanjšanje CFU kot pokazatelj za supresijo P. aeruginosa je bilo primerljivo za zdravilo Vantobra in za referenčno zdravilo.
English: If less than 6 hours remain to the next planned dose, the patient should wait for the next dose and not inhale more to make up for the missed dose.
Slovenian: Če je do naslednjega načrtovanega odmerka manj kot 6 ur, mora bolnik počakati na naslednji odmerek in ne sme inhalirati več ampul, da bi nadomestil izpuščeni odmerek.
English: Vantobra should not be used during pregnancy unless the benefits to the mother outweigh the risks to the
Slovenian: Zdravilo Vantobra se med nosečnostjo ne sme uporabljati, razen če so koristi za mater večje od možnega
English: No studies have been performed on patients with hepatic impairment.
Slovenian: Pri bolnikih z jetrno okvaro niso opravili nobene študije.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili v nebulatorju.
English: Long-term safety data are not available for Vantobra (see also section 5.1).
Slovenian: Podatki o varnosti za dolgotrajno uporabo zdravila Vantobra niso na voljo (glejte tudi poglavje 5.1).
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, povišana
English: In the case of any overdose, the possibility of drug interactions with alterations in the elimination of Vantobra or other medicinal products should be considered.
Slovenian: V primeru prevelikega odmerjanja je treba pomisliti na medsebojno delovanje zdravil s spremembami izločanja zdravila Vantobra ali drugih zdravil.
English: Assessment of tobramycin serum concentrations may be helpful in monitoring overdose.
Slovenian: Ocena koncentracij tobramicina v serumu je lahko koristna pri spremljanju prevelikega odmerjanja.
English: Teratogenicity could not be assessed at higher parenteral doses in rabbits as they induced maternal toxicity and abortion.
Slovenian: Teratogenosti pri višjih parenteralnih odmerkih pri samicah kuncev niso mogli oceniti, saj je zdravilo povzročilo toksičnost za samice in splav.
English: Use Vantobra twice a day for 28 days Do not use any Vantobra for the next 28 days
Slovenian: Brez uporabe zdravila Vantobra Zdravilo Vantobra uporabljajte 28 dni dvakrat na dan Naslednjih 28 dni zdravila Vantobra ne uporabljajte
English: Serum concentrations greater than 12 µg/ml are associated with tobramycin toxicity and treatment should be discontinued if concentrations exceed this level.
Slovenian: Pri koncentracijah, ki presegajo 12 μg/ml, prihaja do toksičnega delovanja tobramicina, zato je treba zdravljenje prekiniti, če koncentracija presega to vrednost.
English: The recommended dose is one ampoule (170 mg/1.7 ml) administered twice daily (i.e. total daily dose is 2 ampoules) for 28 days.
Slovenian: Priporočeni odmerek je ena ampula (170 mg/1,7 ml), ki ga bolnik 28 dni uporablja dvakrat na dan (tj. skupni dnevni odmerek sta 2 ampuli).
English: Your doctor may ask you to use other appropriate medicines to widen the airways before using
Slovenian: Vaš zdravnik vas bo morda prosil, da uporabljate ustrezna zdravila za razširitev dihalnih poti, preden uporabite zdravilo Vantobra.
English: Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius.
Slovenian: Tobramicin je aminoglikozidni antibiotik, ki ga izdelujejo bakterije Streptomyces tenebrarius.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/932/001 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 18 March 2015
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/14/932/001
English: 6.6 Special precautions for disposal and other handling 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 Vsebina ene ampule se izlije v vsebnik za zdravilo nebulatorje Tolero in inhalira, dokler v vsebniku ni več zdravila.
English: Treatment with the 28-days on and 28-days off dose regimen in clinical studies showed a small but clear increase in tobramycin, amikacin and gentamicin MICs for P. aeruginosa isolates tested.
Slovenian: V kliničnih študijah se je pri zdravljenju z režimom 28 dni zdravljenja in 28 dni brez zdravljenja pokazalo majhno, a očitno povečanje MIK za tobramicin, amikacin in gentamicin za testirane isolate P. aeruginosa.
English: • Inhale by mouth the full content of one ampoule in the morning, and one ampoule in the evening using
Slovenian: • Celotno vsebino ampule zjutraj inhalirajte skozi usta, eno ampulo pa zvečer z uporabo nebulatorja
English: What Vantobra is and what it is used for
Slovenian: Kaj je zdravilo Vantobra in za kaj ga uporabljamo
English: The serum concentration of tobramycin should only be monitored using validated methods.
Slovenian: Koncentracijo tobramicina v serumu je treba meriti samo z validiranimi metodami.
English: In general, toxicity is seen at higher systemic tobramycin levels than are achievable by inhalation of the recommended clinical dose.
Slovenian: Večinoma so toksičnost opažali pri sistemskih koncentracija tobramicina, ki so bile višje od tistih, ki jih je mogoče doseči pri inhalaciji priporočenih kliničnih odmerkov.
English: Vantobra is supplied in polyethylene (PE) ampoules that are packed in sealed aluminium foil pouches (8 ampoules per pouch).
Slovenian: Zdravilo Vantobra je dobavljeno v polietilenskih (PE) ampulah, pakiranih v vrečice (8 ampul v vrečici).
English: Based upon in-vitro data and/or clinical trial experience, the organisms associated with pulmonary infections in CF may be expected to respond to Vantobra therapy as follows:
Slovenian: Na podlagi podatkov in vitro in/ali izkušenj iz kliničnih preskušanj je mogoče pričakovati, da se bodo organizmi, ki povzročajo okužbe pljuč pri cistični fibrozi, odzivali na zdravljenje z zdravilom VANTOBRA,
English: It is supplied in a carton that contains two inner cartons, one with the medicine (56 ampoules with nebuliser solution in 7 pouches), and one with the nebuliser handset.
Slovenian: Na voljo je v škatli, ki vsebuje dve notranji škatli, eno z zdravilom (56 ampul z inhalacijsko raztopino za nebulator v 7 vrečicah), in eno z nebulatorjem.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je
English: What you need to know before you use Vantobra
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Vantobra
English: As tobramycin is not metabolised, an effect of hepatic impairment on the exposure to tobramycin is not expected.
Slovenian: Ker se tobramicin ne presnavlja, ni pričakovati, da bi okvara jeter vplivala na izpostavljenost tobramicinu.