FrancophonIA/ELRC3.0 huggingface dataset:
English: Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid
Croatian: Sandoz Farmacéutica, S.A Centro Empresarial Parque Norte C/ Serrano Galvache Nº 56, Edificio Roble E-28033 Madrid Tel: +34 91 602 30 62 registros.spain@sandoz.com
English: This was followed by monotherapy TMZ (150-200 mg/m2) on Days 1-5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Croatian: Nakon toga je slijedila monoterapija TMZ-om (150-200 mg/m 2) od 1. do 5. dana svakog ciklusa od 28 dana.
English: You will take your new dose of Temozolomide Hexal alone once daily for the first 5 days (“dosing days”) of each cycle.
Croatian: Hexal jedanput na dan prvih 5 dana svakog ciklusa („dani doziranja“).
English: How to take Temozolomide Hexal
Croatian: Kako uzimati Temozolomid Hexal
English: Hepatic enzymes increased, Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Croatian: Povišene vrijednosti jetrenih enzima, povišene vrijednosti gama-GT-a, povišene vrijednosti AST-a *Jedan bolesnik koji je bio randomiziran u skupinu koja je primala samo RT, primio je TMZ + RT.
English: • inability to fall asleep or stay asleep
Croatian: • nemogućnost da usnivanja ili prosnivanja
English: Then you will have 23 days without Temozolomide Hexal.
Croatian: Zatim slijede 23 dana bez uzimanja Temozolomida Hexal.
English: • blood clot in the legs
Croatian: • krvni ugrušak u nogama
English: ≥ 0.5 and < 1.5 x 109/l
Croatian: ≥ 0,5 i < 1,5 x 10
English: • reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia)
Croatian: • smanjen broj krvnih stanica (neutropenija, trombocitopenija, limfopenija, leukopenija)
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Croatian: intersiticijski pneumonitis/pneumonitis, plućna fibroza,
English: • in adults with newly-diagnosed glioblastoma multiforme.
Croatian: • u odraslih s novodijagnosticiranim multiformnim glioblastomom.
English: Patients receiving temozolomide in combination with radiotherapy may experience different side effects than patients taking temozolomide alone.
Croatian: Temozolomid u kombinaciji sa zračenjem u liječenju novodijagnosticiranog glioblastoma Bolesnici koji uzimaju temozolomid u kombinaciji sa zračenjem mogu imati drugačije nuspojave od bolesnika koji uzimaju samo temozolomid.
English: Your doctor will work out your dose of Temozolomide Hexal.
Croatian: Vaš liječnik će izračunati točnu dozu Temozolomida Hexal koja Vam je potrebna.
English: • reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia)
Croatian: • smanjen broj krvnih stanica (neutropenija ili limfopenija, trombocitopenija)
English: • impaired sensations
Croatian: • loše osjećanje
English: If you are a newly-diagnosed patient, treatment will occur in two phases:
Croatian: Ako ste novodijagnosticirani bolesnik, liječenje će se odvijati u dvije faze: • prvo liječenje zajedno sa zračenjem (faza istodobnog liječenja)
English: Temozolomide Hexal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Croatian: Odrasli bolesnici s novodijagnosticiranim multiformnim glioblastomom Temozolomid Hexal se primjenjuje u kombinaciji s fokalnom radioterapijom (faza istodobnog liječenja), nakon čega slijedi do 6 ciklusa monoterapije temozolomidom (TMZ) (faza monoterapije).
English: • vaginal irritation
Croatian: • vaginalna nadraženost
English: • forgetfulness
Croatian: • zaboravljivost
English: (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known: frequency cannot be estimated from the available data.
Croatian: <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • radiation injury
Croatian: • vrućica • ozljeda zbog zračenja
English: • difficulty with holding your urine
Croatian: • učestalo mokrenje • poteškoće sa zadržavanjem urina
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and
Croatian: TMZ-a izloženost MTIC-u iznosi ~2,4 %, a izloženost AIC-u 23 %.
English: hypoesthesia, neurological disorder (NOS), peripheral neuropathy sensory disturbance
Croatian: hipoestezija, nespecificirani neurološki poremećaj, periferna neuropatija
English: Temozolomide Hexal is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Croatian: odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom, istodobno s radioterapijom (RT), a zatim kao monoterapija, djece od navršene tri godine starosti, adolescenata i odraslih bolesnika s malignim gliomom,
English: Temozolomide Hexal 5 mg
Croatian: Temozolomid Hexal 5 mg
English: D-83607 Holzkirchen Tél/Tel: +49 39205 42-1305 dra.co_de@hexal.com
Croatian: D-83607 Holzkirchen Tél/Tel: +49 39205 42-1305
English: Temozolomide Hexal 250 mg
Croatian: Temozolomid Hexal 250 mg
English: • allergic reactions.
Croatian: • kožni osip • alergijske reakcije.
English: Temozolomide Hexal 20 mg
Croatian: Temozolomid Hexal 20 mg
English: Temozolomide Hexal hard capsules should be administered in the fasting state.
Croatian: Temozolomid Hexal tvrde kapsule moraju se uzimati natašte.
English: During the monotherapy phase, the dose and way you take Temozolomide Hexal will be different.
Croatian: Doza i način uzimanja Temozolomida Hexal u fazi monoterapije razlikovat će se od prethodne faze.
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Croatian: Kako čuvati Temozolomid Hexal Ovaj lijek čuvajte izvan pogleda i dohvata djece, najbolje u zaključanom ormariću.
English: Temozolomide Hexal 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Croatian: Temozolomid Hexal 250 mg tvrde kapsule Jedna kapsula sadrži 250 mg temozolomida.
English: Very common (may affect more than 1 in 10 people ):
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
English: Temozolomide Hexal 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Croatian: Temozolomid Hexal 5 mg tvrde kapsule Jedna kapsula sadrži 5 mg temozolomida.
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Croatian: Hemipareza, afazija, poremećaj ravnoteže, somnolencija, konfuzija, omaglica, narušeno pamćenje, narušena koncentracija, disfazija, nespecificirani neurološki poremećaj, neuropatija,
English: • partial paralysis
Croatian: • djelomična paraliza • poremećaj koordinacije
English: Temozolomide Hexal 140 mg
Croatian: Temozolomid Hexal 140 mg
English: Temozolomide Hexal 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Croatian: Temozolomid Hexal 20 mg tvrde kapsule Jedna kapsula sadrži 20 mg temozolomida.
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia,
Croatian: Status epilepticus, ekstrapiramidalni poremećaj, hemipareza, ataksija, narušene kognitivne funkcije,
English: Temozolomide Hexal 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Croatian: Temozolomid Hexal 180 mg tvrde kapsule Jedna kapsula sadrži 180 mg temozolomida.
English: Temozolomide Hexal 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Croatian: Temozolomid Hexal 140 mg tvrde kapsule Jedna kapsula sadrži 140 mg temozolomida.
English: • hot flushes
Croatian: • navale vrućine
English: Temozolomide Hexal 180 mg
Croatian: Temozolomid Hexal 180 mg
English: • tiredness.
Croatian: • umor.
English: Temozolomide Hexal 20 mg hard capsules yellow
Croatian: Temozolomid Hexal 20 mg tvrde kapsule žuta
English: Temozolomide monotherapy in recurrent or progressive glioma
Croatian: Monoterapija temozolomidom kod ponovne pojave ili pogoršanje glioma
English: Temozolomide Hexal 100 mg
Croatian: Temozolomid Hexal 100 mg
English: • haemorrhoids
Croatian: • želučane tegobe
English: Temozolomide Hexal 5 mg hard capsules green
Croatian: Temozolomid Hexal 5 mg tvrde kapsule zelena
English: Temozolomide Hexal 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Croatian: Temozolomid Hexal 100 mg tvrde kapsule Jedna kapsula sadrži 100 mg temozolomida.
English: Temozolomide Hexal 250 mg hard capsules white
Croatian: Temozolomid Hexal 250 mg tvrde kapsule bijela
English: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol Τηλ: 00357 - 25372425 info.pth@cytanet.com.cy
Croatian: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide Hexal
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Temozolomid Hexal, • jer će Vas se morati pomno nadzirati zbog moguće pojave teškog oblika upale pluća uzrokovane s Pneumocystis jirovecii (PCP).
English: Temozolomide Hexal 100 mg hard capsules pink
Croatian: Temozolomid Hexal 100 mg tvrde kapsule ružičasta
English: Eye disorders
Croatian: suhoća oka
English: Temozolomide Hexal 20 mg hard capsules
Croatian: Temozolomid Hexal 20 mg tvrde kapsule
English: Constipation, nausea, vomiting
Croatian: Konstipacija, mučnina, povraćanje Konstipacija, mučnina, povraćanje
English: In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
Croatian: U ispitivanju s 288 ispitanika s novodijagnosticiranim multiformnim glioblastomom neutropenija stupnja 4 nastupila je u 3 % žena naspram 0 % muškaraca, a trombocitopenija stupnja 4 u 1% žena naspram 0 % muškaraca tijekom prvog ciklusa terapije.
English: Temozolomide Hexal 5 mg hard capsules
Croatian: Temozolomid Hexal 5 mg tvrde kapsule
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Temozolomide Hexal 140 mg hard capsules blue
Croatian: Temozolomid Hexal 140 mg tvrde kapsule plava
English: The cap is imprinted with “TMZ” and the body is imprinted with “100”.
Croatian: Na kapici je otisnuta oznaka „TMZ“, a na tijelu oznaka„100“.
English: Asthenia, flushing, hot flushes, condition aggravated, rigors, tongue discolouration, parosmia, thirst
Croatian: Astenija, crvenilo praćeno osjećajem užarenosti, valunzi, pogoršanje stanja, tresavica, promjena boje jezika, parosmija, žeđ
English: At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia,
Croatian: Na početku drugog ciklusa doza se povećava na 200 mg/m ako je CTC stupanj nehematološke toksičnosti za prvi ciklus bio ≤ 2 (osim za alopeciju, mučninu i povraćanje) te ako je apsolutni broj neutrofila (ABN) ≥ 1,5 x 109/l, a broj trombocita ≥ 100 x 109/l.
English: Temozolomide Hexal 250 mg hard capsules
Croatian: Temozolomid Hexal 250 mg tvrde kapsule
English: Temozolomide Hexal 140 mg hard capsules
Croatian: Temozolomid Hexal 140 mg tvrde kapsule
English: Temozolomide Hexal 250 mg capsules temozolomide
Croatian: Temozolomid Hexal 250 mg kapsule temozolomid
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Croatian: Stomatitis, proljev, dispepsija,
English: Temozolomide Hexal 5 mg capsules temozolomide
Croatian: Temozolomid Hexal 5 mg kapsule temozolomid
English: Temozolomide Hexal 180 mg hard capsules
Croatian: Temozolomid Hexal 180 mg tvrde kapsule
English: Temozolomide Hexal 100 mg hard capsules
Croatian: Temozolomid Hexal 100 mg tvrde kapsule
English: • earache
Croatian: • svrbež
English: Temozolomide Hexal 140 mg capsules temozolomide
Croatian: Temozolomid Hexal 140 mg kapsule temozolomid
English: Neoplasm benign, malignant and unspecified
Croatian: dugotrajna pancitopenija, aplastična anemija Dobroćudne, zloćudne i nespecificirane novotvorine
English: Your dose of Temozolomide Hexal may need to be adjusted.
Croatian: Možda će biti potrebno prilagoditi dozu
English: Temozolomide Hexal 20 mg capsules temozolomide
Croatian: Temozolomid Hexal 20 mg kapsule temozolomid
English: Temozolomide Hexal 180 mg capsules temozolomide
Croatian: Temozolomid Hexal 180 mg kapsule temozolomid
English: If you have been previously treated with chemotherapy, your first dose of Temozolomide Hexal will be 150 mg/m2 once daily for the first 5 days.
Croatian: Temozolomida Hexal biti će 150 mg/m2 jedanput na dan tijekom prvih 5 dana.
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Sadržaj kapsule: bezvodna laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
English: Temozolomide Hexal 20 mg hard capsules temozolomide
Croatian: Temozolomid Hexal 20 mg tvrde kapsule temozolomid
English: • peeling skin
Croatian: • crvenilo kože
English: Temozolomide Hexal 5 mg hard capsules temozolomide
Croatian: Temozolomid Hexal 5 mg tvrde kapsule temozolomid
English: • swollen legs
Croatian: • upala sinusa
English: Temozolomide Hexal 250 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Temozolomid Hexal 250 mg tvrde kapsule Sadržaj kapsule: bezvodna laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
English: • abnormal taste
Croatian: • promjena osjeta okusa
English: Temozolomide Hexal 140 mg hard capsules temozolomide
Croatian: Temozolomid Hexal 140 mg tvrde kapsule temozolomid
English: Temozolomide Hexal 140 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Temozolomid Hexal 140 mg tvrde kapsule Sadržaj kapsule: bezvodna laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
English: Temozolomide Hexal 250 mg hard capsules temozolomide
Croatian: Temozolomid Hexal 250 mg tvrde kapsule temozolomid
English: Temozolomide Hexal 180 mg hard capsules temozolomide
Croatian: Temozolomid Hexal 180 mg tvrde kapsule temozolomid
English: Temozolomide Hexal 100 mg capsules temozolomide
Croatian: Temozolomid Hexal 100 mg kapsule temozolomid
English: • shivering
Croatian: • trnci
English: There is limited information in patients over 3 years of age who have taken Temozolomide Hexal.
Croatian: Informacije o primjeni Temozolomida Hexal u djece starije od 3 godine su ograničene.
English: Temozolomide Hexal 100 mg hard capsules temozolomide
Croatian: Temozolomid Hexal 100 mg tvrde kapsule temozolomid
English: How to store Temozolomide Hexal
Croatian: Moguće nuspojave Kako čuvati Temozolomid Hexal
English: Temozolomide Hexal 100 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Croatian: Temozolomid Hexal 100 mg tvrde kapsule Sadržaj kapsule: bezvodna laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat vrste A, tartaratna kiselina, stearatna kiselina.
English: • tooth disorder.
Croatian: • promjene na zubima.
English: Hearing impairment
Croatian: Psihijatrijski poremećaji
English: • difficulty in urinating
Croatian: • otežano gutanje
English: EU/1/10/616/038 20 (4 packs of 5) hard capsules
Croatian: EU/1/10/616/038 20 (4 pakiranja od 5) tvrdih kapsula
English: The Temozolomide Hexal dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Croatian: Ovisno o broju Vaših krvnih stanica i o tome kako podnosite lijek u svakom terapijskom ciklusu, može se prilagoditi doza Temozolomida Hexal, odnosno odgoditi ili prekinuti davanje lijeka.
English: EU/1/10/616/041 20 (4 packs of 5) hard capsules
Croatian: EU/1/10/616/041 20 (4 pakiranja od 5) tvrdih kapsula
English: EU/1/10/616/037 20 (4 packs of 5) hard capsules
Croatian: EU/1/10/616/037 20 (4 pakiranja od 5) tvrdih kapsula
English: Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid Stearic acid
Croatian: Laktoza, bezvodna Silicijev dioksid, koloidni, bezvodni Natrijev škroboglikolat, vrste A Tartaratna kiselina Stearatna kiselina
English: EU/1/10/616/042 20 (4 packs of 5) hard capsules
Croatian: EU/1/10/616/042 20 (4 pakiranja od 5) tvrdih kapsula
English: • difficulty controlling your bowel movements
Croatian: • poteškoće s kontroliranjem stolice
English: • skin irritation or redness
Croatian: • nadraženost ili crvenilo kože
English: • heartburn
Croatian: • drhtavica
English: EU/1/10/616/039 20 (4 packs of 5) hard capsules
Croatian: EU/1/10/616/039 20 (4 pakiranja od 5) tvrdih kapsula
English: Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Croatian: Tijekom radioterapije i kombiniranog liječenja TMZ-om morala se primijeniti profilaksa protiv Pneumocystis jirovecii pneumonije
English: EU/1/10/616/040 20 (4 packs of 5) hard capsules
Croatian: EU/1/10/616/040 20 (4 pakiranja od 5) tvrdih kapsula
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Indigo carmine (E132) Water
Croatian: Ovojnica kapsule Želatina Titanijev dioksid (E171) Željezov oksid, žuti (E172) Indigo karmin (E132) Voda
English: • mood swings
Croatian: • promjene raspoloženja
English: nausea, vomiting).
Croatian: (osim alopecije, mučnine i povraćanja).
English: CZ.Sandoz.Regulatory_ORG_GX_cz@dl.mgd.no vartis.com
Croatian: dra.co_de@hexal.com
English: Temozolomide Hexal 180 mg hard capsules maroon
Croatian: Temozolomid Hexal 180 mg tvrde kapsule kestenjasta
English: • Skin redness
Croatian: • oticanje lica
English: Cytotoxic.
Croatian: IE-Bantry Co.
English: The medicine is not to be inhaled with any other device.
Croatian: Lijek se ne smije inhalirati drugim uređajem.
English: The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Croatian: Preporučena doza je jedna ampula dva puta na dan, idealno u razmaku od 12 sati.
English: After 28 days of treatment, the patient stops treatment for 28 days, before starting another 28-day treatment.
Croatian: Nakon 28 dana terapije, bolesnik prekida terapiju na 28 dana, prije početka novog terapijskog ciklusa od 28 dana.
English: Treatment cycles may be repeated for as long as the doctor considers the patient to be benefiting from it.
Croatian: Terapijski ciklusi se mogu ponoviti tako dugo dok liječnik smatra da bolesnik ima koristi od lijeka.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vantobra on 18 March 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Vantobra na snazi u Europskoj uniji od 18. ožujka 2015.
English: As regards safety, the Committee noted that safety profile of inhaled tobramycin was well known.
Croatian: Vezano uz sigurnu primjenu, Povjerenstvo je zaključilo da je sigurnosni profil inhaliranog tobramicina dobro poznat.
English: However, the following side effects are seen between 1 and 10 patients in 1,000: dyspnoea (difficulty breathing), dysphonia (hoarseness), pharyngitis (sore throat) and cough.
Croatian: No, sljedeće nuspojave uočene su u između 1 i 10 bolesnika na 1.000 osoba: dispneja (otežano disanje), disfonija (promuklost), faringitis (upala grla) i kašalj.
English: Both medicines are available as a nebuliser solution.
Croatian: Oba su lijeka dostupna kao otopina za nebulizer.
English: What is Vantobra and what is it used for?
Croatian: Što je Vantobra i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for Vantobra.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Vantobra.
English: Before using Vantobra, doctors should consider official guidance on the appropriate use of antibiotics.
Croatian: Prije primjene Vantobra liječnici trebaju proučiti službene smjernice o odgovarajućoj primjeni antibiotika.
English: If the patient is also receiving other inhaled treatments or chest physiotherapy, it is recommended that Vantobra is used last.
Croatian: Ako bolesnik također prima druge inhalacijske terapije ili fizioterapiju za prsa, preporuča se da se lijek Vantobra primjenjuje kao posljednji.
English: It is not intended to provide practical advice on how to use Vantobra.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Vantobra.
English: Vantobra therefore offers the advantage of better convenience and a higher likelihood of patients keeping to their treatment.
Croatian: Stoga, Vantobra nudi prednosti bolje praktičnosti i povećava izglede da će se bolesnici pridržavati svojih terapija.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vantobra's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Vantobra nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: A risk management plan has been developed to ensure that Vantobra is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vantobra.
English: It contains the active substance tobramycin, which is the same active substance as that of the reference medicine, Tobi.
Croatian: Sadrži djelatnu tvar tobramicin, koji je ista djelatna tvar kao i u referentnom lijeku, Tobi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vantobra, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Vantobra nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In addition, the applicant conducted a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above to determine whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Croatian: Nadalje, podnositelj zahtjeva proveo je ispitivanje "bioekvivaletnosti" u 58 bolesnika sa cističnom fibrozom u dobi od 6 godina i starijih kako bi utvrdio proizvodi li lijek Vantobra slične razine djelatne tvari u tijelu kao referenti lijek, Tobi.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily causing infections.
Croatian: Cistična fibroza je nasljedna bolest, pri kojoj dolazi do akumulacije debelog sloja sluzi u plućima što omogućuje brži rast bakterije rezultirajući infekcijama.
English: In addition, the time it takes to inhale Vantobra is shorter than for other tobramycin nebulisers and comparable to the time taken to inhale the dry powder.
Croatian: Nadalje, vrijeme koje je potrebno za inhalaciju lijeka Vantobra kraće je od drugih nebulizera tobramicina i usporedivo je s vremenom potrebnim da se inhalira suhi prašak.
English: Vantobra is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis.
Croatian: Vantobra je antibiotik koji se koristi za liječenje dugoročne upale pluća uzrokovane bakterijom Pseudomonas aeruginosa u bolesnika u dobi od šest godina i starijih koji imaju cističnu fibrozu.