FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Temozolomide Hexal Contents of the pack and other information
Slovenian: Shranjevanje zdravila Temozolomid Hexal Vsebina pakiranja in dodatne informacije
English: Temozolomide Hexal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Slovenian: Zdravilo Temozolomid Hexal se uporablja v kombinaciji z žariščno radioterapijo (faza sočasne terapije), temu pa sledi do 6 ciklov monoterapije (monoterapijska faza) s temozolomidom (TMZ).
English: Temozolomide Hexal may cause permanent infertility.
Slovenian: Zdravilo Temozolomid Hexal lahko povzroči trajno neplodnost.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Hexal for 42 days in combination with radiotherapy.
Slovenian: (multiformni glioblastom) ugotovili na novo, boste morda zdravilo Temozolomid Hexal prejemali 42 dni v kombinaciji z radioterapijo.
English: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Slovenian: MTIK pa spontano hidrolizira do 5-amino-imidazol4-karboksamida (AIK), znanega intermediata v biosintezi purinov in nukleinskih kislin, ter metilhidrazina, za katerega menijo, da je aktivni alkilirajoči presnovek.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and
Slovenian: Glede na vrednost AUC za temozolomid sta izpostavljenosti MTIK-u in AIK-u ~ 2,4 % in 23 %.
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis†
Slovenian: okužba s citomegalovirusom, reaktivacija okužbe, npr. citomegalovirus, virus hepatitisa B†, herpetični meningoencefalitis†, sepsa†
English: A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies.
Slovenian: V študijah 6 ciklov pri podganah so opažali različne neoplazme, vključno s karcinomom dojk, keratoakantomom kože in bazalnoceličnim adenomom, v študijah pri psih pa niso opažali nobenih tumorjev ali preneoplastičnih sprememb.
English: During the concomitant phase, your doctor will start Temozolomide Hexal at a dose of 75 mg/m2
Slovenian: Med fazo sočasnega zdravljenja vam bo zdravnik začel dajati zdravilo Temozolomid Hexal v odmerku 75 mg/m2 (običajni odmerek).
English: Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Slovenian: Zdravilo Temozolomid Hexal pri kombiniranem zdravljenju z radioterapijo pri novo diagnosticiranem glioblastomu
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia,
Slovenian: Sočasno zdravljenje s TMZ lahko nadaljujete, če so izpolnjeni vsi od naslednjih pogojev: absolutno število nevtrofilcev ≥ 1,5 x 109/l; število trombocitov ≥ 100 x 109/l; SMT za nehematološko toksičnost ≤ 1. stopnje (z izjemo alopecije, slabosti in bruhanja).
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.
Slovenian: Če ste se v preteklosti zdravili s kemoterapijo, bo prvi odmerek zdravila Temozolomid Hexal 150 mg/m2 enkrat na dan prvih 5 dni.
English: If you have not been previously treated with chemotherapy, your first dose of Temozolomide Hexal will be 200 mg/m2 once daily for the first 5 days.
Slovenian: Če se v preteklosti niste zdravili s kemoterapijo, bo prvi odmerek zdravila Temozolomid Hexal 200 mg/m2 enkrat na dan prvih 5 dni.
English: (usual dose).
Slovenian: dnevni cikel).
English: Multipack containing 20 hard capsules (4 packs of 5 hard capsules in an amber glass bottle [Type 3 glass] with polypropylene child-resistant closure.
Slovenian: Večkratno pakiranje z 20 trdimi kapsulami (4 paketi po 5 trdih kapsul v steklenici iz rumenorjavega stekla (vrste 3) s polipropilenskim varnostnim pokrovčkom za otroke.
English: Multipack containing 20 hard capsules (4 packs of 5 hard capsules in a type III amber glass bottle with polypropylene child-resistant closure.
Slovenian: Večkratno pakiranje z 20 trdimi kapsulami (4 paketi po 5 trdih kapsul v steklenici iz rumenorjavega stekla vrste III s polipropilenskim varnostnim pokrovčkom za otroke.
English: What Temozolomide Hexal looks like and contents of the pack
Slovenian: Izgled zdravila Temozolomid Hexal in vsebina pakiranja
English: TMZ dose levels for monotherapy treatment Dose level
Slovenian: Ravni odmerkov TMZ za monoterapijo Raven odmerka
English: You will take Temozolomide Hexal alone once daily for the first 5 days.
Slovenian: Prvih 5 dni boste jemali samo zdravilo Temozolomid Hexal enkrat na dan.
English: Multipack: 20 (4 packs of 5) hard capsules
Slovenian: Večkratno pakiranje: 20 trdih kapsul (4 paketi po 5)
English: nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 10
Slovenian: - absolutno število nevtrofilcev (ANC - Absolute Neutrophil Count) ≥ 1,5 x 109/l,
English: The bottles contain a desiccant pouch.)
Slovenian: Steklenica vsebuje vrečko s sušilom.)
English: See footnote b
Slovenian: 9/l glejte opombo b
English: Dose level
Slovenian: Odmerek zdravila
English: How to take Temozolomide Hexal
Slovenian: Kako jemati zdravilo Temozolomid Hexal
English: Then, you will have 23 days without Temozolomide Hexal.
Slovenian: Nato bo sledilo 23-dnevno obdobje, v katerem zdravila Temozolomid Hexal ne boste jemali.
English: Temozolomide Hexal contains a medicine called temozolomide.
Slovenian: Temozolomid Hexal vsebuje zdravilno učinkovino temozolomid.
English: Temozolomide Hexal 5 mg
Slovenian: Temozolomid Hexal 5 mg
English: Table 1.TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Slovenian: Prekinitev jemanja ali ukinitev TMZ med sočasno radioterapijo in zdravljenjem s TMZ
English: - If you get any side effects , talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Method of administration Temozolomide Hexal hard capsules should be administered in the fasting state.
Slovenian: Način uporabe Temozolomid Hexal trde kapsule mora bolnik jemati na tešče.
English: The Temozolomide Hexal dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Slovenian: Zdravnik lahko odmerek zdravila Temozolomid Hexal prestavi ali zdravljenje prekine glede na vašo krvno sliko in na to, kako dobro prenašate zdravilo.
English: Temozolomide Hexal 250 mg
Slovenian: Temozolomid Hexal 250 mg
English: hypoesthesia, neurological disorder (NOS), peripheral neuropathy sensory disturbance
Slovenian: hiperestezija, senzorične motnje nevrološke motnje (NOS), periferna nevropatija
English: Temozolomide Hexal 20 mg
Slovenian: Temozolomid Hexal 20 mg
English: Temozolomide Hexal 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Slovenian: Temozolomid Hexal 5 mg trde kapsule Ena kapsula vsebuje 5 mg temozolomida.
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide Hexal on your blood cells.
Slovenian: Med zdravljenjem vam bodo pogosto pregledovali kri, da bodo lahko spremljali učinke zdravila
English: Hepatic enzymes increased, Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Slovenian: zvišane vrednosti jetrnih encimov, zvišana vrednost gama-GT, zvišana vrednost AST * Bolnik, ki je bil randomiziran v skupino, ki je prejemala samo RT, je prejemal TMZ in RT.
English: Temozolomide Hexal 140 mg
Slovenian: Temozolomid Hexal 140 mg
English: Temozolomide Hexal hard capsules should be administered in the fasting state.
Slovenian: Temozolomid Hexal trde kapsule mora bolnik jemati na tešče.
English: Always take Temozolomide Hexal exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Temozolomid Hexal natančno upoštevajte navodila zdravnika.
English: Temozolomide Hexal 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Slovenian: Temozolomid Hexal 20 mg trde kapsule Ena kapsula vsebuje 20 mg temozolomida.
English: Tell your doctor immediately if this occurs.
Slovenian: Če se pojavijo ti znaki, takoj obvestite zdravnika.
English: Temozolomide Hexal 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Slovenian: Temozolomid Hexal 140 mg trde kapsule Ena kapsula vsebuje 140 mg temozolomida.
English: Temozolomide Hexal 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Slovenian: Temozolomid Hexal 180 mg trde kapsule Ena kapsula vsebuje 180 mg temozolomida.
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Hexal to prevent or control nausea and vomiting.
Slovenian: (antiemetike), ki preprečujejo ali nadzorujejo slabost in bruhanje.
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia,
Slovenian: status epilepticus, ekstrapiramidne motnje, hemipareza, ataksija, motnje kognitivnih procesov, disfazija, nenormalna hoja, hiperestezija, hipoestezija,
English: Temozolomide Hexal 180 mg
Slovenian: Temozolomid Hexal 180 mg
English: If you accidentally take more Temozolomide Hexal capsules than you were told to, contact your doctor or pharmacist or nurse immediately .
Slovenian: Če ste vzeli večji odmerek zdravila Temozolomid Hexal, kot bi smeli Če pomotoma vzamete preveč kapsul Temozolomid Hexal, se takoj posvetujte zdravnikom,
English: Temozolomide Hexal 100 mg
Slovenian: Temozolomid Hexal 100 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS OF 20 (4 PACKS OF 5) HARD CAPSULES - WITH THE BLUE BOX
Slovenian: ZUNANJA ŠKATLA ZA VEČKRATNA PAKIRANJA PO 20 TRDIH KAPSUL (4 PAKETI PO
English: You should stop breast-feeding while receiving treatment with Temozolomide Hexal.
Slovenian: Med zdravljenjem z zdravilom Temozolomid Hexal morate prekiniti dojenje.
English: Temozolomide Hexal 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Slovenian: Temozolomid Hexal 100 mg trde kapsule Ena kapsula vsebuje 100 mg temozolomida.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR MULTIPACKS OF 20 (4 PACKS OF 5) HARD CAPSULES - WITHOUT THE BLUE BOX
Slovenian: VMESNA ŠKATLA ZA VEČKRATNA PAKIRANJA PO 20 TRDIH KAPSUL (4 PAKETI PO
English: Temozolomide Hexal 100 mg hard capsules pink
Slovenian: Temozolomid Hexal 100 mg trde kapsule rožnata
English: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol Τηλ: 00357 - 25372425 info.pth@cytanet.com.cy
Slovenian: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol
English: Temozolomide Hexal 5 mg hard capsules green
Slovenian: Temozolomid Hexal 5 mg trde kapsule zelena
English: Temozolomide Hexal 250 mg hard capsules white
Slovenian: Temozolomid Hexal 250 mg trde kapsule bela
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.
Slovenian: - otrok, starih 3 leta in več, mladostnikov in odraslih bolnikov z malignim gliomom, na primer multiformnim glioblastomom ali anaplastičnim astrocitomom, ki se po standardnem zdravljenju ponovi ali napreduje.
English: *A patient who was randomised to the RT arm only, received TMZ + RT.
Slovenian: Bolniki iz dela študije, ki so prejemali TMZ + RT, so sočasno jemali tudi
English: Temozolomide Hexal 20 mg hard capsules yellow
Slovenian: Temozolomid Hexal 20 mg trde kapsule rumena
English: GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Slovenian: zvišane vrednosti jetrnih encimov, zvišana vrednost gama-GT, zvišana vrednost AST *Bolnik, ki je bil randomiziran v skupino, ki je prejemala samo RT, je prejemal TMZ in RT.
English: How to store Temozolomide Hexal
Slovenian: Shranjevanje zdravila Temozolomid Hexal
English: Temozolomide Hexal 5 mg hard capsules
Slovenian: Temozolomid Hexal 5 mg trde kapsule
English: Temozolomide Hexal 140 mg hard capsules blue
Slovenian: Temozolomid Hexal 140 mg trde kapsule modra
English: Temozolomide Hexal 20 mg hard capsules
Slovenian: Temozolomid Hexal 20 mg trde kapsule
English: Temozolomide Hexal 250 mg hard capsules
Slovenian: Temozolomid Hexal 250 mg trde kapsule
English: Temozolomide Hexal 100 mg hard capsules
Slovenian: Temozolomid Hexal 100 mg trde kapsule
English: Temozolomide Hexal 180 mg hard capsules
Slovenian: Temozolomid Hexal 180 mg trde kapsule
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia,
Slovenian: hemiplegija, ataksija, motnje koordinacije, nenormalna hoja,
English: Temozolomide Hexal 140 mg hard capsules
Slovenian: Temozolomid Hexal 140 mg trde kapsule
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide Hexal
Slovenian: Pred začetkom jemanja zdravila Temozolomid Hexal se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Temozolomide Hexal 250 mg capsules temozolomide
Slovenian: Temozolomid Hexal 250 mg trde kapsule temozolomid
English: Temozolomide Hexal 5 mg capsules temozolomide
Slovenian: Temozolomid Hexal 5 mg trde kapsule temozolomid
English: Temozolomide Hexal 20 mg capsules temozolomide
Slovenian: Temozolomid Hexal 20 mg trde kapsule temozolomid
English: Temozolomide Hexal 100 mg capsules temozolomide
Slovenian: Temozolomid Hexal 100 mg trde kapsule temozolomid
English: Temozolomide Hexal 140 mg capsules temozolomide
Slovenian: Temozolomid Hexal 140 mg trde kapsule temozolomid
English: Your dose of Temozolomide Hexal may need to be adjusted.
Slovenian: Morda vam bodo morali prilagoditi odmerek zdravila
English: Temozolomide Hexal 180 mg capsules temozolomide
Slovenian: Temozolomid Hexal 180 mg trde kapsule temozolomid
English: EU/1/10/616/038 20 (4 packs of 5) hard capsules
Slovenian: EU/1/10/616/038 20 trdih kapsul (4 paketi po 5)
English: Temozolomide Hexal 250 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovenian: Temozolomid Hexal 250 mg trde kapsule - vsebina kapsul: brezvodna laktoza, brezvodni koloidni silicijev dioksid, natrijev karboksimetilškrob vrsta A, vinska kislina, stearinska kislina, - ovojnica kapsul: želatina, titanov dioksid (E171), voda,
English: • peeling skin
Slovenian: • draženje nožnice,
English: EU/1/10/616/039 20 (4 packs of 5) hard capsules
Slovenian: EU/1/10/616/039 20 trdih kapsul (4 paketi po 5)
English: EU/1/10/616/041 20 (4 packs of 5) hard capsules
Slovenian: EU/1/10/616/041 20 trdih kapsul (4 paketi po 5)
English: EU/1/10/616/042 20 (4 packs of 5) hard capsules
Slovenian: EU/1/10/616/042 20 trdih kapsul (4 paketi po 5)
English: EU/1/10/616/037 20 (4 packs of 5) hard capsules
Slovenian: EU/1/10/616/037 20 trdih kapsul (4 paketi po 5)
English: Temozolomide Hexal 180 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovenian: Temozolomid Hexal 180 mg trde kapsule vsebina kapsul: brezvodna laktoza, brezvodni koloidni silicijev dioksid, natrijev karboksimetilškrob vrsta A, vinska kislina, stearinska kislina, - ovojnica kapsul: želatina, titanov dioksid (E171), rumeni železov oksid
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance peripheral neuropathy
Slovenian: hemiplegija, ataksija, motnje koordinacije, nenormalna hoja, hiperestezija, senzorične disfazija, nenormalna hoja, hiperestezija, hipoestezija, nevrološke motnje (NOS), periferna nevropatija motnje
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Slovenian: hiperestezija, senzorične disfazija, nenormalna hoja, hiperestezija, hipoestezija, nevrološke motnje (NOS), periferna nevropatija motnje
English: Temozolomide Hexal 140 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovenian: Temozolomid Hexal 140 mg trde kapsule - vsebina kapsul: brezvodna laktoza, brezvodni koloidni silicijev dioksid, natrijev karboksimetilškrob vrsta A, vinska kislina, stearinska kislina, - ovojnica kapsul: želatina, titanov dioksid (E171), indigotin (E132), voda,
English: Common (may affect up to 1 in 10 people ):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 do 10 bolnikov):
English: Temozolomide Hexal 5 mg hard capsules temozolomide
Slovenian: Temozolomid Hexal 5 mg trde kapsule temozolomid peroralna uporaba
English: Temozolomide Hexal 250 mg hard capsules temozolomide
Slovenian: Temozolomid Hexal 250 mg trde kapsule temozolomid peroralna uporaba
English: EU/1/10/616/040 20 (4 packs of 5) hard capsules
Slovenian: EU/1/10/616/040 20 trdih kapsul (4 paketi po 5)
English: Temozolomide Hexal 20 mg hard capsules temozolomide
Slovenian: Temozolomid Hexal 20 mg trde kapsule temozolomid peroralna uporaba
English: Temozolomide Hexal 140 mg hard capsules temozolomide
Slovenian: Temozolomid Hexal 140 mg trde kapsule temozolomid peroralna uporaba
English: Temozolomide Hexal 100 mg hard capsules temozolomide
Slovenian: Temozolomid Hexal 100 mg trde kapsule temozolomid peroralna uporaba
English: Temozolomide Hexal 180 mg hard capsules temozolomide
Slovenian: Temozolomid Hexal 180 mg trde kapsule temozolomid peroralna uporaba
English: CZ.Sandoz.Regulatory_ORG_GX_cz@dl.mgd.no vartis.com
Slovenian: regulatory.greece@sandoz.com
English: Temozolomide Hexal 100 mg hard capsules Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Slovenian: Temozolomid Hexal 100 mg trde kapsule - vsebina kapsul: brezvodna laktoza, brezvodni koloidni silicijev dioksid, natrijev karboksimetilškrob vrsta A, vinska kislina, stearinska kislina, ovojnica kapsul: želatina, titanov dioksid (E171), rdeči železov oksid (E172), voda,
English: After 28 days of treatment, the patient stops treatment for 28 days, before starting another 28-day treatment.
Slovenian: Po 28 dneh zdravljenja bolnik prekine z zdravljenjem za 28 dni, preden začne z naslednjim 28-dnevnim ciklom zdravljenja.
English: The medicine is not to be inhaled with any other device.
Slovenian: Zdravilo se ne sme inhalirati z nobenim drugim pripomočkom.
English: The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Slovenian: Priporočeni odmerek je ena ampula dvakrat dnevno, po možnosti v razmaku 12 ur.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vantobra on 18 March 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vantobra, veljavno po vsej Evropski uniji, izdala 18. marca 2015.
English: As regards safety, the Committee noted that safety profile of inhaled tobramycin was well known.
Slovenian: Kar zadeva varnost, je Odbor ugotovil, da je varnostni profil tobramicina, ki se inhalira, dobro znan.
English: Treatment cycles may be repeated for as long as the doctor considers the patient to be benefiting from it.
Slovenian: Cikli zdravljenja se lahko ponavljajo, dokler to bolniku po zdravnikovi presoji koristi.
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.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Vantobra večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Vantobra.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vantobra.
English: The full EPAR and risk management plan summary for Vantobra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Vantobra sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Slovenian: Kljub temu se pri 1 do 10 bolnikih od 1 000 pojavijo naslednji neželeni učinki: dispneja (težave z dihanjem), disfonija (hripavost), faringitis (vneto žrelo) in kašelj.
English: A risk management plan has been developed to ensure that Vantobra is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Vantobra je bil pripravljen načrt obvladovanja tveganj.
English: Vantobra is a ‘hybrid medicine'.
Slovenian: Zdravilo Vantobra je „hibridno zdravilo“.
English: Both medicines are available as a nebuliser solution.
Slovenian: Obe zdravili sta na voljo kot raztopini za nebulator.
English: If the patient is also receiving other inhaled treatments or chest physiotherapy, it is recommended that Vantobra is used last.
Slovenian: Če bolnik prejema tudi druga inhalacijska zdravila ali fizioterapijo prsnega koša, je priporočljivo, da vzame zdravilo Vantobra nazadnje.
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.
Slovenian: Poleg tega je čas, potreben za inhaliranje zdravila Vantobra, krajši kot pri drugih nebulatorjih tobramicina in primerljiv s časom, potrebnim za inhaliranje suhega praška.
English: What measures are being taken to ensure the safe and effective use of Vantobra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria, which eventually kills them.
Slovenian: Deluje tako, da ovira nastajanje beljakovin, ki jih bakterija P. aeruginosa potrebuje za izgradnjo svojih celičnih sten, kar bakterijo poškoduje in nazadnje uniči.
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.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vantobra in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: It contains the active substance tobramycin, which is the same active substance as that of the reference medicine, Tobi.
Slovenian: Vsebuje zdravilno učinkovino tobramicin, ki je enaka zdravilni učinkovini v referenčnem zdravilu Tobi.
English: Before using Vantobra, doctors should consider official guidance on the appropriate use of antibiotics.
Slovenian: Preden zdravnik predpiše zdravilo Vantobra, mora pretehtati njegovo uporabo glede na uradne smernice za ustrezno uporabo antibiotikov.