FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c)
English: One ampoule contains 170 mg of tobramycin as a single dose.
Croatian: Jedna ampula sadrži 170 mg tobramicina što čini pojedinačnu dozu.
English: Use Vantobra twice a day for 28 days Do not use any Vantobra for the next 28 days
Croatian: Primjenjujte lijek Vantobra dva puta na dan tijekom 28 dana.
English: Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of Vantobra is not recommended with other medicinal products with nephrotoxic or ototoxic potential, such as:
Croatian: Na temelju profila interakcija za tobramicin nakon intravenske primjene i primjene aerosolom, ne preporučuje se istodobna i/ili sekvencijska primjena lijeka Vantobra s drugim lijekovima koji mogu imati nefrotoksične ili ototoksične učinke, kao što su: - amfotericin B, cefalotin, ciklosporin, takrolimus, polimiksin (rizik od povećane nefrotoksičnosti);
English: Physicians should consider the potential for aminoglycosides to cause vestibular and cochlear toxicity and carry out appropriate assessments of auditory function during Vantobra therapy.
Croatian: Liječnici moraju uzeti u obzir mogućnost vestibularne i kohlearne toksičnosti aminoglikozida te provjeravati sluh tijekom terapije lijekom Vantobra.
English: Bronchodilator therapy, such as salbutamol
Croatian: Terapija bronhodilatatorima, kao što je salbutamol Ostali lijekovi za inhalaciju Vantobra
English: Package leaflet: Information for the patient Vantobra 170 mg nebuliser solution Tobramycin
Croatian: Uputa o lijeku: Informacije za bolesnika Vantobra 170 mg otopina za atomizator tobramicin
English: water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Croatian: sumporna kiselina i natrijev hidroksid (za podešavanje pH).
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet PARI Pharma GmbH
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: • One carton with a Tolero nebuliser handset.
Croatian: • Jedna kutija s ručnim atomizatorom Tolero.
English: The drug delivery rate of Vantobra with the Tolero nebuliser is independent of the breathing pattern applied i.e. adult or child in contrast to the PARI LC PLUS nebuliser.
Croatian: Brzina isporuke lijeka Vantobra ne ovisi o načinu disanja npr. odrasla osoba ili dijete u odnosu na atomizator
English: Vantobra is administered by inhalation using the Tolero nebuliser handset provided in the pack.
Croatian: Lijek Vantobra primjenjuje se inhalacijom uz pomoć ručnog atomizatora Tolero isporučenog zajedno s lijekom u pakiranju.
English: Package contains 56 ampoules with nebuliser solution in 7 pouches.
Croatian: Pakiranje sadrži 56 ampula s otopinom za atomizator zapakiranih u 7 vrećica.
English: Inhalation of nebulised tobramycin produces high sputum concentrations and
Croatian: Inhalacija atomiziranog tobramicina dovodi do visokih koncentracija u sputumu , a niskih u plazmi.
English: Vantobra is available together with a Tolero nebuliser handset.
Croatian: Lijek Vantobra dostupan je zajedno s ručnim atomizatorom Tolero.
English: Adverse drug reactions reported for tobramycin nebuliser solution are listed in Table 1.
Croatian: Nuspojave zabilježene pri primjeni atomizirane otopine tobramicina navedene su u Tablici
English: You should not mix or dilute Vantobra with any other medicine in your Tolero nebuliser handset which is If you are taking several different treatments for cystic fibrosis, you should take them in the following order: 1.
Croatian: Ne smijete miješati ili razrjeđivati lijek Vantobra s bilo kojim drugim lijekom u Vašem ručnom atomizatoru Tolero isporučenom uz lijek Vantobra.
English: Vantobra is supplied in polyethylene (PE) ampoules that are packed in sealed aluminium foil pouches (8 ampoules per pouch).
Croatian: 6.5 Vrsta i sadržaj spremnika Lijek Vantobra isporučuje se u polietilenskim ampulama (PE) zapakiranim u zatvorene aluminijske vrećice
English: Elimination
Croatian: Distribucija
English: Where patients are receiving several inhaled medicinal products and chest physiotherapy, it is recommended
Croatian: Ako bolesnici primaju nekoliko različitih inhalacijskih lijekova i respiratornu fizioterapiju, preporučuje se da se lijek Vantobra uzima posljednji.
English: Vantobra is used in patients with cystic fibrosis aged 6 years and older to treat lung infections caused by
Croatian: Vantobra se koristi u bolesnika s cističnom fibrozom u dobi od 6 i više godina za liječenje plućnih infekcija uzrokovanih bakterijom koja se zove Pseudomonas aeruginosa.
English: • Use Vantobra only with the Tolero nebuliser handset shown in the picture below to make sure you inhale the correct dose.
Croatian: Priprema lijeka Vantobra za inhaliranje • Koristite lijek Vantobra isključivo s ručnim atomizatorom Tolero koji je prikazan na slici ispod kako biste inhalirali točnu dozu.
English: The use of an alternative untested nebuliser system may alter the pulmonary deposition of the active substance.
Croatian: Korištenje drugog neprovjerenog atomizatorskog sustava može izmijeniti taloženje djelatne tvari u plućima, a to može utjecati na djelotvornost i sigurnost lijeka.
English: In the event of accidental ingestion of Vantobra, toxicity is unlikely as tobramycin is poorly absorbed from
Croatian: Kod nenamjernog gutanja lijeka Vantobra, toksičnost se vjerojatno neće razviti s obzirom da se tobramicin slabo apsorbira iz neoštećenog probavnog trakta.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: NJEMAČKA B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: If any of these apply to you, tell your doctor before using Vantobra.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije primjene Vantobra.
English: 1, and TOBI/PARI LC PLUS Performance parameter/ Drug/Device combination*
Croatian: Parametar funkcionalnosti/lijek/sklop uređaja*
English: • One carton with the medicinal product: 56 ampoules with nebuliser solution in 7 pouches.
Croatian: • Jedna kutija s lijekom: 56 ampula s otopinom za atomizator zapakiranih u 7 vrećica.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U
English: • Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with
Croatian: • Za svaki ciklus liječenja (28 dana liječenja) koristite novi ručni atomizator Tolero isporučen uz lijek.
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.
Croatian: Sadržaj jedne ampule potrebno je uliti u spremnik za lijek koji se nalazi na ručnom atomizatoru Tolero te se primijeniti inhalacijom dok se lijek iz spremnika ne potroši.
English: • The nebuliser handset must be kept horizontally during operation.
Croatian: • Ručni atomizator se mora držati u vodoravnom položaju prilikom korištenja.
English: Geometric Standard Deviation ±SD 1.5 ± 0.0
Croatian: Geometrijska standardna devijacija ±SD 1,5 ± 0,0 Vrijeme raspršivanja [min] *Podaci dobiveni simulacijom disanja i mjerenjima kaskadnim impaktorom.
English: - The other ingredient(s) (excipient(s)) are: sodium chloride, calcium chloride, magnesium sulphate,
Croatian: - Drugi sastojak(ci) (pomoćna(e) tvar(i)) je(su): natrijev klorid, kalcijev klorid, magnezijev sulfat, voda za injekcije, sumporna kiselina i natrijev hidroksid za podešavanje pH vrijednosti.
English: Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include:
Croatian: Drugi lijekovi za koje je zabilježeno da povećavaju potencijalnu toksičnost parenteralno primijenjenih aminoglikozida uključuju: - antikolinesteraze, botulinum toksin (neuromuskularni učinci).
English: Anorexia
Croatian: Ototoksičnost
English: • One carton with: 56 ampoules with nebuliser solution in 7 pouches.
Croatian: • Jedna kutija s: 56 ampula s otopinom za atomizator zapakiranih u 7 vrećica.
English: 6.5 Nature and contents of container
Croatian: 6.1 Popis pomoćnih tvari
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution Tobramycin
Croatian: NAZIV LIJEKA Vantobra 170 mg otopina za atomizator
English: Vantobra
Croatian: • zaduha
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING POUCH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: (RMP), dokumenti mogu biti podneseni istodobno.
English: Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the
Croatian: Za svaki ciklus liječenja (28 dana liječenja) koristite novi ručni atomizator Tolero koji je isporučen uz lijek.
English: PHARMACOLOGICAL PROPERTIES
Croatian: 5.2 Farmakokinetička svojstva
English: Haemoptysis Epistaxis
Croatian: Tablica 1 Nuspojave
English: In patients with a predisposing risk due to previous prolonged systemic aminoglycoside therapy it may be necessary to consider audiological assessment before initiating Vantobra therapy.
Croatian: Možda će biti neophodno razmotriti provođenje audiološke obrade prije početka terapije lijekom Vantobra u bolesnika s predisponirajućim rizikom zbog prethodne dugotrajne sustavne terapije aminoglikozidima.
English: Fungal infection
Croatian: Inhalacija.
English: Ear disorder
Croatian: Oštećenje jetre
English: Hypoxia Hyperventilation
Croatian: Krvožilni poremećaji hemoptiza epistaksa
English: Hepatic impairment
Croatian: • glavobolja, slabost
English: What Vantobra looks like and contents of the pack Vantobra nebuliser solution is provided in a ready-to-use ampoule.
Croatian: Kako Vantobra izgleda i sadržaj pakiranja
English: Clinical experience with tobramycin nebuliser solutions reports dysphonia and tinnitus in patients treated with tobramycin.
Croatian: U bolesnika koji su liječeni tobramicinom zabilježena je pojava disfonije i tinitusa prilikom kliničke primjene atomiziranih otopina tobramicina.
English: Diarrhoea Abdominal pain
Croatian: Poremećaji živčanog sustava omaglica afonija glavobolja somnolencija
English: Lymphadenopathy
Croatian: • grlobolja
English: amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins (risk of increased nephrotoxicity); platinum compounds (risk of increased nephrotoxicity and ototoxicity);
Croatian: - lijekovi koji sadržavaju platinu (rizik od povećane nefrotoksičnosti i ototoksičnosti);
English: It belongs to a class of antibiotic medicines
Croatian: Pripada skupini antibiotika koja se naziva aminoglikozidi.
English: Lung disorder Chest discomfort Productive cough Rhinitis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja disfonija faringitis kašalj astma poremećaji pluća nelagoda u prsištu produktivni kašalj rinitis bronhospazam hipoksija hiperventilacija sinusitis
English: Chest pain Malaise
Croatian: • koprivnjača, svrbež
English: Bronchospasm
Croatian: Biotransformacija
English: Inhalation should be performed by applying a normal breathing pattern without interruption.
Croatian: Inhalacija se provodi normalnim
English: Somnolence
Croatian: Hemoptiza
English: Vomiting Mouth ulceration Nausea
Croatian: Infekcije i infestacije laringitis gljivične infekcije oralna kandidijaza
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji krvi i limfnog sustava limfadenopatija
English: Other inhaled medicines
Croatian: Ukupna isporučena količina lijeka
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Ostale nuspojave mogu uključivati: Manje često (može se javiti u najviše 1 od 100 osoba)
English: Gastrointestinal disorders
Croatian: Kalcijev klorid
English: Preclinical and clinical safety
Croatian: Neklinička i klinička sigurnost
English: • restrict the indication to the second line use;
Croatian: • se ograniči indikacija za drugu liniju uporabe;
English: • is carcinogenic in humans as stated by the IARC (Group 1),
Croatian: • kancerogen u ljudi kako to navodi IARC (Skupina 1),
English: • the efficacy was also high in case where it was not possible to place the product directly in contact with the pulp,
Croatian: • je djelotvornost također bila visoka u slučaju kada nije bilo moguće staviti lijek u izravan kontakt s pulpom,
English: • a number of ADRs have reported a lack of effect.
Croatian: • brojne prijavljene nuspojave potvrdile su nedostatak učinka.
English: • introduce a contraindication in children, pregnant and lactating women;
Croatian: • uvede kontraindikacija kod djece, trudnica i dojilja;
English: Alternative techniques (such as several types of local/regional anesthesics, general anesthesia, gas for inhalation) may be available.
Croatian: Eventualno, dostupne su alternativne tehnike (poput nekoliko tipova lokalnih/regionalnih anestetika, opća anestezija, plin za inhalaciju).
English: • Communication to Health Care Professionals concerning the instructions of use (via a dear Health Care Professional Communication and educational materials).
Croatian: • obavijest zdravstvenim djelatnicima u vezi s uputama za uporabu (putem pisama zdravstvenim djelatnicima i edukacijskih materijala)
English: Finally, with regards to the reduction of exposure from 7 to 3 days, the CHMP does not find this measures acceptable since half of the periodontal necrosis cases reported in post-marketing period occurred within 3 days.
Croatian: Naposljetku, s obzirom na smanjivanje izlaganja sa 7 dana na 3, CHMP ne smatra da je ova mjera prihvatljiva s obzirom da je polovica slučajeva nekroze periodonta prijavljenih u razdoblju nakon stavljanja lijeka u promet prijavljena unutar 3 dana.
English: The design of the study and the small number of subjects included did not allow a reliable assessment of the efficacy in a way to have a comparison with the current standard treatment.
Croatian: Dizajn ispitivanja i mali broj uključenih ispitanika nisu omogućili pouzdanu procjenu djelotvornosti na način koji bi omogućio usporedbu s trenutnim standardnim liječenjem.
English: Scientific conclusions and grounds for revocation of the marketing authorisations
Croatian: Znanstveni zaključci i razlozi za oduzimanje odobrenja za stavljanje lijeka u promet
English: The CHMP is of the view that the reported systemic exposure aggravates the earlier concern about the potential genotoxicity of the products.
Croatian: CHMP smatra da navedeno sistemsko izlaganje pogoršava ranije bojazni o potencijalnoj genotoksičnosti lijekova.
English: The CHMP considers that this risk is unacceptable taking into account the estimated benefit of the product and the existing safer alternatives.
Croatian: CHMP smatra da je taj rizik neprihvatljiv uzimajući u obzir procijenjenu korist lijeka i postojeće sigurnije alternative.
English: The efficacy of the product is based on the above-mentioned single small prospective non-comparative study dated 1969, which estimated the efficacy in painless devitalisation of pulp to be 88% under optimal circumstances of use.
Croatian: Djelotvornost lijeka temelji se na prethodno navedenom pojedinačnom malom, nekomparativnom ispitivanju iz 1969. koje je procijenilo da je djelotvornost kod bezbolne devitalizacije pulpe 88 % pod optimalnim uvjetima uporabe.
English: Therefore, the CHMP recommended the revocation of the marketing authorisations for the medicinal products referred to in Annex I.
Croatian: Stoga je CHMP preporučio oduzimanje odobrenja za stavljanje u promet lijekova navedenih u Prilogu I.
English: Even in case of the best practice the necrotic adverse reactions cannot be ruled out due to the specifics of dental anatomy or accidental spillage.
Croatian: Čak i u slučaju najbolje prakse nije moguće isključiti nekrotične štetne reakcije zbog specifičnih odlika zubne anatomije ili slučajnog prolijevanja.
English: In addition, the Committee is of the view that the risk of tissue necrosis cannot be ruled out even under the conditions of careful dental practice and the proposed SmPC recommendations.
Croatian: Pored toga, Povjerenstvo smatra da se rizik od nekroze tkiva ne može isključiti čak niti pod uvjetima pažljive dentalne prakse i uz primjenu preporuka predloženih u SmPC-u.
English: • The monitoring and analysis of reported cases including a specific questionnaire to collect evidence of the indication of the product (use in second intention), sealing of the cavity and the duration of the application.
Croatian: • nadzor i analiza prijavljenih slučajeva uključujući i specifičan upitnik za prikupljanje dokaza o indikaciji lijeka (uporaba za druge namjere), plombiranje karijesa i trajanje primjene.
English: The French National Competent Authority (NCA) considered that the modifications of the SmPC proposed by the MAHs were neither acceptable nor appropriate given the genotoxicity data provided and the recommendation of the expert panel.
Croatian: Francusko nacionalno nadležno tijelo (NCA) smatralo je da izmjene SmPC-a koje je predložio nositelj odobrenja nisu prihvatljive ni odgovarajuće s obzirom na dostavljene podatke o genotoksičnosti i preporuku panela stručnjaka.
English: • no clinical practice guideline endorses the use of arsenic dental paste,
Croatian: • nijedna smjernica za kliničku praksu ne podržava uporabu arsenove zubne paste,
English: In addition, for safety assessment, the CHMP noted that this short study does not confirm the absence of arsenic leakage, granulomas or decrease in bone density.
Croatian: Pored toga, u svrhu procjene sigurnosti CHMP je zabilježio da ovo kratko ispitivanje ne potvrđuje izostanak propuštanja arsena, granulome ili smanjenja gustoće kostiju.
English: Finally the CHMP noted that no national, European and international guideline endorse the use of arsenic dental paste in clinical practice.
Croatian: Naposljetku, CHMP je uočio da nijedna nacionalna, europska ili međunarodna smjernica ne preporučuje uporabu arsenove zubne paste u kliničke svrhe.
English: • is genotoxic in vitro and in vivo in rodents (clastogenicity) which would not allow a safe level of use of arsenic trioxide for achieving active concentrations,
Croatian: • genotoksičan in vitro i in vivo u glodavaca (klastogenost) što ne dopušta sigurnu razinu uporabe arsenova trioksida za postizanje djelatnih koncentracija,
English: The MAH created in June 2013 an expert panel to characterise the risks and further assess the need for potential changes to the Marketing Authorisations (MAs) of the concerned product.
Croatian: Nositelj odobrenja oformio je u lipnju 2013. panel stručnjaka za karakterizaciju rizika i daljnju procjenu potrebe za potencijalnim promjenama u odobrenjima za stavljanje lijeka u promet za spomenute lijekove.
English: The CHMP concludes that arsenic trioxide:
Croatian: CHMP zaključuje da je arsenov trioksid:
English: • the risk of necrosis to periodontal tissues is high in comparison to the other serious adverse events and the necrosis of periodontal tissues together with infectious complications remain a very serious known adverse effect, hard to treat and difficult to control despite the SmPC
Croatian: • rizik od periodontalne nekroze je visok u odnosu na druge ozbiljne nuspojave i nekroza periodentalnog tkiva zajedno s infekcijskim komplikacijama ostaje vrlo ozbiljna poznata nuspojava koja se teško liječi i kontrolira usprkos preporukama iz SmPC-a.
English: The risk of carcinogenicity is established by the local or systemic passage of arsenic.
Croatian: Rizik od kancerogenosti utvrđen je lokalnim ili prolaskom arsena kroz sistemski krvotok.
English: This included the MAHs' responses, data available to Member States and published literature which became available since the original marketing authorisations.
Croatian: To je uključivalo odgovore nositelja odobrenja, podatke dostupne u državama članicama i objavljenu literaturu koja je postala dostupna nakon početnih odobrenja za stavljanje lijeka u promet.
English: In addition, the CHMP is of the view that the proposed measures to mitigate the risk of necrosis are not so different from the current recommendations and common knowledge on the conditions of use of the product and though the effectiveness of those current measures would not mitigate the risk associated with those products.
Croatian: Osim toga, CHMP smatra da predložene mjere za smanjivanje rizika od nekroze nisu tako različite od trenutnih preporuka i općih spoznaja o uvjetima uporabe lijeka i da djelotvornost ovih aktualnih mjera neće umanjiti rizik povezan s ovim lijekovima.
English: The CHMP notes that:
Croatian: CHMP napominje da:
English: The CHMP also considered the overview of cases reported submitted by the MAHs which compiles safety data from a Global Safety Database as well as published literature and data available to the Member states.
Croatian: CHMP je također razmotrio pregled prijavljenih slučajeva koji su podnijeli nositelji odobrenja, a koji objedinjuje sigurnosne podatke iz globalne baze sigurnosnih podataka kao i objavljenu literaturu i podatke dostupne državama članicama.
English: To further address the risks of carcinogenicity and tissue necrosis and in response to the outstanding issues expressed by the CHMP, the MAHs propose the following additional risk minimisation measures:
Croatian: Kako bi se dodatno ispitali rizici od kancerogenosti i nekroze tkiva te kao odgovor na neriješena pitanja koja je iznio CHMP, nositelji odobrenja predlažu sljedeće dodatne mjere za smanjivanje rizika:
English: Therefore, in accordance with Article 32 of Directive 2001/83/EC, the CHMP recommends the revocation of the marketing authorisations for all medicinal products referred to in Annex I pursuant to Article 116 of Directive 2001/83/EC.
Croatian: Direktive 2001/83/EZ, CHMP preporučuje oduzimanje odobrenja za stavljanje lijeka u promet za sve lijekove koji su navedeni u Prilogu I. u skladu s člankom 116.
English: Based on this positive genotoxicity results (clastogenicity) the MAHs informed the Competent Authorities of a potential serious impact on the benefit risk balance of the products.
Croatian: Na temelju pozitivnih rezultata testiranja genotoksičnosti (klastogenost), nositelji odobrenja obavijestili su nadležne vlasti o potencijalnom ozbiljnom utjecaju na omjer koristi i rizika lijeka.
English: With regards to the proposed DUS, the CHMP is of the opinion that it would not be ethically acceptable to expose patients to arsenic trioxide for which an expert panel concluded that a genotoxic, reprotoxic and carcinogenic risks have been demonstrated.
Croatian: S obzirom na predloženo ispitivanje potrošnje lijeka, CHMP smatra da ne bi bilo etički prihvatljivo izložiti bolesnike arsenovom trioksidu za koji je panel stručnjaka zaključio da je genotoksičan, reproduktivno toksičan te sadrži rizik od kancerogenosti.
English: These products contain arsenous anhydride (arsenic trioxide) which is used for pulp cauterization (necrosis of the tooth pulp).
Croatian: Ti lijekovi sadrže arsenov anhidrid (arsenov trioksid) koji se koristi za kauterizaciju pulpe (nekroze zubne pulpe).