natgillin/translations-raw huggingface dataset:
International Non-proprietary Name (INN): pradofloxacin
Mednarodno nelastniško ime (INN): pradofloksacin
After having considered the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the recommendation of the refusal of the marketing authorisation application on 14 September 2006.
Po preučitvi podlage za to zahtevo je CVMP ponovno pregledal prvotno mnenje in dne 14. septembra 2006 potrdil priporočilo za zavrnitev vloge za dovoljenje za promet.
For this reason the Committee concluded that the safety of pradofloxacin had not been conclusively proven.
Iz tega razloga je Odbor zaključil, da varnost pradofloksacina ni bila prepričljivo dokazana.
The CVMP considered that the company had not been able to identify a dose that was effective whilst at the same time providing an adequate margin of safety.
CVMP je bil mnenja, da podjetju ni uspelo določiti odmerka, ki bi bil učinkovit in hkrati zagotavljal primerno varnost.
They noted that the genotoxicity data (the potential for the substance to damage genes) showed differences from that for other antibiotics in the same class, and that the reasons for these differences were unclear.
Odbor je izpostavil, da podatki o genotoksičnosti (možnost, da snov povzroči poškodbe genetskega materiala) kažejo na razlike v primerjavi z drugimi antibiotiki istega razreda, razlogi za te razlike pa niso jasni.
What documentation did the Company present to support its application to the CVMP?
Katero dokumentacijo je podjetje predložilo CVMP v podporo svoji vlogi ?
Like other antibiotics, pradofloxacin is not effective against every type of bacteria.
Podobno kot drugi antibiotiki tudi pradofloksacin ni učinkovit proti vsem vrstam bakterij.
The CVMP was therefore of the opinion that Veraflox's benefits had not been shown to be greater than its risks.
CVMP je bil posledično mnenja, da ni bilo dokazano, da bi bile koristi zdravila Veraflox večje od z njim povezanih tveganj.
On 17 May 2006 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Veraflox 15 mg, 60 mg & 120 mg Tablets for Cats and Dogs, and Veraflox 25 mg/ml Oral Suspension for Cats.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je v negativnem mnenju z dne 17. maja 2006 priporočil zavrnitev dovoljenja za promet z zdravilom Veraflox - 15 mg, 60 mg in 120 mg tablete za pse in mačke ter Veraflox - 25 mg/ml peroralna suspenzija za mačke.
Which were the major concerns that lead the CVMP to recommend the refusal of a marketing authorisation?
Kateri so bili glavni zadržki, zaradi katerih je CVMP priporočil zavrnitev dovoljenja za promet?
This results in the bacteria dying and so the infection is cured.
To privede do odmrtja bakterije in ozdravljenja okužbe.
In all studies the effectiveness of Veraflox was compared to antibiotics which are commonly used for the treatment of the infection studied.
Pri vseh raziskavah so učinkovitost zdravila Veraflox primerjali z antibiotiki, ki se običajno uporabljajo za zdravljenje obravnavanih okužb.
All these fluoroquinolones, including pradofloxacin, kill bacteria by interacting with some of the enzymes in bacteria responsible for major DNA functions.
Vsi ti fluorokinoloni, vključno s pradofloksacinom, uničujejo bakterije na podlagi interakcije z nekaterimi encimi v bakteriji, odgovornimi za glavne funkcije DNA.
Veraflox is an antibiotic.
Zdravilo Veraflox je antibiotik.
Veraflox Oral Suspension contains 25 mg/ml pradofloxacin.
Peroralna suspenzija Veraflox vsebuje 25mg/ml pradofloksacina.
Pradofloxacin is an antibiotic.
Pradofloksacin je antibiotik.
No adverse consequences for animals have been identified by the CVMP, as other medicines exist for all the infections in cats and dogs which Veraflox was intended to treat.
CVMP ni ugotovil nikakršnih neželenih posledic za živali, saj so za zdravljenje vseh okužb psov in mačk, za katere bi se naj uporabljalo zdravilo Veraflox, na voljo druga zdravila.
The active substance in Veraflox, pradofloxacin, belongs to a class of antibiotics called third generation fluoroquinolones.
Pradofloksacin, zdravilna učinkovina v zdravilu Veraflox, sodi v razred antibiotikov, imenovanih fluorokinoloni tretje generacije.
What are the consequences for animals of the refusal for Veraflox?
Kakšne so posledice zavrnitve dovoljenja za promet z zdravilom Veraflox za živali?
The company presented the results of studies examining the effectiveness of Veraflox against a range of conditions involving bacterial infections in cats and dogs.
Podjetje je predložilo rezultate raziskav, ki so preučevale učinkovitost zdravila Veraflox pri različnih bolezenskih stanjih, ki vključujejo bakterijske okužbe pri psih in mačkah.
The company who applied for a marketing authorisation is Bayer HealthCare AG.
Vlagatelj je podjetje Bayer HealthCare AG.
Veraflox Tablets contain 15 mg, 60 mg & 120 mg of the active substance, pradofloxacin.
Tablete Veraflox vsebujejo 15 mg, 60 mg ali 120 mg zdravilne učinkovine pradofloksacin.
How is Veraflox expected to work?
Kako naj bi zdravilo Veraflox delovalo?
What was Veraflox to be used for?
Za kaj naj bi se zdravilo Veraflox uporabljalo?
Hence, the CVMP recommended that Veraflox be refused a marketing authorisation.
Zato je CVMP priporočil zavrnitev dovoljenja za promet z zdravilom Veraflox.
What is Veraflox?
Kaj je zdravilo Veraflox?
In cats, the medicine was studied in acute infections of the upper respiratory tract and also some skin conditions caused by certain specific bacteria.
Pri mačkah so zdravilo preučevali pri akutnih okužbah zgornjih dihal ter tudi nekaterih stanjih kože, ki jih povzročajo določene specifične bakterije.
In cats, Veraflox Tablets were to be used for the treatment of acute infections of the upper respiratory tract caused by certain specific bacteria.
Pri mačkah bi se naj tablete Veraflox uporabljale za zdravljenje akutnih okužb zgornjih dihal, ki jih povzročajo določene specifične bakterije.
Veraflox Oral Suspension was to be used for the treatment of cats with acute infections of the upper respiratory tract and also some skin conditions caused by certain specific bacteria.
Peroralna suspenzija Veraflox bi se naj uporabljala za zdravljenje akutnih okužb zgornjih dihal ter tudi nekaterih stanj kože, ki jih povzročajo določene specifične bakterije.
In dogs, Veraflox Tablets were to be used for the treatment of skin, urinary tract and gum infections caused by certain specific bacteria.
Pri psih bi se naj tablete Veraflox uporabljale za zdravljenje okužb kože, sečil in dlesni, ki jih povzročajo določene specifične bakterije.
In dogs, the medicine was studied in some skin, urinary tract and gum infections caused by certain specific bacteria.
Pri psih so zdravilo preučevali pri nekaterih okužbah kože, sečil in dlesni, ki jih povzročajo določene specifične bakterije.
A European Commission issued a decision on 27 July 2010.
Evropska komisija je odločbo izdala 27. julija 2010.
Andrea Laslop (Austria)
Andrea Laslop (Avstrija)
Medicines containing bufexamac have been authorised in Austria, Bulgaria, the Czech Republic, France, Hungary, Italy, Latvia, Lithuania, Luxembourg, Portugal, Romania and Slovakia.
Zdravila, ki vsebujejo bufeksamak, so pridobila dovoljenje za promet v Avstriji, Bolgariji, Češki republiki, Franciji, Madžarski, Italiji, Latviji, Litvi, Luksemburgu, na Portugalskem, v Romuniji in na Slovaškem.
The allergic reactions can be serious enough to require hospitalisation.
Alergijske reakcije so lahko tako resne, da zahtevajo sprejem v bolnišnico.
• Doctors should stop prescribing medicines containing bufexamac.
• Zdravniki morajo prenehati predpisovati zdravila, ki vsebujejo bufeksamak.
It is also likely that the difficulty to differentiate between a treatment failure and an allergic reaction has led to the cases of contact allergic reaction being underreported.
Verjetno je tudi, da je težavno razlikovanje med neuspešnim zdravljenjem in alergijsko reakcijo povzročilo, da se o primerih kontaktne alergijske reakcije ni dovolj poročalo.
Blocking their production helps to reduce the signs of inflammation.
Zaviranje njihovega nastanka pripomore k zmanjšanju znakov vnetja.
What is bufexamac?
Kaj je bufeksamak?
Co-rapporteur(s):
Soporočevalka:
The risk of developing a contact allergic reaction to bufexamac is high, and the risk is even higher in patients with pre-disposing conditions, such as certain forms of eczema, for which bufexamac is frequently prescribed.
Tveganje pojava kontaktne alergijske reakcije na bufeksamak je veliko, tveganje pa je še večje pri bolnikih s predispozicijskimi stanji, kot so določene oblike ekcema, za katerega se bufeksamak pogosto predpisuje.
Furthermore, because these reactions are very similar to the disease being treated, it can lead to delays in the diagnosis or treatment of the patient's condition.
Ker so te reakcije zelo sorodne bolezni, ki se zdravi, lahko pride do zakasnitev pri diagnostiki in zdravljenju bolnikovega stanja.
Most of the studies dated from the original development of bufexamac in the 1970s and 1980s, and were of a lower standard than that expected today.
Večina študij je bila opravljenih pri prvotnem razvoju bufeksamaka v sedemdesetih in osemdesetih letih dvajsetega stoletja, zato ne dosegajo kakovosti, ki se pričakuje danes.
• Patients currently using bufexamac-containing medicines should speak to their doctor so they can switch to an appropriate alternative treatment.
• Bolniki, ki trenutno uporabljajo zdravila, ki vsebujejo bufeksamak, se morajo posvetovati s svojim zdravnikom o prehodu na ustreznejše, alternativno zdravljenje.
Why was bufexamac reviewed?
Zakaj je bil bufeksamak pregledan?
Bufexamac is a non-steroidal anti-inflammatory drug (NSAID).
Bufeksamak je nesteroidno protivnetno zdravilo (NSAID).
The Committee noted that the data presented to support the effectiveness of bufexamac were very limited.
Odbor je ugotovil, da je podatkov, predloženih v podporo učinkovitosti bufeksamaka, zelo malo.
Prostaglandins are messengers in the development of inflammation.
Prostaglandini so sporočilne molekule pri razvoju vnetja.
The European Medicines Agency has completed a review of the safety and effectiveness of bufexamac.
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti bufeksamaka.
The CHMP noted that bufexamac-containing medicines have been available since the 1970s, and that contact allergic reactions have been reported over the years, leading to restrictions on the use of the medicines in a number of countries.
CHMP je ugotovil, da so zdravila, ki vsebujejo bufeksamak, na voljo od 70. let dvajsetega stoletja ter da so od takrat poročali o kontaktnih alergijskih reakcijah, ki so v številnih državah povzročile omejitve uporabe zdravil.
In December 2009, the German medicines regulatory agency completed a review of the benefits and risks of bufexamac-containing medicines.
Decembra 2009 je nemška regulativna agencija za zdravila zaključila pregled koristi in tveganja z zdravili, ki vsebujejo bufeksamak.
They may be available as creams, rectal ointments and suppositories, and under the following invented names: Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan, and other trade names.
Na voljo so v obliki kreme, rektalnega mazila in svečk ter pod naslednjimi izmišljenimi imeni: Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan in druga lastniška imena.
As required by Article 107, the agency informed the CHMP of its action so that the Committee could prepare an opinion on whether the marketing authorisations for products containing bufexamac should be maintained, changed, suspended or revoked across the EU.
Skladno z določbami člena 107 je agencija obvestila CHMP o svojih ukrepih, da bi lahko Odbor pripravil mnenje o tem, ali se v celotni EU dovoljenja za promet z zdravili, ki vsebujejo bufeksamak, ohranijo, spremenijo, začasno prekličejo ali umaknejo.
In addition, when looking at the few more recent, controlled studies, the CHMP noted that the effectiveness of bufexamac had not been shown.
Poleg tega je CHMP po pregledu nekaterih novejših, kontroliranih študij ugotovil, da učinkovitost bufeksamaka ni dokazana.
Alternative anti-inflammatory treatments are widely available.
Na voljo so alternativni načini protivnetnega zdravljenja.
The CHMP also noted that bufexamac is a ‘sensitizer' causing reactions to get worse with repeated exposure.
CHMP je ugotovil tudi, da bufeksamak povzroča „senzibilizacijo“, kar povzroči poslabšanje reakcije pri ponovni izpostavljenosti.
Bufexamac is used to control the symptoms of inflammation of the skin (such as redness and itching) in diseases such as eczema and dermatitis.
Bufeksamak se uporablja za obvladovanje simptomov vnetja kože (kot je pordelost in srbenje) pri boleznih, kot sta ekcem in dermatitis.
It can also be used, in combination with other substances, to control the symptoms of inflammation that can occur around the anus in patients with haemorrhoids (piles) or an anal fissure (a tear in the lining of the anal canal).
Lahko se uporabi tudi v kombinacijami z drugimi zdravili za obvladovanje simptomov vnetja, ki se pojavlja okoli anusa pri bolnikih s hemeroidi ali analno fisuro (raztrganino sluznice analnega kanala).
The CHMP looked at the data used by the German agency in its review, and the information provided by the companies marketing bufexamac in other EU countries.
CHMP je pregledal podatke, ki jih je nemška agencija uporabila v svojem pregledu, ter podatke, ki so jih poslale družbe, ki tržijo bufeksamak v drugih državah EU.
In particular, the Committee considered the responses given by the companies to a list of questions on allergic reactions reported following contact with bufexamac.
CHMP je zlasti obravnaval odgovore, ki so jih družbe podale na vprašanja o alergijskih reakcijah, o katerih so poročali po stiku z bufeksamakom.
During this review, the agency obtained information from the companies marketing bufexamac in Germany, and looked at published studies on the effectiveness of bufexamac.
Med pregledom je agencija pridobila informacije od družb, ki tržijo bufeksamak v Nemčiji, ter pregledala objavljene študije o njegovi učinkovitosti.
27 July 2010
27. julij 2010
Because of this, no evidence of the effectiveness of bufexamac could be derived from them.
Zaradi tega iz njih ni bilo mogoče pridobiti dokazov o učinkovitosti bufeksamaka.
NSAIDs work by blocking an enzyme called cyclo-oxygenase, which is involved in the production of prostaglandins.
Nesteroidna protivnetna zdravila delujejo tako, da zavirajo encim, imenovan ciklooksigenaza, ki sodeluje pri nastajanju prostaglandinov.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bufexamac do not outweigh its risks, and recommended that the marketing authorisations for medicines containing bufexamac be revoked (withdrawn) throughout the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da koristi bufeksamaka ne odtehtajo z njim povezanih tveganj, in priporočil razveljavitev (umik) dovoljenj za promet z zdravili, ki vsebujejo bufeksamak, po vsej Evropski uniji (EU).
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of bufexamac-containing medicines do not outweigh their risks, and therefore recommended that all marketing authorisations be revoked in the EU.
CHMP je po vrednotenju trenutno razpoložljivih podatkov in znanstvene razprave v Odboru menil, da koristi zdravil, ki vsebujejo bufeksamak, ne odtehtajo z njimi povezanih tveganj, in priporočil razveljavitev vseh dovoljenj za promet z zdravilom v EU.
Company responses provided on: 19 February 2010 Opinion date:
Odgovori družbe, poslani dne:
The German agency concluded that the benefits of bufexamac-containing medicines do not outweigh their risks, and recommended that the marketing authorisations be withdrawn in Germany.
Nemška agencija je menila, da koristi zdravil, ki vsebujejo bufeksamak, ne odtehtajo z njimi povezanih tveganj, in priporočila umik dovoljenj za promet z njim v Nemčiji.
Elderly (65 years of age or above)
Starejši (stari 65 let ali več)
Date of first authorisation: 27 July 2000 Date of latest renewal: 05 May 2010
Datum prve odobritve: 27. julij 2000 Datum zadnjega podaljšanja: 05. maj 2010
26 rue de la Chapelle 68330 Huningue France
26 rue de la Chapelle 68330 Huningue Francija
Your doctor will advise you.
Glede tega vam bo svetoval zdravnik.
Ethnic groups/races
Etnične skupine/rase
It is important to tell your doctor if you are pregnant, if you think you may be pregnant or if you plan to become pregnant.
Pomembno je, da zdravniku poveste, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
During this time, you will have to follow your doctor's instructions and keep your eyes still.
V tem času se boste morali ravnati po zdravnikovih navodilih in ne boste smeli premikati oči.
This indicates that clinical benefit may diminish over time.
To kaže, da se lahko klinična koristnost sčasoma zmanjša.
Patients should be re-evaluated every 3 months.
Bolnike je potrebno kontrolirati vsake 3 mesece.
In relation to VIP-PM extension:
Podaljšanje študije VIP-PM:
No death was considered to be related to treatment.
Nobene smrti niso povezovali z zdravljenjem.
Infusion-related problems may also include sudden loss of consciousness.
Težave v povezavi z infundiranjem lahko vključujejo tudi nenadno izgubo zavesti.
Not known (frequency cannot be estimated from the available data)
Pogostnost neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
No additional safety concern was identified.
Ugotovili niso nobenega novega problema glede varnosti.
Some side effects could be serious:
Nekateri neželeni učinki so lahko resni:
If this happens to you, do not drive or use any tools or machines until your vision improves.
V tem primeru ne vozite in ne uporabljajte orodij ali strojev, dokler se vam vid ne izboljša.
From a microbiological point of view, the medicine should be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
Risk of severe decrease of vision
Tveganje za močno poslabšanje vida
For storage conditions, please see section 5 of this leaflet.
Za pogoje shranjevanja glejte poglavje 5 v tem navodilu.
The posology and retreatments were the same as in the AMD studies.
Odmerjanje in shema ponovnega zdravljenja sta bila enaka kot v študijah AMD.
Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 4 ure pri 25 °C.
When energy absorbed by the porphyrin is transferred to oxygen, highly reactive short-lived singlet oxygen is generated.
Ko se energija, ki jo absorbira porfirin, prenese na kisik, nastaja močno reaktivni, kratkoživi singlet kisik.
Use of rubber gloves and eye protection is recommended.
Priporočljiva je uporaba gumijastih rokavic in zaščite za oči.
Your doctor will put a special contact lens onto your eye and treat your eye using a special laser.
Zdravnik vam bo v oko vložil posebno kontaktno lečo in vam posvetil v oko s posebnim laserjem.
There are no clinical data to support concomitant treatment of the second eye.
Ni kliničnih podatkov, ki bi podpirali sočasno zdravljenje drugega očesa.
The relief of pain may require analgesic treatment.
Za lajšanje bolečine je lahko potrebno analgetično zdravljenje.
The efficacy parameter was the same as in TAP and VIO (see above).
Parameter učinkovitosti je bil enak kot pri TAP in VIO (glejte zgoraj).
This medicinal product is intended for intravenous infusion only.
Način uporabe Zdravilo je namenjeno samo za intravensko infuzijo.
Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake “EXP”.
UV sunscreens are not effective in protecting against photosensitivity reactions.
UV zaščitni faktorji v kremah za sončenje niso učinkoviti za varovanje pred fotosenzitivnostnimi reakcijami.
Pack containing 1 vial.
Pakiranje vsebuje 1 vialo.
No interaction studies have been performed in humans.
Študij medsebojnega delovanja pri ljudeh niso izvedli.
These diseases lead to vision loss.
Ti dve bolezni povzročata slabšanje vida.
In relation to TAP extension:
Podaljšanje študije TAP:
• First your doctor or the pharmacist will prepare the Visudyne infusion solution.
• Najprej bo vaš zdravnik ali farmacevt pripravil infuzijsko raztopino zdravila Visudyne.
There are two types of choroidal neovascularisation: classic and occult.
Obstajata dve vrsti horioidalne neovaskularizacije in sicer klasična in okultna.
Overdose of the medicinal product may result in the prolongation of the period during which the patient remains photosensitive.
Prevelik odmerek zdravila ima lahko za posledico podaljšanje obdobja, med katerim je bolnik fotosenzitiven.
On rare occasions these reactions may be severe and potentially include convulsions.
V redkih primerih so te reakcije lahko hude in lahko vključujejo konvulzije.
If necessary, Visudyne therapy can be repeated every 3 months, up to 4 times per year.
Po potrebi se lahko zdravljenje z zdravilom Visudyne ponovi vsake 3 mesece, do 4-krat na leto.
What Visudyne is and what it is used for
Kaj je zdravilo Visudyne in za kaj ga uporabljamo
The clinical relevance is unknown.
Klinični pomen za ljudi ni znan.
The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so navedeni po organskih sistemih in pogostnosti po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
No experience is available in these patients.
Z uporabo zdravila pri teh bolnikih ni nobenih izkušenj.
Such reactions should be avoided by compliance with the photosensitivity protection instructions given in section 4.4.
Bolniki naj se takim reakcijam izogibajo, tako da se ravnajo po navodilih za zaščito pri fotosenzitivnosti v poglavju 4.4.
Use in children Visudyne is a treatment for adults only and not indicated for the use in children.
Uporaba pri otrocih Zdravilo Visudyne je namenjeno samo zdravljenju odraslih in ni indicirano za uporabo pri otrocih.
Visudyne should not be used during pregnancy unless clearly necessary (only if the benefit justifies the potential risk to the foetus).
Zdravila Visudyne ne smete uporabljati med nosečnostjo, razen če je nujno potrebno (le če korist upravičuje možno tveganje za plod).
Although mean plasma Cmax and AUC values in elderly patients who received verteporfin are higher than those in young volunteers or patients, these differences are not considered to be clinically significant.
Čeprav sta povprečni vrednosti Cmax in AUC pri starejših bolnikih, ki so prejemali verteporfin, višji kot pri mladih prostovoljcih ali bolnikih, ti razliki ne veljata za klinično pomembni.
Photosensitivity and exposure to light
Fotosenzitivnost in izpostavljanje svetlobi
• Localised death of skin tissue (necrosis).
• Lokalno pojavljanje odmrlega kožnega tkiva (nekroze).
The extent of exposure and the maximal plasma concentration are proportional to the dose between 6 and 20 mg/m
Izpostavljenost in najvišja koncentracija v plazmi sta sorazmerni velikosti odmerka v okviru od 6 do 20 mg/m
You should only be given Visudyne if your doctor considers it absolutely essential.
Zdravilo Visudyne lahko dobite samo, če vaš zdravnik presodi, da je to neizogibno potrebno.
The extent and severity of these effects were consistent among all studies and were dependent on drug dose and dosing duration.
Obseg in izraženost teh učinkov sta bila v vseh študijah približno enaka ter odvisna od odmerka zdravila in trajanja odmerjanja.