natgillin/translations-raw huggingface dataset:
The Committee, having considered the matter, concluded that on the basis of the available data for Equimectin bioequivalence with the reference product has not been shown.
Odbor je po presoji zadeve sklenil, da na osnovi razpoložljivih podatkov o zdravilu Equimectin bioekvivalenca z referenčnim izdelkom ni bila dokazana.
- The number of horses recruited was too low to produce meaningful results.
- Število preučevanih konj je bilo prenizko, da bi bili rezultati merodajni.
Therefore, if the product is administered at the recommended dose rate, there is the possibility of lack of efficacy and the potential for anthelmintic resistance.
Posledično obstaja v primeru, ko se zdravilo daje ob upoštevanju priporočenega odmerka, možnost neobstoja učinkovitosti ter potencial za razvoj odpornosti na antihelmintike.
Ivermectin containing pastes/oral gels for horses are well established on the market and the prescriber/animal owner would expect Equimectin to be interchangeable with other available products of the avermectin class.
Paste/peroralni geli z ivermektinom za konje so dobro uveljavljeni na trgu, zato bi predpisovalec zdravila/lastnik živali pričakoval, da je zdravilo Equimectin medsebojno zamenljivo z drugimi razpoložljivimi izdelki iz razreda avermektinov.
During the referral procedure, it has been established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/CVMP/016/00-corrFINAL), however from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
Med postopkom napotitve je bilo ugotovljeno, da predložena bioekvivalenčna raziskava ni ustrezna, da bi lahko dokazala bioekvivalenco (kot jo določa veljavna smernica EMEA/CVMP/016/00-corrFINAL), vendar pa je glede na primerjalne farmakokinetične podatke mogoče, da je testni izdelek sistemsko biološko manj uporaben od referenčnega izdelka.
These results were below the accepted 90% or higher and, as there was no control group to compare the differences in parasite counts statistically, which should be significant at p<0.05, it is not possible to determine the efficacy of Equimectin from this study.
Ti rezultati so bili pod sprejetimi 90 % ali več, ker pa ni bilo kontrolne skupine za statistično primerjavo razlik v številu zajedavcev, ki bi naj bile statistično značilne s p < 0,05, iz te raziskave ni mogoče določiti učinkovitosti zdravila Equimectin.
The documentation submitted with this application consists of literature referring to the use of the originator product Eqvalan, a comparative pharmacokinetic study using Equimectin and Eqvalan, and a supplementary clinical field study.
Dokumentacija, ki je bila predložena s to vlogo, obsega literaturo v zvezi z uporabo originatorskega izdelka Eqvalan, primerjalno farmakokinetično raziskavo zdravil Equimectin in Eqvalan ter dodatno klinično terensko raziskavo.
- The principle criteria used for a comparison of effect is egg count reduction/larval identification or parasite counts in dose confirmation studies.
- Načelni kriterij, uporabljen za primerjavo učinka, je zmanjšanje števila jajčec/identifikacija ličink ali število zajedavcev v raziskavah za določitev odmerka.
It is not practical for an SPC for an equine wormer to only indicate use of the product against 5 specific parasites that do not include the important Strongylus genus in horses, but to imply that the product has efficacy against a wider population of parasites.
Ni primerno, da SPC antiparazitika za konje navaja uporabo izdelka samo proti 5 specifičnim zajedavcem, med katerimi ni za konje pomembnega rodu Strongylus, pri čemer pa iz drugih navedb izhaja, da je izdelek učinkovit proti širši populaciji zajedavcev.
Efficacy could be claimed if effectiveness against each parasite declared on the labelling was at 90% or above based on calculation of geometric means and there was a statistically significant difference in parasite numbers between control and treated horses.
Učinkovitost bi bilo mogoče uveljavljati, če bi bila učinkovitost proti posameznemu zajedavcu, označenemu na ovojnini, 90 % ali več, izračunana na podlagi geometričnih povprečij, ter če bi bila razlika med številom zajedavcev pri konjih v kontrolni skupini in pri zdravljenih konjih statistično značilna.
There is no reference in the Marketing Authorisation Holder's responses to the study that generated the results tables.
V odgovorih imetnika dovoljenja za promet ni sklicevanja na raziskavo, iz katere izhajajo tabele z rezultati.
- Based on the type of study conducted, the background exposure of the ponies included in the trial was not stated therefore the adequacy of the infections cannot be documented.
- V odvisnosti od vrste izvedene raziskave ni bila podana obremenitev v okolju, kateri so bili izpostavljeni poniji, ki so bili vključeni v raziskavo, zato ustreznosti okužb ni mogoče dokumentirati.
The dose of Eqvalan was found to be 10% higher in the field trial than indicated.
Odmerek zdravila Eqvalan pri terenski raziskavi je bil 10 % večji od navedenega.
No data were provided concerning the efficacy against ectoparasites.
Podatki o učinkovitosti proti ektoparazitom niso bili predloženi.
The effect against e.g. the large strongyles that are important parasites in the horse is not supported by the presented data and moreover, as the effect on the L4 stage of the small strongyles is not substantiated, the period between necessary prophylactic deworming will be significantly shortened.
Predloženi podatki ne potrjujejo učinka proti npr. velikim strongilidom, ki so pomembni zajedavci pri konju, poleg tega pa se bo interval med potrebnimi profilaktičnimi zatiranji notranjih zajedavcev bistveno skrajšal, saj učinek proti razvojni stopnji L4 malih strongilidov ni dokazan.
- The tables included in the response dossier do not indicate which parasites are referred to, and there is no break down of species of parasite.
- Iz tabel, ki so vključene v dokumentaciji odgovora, ni razvidno, za katere zajedavce veljajo, prav tako ni razdelitve po vrstah zajedavcev.
The results were not divided for each parasite species.
Rezultati niso bili razdeljeni glede na vrste zajedavcev.
- The test product demonstrated lower bioavailability compared to Eqvalan, the cited reference product, during the bioequivalence study, and the test product was administered at greater than the recommended treatment dose in the field study.
- Testni izdelek je med bioekvivalenčno raziskavo izkazal manjšo biološko uporabnost od zdravila Eqvalan, ki je naveden kot referenčni izdelek, poleg tega pa je bil uporabljeni odmerek testnega izdelka pri terenski raziskavi večji od priporočenega odmerka za zdravljenje.
Equimectin Oral gel
Equimectin Peroralni gel mg/g
January 2007
Nizozemska
It is used to treat adults and children (including newborn babies) who have:
Uporablja se za zdravljenje odraslih in otrok (vključno novorojenčkov), ki imajo:
Studies in adults
Študije pri odraslih
Studies in children
Študije pri otrocih
This overview was last updated in 06-2019.
Povzetek je bil nazadnje posodobljen 06-2019.
‘Complicated' means that the infection is difficult to treat;
„Zapletena okužba“ pomeni, da jo je težko zdraviti;
Further information on Zinforo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zinforo
Nadaljnje informacije o zdravilu Zinforo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zinforo
What measures are being taken to ensure the safe and effective use of Zinforo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zinforo?
Zinforo received a marketing authorisation valid throughout the EU on 23 August 2012.
Za zdravilo Zinforo je bilo 23. avgusta 2012 izdano dovoljenje za promet, veljavno po vsej EU.
However, as there were uncertainties about the effects of Zinforo in patients with certain very severe infections these effects will be investigated in further studies.
Kljub temu bodo zaradi negotovosti glede učinkov zdravila Zinforo pri bolnikih z določenimi zelo resnimi okužbami ti učinki raziskani v nadaljnjih študijah.
• community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
• zunajbolnišnično pljučnico (okužbo pljuč, pridobljeno zunaj bolnišnice).
Why is Zinforo authorised in the EU?
Zakaj je bilo zdravilo Zinforo odobreno v EU?
What is Zinforo and what is it used for?
Kaj je zdravilo Zinforo in za kaj se uporablja?
Prescribers should consider official guidance on the appropriate use of antibiotics.
Zdravniki, ki predpisujejo zdravilo, morajo upoštevati uradne smernice za ustrezno uporabo antibiotikov.
The Agency decided that Zinforo's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zaključila, da so koristi zdravila Zinforo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In children and adolescents weighing less than 33 kilograms, the dose depends on the patient's weight.
Pri otrocih in mladostnih, ki tehtajo manj kot 33 kilogramov, je odmerek odvisen od bolnikove telesne mase.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinforo have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Zinforo, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For some serious skin infections, the recommended dose is 600 mg every 8 hours, with each infusion lasting 120 minutes.
Pri nekaterih resnih okužbah kože znaša priporočeni odmerek 600 mg vsakih osem ur, pri čemer vsako infundiranje traja 120 minut.
What benefits of Zinforo have been shown in studies?
Kakšne koristi zdravila Zinforo so se pokazale v študijah?
What are the risks associated with Zinforo?
Kakšna tveganja so povezana z zdravilom Zinforo?
Zinforo is an antibiotic.
Zdravilo Zinforo je antibiotik.
Zinforo (ceftaroline fosamil)
Zinforo (fosamilceftarolin)
As for all medicines, data on the use of Zinforo are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zinforo stalno spremljajo.
Patients with complicated skin and soft tissue infections should be treated for 5 to 14 days and patients who have community-acquired pneumonia should be treated for 5 to 7 days.
Bolnike z zapletenimi okužbami kože in mehkih tkiv je treba zdraviti od pet do 14 dni, bolnike z zunajbolnišnično pljučnico pa od pet do sedem dni.
Side effects reported with Zinforo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Zinforo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Other information about Zinforo
Druge informacije o zdravilu Zinforo
In adults and adolescents from 12 years of age weighing at least 33 kg, the usual dose is 600 mg every 12 hours.
Običajni odmerek pri odraslih in mladostnikih, starejših od 12 let in s telesno maso vsaj 33 kg, je 600 mg vsakih 12 ur.
An overview of Zinforo and why it is authorised in the EU
Pregled zdravila Zinforo in zakaj je odobreno v EU
• complicated infections of the skin and soft tissue (tissue below the skin).
• zapletene okužbe kože in mehkih (podkožnih) tkiv.
For more information about using Zinforo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Zinforo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
This weakens the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
To oslabi bakterijske celične stene, ki zato lažje propadejo, zaradi česar bakterije sčasoma odmrejo.
The most common side effects with Zinforo (seen in more than 3% of patients) are diarrhoea, headache, nausea (feeling sick) and pruritus (itching).
Najpogostejši neželeni učinki zdravila Zinforo (opaženi pri več kot 3 % bolnikov) so driska, glavobol, navzeja (slabost) in pruritus (srbenje).
It interferes with the production of complex molecules called peptidoglycans, which are essential components of bacterial cell walls.
Vpliva na tvorbo zapletenih molekul, imenovanih peptidoglikani, ki so temeljne sestavine celičnih sten bakterij.
In laboratory studies Zinforo was active against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work (meticillin-resistant Staphylococcus aureus (MRSA) and penicillin non-susceptible Streptococcus pneumoniae (PNSP)).
V laboratorijskih študijah je bilo zdravilo Zinforo učinkovito zoper določene bakterije, proti katerim drugi antibiotiki iz skupine betalaktamov ne delujejo (na Staphylococcus aureus, odporno proti meticilinu (MRSA), in Streptococcus pneumoniae, neobčutljivo na penicilin (PNSP)).
It does so by blocking enzymes, called penicillin-binding protein transpeptidases, that are involved in the last steps of bacterial cell wall production.
V ta namen zavira encime, imenovane beljakovinske transpeptidaze, ki se vežejo na penicilin in so vključene v zadnje faze tvorbe celičnih sten bakterij.
Zinforo must also not be used in patients who are hypersensitive to other antibiotics belonging to the cephalosporin class and in patients who are severely allergic to other betalactam antibiotics.
Prav tako ga ne smejo uporabljati bolniki, ki so preobčutljivi za druge antibiotike iz skupine cefalosporinov, in bolniki, ki so hudo alergični na druge betalaktamske antibiotike.
The Agency also noted that in laboratory studies Zinforo had shown activity against certain bacteria, such as MRSA, against which other beta-lactam antibiotics do not work.
Prav tako je poudarila, da je bilo v laboratorijskih študijah ugotovljeno, da to zdravilo deluje zoper nekatere bakterije, kot je MRSA, na katere drugi antibiotiki iz skupine betalaktamov ne delujejo.
The active substance in Zinforo, ceftaroline fosamil, is a type of antibiotic called cephalosporin belonging to the group ‘beta-lactams'.
Učinkovina v zdravilu Zinforo, fosamilceftarolin, je vrsta antibiotika, ki se imenuje cefalosporin in spada v skupino betalaktamov.
The European Medicines Agency concluded that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and its side effects in both adults and children were manageable.
Evropska agencija za zdravila je ugotovila, da je bilo zdravilo Zinforo učinkovito pri zdravljenju zapletenih okužb kože in mehkih tkiv ter zunajbolnišnične pljučnice ter da so ga odrasli in otroci na splošno dobro prenašali.
Zinforo must not be used in people who are hypersensitive (allergic) to ceftaroline fosamil or any of the other ingredients.
Zdravila Zinforo ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) fosamilceftarolin ali katero koli drugo sestavino zdravila.
How is Zinforo used?
Kako se zdravilo Zinforo uporablja?
Among those with complicated community-acquired pneumonia, 90% of the patients treated with Zinforo were cured, compared with 100% of those receiving ceftriaxone plus vancomycin.
Med tistimi z zapleteno zunajbolnišnično pljučnico je bilo ozdravljenih 90 % bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi s 100 % bolnikov, ki so prejemali ceftriakson in vankomicin.
Zinforo contains the active substance ceftaroline fosamil.
Zdravilo Zinforo vsebuje učinkovino fosamilceftarolin.
In a children's study of complicated skin and soft tissue infection, 94% of the children receiving Zinforo were cured (101 out of 107), compared with 87% of those receiving vancomycin or cefazolin, with or without aztreonam (45 out of 52).
V študiji z otroki z zapletenimi okužbami kože in mehkih tkiv je bilo ozdravljenih 94 % (101 od 107) bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi s 87 % (45 od 52) bolnikov, ki so prejemali vankomicin ali cefazolin, uporabljenima s aztreonamom ali brez njega.
Zinforo is given by infusion (drip) into a vein usually over 5 to 60 minutes.
Zdravilo Zinforo se daje od 5 do 60 minut z infundiranjem (kapalno infuzijo) v veno.
Zinforo was as effective as other antibiotics in curing skin and soft tissue infections and pneumonia in adults.
Zdravilo Zinforo je bilo pri zdravljenju okužb kože in mehkih tkiv ter pljučnice pri odraslih enako učinkovito kot drugi antibiotiki.
Among children with community-acquired pneumonia that required hospital stay, 88% of those on Zinforo were cured (94 out of 107), compared with 89% of those receiving ceftriaxone.
Med otroki z zunajbolnišnično pljučnico, zaradi katere je bilo potrebno zdravljenje v bolnišnici, je bilo ozdravljenih 88 % (94 od 107) bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi z 89 % bolnikov, ki so prejemali ceftriakson.
For community-acquired pneumonia, one study showed that 84% of the patients receiving Zinforo were cured (244 out of 291), compared with 78% of the patients receiving ceftriaxone (233 out of 300).
Pri zunajbolnišnični pljučnici je ena študija pokazala, da je bilo ozdravljenih 84 % (244 od 291) bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi z 78 % (233 od 300) bolnikov, ki so prejemali ceftriakson.
In another study, 81% of patients receiving Zinforo were cured (235 out of 289) compared with 76% of the patients receiving ceftriaxone (206 out of 273).
V drugi študiji je bilo ozdravljenih 81 % (235 od 289) bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi s 76 % (206 od 273) bolnikov, ki so prejemali ceftriakson.
In a second study, 85% of patients receiving Zinforo were cured (291 out of 342) compared with 86% of the patients receiving the combination of vancomycin and aztreonam (289 out of 338).
V drugi študiji je bilo ozdravljenih 85 % (291 od 342) bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi s 86 % (289 od 338) bolnikov, ki so prejemali kombinacijo vankomicina in aztreonama.
How does Zinforo work?
Kako zdravilo Zinforo deluje?
In a study of patients with complicated skin and soft tissue infection, 87% of the patients receiving Zinforo were cured (304 out of 351), compared with 86% of the patients receiving the combination of vancomycin and aztreonam (297 out of 347).
Pri bolnikih z zapletenimi okužbami kože in mehkih tkiv je ena študija pokazala, da je bilo ozdravljenih 87 % (304 od 351) bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi s 86 % (297 od 347) bolnikov, ki so prejemali kombinacijo vankomicina in aztreonama.
For the full list of side effects of Zinforo, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Zinforo glejte navodilo za uporabo.
In this latter case, appropriate other measures should be taken.
V tem zadnjem primeru je potrebno ustrezno ukrepati.
4.8 Undesirable effects a) General Description:
4.8 Neželeni učinki a) Splošen opis:
Results are emerged from a meta-analysis of both trials.
Rezultati izhajajo iz meta-analize obeh preskušanj.
See 4.2 and 4.4 for information on rest periods.
Glejte poglavji 4.2 in 4.4 za podatke o obdobjih prekinitve.
The significance for man is unknown.
Pomen tega opažanja za človeka ni poznan.
Dose proportionality was not observed.
Sorazmernost odmerka ni bila opazovana.
White to slightly yellow cream.
krema Bela do rahlo rumena krema.
Do not shower or bathe during this time.
V tem času se ne tuširajte ali kopajte.
Do not use this medication for more than one course if you have problems with your immune system, either due to illness or because of the medicines you are already taking.
Ne uporabite tega zdravila za več kot en cikel zdravljenja, če imate težave z vašim imunskim sistemom (ali zaradi bolezni ali zaradi zdravil, ki jih trenutno jemljete).
You must tell your doctor if you are pregnant or intend to become pregnant.
Svojega zdravnika morate opozoriti, če ste noseči oziroma nameravate zanositi.
Alternative forms of contraception should be considered.
Preučiti je potrebno druge oblike kontracepcije.
Aldara cream may be used for three different conditions.
Krema Aldara se lahko uporablja za tri različna stanja.
The maximum recommended dose is one sachet.
Priporočen maksimalni odmerek je ena vrečka.
• Tell your doctor if you have problems with your immune system.
• Obvestite zdravnika, če imate težave z imunskim sistemom.
Four weeks after finishing this first treatment, your doctor will assess your skin.
Štiri tedne po zaključku prvega zdravljenja bo vaš zdravnik ocenil kožo.
If this occurs you should seek medical help immediately.
Če pride do tega, nemudoma poiščite zdravniško pomoč.
Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended.
V zelo redkih primerih, so se pojavile hude in boleče reakcije, predvsem kadar je bilo uporabljene več kreme, kot je priporočeno.
Adults:
Pri odraslih:
The extent of percutaneous absorption did not change significantly between the first and last doses of this study.
Obseg perkutane absorpcije se v tej raziskavi ni pomenljivo spremenil med prvim in zadnjim odmerkom.
Mice were maintained for an additional 12 weeks for a total of 52 weeks.
Miši so opazovali še dodatnih 12 tednov (vse skupaj 52 tednov).
Do not store above 25 °C.
Shranjujte pri temperaturi do 25 C.
However, the incidences of hepatocellular tumours among treated animals were greater than those for controls.
Vendar pa je bila pojavnost hepatoceličnih tumorjev med zdravljenimi živalmi večja kot pri kontrolnih živalih.
However, in some cases these reactions have been severe, requiring treatment and/or causing incapacitation.
Vendar pa so bile v nekaterih primerih te reakcije hude in so zahtevale zdravljenje in/ali so povzročile nezmožnost.
Imiquimod has no direct antiviral activity.
Imikvimod nima neposrednega protivirusnega delovanja.
All patients were followed-up until withdrawal or up to 3 years after randomisation.
Vse bolnike so spremljali do umika iz študije ali do 3 leta po randomizaciji.
While these changes have tended to improve with time, in some patients they may be permanent.
Te spremembe so se s časoma popravile, vendar so pri določenih bolnikih lahko trajne.
These local skin reactions may be related to the stimulation of local immune response.
Te lokalne reakcije na koži se lahko povezane s stimulacijo lokalnega imunskega odziva.
• Avoid contact with the eyes, lips and nostrils.
• Preprečite stik z očmi, ustnicami in nosnicami.
Your doctor will discuss the risks and benefits of using Aldara cream during pregnancy.
Vaš zdravnik vas bo opozoril na tveganja in koristi uporabe kreme Aldara med nosečnostjo.
Treatment should be initiated and monitored by a physician.
Začetek in potek zdravljenja mora biti pod nadzorom zdravnika.
He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).
Zdravnik vam bo lahko priporočil prekinitev uporabe kreme Aldara za nekaj dni (tj. kratka prekinitev zdravljenja).
e) Paediatric population:
e) Pediatrična populacija:
Serious skin reactions have been reported rarely.
Poročila o resnih kožnih reakcijah so redka.
In younger patients aged 2-5 years absorption, based on Cmax values, was higher compared to adults.
Pri mlajših bolnikih od 2 - 5 let je bila absorbcija, na podlagi vrednosti Cmax, višja v primerjavi z odraslimi.
Remember, Aldara cream does not protect against giving HIV or other sexually transmitted diseases to someone else.
Upoštevajte, da krema Aldara ne prepreči prenosa virusa HIV ali drugih spolno prenosljivih bolezni na druge.
Follow-up information suggests that these skin colour changes may be permanent in some patients.
Spremljanje podatkov nakazuje, da so te spremembe barve kože pri nekaterih bolnikih lahko trajne.
It usually occurs in middle-aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure.
Običajno se pojavi pri srednje starih ali starih ljudeh, posebno tistih s svetlo kožo, in ga povzroči preveliko izpostavljanju soncu.
Some are skin coloured, others are greyish, pink, red or brown.
Pri nekaterih je koža obarvana, druge so sive, rožnate, rdeče ali rjave.
As soon as the problem has stopped you may restart to apply the cream.
Ko težave prenehajo, lahko ponovno začnete z nanašanjem kreme.
Treatments were given as officially recommended.
Zdravili sta bili uporabljeni v skladu z uradnimi priporočili.