natgillin/translations-raw huggingface dataset:
Kriptazen contains the active substance halofuginone and is a ‘generic medicine'.
Zdravilo Kriptazen vsebuje učinkovino halofuginon in je „generično zdravilo“.
This means that Kriptazen contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Halocur.
To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot referenčno zdravilo Halocur, ki je že odobreno v Evropski uniji (EU).
Safety information has been included in the summary of product characteristics and the package leaflet for Kriptazen, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila Kriptazen in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Kriptazen is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum.
Kriptazen je zdravilo, ki se uporablja za zdravljenje novorojenih telet, da se prepreči ali zmanjša driska, ki jo povzroči organizem, imenovan Cryptosporidium parvum.
For more information about using Kriptazen, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Kriptazen glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
It also limits the spread of the disease by preventing the formation of oocysts, which are a stage in the lifecycle of the parasite where it is infectious and which are passed in the faeces.
Prav tako omejuje širjenje bolezni s preprečevanjem nastajanja oocist, ki so razvojna stopnja življenjskega kroga zajedavca, ki so kužne in prehajajo v iztrebke.
This is a parasite belonging to the ‘protozoa' family that invades the digestive system, producing an infection called cryptosporidiosis that results in diarrhoea.
To je parazit iz družine „protozojev“, ki se naseli v prebavni sistem in povzroči okužbo, imenovano kriptosporidioza, ki povzroča drisko.
The active substance in Kriptazen, halofuginone lactate, prevents the growth of Cryptosporidium parvum.
Učinkovina v zdravilu Kriptazen, halofuginon laktat, preprečuje rast zajedavca Cryptosporidium parvum.
Kriptazen should be given after feeding.
Zdravilo Kriptazen je treba dati po krmljenju.
Kriptazen can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth).
Predpisovanje in izdaja zdravila Kriptazen je le na recept, na voljo pa je v obliki peroralne raztopine (tekočine za zaužitje skozi usta).
How is Kriptazen used?
Kako se zdravilo Kriptazen uporablja?
Therefore, the Agency's view was that, as for Halocur, the benefit of Kriptazen outweighs the identified risk and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Kriptazen enako kot pri zdravilu Halocur odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How does Kriptazen work?
Kako zdravilo Kriptazen deluje?
How has Kriptazen been studied?
Kako je bilo zdravilo Kriptazen raziskano?
1 Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Romania, Spain, Sweden, Slovenia, Slovakia and the United Kingdom
1 Avstrija, Belgija, Češka, Danska, Francija, Nemčija, Grčija, Irska, Italija, Poljska, Portugalska, Romunija, Španija, Švedska, Slovenija, Slovaška in Združeno kraljestvo
The European Commission issued a decision on 22 March 2016.
Evropska komisija je sklep izdala 22. marca 2016.
Outcome of a procedure under Article 78 of Directive 2001/82/EC
Izid postopka v skladu s členom 78 Direktive 2001/82/ES
Accordingly, the CVMP was requested to give its opinion on the matter concerning animal safety.
Odbor CVMP je bil v skladu s tem pozvan k predložitvi svojega mnenja o vprašanju varnosti živali.
Questions and answers on Closamectin Pour-On Solution and associated names EMA/672999/2015
Vprašanja in odgovori v zvezi z zdravilom Closamectin Pour-On Solution in povezanimi imeni EMA/672999/2015
Closamectin Pour-On Solution and associated names contain closantel and ivermectin and are authorised in several European Union (EU) Member States1 via decentralised and national procedures.
Zdravilo Closamectin Pour-On Solution in povezana imena vsebujejo klozantel in ivermektin ter so bila odobrena v več državah članicah Evropske unije (EU)1 z decentraliziranim postopkom in nacionalnimi postopki.
The product was also recalled at veterinary clinic and wholesale level.
Zdravilo je bilo odpoklicano tudi na ravni veterinarskih klinik in veleprodaje.
It was also recommended that the suspension of the marketing authorisation for CLOSAMECTIN POURON SOLUTION POUR BOVINS in France be lifted.
Priporočeno je bilo tudi, da se začasni umik dovoljenja za promet z zdravilom CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS v Franciji odpravi.
Between 25 May 2011 and 31 May 2015 the French medicines regulatory agency (Agence Nationale du Médicament Vétérinaire (ANMV)) received a total of 123 adverse event reports involving CLOSAMECTIN POUR-ON POUR BOVINS in which 401 animals were affected and 121 died.
Od 25. maja 2011 do 31. maja 2015 je francoska regulativna agencija za zdravila (Agence Nationale du Médicament Vétérinaire (ANMV)) prejela skupno 123 poročil o neželenih učinkih v zvezi z zdravilom CLOSAMECTIN POUR-ON POUR BOVINS, ki so zadevali 401 okuženo žival, od katerih jih je 121 poginilo.
Although the overall incidence of adverse events was considered to be within acceptable limits (0.006% in the last annual periodic safety update report ) the continued occurrence of serious adverse events and the severity of subsequent losses on farms in France were considered significant, which led to the suspension of the marketing authorisation in France on 6 July 2015.
Čeprav je bilo ocenjeno, da je skupna pojavnost neželenih učinkov znotraj dopustnih meja (0,006 % v zadnjem letnem redno posodobljenem poročilu o varnosti zdravila), so bili stalni pojavi resnih neželenih učinkov in resnost posledičnih poginov na kmetijah v Franciji ocenjeni kot pomembni, zaradi česar je bilo
• conditions of the marketing authorisations concerning risk mitigation and surveillance measures.
• se upoštevajo pogoji v zvezi z dovoljenjem za promet z zdravilom glede ukrepov za zmanjšanje tveganja in nadzornih ukrepov.
The adverse events principally related to neurological signs (ataxia, recumbency, paresis/paralysis and blindness) and/or gastrointestinal disorders (diarrhoea, anorexia etc.) some of which had a fatal outcome.
Neželeni učinki so se v glavnem nanašali na nevrološke znake (ataksijo, nezmožnost vstajanja, parezo/paralizo in slepoto) in/ali bolezni prebavil (diarejo, anoreksijo itd.); nekateri so se končali s poginom.
Questions and answers on Closamectin Pour-On Solution and associated names
Vprašanja in odgovori v zvezi z zdravilom Closamectin Pour-On Solution in povezanimi imeni
On 8 October 2015, the European Medicines Agency (the Agency) completed a review of the animal safety of Closamectin Pour-On Solution and associated names.
Evropska agencija za zdravila (EMA) je 8. oktobra 2015 zaključila pregled varnosti zdravila Closamectin Pour-On Solution in povezanih imen pri živalih.
This included a review of scientific literature regarding the pharmacology and toxicology of ivermectin and closantel, cumulative pharmacovigilance experience following use of the products in the EU since 2009, a comparison with ivermectin-based products and with ivermectin/closantel injectable formulations held by the MAH, investigations carried out by the MAH to identify possible factors involved in reported adverse events and proposals for risk mitigation measures and actions.
Ti so vključevali pregled znanstvene literature glede farmakoloških in toksikoloških značilnosti ivermektina in klozantela, skupne farmakovigilančne izkušnje, ki izhajajo iz uporabe teh zdravil v EU od leta 2009, primerjavo z zdravili, ki temeljijo na ivermektinu, in s formulacijami ivermektina/klozantela za injiciranje, ki jih proizvaja imetnik dovoljenja za promet z zdravilom, preiskave, ki jih je izvedel imetnik dovoljenja za promet z zdravilom, da bi opredelil morebitne dejavnike, ki so vplivali na neželene učinke, o katerih so poročali, ter predloge za ukrepe za zmanjšanje tveganja.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of Closamectin Pour-On Solution and associated names continue to outweigh their risks subject to:
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru je odbor CVMP zaključil, da koristi zdravila Closamectin Pour-On Solution in povezanih imen še vedno odtehtajo tveganja, če:
Why were Closamectin Pour-On Solution and associated names reviewed?
Zakaj so bili zdravilo Closamectin Pour-On Solution in povezana imena pregledani?
• variation of the marketing authorisations for Closamectin Pour-On Solution and associated names to amend the summary of product characteristics and package leaflet to include new precautionary measures and adverse reactions; and
• se spremenijo dovoljenja za promet z zdravilom Closamectin Pour-On Solution in povezanimi imeni tako, da se spremenita povzetek glavnih značilnosti zdravila in navodilo za uporabo, tako da vključujeta nove previdnostne ukrepe in neželene učinke; ter
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Closamectin Pour-On Solution and associated names continue to outweigh their risks subject to variation of the marketing authorisations to include new adverse reactions and precautionary measures and conditions concerning risk mitigation and surveillance measures.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da koristi zdravila Closamectin Pour-On Solution in povezanih imen še vedno odtehtajo tveganja, če se spremenijo dovoljenja za promet z zdravilom, tako da vključujejo nove neželene učinke in previdnostne ukrepe, ter se upoštevajo pogoji glede ukrepov za zmanjšanje tveganja in nadzornih ukrepov.
What is Closamectin Pour-On Solution and associated names?
Kaj so zdravilo Closamectin Pour-On Solution in povezana imena?
To investigate the potential relation between the adverse events observed and Closamectin Pour-On Solution and associated names, the CVMP considered the data provided by the marketing authorisation holder (MAH).
Da bi odbor CVMP raziskal morebitno povezavo med opaženimi neželenimi učinki in zdravilom Closamectin Pour-On Solution in povezanimi imeni, je proučil podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom.
On 19 June 2015, France triggered a procedure under Article 78 of Directive 2001/82/EC for Closamectin Pour-On Solution and associated names following evaluation of pharmacovigilance data indicating serious concerns for animal safety and subsequent suspension of the marketing authorisation for the product.
Francija je 19. junija 2015 po oceni farmakovigilančnih podatkov, ki so pokazali resno zaskrbljenost za varnost živali, in poznejšem začasnem umiku dovoljenja za promet z zdravilom sprožila postopek iz člena 78 Direktive 2001/82/ES za zdravilo Closamectin Pour-On Solution in povezana imena.
in and blisters (exanthemous pustulosis).
Driska pogosti
(this is a minimum volume).
(to je najmanjša količina).
Not known (cannot be estimated from the available data)
Neznano (ni mogoče oceniti na podlagi podatkov, ki so na voljo)
<{Tel}> <{Fax}> <{e-mail}>
{Ime in naslov} <{Tel}> <{Fax}> <{e-mail}>
After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Po odločbi komisije bodo pristojni organi držav članic v povezavi z referenčno državo članico posodobili informacije o zdravilu, kot bo potrebno.
The possibility of sensitisation should be taken into account.
Upoštevati je treba možnost senzibilizacije.
These are usually reversible.
Po navadi so reverzibilni.
This is so they can be swallowed more easily.
Na ta način jih lažje pogoltnete.
These events have been very rarely reported in children.
Zelo redko so bili ti dogodki opisani pri otrocih.
Your doctor may repeat the dose if your surgery takes longer than 1 hour.
Zdravnik lahko odmerek ponovi, če operacija traja več kot 1 uro.
Don't drive or operate machinery unless you are feeling well.
Ne vozite in ne upravljajte strojev, če se ne počutite dobro.
Dosing recommendations in this population therefore cannot be made.
Zato za to populacijo ni mogoče dati priporočil za odmerjanje.
Urinary recovery (%, 0 to 6 h )
Pojavljanje v urinu (%, 0 do 6 h )
The plasma profiles of both components are similar and the time to peak plasma concentration (Tmax) in each case is approximately one hour.
Plazemska profila obeh učinkovin sta podobna in čas do največje koncentracije v plazmi (tmax) je v obeh primerih približno eno uro.
This is not intended to reduce the dose of medication: both halves must be taken at the same time.
Zareza ni namenjena za zmanjševanje odmerka zdravila: bolnik mora obe polovici vzeti hkrati.
In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased.
V vseh populacijah se znaki in simptomi po navadi pojavijo med zdravljenjem ali kmalu po njem, včasih pa se razvijejo šele več tednov po prenehanju zdravljenja.
Other micro-organisms
Drugi mikroorganizmi
Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.
Dobra ustna higiena lahko pomaga preprečiti obarvanje zob, ker ga je po navadi mogoče odstraniti s ščetkanjem.
The following terminologies have been used in order to classify the occurrence of undesirable effects.
Za razvrstitev pojavljanja neželenih učinkov so uporabljeni naslednji izrazi.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Po potrebi je treba poiskati nasvet strokovnjaka, če je lokalna prevalenca odpornosti takšna, da je uporabnost tega zdravila vsaj pri nekaterih vrstah okužb vprašljiva.
The duration of therapy should be determined by the response of the patient.
Trajanje zdravljenja je treba določiti glede na bolnikov odziv.
Symptoms and signs of overdose
Simptomi in znaki prevelikega odmerjanja
Shake the bottle before each dose (see section 6.6).
Stekleničko pretresite pred vsakim odmerkom (glejte poglavje 6.6).
The prevalence of resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Prevalenca odpornosti za izbrane vrste se lahko razlikuje zemljepisno in v času, zato so zaželene lokalne informacije o odpornosti, zlasti pri zdravljenju hudih okužb.
• You will not normally be given Augmentin for longer than 2 weeks without the doctor reviewing your treatment.
• Običajno ne boste prejemali zdravila Augmentin dlje kot dva tedna, ne da bi zdravnik ponovno preučil vaše zdravljenje.
In the case of clavulanic acid, the largest amount of drug is excreted during the first 2 hours after administration.
V primeru klavulanske kisline se največja količina zdravila izloči v prvih 2 urah po uporabi.
Children < 16 years
Otroci < 16 let
Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant).
Obe snovi se izločata v materinem mleku (o vplivih klavulanske kisline na dojenega otroka ni nič znanega).
Both halves of each tablet must be taken at the same time.
Obe polovici tablete morate pogoltniti istočasno.
Some infections (e.g. osteomyelitis) require longer periods of treatment.
Nekatere okužbe (npr. osteomielitis) zahtevajo dolgotrajnejše zdravljenje.
Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction.
Peroralni antikoagulansi in penicilinski antibiotiki so bili v praksi široko uporabljani, ne da bi bila zabeležena kakšna medsebojna delovanja.
For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination.
Pri zelo mladih otrocih (vključno z nedonošenimi novorojenčki) v prvem tednu življenja interval uporabe zaradi nezrelosti ledvične poti izločanja ne sme presegati dajanja dvakrat na dan.
Advice/medical education
Nasvet/zdravstvena vzgoja
The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and adults.
Eliminacijski razpolovni čas amoksicilina je podoben pri otrocih od približno 3 mesecev do 2 let starosti, starejših otrocih in odraslih.
Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose.
Amoksicilin se delno izloči v urinu kot neaktivna penicilojska kislina v količinah, ki ustrezajo od 10 do 25 % začetnega odmerka.
Adults and children over 16 years The usual dose is:
Odrasli in otroci, starejši od 16 let Običajen odmerek je:
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Dolgotrajna uporaba lahko občasno povzroči razrast neobčutljivih organizmov.
To stop infections during and after surgery
Za zaustavitev okužb med operacijami in po operacijah
If some bacteria survive they can cause the infection to come back.
Če nekatere bakterije preživijo, lahko povzročijo ponovitev okužbe.
This medicine is usually prescribed for a baby or child. Do not pass it on to others.
- To zdravilo je ponavadi predpisano dojenčku ali otroku in ga ne smete dajati drugim.
If you forget to take a dose, take it as soon as you remember.
Če pozabite vzeti odmerek, ga vzemite, čim se spomnite.
Concomitant use of probenecid is not recommended.
Sočasna uporaba probenecida se ne priporoča.
Both components are rapidly and well absorbed by the oral route of administration.
Obe učinkovini se po peroralni uporabi hitro in dobro absorbirata.
However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8).
Vendar se lahko pojavijo neželeni učinki (npr. alergijske reakcije, omotica, konvulzije), ki lahko vplivajo na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4.8).
Blood and urine tests
Preiskave krvi in urina
Volume of water to be added at reconstitution (ml)
Količina vode, ki jo je treba dodati pri pripravi (ml)
Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.
Jasni klinični znaki okužbe pri operaciji zahtevajo normalen ciklus intravenskega ali peroralnega zdravljenja pooperativno.
For susceptibility testing purposes, the concentration of Clavulanic acid is fixed at 2 mg/l.
Za namene preizkušanja občutljivosti je koncentracija klavulanske kisline fiksirana pri 2 mg/l.
About 25% of total plasma clavulanic acid and 18% of total plasma amoxicillin is bound to protein.
Približno 25 % celotne količine klavulanske kisline v plazmi in 18 % celotne količine amoksicilina v plazmi je vezanih na beljakovine.
It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days.
1 Zelo pomembno je, da antibiotik jemljete v pravem odmerku, ob pravem času in pravo število dni.
Adults and adolescents  16 years
Odrasli in mladostniki ≥ 16 let
4 The resistant breakpoint of R>8 mg/l ensures that all isolates with resistance mechanisms are reported resistant.
4 Mejna vrednost odpornosti R > 8 mg/l zagotavlja, da so vsi izolati s tem mehanizmom odpornosti prijavljeni kot odporni.
Clavulanic acid alone does not exert a clinically useful antibacterial effect.
Klavulanska kislina sama nima klinično uporabnega protibakterijskega učinka.
• Acute otitis media
• akutni otitis media
Anaerobic micro-organisms Bacteroides fragilis Fusobacterium nucleatum Prevotella spp.
Anaerobni mikroorganizmi Bacteroides fragilis Fusobacterium nucleatum Prevotella spp.
Blood and lymphatic system disorders Reversible leucopenia (including neutropenia)
Bolezni krvi in limfatičnega sistema Reverzibilna levkopenija (vključno z nevtropenijo)
These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals.
Te reakcije so verjetnejše pri osebah z anamnezo preobčutljivosti za penicilin in pri atopičnih posameznikih.
Consideration should be given to local guidelines on appropriate dosing frequencies for amoxicillin/clavulanic acid.
Upoštevati je treba lokalne smernice glede ustrezne pogostnosti odmerjanja amoksicilin/klavulanske kisline.
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Penicilini lahko zmanjšajo izločanje metotreksata in tako lahko povečajo toksičnost.
Hepatic events may be severe and, in extremely rare circumstances, deaths have been reported.
Jetrni dogodki so lahko hudi in v izredno redkih okoliščinah so bili opisani smrtni primeri.
Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment.
Jetrni dogodki so bili opisani predvsem pri moških in starejših bolnikih in so morda povezani z dolgotrajnim zdravljenjem.
ND − Not determined * Median (range) ^ for an MIC of 4 mg/l
ND − ni določeno * Mediana (razpon) ^ za MIK 4 mg/l
A transient pink colouration may or may not develop during reconstitution.
Med pripravo se lahko pojavi prehodno rožnato obarvanje ali pa tudi ne.
The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin.
Čas, ko koncentracija v serumu ostane nad minimalno inhibicijsko koncentracijo (t >MIK) velja kot glavna determinanta učinkovitosti amoksicilina.
Treatment should not be extended beyond 14 days without review.
Zdravljenja se ne sme podaljšati preko 14 dni brez ponovne ocene stanja.
Anti-peristaltic medicinal products are contra-indicated in this situation.
Antiperistaltična zdravila so v takšnem primeru kontraindicirana.
Stevens-Johnson syndrome
Stevens-Johnsonov sindrom neznano
Use should be avoided during pregnancy, unless considered essential by the physician.
Uporabi med nosečnostjo se je treba izogibati, razen če zdravnik presodi, da je nujna.
• Inactivation by those bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including class B, C and D.
• Inaktivacija s tistimi bakterijskimi beta-laktamazami, ki jih ne zavre klavulanska kislina, vključno s skupinami B, C in D.
You should use this to give the correct dose to your baby or child.
Uporabite jo, da boste svojemu dojenčku ali otroku dali pravilen odmerek.
Add volume of water (as indicated below) invert and shake well.
Dodajte količino vode (ki je navedena spodaj), obrnite in dobro pretresite.
Bacteria can become resistant to antibiotics for many reasons.
Bakterije lahko postanejo odporne proti antibiotikom zaradi številnih razlogov.
• Augmentin will be given as an injection into a vein or by intravenous infusion.
• Zdravilo Augmentin boste dobili v obliki injekcije v veno ali v obliki intravenske infuzije.
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall.
Amoksicilin je polsintetski penicilin (betalaktamski antibiotik), ki zavira enega ali več encimov (beljakovine, ki vežejo penicilin) v biosintezni poti bakterijskega peptidoglikana, ki je integralna sestavina zgradbe bakterijske celične stene.
2 Strains with decreased susceptibility have been reported in some countries in the EU with a frequency higher than 10%.
2 V nekaterih državah EU so bili sevi z zmanjšano občutljivostjo opisani s pogostnostjo nad
3 At the site of injection
3 Na mestu injiciranja.