natgillin/translations-raw huggingface dataset:
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.
$ Natural intermediate susceptibility in the absence of acquired mechanism of resistance. 
$ Naravna srednja občutljivost brez mehanizma pridobljene odpornosti.
Prolongation of bleeding time and prothrombin time1 
Podaljšanje časa krvavitve in protrombinskega časa1
Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. 
Zavrtje sinteze peptidoglikana oslabi celično steno, temu po navadi sledi liza celice in smrt.
• Head and neck 
• glave in vratu,
This is in order to avoid administration of unnecessarily high daily doses of clavulanic acid. 
Namen tega je, da bi se izognili uporabi nepotrebno velikih dnevnih odmerkov klavulanske kisline.
Higher dose 
Višji odmerek
From animal studies there is no evidence for significant tissue retention of drug-derived material for either component. 
Študije na živalih v tkivih niso pokazale znakov bistvenega zadrževanja snovi, nastalih iz katerekoli od obeh učinkovin.
Amoxicillin, like most penicillins, can be detected in breast milk. 
Tako kot večino penicilinov je tudi amoksicilin mogoče najti v materinem mleku.
Children < 40 kg (aged  3 months) 
Otroci < 40 kg (stari ≥ 3 mesece)
Germany - Augmentan IV 
Nemčija - Augmentan IV
When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. 
Ko vam zdravnik predpiše antibiotik, je ta namenjen le za zdravljenje vaše trenutne bolezni.
Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the: 
Profilaksa pred okužbami, povezanimi z večjimi kirurškimi posegi pri odraslih, npr.:
• Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target. 
• Sprememba penicilin-vežočih beljakovin (PBP), ki zmanjša afiniteto protibakterijskega zdravila za tarčo.
Do not use Augmentin after the expiry date which is stated on the carton. 
Zdravila Augmentin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
For treatment of infections as indicated in section 4.1: 1000 mg/ 200 mg every 8 hours 
Za zdravljenje okužb, kot je navedeno v poglavju 4.1: 1000 mg/200 mg na 8 ur
Final volume of reconstituted oral suspension (ml) 
Končna količina pripravljene peroralne suspenzije (ml)
This means that they can survive and even multiply despite the antibiotic. 
To pomeni, da lahko bakterije kljub antibiotiku preživijo in se celo razmnožujejo.
Mycoplasma pneumoniae $ Natural intermediate susceptibility in the absence of acquired mechanism of resistance. 
Mycoplasma pneumoniae $ Naravna srednja občutljivost brez mehanizma pridobljene odpornosti.
Treatment should not be extended beyond 14 days without review (see section 4.4 regarding prolonged therapy). 
Zdravljenja se ne sme podaljšati preko 14 dni brez ponovne ocene stanja (glejte poglavje 4.4. glede dolgotrajnega zdravljenja).
The recommended dose of Augmentin is two tablets twice a day. 
Priporočeni odmerek zdravila Augmentin je dve tableti dvakrat na dan.
Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria. 
Nepermeabilnost bakterij ali mehanizmi efluksne črpalke lahko povzročijo odpornost bakterij ali pripomorejo k takšni odpornosti, zlasti pri gramnegativnih bakterijah.
Germany - Augmentan 
Nemčija - Augmentan
• The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) 
• pričakovane patogene in verjetnost njihove občutljivosti za protibakterijska zdravila (glejte poglavje 4.4)
• hyperactivity 
• hiperaktivnost,
In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. 
V eni sami študiji pri ženskah s predčasnim, prezgodnjim pretrganjem plodove ovojnice je bilo opisano, da je lahko profilaktično zdravljenje z amoksicilin/klavulansko kislino povezano z večjim tveganjem nekrotizirajočega enterokolitisa pri novorojenčkih.
• The age, weight and renal function of the patient as shown below. 
• bolnikovo starost, telesno maso in delovanje ledvic, kot je prikazano spodaj.
The dose can differ depending on the type of operation you are having. 
Odmerek se lahko spreminja v odvisnosti od vrste operacije.
Amoxicillin does not adequately distribute into the cerebrospinal fluid. 
Amoksicilin se ne porazdeli ustrezno v cerebrospinalno tekočino.
• stained teeth (in children), usually removed by brushing. 
• obarvanje zob (pri otrocih), ki ga je po navadi mogoče odstraniti s ščetkanjem.
• diarrhoea (in adults). 
• driska (pri odraslih).
Absorption of amoxicillin/clavulanic acid is optimised when taken at the start of a meal. 
Absorpcija amoksicilina/klavulanske kisline je optimalna, če sta uporabljena na začetku obroka.
Talk to your doctor as soon as possible. 
Čim prej se posvetujte z zdravnikom.
There is no experience with Augmentin suspension in adults and children  40 kg, and therefore no dose recommendation can be given. 
S suspenzijo zdravila Augmentin ni izkušenj pri odraslih in otrocih s telesno maso ≥ 40 kg in zato ni mogoče dati priporočil za odmerjanje.
• Make sure you drink plenty of fluids while having Augmentin. 
• Poskrbite, da boste med zdravljenjem z zdravilom Augmentin zaužili dovolj tekočine.
• increase in some substances (enzymes) produced by the liver. 
• zvišanje nekaterih snovi (encimov), ki jih izdelujejo jetra.
The apparent volume of distribution is around 0.3-0.4 l/kg for amoxicillin and around 0.2 l/kg for clavulanic acid. 
Navidezni volumen porazdelitve je približno 0,3-0,4 l/kg za amoksicilin in približno 0,2 l/kg za klavulansko kislino.
The total serum clearance of amoxicillin/clavulanic acid decreases proportionately with decreasing renal function. 
Celotni serumski očistek amoksicilina/klavulanske kisline se zmanjšuje sorazmerno z zmanjševanjem delovanja ledvic.
Therefore, positive test results in patients receiving amoxicillin/clavulanic acid should be interpreted cautiously and confirmed by other diagnostic methods. 
Zato je treba pozitivne izvide pri bolnikih, ki dobivajo amoksicilin/klavulansko kislino, tolmačiti previdno in jih potrditi z drugimi diagnostičnimi metodami.
Antibiotic-associated colitis4 
Z antibiotikom povezani kolitis4
Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes. 
Amoksicilin je občutljiv za razgradnjo z betalaktamazami, ki jih proizvaja rezistentna bakterija, in zato spekter delovanja samega amoksicilina ne zajema organizmov, ki izdelujejo te encime.
• Allergic reactions (see above) 
• alergijske reakcije (glejte zgoraj),
The dose of Augmentin that is selected to treat an individual infection should take into account: 
Pri izbiri odmerka zdravila Augmentin za zdravljenje posamezne okužbe je treba upoštevati:
Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid. 
Sočasna uporaba probenecida lahko povzroči povečanje in podaljšanje koncentracije amoksicilina v krvi, ne pa tudi klavulanske kisline.
This can include a skin rash or swelling of the face or neck 
Ta lahko obsega izpuščaj na koži ali oteklost obraza ali vratu.
At recommended doses of up to 1000 mg/100 mg every 8 hours, this presentation may not be suitable for treatment of penicillin-resistant S. pneumoniae. 
V priporočenih odmerkih do 1000 mg/100 mg na 8 ur je ta oblika lahko neprimerna za zdravljenje S. pneumoniae, odpornega proti penicilinu.
Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. 
Med sočasno uporabo antikoagulansov so potrebne ustrezne kontrole.
Do not take 2 doses in 1 hour. 
Ne vzemite 2 odmerkov v 1 uri.
Overgrowth of non-susceptible organisms 
Razrast neobčutljivih organizmov neznano
• Space the doses evenly during the day, at least 4 hours apart. 
• Odmerke razvrstite enakomerno čez dan s presledkom vsaj 4 ure.
They have no effect against infections caused by viruses. 
Nobenega učinka nimajo proti okužbam, ki jih povzročajo virusi.
Children under 16 years Augmentin tablets are not recommended. 
Otroci, mlajši od 16 let Uporaba zdravila Augmentin tablet ni priporočljiva.
However, in the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. 
Vendar so v literaturi opisani primeri povečanja internacionalnega normaliziranega razmerja pri bolnikih, ki so jemali acenokumarol ali varfarin, in so dobili ciklus amoksicilina.
Augmentin vials are not suitable for multi-dose use. 
Viale zdravila Augmentin niso primerne za večodmerno uporabo.
Reconstituted solutions are normally colourless or a pale straw colour. 
Pripravljene raztopine so po navadi brezbarvne ali blede slamnate barve.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 
Ker je verjetnost zmanjšanega delovanja ledvic pri starejših bolnikih večja, jim je treba odmerek določiti previdno, koristno pa je tudi nadziranje delovanja ledvic.
Spain - Augmentine Intravenoso 
Španija - Augmentine Intravenoso
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. 
Sočasna uporaba alopurinola med zdravljenjem z amoksicilinom lahko poveča verjetnost alergijskih kožnih reakcij.
It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. 
Inaktivira nekatere betalaktamaze in tako prepreči inaktivacijo amoksicilina.
Commonly susceptible species 
Pogosto občutljive vrste
Serum sickness-like syndrome 
Serumski bolezni podoben sindrom neznano
Dispersible tablets should be stirred into a little water before taking. 
Disperzibilne tablete je treba pred zaužitjem zmešati z majhno količino vode.
6.2 Incompatibilities [To be completed nationally] 
6.2 Inkompatibilnosti [Izpolni država članica]
Spain - Augmentine, Clavumox 
Španija - Augmentine, Clavumox
Add 91 ml water, invert and shake well. 
Dodajte 91 ml vode, obrnite in dobro pretresite.
Denmark - Spektraforte 
Danska - Spektraforte
• diarrhoea (in children). 
• driska (pri otrocih).