natgillin/translations-raw huggingface dataset:
The residue depletion study in milk was considered acceptable, but the recommended method for the calculation of a milk withdrawal period according to the CVMP note for guidance for the determination of withdrawal periods in milk (EMEA/CVMP/473/98)3 - the Time to safe concentration (TTSC) methodcannot be used due to the insufficient number of animals included in the study.
Študijo izločanja ostankov za mleko so ocenili kot sprejemljivo, vendar priporočenega načina za izračun karence za mleko v skladu z navodili CVMP za določitev karenc za mleko (EMEA/CVMP/473/98)3 - s pristopom časa do varne koncentracije (TTSC) - ni mogoče uporabiti zaradi nezadostnega števila živali, vključenih v študijo.
Therefore, none of the studies was conducted at the maximum intended dose as requested in VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)1 and safe withdrawal periods in cattle tissues and milk can only be set for single treatment.
Zato nobena od študij ni bila izvedena pri največjem predvidenem odmerku, kot je bilo zahtevano v VICH GL48: Študije za oceno presnove in kinetike ostankov zdravil za uporabo v veterinarski medicini pri živalih, namenjenih za proizvodnjo hrane: študije izločanja ostankov označevalca za izračun karenc zdravil (EMA/CVMP/VICH/463199/2009)1, in varne karence pri tkivih goveda in mleku se lahko določijo samo za enkratno zdravljenje.
• the CVMP considered that the overall benefit-risk balance is positive for Dexadreson 2 mg/ml and associated names, and generic products thereof subject to amendments in the product information; the CVMP has recommended variations of the marketing authorisations for Dexadreson 2 mg/ml and associated names, and generic products thereof (see annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in annex III.
• CVMP je menil, da je celokupno razmerje med tveganji in koristmi za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila pozitivno, če se upoštevajo spremembe v informacijah o zdravilu; je CVMP priporočil spremembe dovoljenj za promet z zdravilom Dexadreson 2 mg/ml in povezanimi imeni ter njegovimi generičnimi zdravili (glejte prilogo I), da se dopolni povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo v skladu s priporočenimi spremembami v informacijah o zdravilu, navedenih v prilogi III.
No safe withdrawal period for these dosages can be set and the CVMP considered that the shock indication should be withdrawn from the product information of Dexadreson and its generic products, where applicable.
Določiti ni mogoče nobene varne karence za te odmerke in CVMP je menil, da je treba indikacijo šoka izključiti iz informacij o zdravilu Dexadreson in njegovih generičnih zdravilih, kjer je primerno.
DOSAGES FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE
In the absence of residue depletion data at the maximum intended dose and further to the concerns expressed above, the marketing authorisation holders agreed to remove the advice on repeat dose treatment after 24-48 hours in cattle from the product information.
Zaradi odsotnosti podatkov o izločanju ostankov pri največjem predvidenem odmerku in zgoraj navedenih zadržkov so se imetniki dovoljenj za promet z zdravili strinjali, da se iz informacij o zdravilu odstrani nasvet o zdravljenju s ponovnim odmerkom po 24 do 48 urah pri govedu.
Therefore a 20% safety span was applied to the observed period of 60 hours, resulting in a withdrawal period of 72 hours, i.e. 3 days, in milk from cows treated at a single dose of 0.06 mg dexamethasone per kg body weight.
Zato je bil za opazovano obdobje 60 ur uporabljen 20-odstotni varnostni razpon, kar je povzročilo 72-urno karenco, tj. 3 dni, za mleko krav, zdravljenih z enkratnim odmerkom 0,06 mg deksametazona na kg telesne mase.
Applicant/marketing authorisation holder
Imetnik dovoljenja za promet z zdravilom
• In the absence of residue depletion or pharmacokinetic data for the higher dosages recommended for the indication concerning treatment of shock in horses, no safe withdrawal period for these dosages can be set for Dexadreson 2 mg/ml and associated names, and generic products thereof.
• zaradi odsotnosti podatkov o izločanju ostankov in farmakokinetičnih podatkov za višje odmerke, priporočene za indikacijo zdravljenja šoka pri konjih, za te odmerke ni mogoče določiti nobene varne karence za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila.
As there were no residue depletion data with the recommended repeat dose treatment in cattle and horses, the CVMP concluded that the advice on repeat dose treatment in cattle and horses should be removed from the product information.
Ker niso bili predloženi nobeni podatki o izločanju ostankov pri zdravljenju s priporočenim ponovnim odmerkom pri govedu in konjih, je CVMP zaključil, da je treba nasvet o zdravljenju s ponovnim odmerkom pri govedu in konjih izbrisati iz informacij o zdravilu.
• In the absence of residue depletion or pharmacokinetic data following a repeat treatment in cattle and horses for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that the advice on repeat dose treatment after 24-48 hours in cattle and horses should be removed from the product information;
• zaradi odsotnosti podatkov o izločanju ostankov in farmakokinetičnih podatkov po ponovnem zdravljenju pri govedu in konjih za zdravilo Dexadreson 2 mg/ml in povezana imena ter njegova generična zdravila je CVMP menil, da je treba nasvet o zdravljenju s ponovnim odmerkom po 24 do 48 urah pri govedu in konjih iz informacij o zdravilu odstraniti;
The same withdrawal period for edible tissues may be applied for cattle and horses for the same dosing regimen, resulting in a withdrawal period for horse meat and offal of 8 days for the single dose treatment of 0.06 mg dexamethasone per kg body weight.
Za govedo in konje se lahko uporabi enaka karenca za užitna tkiva za enak režim odmerjanja, kar povzroči karenco za konjsko meso in drobovino 8 dni za zdravljenje z enkratnim odmerkom 0,06 mg deksametazona na kg telesne mase.
Residue depletion data was made available and supported a cattle meat and offal withdrawal period of 8 days and a cattle milk withdrawal period of 72 hours, as well as a horse meat and offal withdrawal period of 8 days following a single injection at the recommended dose of 0.06 mg dexamethasone per kg body weight.
Podatki o izločanju ostankov so bili predloženi in so podpirali 8-dnevno karenco za goveje meso in drobovino, 72-urno karenco za goveje mleko ter 8-dnevno karenco za konjsko meso in drobovino po enkratnem injiciranju pri priporočenem odmerku 0,06 mg deksametazona na kg telesne mase.
As there were no data available to support safe withdrawal periods for horse meat and offal following administration of high dosages in case of treatment of shock, the CVMP concluded that the shock indication in horses should be removed from the product information for Dexadreson and its generic products, where applicable.
Ker niso bili predloženi nobeni podatki v podporo varnih karenc za konjsko meso in drobovino po dajanju visokih odmerkov v primeru zdravljenja šoka, je CVMP zaključil, da je treba indikacijo šoka odstraniti iz informacij o zdravilu Dexadreson in njegovih generičnih zdravilih, kjer je primerno.
• On the basis of the residue depletion data in cattle and the pharmacokinetic data in horses submitted by the marketing authorisation holders for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that withdrawal periods of 8 days for cattle meat and offal, 72 hours for cattle milk and 8 days for horse meat and offal were safe;
• na podlagi podatkov o izločanju ostankov pri govedu in farmakokinetičnih podatkov pri konjih, ki so jih predložili imetniki dovoljenj za promet z zdravilom Dexadreson 2 mg/ml in povezanimi imeni ter njegovimi generičnimi zdravili, je CVMP menil, da so varne 8-dnevna karenca za goveje meso in drobovino, 72-urna karenca za goveje mleko in 8-dnevna karenca za konjsko meso in drobovino;
Six days after administration the residue concentrations were
Šest dni po dajanju so bile koncentracije ostankov pod vrednostmi MRL v ledvicah in jetrih.
Cattle, pigs, dogs and cats
Govedo, prašiči, psi in mačke
Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Spremembe v določenih poglavjih povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
Cattle, horses, goat, pigs, dogs and cats
Govedo, konji, koze, prašiči, psi in mačke
The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products are solutions for injection which contain 2 mg dexamethasone per ml.
Zdravilo za uporabo v veterinarski medicini Dexadreson 2 mg/ml in povezana imena ter generična zdravila so raztopine za injiciranje, ki vsebujejo 2 mg deksametazona na ml. Deksametazon je dolgo delujoči sintetični glukokortikoid, ki se uporablja proti vnetjem, alergijam in kot glukoneogena snov za dajanje kmetijskim in domačim živalim.
No residue depletion or pharmacokinetic data are available for the much higher dosages recommended for the treatment of shock in horses.
Za veliko višje odmerke, priporočene za zdravljenje šoka pri konjih, niso na voljo nobeni podatki o izločanju ostankov ali farmakokinetični podatki.
Elimination through urine is negligible (<1%).
Izločanje z urinom je zanemarljivo (<1%).
However, the potential for adverse reactions cannot be ruled out and general supportive measures are recommended.
Vseeno pa možnosti za neželene učinke ni mogoče izključiti in se priporočajo splošni podporni ukrepi.
− decreased appetite
− zmanjšan apetit
The bioavailability in humans is unknown.
Biološka razpoložljivost pri ljudeh ni znana.
Date of latest renewal: 22 August 2016
Datum zadnjega podaljšanja: 22. avgust 2016
Adults and elderly (≥65 years of age)
Odrasli in starejši (≥ 65 let)
Swallow the tablets whole with a glass of water.
Tableto pogoltnite celo s kozarcem vode.
This serious illness can result in painful, severe diarrhoea.
To resno obolenje ima lahko za posledico bolečo, hudo drisko.
This difference is not considered clinically relevant.
Ta razlika ni klinično pomembna.
Antimicrobial spectrum
Antimikrobni spekter
Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Upoštevati je treba uradne smernice za pravilno uporabo antibiotikov.
If you stop taking this medicine too soon, the infection may come back.
Če prenehate jemati zdravilo prezgodaj, se okužba lahko ponovi.
Take the tablet as soon as you remember, unless it is time for the next dose.
Vzemite tableto takoj, ko se spomnite, razen če je že čas za naslednji odmerek.
Description of the patient population in clinical trials
Opis populacije bolnikov v kliničnih preskušanjih
Take the medicine pack with you so the doctor knows what you have taken.
Pakiranje zdravila vzemite s seboj, da bo zdravnik vedel, kaj ste vzeli.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 December 2011
Datum prve odobritve: 5. december 2011
This is because it is not known whether fidaxomicin can harm your baby.
To je zato, ker ni znano, ali lahko fidaksomicin škoduje vašemu otroku.
The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established.
Varnost in učinkovitost fidaksomicina pri otrocih, mlajših od 18 let, še nista bili dokazani.
DIFICLIR can be taken with or without food.
Zdravilo DIFICLIR se lahko vzame s hrano ali brez nje.
Other possible side effects are the following:
Drugi možni neželeni učinki so:
The half life of fidaxomicin is approximately 8-10 h.
Razpolovna doba fidaksomicina je približno 8-10 ur.
In the pivotal clinical trials the rate of recurrence in the 30 days following treatment was assessed as a secondary endpoint.
V osrednjih kliničnih preskušanjih je bil ponovni pojav v 30. dneh po zdravljenju ocenjen kot druga končna točka.
Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov glede reprodukcijske toksičnosti.
The frequency of adverse reactions is defined as follows: 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 po pogostnosti opredeljeni kot: 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) ali zelo redki (<1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
If a severe allergic reaction occurs during treatment with DIFICLIR, the medicinal product should be discontinued and appropriate measures taken.
Če se med zdravljenjem z zdravilom DIFICLIR pojavi huda alergijska reakcija, je treba zdravilo ukiniti in sprejeti ustrezne ukrepe.
DIFICLIR should not be used in children or adolescents aged below 18 years as there is no information on this use in this population.
Zdravila DIFICLIR ne uporabljajte za otroke ali mladostnike do 18 let, ker pri tej skupini ni podatkov za to uporabo.
As a precautionary measure, it is preferable to avoid the use of DIFICLIR during pregnancy.
Iz previdnostnih razlogov je bolje, da zdravila DIFICLIR med nosečnostjo ne uporabljate.
If you have taken more tablets than you should have, talk to a doctor.
Če ste vzeli več tablet, kot bi morali, se posvetujte z zdravnikom.
− dry mouth, altered taste (dysgeusia)
− suha usta, spremenjen okus (disgevzija)
Your doctor will know whether your disease falls in the severe categories and will tell you whether this medicine is suitable for you.
Vaš zdravnik bo vedel, ali sodi vaša bolezen v kategorijo hudih obolenj in vam povedal, ali je to zdravilo za vas primerno.
Plasma levels appear to be elevated in the elderly (age ≥ 65 years).
Zdi se, da se koncentracije v plazmi povečajo pri starejših (≥ 65 let).
Although no effects on the breastfed newborns/infants are anticipated since the systemic exposure to fidaxomicin is low, a risk to the newborns/infants cannot be excluded.
Čeprav se učinkov na dojene novorojence/otroke ne pričakuje, ker je sistemska izpostavljenost fidaksomicinu majhna, tveganja za novorojenca/otroka ne moremo izključiti.
Specific mutations of RNA polymerase are associated with reduced susceptibility to fidaxomicin.
Specifične mutacije RNA polimeraze so povezane z zmanjšano občutljivostjo za fidaksomicin.
The clinical relevance of MRP2 inhibition is not yet known.
Klinični pomen zaviranja MRP2 še ni znan.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003 100 x 1 film-coated tablet EU/1/11/733/004 20 x 1 film-coated tablet 13.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/733/003 100 x 1 filmsko obložena tableta EU/1/11/733/004 20 x 1 filmsko obložena tableta
What DIFICLIR is and what it is used for
Kaj je zdravilo DIFICLIR in za kaj ga uporabljamo
Reproductive and fertility parameters showed no statistically significant differences in rats treated with fidaxomicin at doses up to 6.3 mg/kg/day (intravenous).
Parametri reprodukcije in plodnosti niso pokazali statistično pomembnih razlik pri podganah, ki so dobivale fidaksomicin v odmerkih do 6,3 mg/kg/dan (intravensko).
It is not known whether fidaxomicin passes into breast milk, but it is not expected to do so.
Ni znano, ali se fidaksomicin izloča v materino mleko, vendar se to ne pričakuje.
In the two clinical trials of patients with CDI, 47.9% (479/999) of patients (per protocol population) were ≥65 years of age and 27.5% (275/999) of patients were treated with concomitant antibiotics during the study period.
V dveh kliničnih preskušanjih bolnikov s CDI je bilo 47,9 % (479/999) bolnikov (glede na populacijo v protokolu) starih ≥ 65 let in 27,5 % (275/999) bolnikov je bilo v obdobju trajanja študije sočasno zdravljenih z antibiotiki.
There are no data available from the use of fidaxomicin in pregnant women.
Podatki o uporabi fidaksomicina pri nosečnicah niso na voljo.
The rate of recurrence (including relapses) was significantly lower with fidaxomicin (14.1% versus 26.0% with a 95% CI of [-16.8%, -6.8%]), however these trials were not prospectively designed to prove prevention of reinfection with a new strain.
Stopnja ponovnega pojava (vključno z recidivom) je bila značilno nižja s fidaksomicinom (14,1 % v primerjavi s 26,0 % s 95-% IZ [-16,8 %, -6,8 %]), vendar ta preskušanja niso bila zasnovana prospektivno, da bi dokazali preprečevanje ponovne okužbe z novim sevom.
Your doctor will tell you whether this medicine is suitable for you.
Zdravnik vam bo povedal, ali je to zdravilo primerno za vas.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from DIFICLIR therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom DIFICLIR, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
The volume of distribution in humans is unknown, due to very limited absorption of fidaxomicin.
Volumen porazdelitve pri ljudeh ni znan zaradi zelo omejene absorpcije fidaksomicina.
4.7 Effects on ability to drive and use machines DIFICLIR has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo DIFICLIR nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Metabolism and nutrition disorders decreased appetite
Presnovne in prehranske motnje zmanjšan apetit
This metabolite also shows antimicrobial activity (see section 5.1).
Ta presnovek ima tudi antimikrobno delovanje (glejte poglavje 5.1)
However, a larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilat cannot be excluded.
Vendar pa večjega učinka na substrate P-gp z nižjo biološko razpoložljivostjo, bolj dovzetne na zaviranje črevesnega P-gp, kot je dabigatran eteksilat, ni mogoče izključiti.
Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Farmakokinetično/farmakodinamično (PK/PD) razmerje
Studies have demonstrated that fidaxomicin treatment did not affect Bacteroides concentrations or other major components of the microbiota in the faeces of CDI patients.
Študije so pokazale, da zdravljenje s fidaksomicinom ne vpliva na koncentracije Bacteroides ali drugih pomembnejših sestavin mikrobiotov v fecesu bolnikov s CDI.
The epidemiological cut-off value for fidaxomicin and C. difficile, distinguishing the wild-type population from isolates with acquired resistance traits, is ≥1.0 mg/L.
Epidemiološka mejna vrednost za fidaksomicin pri C. difficile, ki ločuje populacijo divjega tipa od izolatov s pridobljeno rezistenco, je ≥ 1,0 mg/l.
In that case, skip the missed dose.
V tem primeru preskočite pozabljeni odmerek.
Fidaxomicin (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure.
Fidaksomicin (200 mg dvakrat na dan) je imel majhen, a klinično nepomemben učinek na izpostavljenost digoksinu.
There are no known transferable elements that confer resistance to fidaxomicin.
Ni znanih prenosnih elementov, ki povzročajo odpornost za fidaksomicin.
DIFICLIR is available in:
Zdravilo DIFICLIR je na voljo v naslednjih pakiranjih:
INFORMATION IN BRAILLE dificlir
PODATKI V BRAILLOVI PISAVI dificlir
The recommended dose is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days.
Priporočeni odmerek je ena tableta (200 mg) dvakrat na dan (ena tableta vsakih 12 ur) 10 dni.
Gram negative organisms are intrinsically not susceptible to fidaxomicin.
Po Gramu negativni organizmi intrinzično niso občutljivi za fidaksomicin.
Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, antibiotics, ATC code: A07AA12
Farmakoterapevtska skupina: antidiaroiki, protivnetna in protimikrobna zdravila, oznaka ATC: A07AA12.
DIFICLIR works by killing the bacteria that cause the infection and helps to reduce the associated diarrhoea.
Zdravilo DIFICLIR učinkuje tako, da ubije bakterijo, ki povzroča okužbo, s čimer pomaga zmanjšati z okužbo povezano drisko.
Cmax for fidaxomicin and OP-1118 in plasma were 22% and 33% lower following a high fat meal vs fasting, but the extent of exposure (AUC0-t) was equivalent.
Cmax za fidaksomicin in OP-1118 v plazmi je bil 22 % in 33 % nižji po zelo mastnem obroku v primerjavi z uporabo na tešče, obseg izpostavljenosti (AUC0-t) pa je bil enak.
Inhibition of the Clostridial RNA polymerase occurs at a concentration 20-fold lower than that for the E. coli enzyme (1 μM vs. 20 μM), partly explaining the significant specificity of fidaxomicin activity.
Do zaviranja klostridijske RNA polimeraze pride pri koncentraciji, ki je 20-krat nižja kot za encim E. coli (1 μM v primerjavi z 20 μM), kar delno pojasnjuje pomembno specifičnost delovanja fidoksamicina.
In vitro metabolism studies showed that the formation of OP-1118 is not dependent on CYP450 enzymes.
Študije presnove in vitro so pokazale, da nastajanje OP-1118 ni odvisno od encimov CYP450.
Some patients with hypersensitivity reactions reported a history of allergy to macrolides.
Nekateri bolniki s preobčutljivostnimi reakcijami so poročali tudi o alergijah na makrolide v preteklosti.
You can take DIFICLIR before, during or after meals.
Zdravilo DIFICLIR lahko vzamete pred obrokom, med njim ali po njem.
Only very low levels of OP-1118 and no fidaxomicin was detectable in human urine.
Le zelo malo OP-1118 in nič fidaksomicina so ugotovili v urinu pri človeku.
Fidaxomicin and OP-1118 levels were approximately 2 times higher in patients ≥ 65 years compared to patients < 65 years.
OP-1118 so bile približno dvakrat višje pri bolnikih ≥ 65 let starosti v primerjavi z bolniki, mlajšimi od 65 let.
If such reaction occurs, stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department.
Če se pojavi takšna reakcija, prenehajte jemati zdravilo DIFICLIR in nujno poiščite zdravstveno pomoč pri svojem zdravniku, farmacevtu ali urgentnem centru lokalne bolnišnice.
Limited data suggest that there is no major difference in plasma concentration of fidaxomicin or OP-1118 between patients with reduced renal function (creatinine clearance < 50 ml/min) and patients with normal renal function (creatinine clearance ≥ 50 ml/min).
Maloštevilni podatki kažejo, da ni bistvene razlike v koncentraciji fidaksomicina ali OP-1118 v plazmi med bolniki z zmanjšanim delovanjem ledvic (očistek kreatinina < 50 ml/min) in bolniki z normalnim delovanjem ledvic (očistek kreatinina ≥ 50 ml/min).
You should not use DIFICLIR in combination with one of these medicines, unless your doctor tells you otherwise.
Ne uporabljajte zdravila DIFICLIR v kombinaciji s katerim od teh tzdravil, razen če vam vaš zdravnik svetuje drugače.
Co-administration of 200 mg fidaxomicin twice daily with a single dose of 10 mg rosuvastatin to healthy subjects did not have a clinically significant effect on the AUCinf of rosuvastatin.
Sočasno dajanje 200 mg fidaksomicina dvakrat na dan z enkratnim odmerkom 10 mg rosuvastatina pri zdravih osebah ni imela klinično pomembnega učinka na AUCinf rosuvastatina.
If you forget to take DIFICLIR
Če ste pozabili vzeti zdravilo DIFICLIR
The European Medicines Agency has deferred the obligation to submit the results of studies with fidaxomicin in one or more subsets of the paediatric population in enterocolitis caused by C. difficile (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s fidaksomicinom za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
No dose adjustment is considered necessary.
Prilagajanje odmerka ni potrebno.