natgillin/translations-raw huggingface dataset:
During their May 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Ceftriaxone Tyrol Pharma and associated names, that the objections raised by United Kingdom should
Med svojim zasedanjem maja 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Ceftriaxone Tyrol Pharma in povezana imena ugodno, da ugovori, podani s strani Združenega
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged kraljestva, ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
London, 22 August 2007 EMEA/ CHMP/ 248862/ 2007
London, 22. avgust 2007 EMEA/ CHMP/ 248862/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA
Cefuroximaxetil and associated names International Non-Proprietary Name (INN): cefuroxime (as axetil)
Mednarodno nelastniško ime (INN): cefuroksim (kot aksetil)
BACKGROUND INFORMATION Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets is a cephalosporin (β - lactam group of antibiotics), indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:
OSNOVNE INFORMACIJE Cefuroximaxetil in povezana imena 125 mg, 250 mg in 500 mg obložene tablete je cefalosporin (iz skupine β- laktamskih antibiotikov), indiciran za zdravljenje blagih do zmerno hudih okužb, ki jih povzročajo mikroorganizmi, občutljivi na cefuroksim, in sicer:
- upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
- okužbe zgornjih dihal: akutno vnetje srednjega ušesa, sinuzitis, tonzilitis in faringitis
- acute bronchitis, acute exacerbations of chronic bronchitis
- akutni bronhitis, akutno poslabšanje kroničnega bronhitisa
- lower uncomplicated urinary tract infections: cystitis
- nezapletene okužbe spodnjih sečil: cistitis
- skin and soft tissue infections: furunculosis, pyoderma and impetigo
- okužbe kože in mehkih tkiv: furunkuloza, piodermija in impetigo
- uncomplicated gonorrhoea: urethritis and cervicitis
- nezapletena gonoreja: vnetje sečnice in vnetje sluznice materničnega vratu
- treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in
- zdravljenje zgodnjega stadija lymske bolezni (stadij I) in naknadno preprečevanje kasnejših zapletov
adults and children above 12 years of age.
pri odraslih in otrocih, starih več kot 12 let.
Sandoz B. V. submitted applications for mutual recognition of Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets on the basis of the marketing authorisation granted by the Netherlands on 1 October 2004.
Družba Sandoz B. V. je predložila vloge za medsebojno priznavanje zdravila Cefuroximaxetil in z njim povezanih imen 125 mg, 250 mg in 500 mg obložene tablete na podlagi dovoljenja za promet z zdravilom, ki ga je 1. oktobra 2004 odobrila Nizozemska.
Significant difference was identified with regard to the indication “ uncomplicated gonorrhoea: urethritis and cervicitis”.
V zvezi z indikacijo "nezapletena gonoreja: vnetje sečnice in vnetje sluznice materničnega vratu" je bila ugotovljena pomembna razlika.
This refers to the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and risk- benefit balance for this sought indication and this was considered to be a serious public health concern.
Nanaša se na varnost in učinkovitost cefuroksimaksetila pri zdravljenju nezapletene gonoreje in na razmerje med tveganji in koristmi za to indikacijo, pri čemer je bilo ugotovljeno, da utegne to predstavljati resen zadržek glede javnega zdravja.
The arbitration procedure started on 18 October 2006 with the adoption of a list of questions.
Poročevalec je bil dr.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The list of the product names concerned is given in Annex I.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Seznam zadevnih imen proizvodov je naveden v Dodatku I.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER / APPLICANTS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH
1
1 Država
Marketing
Imetnik
Pharmaceutical
Pot uporabe
Route of
članica
Member State Authorisation Holder
dovoljenja za promet
Strength
oblika
administration
Nizozemska
Veluwezoom 22 1327 Almere The Netherlands
Veluwezoom 22 1327 Almere Nizozemska
125 mg 250 mg 500 mg
125 mg
Estonia
Za peroralno
1A Pharma GmbH Keltenring 1 + 3 D-82041 Oberhaching Germany
Keltenring 1 + 3 D- 82041 Oberhaching Nemčija
oral use
uporabo
oral use
Za peroralno uporabo
15 2710-693 Sintra Portugal
15 2710- 693 Sintra Portugalska
oral use
Za peroralno
Gran Vía de les Corts Catalanes, 764 08013 Barcelona Spain
Gran Vía de les Corts Catalanes, 764 08013 Barcelona Španija
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CEFUROXIMAXETIL (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CEFUROXIMAXETIL (glejte Dodatek I)
The active substance, cefuroxime axetil, owes its in vivo bactericidal activity to the parent compound cefuroxime.
Zdravilna učinkovina, cefuroksim aksetil ima in vivo baktericidni učinek zaradi svoje matične spojine cefuroksim.
All cephalosporins (β -lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis.
Vsi cefalosporini (β- laktamski antibiotiki) zavirajo tvorjenje celične stene in so selektivni zaviralci sinteze peptidoglikanov.
In the Reference Member State, Cefuroxime axetil tablets are indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:
V referenčni državi članici so tablete Cefuroxime axetil indicirane za zdravljenje blagih do zmerno hudih okužb, ki jih povzročajo mikroorganizmi, občutljivi na cefuroksim, kot so:
- upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
- okužbe zgornjih dihal: akutni otitis media, sinuzitis, tonzilitis in faringitis
- skin and soft tissue infections: furunculosis, pyoderma and impetigo
- okužbe kože in mehkih tkiv: furunkuloza, pioderma in impetigo
- uncomplicated gonorrhoea: urethritis and cervicitis
- nezapletena gonoreja: uretritis in cervicitis
- treatment of early stage Lyme disease (stadium I) and subsequent prevention of late
- zdravljenje zgodnjih stadijev limske borelioze (I. stadij) in naknadno preprečevanje zapletov pri
complications in adults and children above 12 years of age.
odraslih in otrocih, starejših od 12 let.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Upoštevati je treba tudi uradne smernice za primerno uporabo protibakterijskih sredstev.
During CMD (h) referral, Member States could agree on the indications, except the one referring to gonococcal infections.
Med napotitvenim postopkom v okviru usklajevalne skupine za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila za uporabo v humani medicini, CMD( h), so države članice prišle do soglasja o indikacijah, razen o tisti, ki se nanaša na okužbe z gonokoki.
During CHMP arbitration, the applicant was asked to further justify the indication “ uncomplicated gonorrhoea: urethritis and cervicitis”.
Med arbitražo na CHMP je bil vlagatelj pozvan, da dodatno utemelji indikacije „ nezapletena gonoreja: uretritis in cervicitis “.
The applicant had to address the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and to conclude on the risk-benefit balance for this sought indication.
Vlagatelj je moral obrazložiti vprašanje varnosti in učinkovitosti cefuroksimaksetila pri nezapleteni gonoreji ter ugotoviti razmerje med koristmi in tveganji za to indikacijo.
To address the concerns of the CHMP, the Applicant submitted an extensive review of the literature supporting the efficacy of cefuroxime axetil in the treatment of uncomplicated gonorrhoea and specifically in cervicitis and urethritis.
Da bi lahko odgovoril na zadržke CHMP, je vlagatelj predložil obširno poročilo o literaturi, ki podpira učinkovitost cefuroksim aksetila pri zdravljenju nezapletene gonoreje in zlasti cervicitisa in uretritisa.
The experience with cefuroxime axetil in limited numbers of patients with uncomplicated anorectal gonorrhoea or pharyngeal gonorrhoea is not sufficient and the efficacy is not established and therefore not acceptable and should not be included in the product information.
Vendar pa ti podatki niso sprejemljivi in ne bi smeli biti vključeni v informacije o zdravilu, saj izkušnje s cefuroksim aksetilom pri omejenemu številu bolnikov z nezapleteno anorektalno gonorejo ali faringealno gonorejo ne zadostujejo, niti ni bila ugotovljena učinkovitost te učinkovine.
Taking into account the originator SPCs of cefuroxime axetil and recommendations from the literature on the use of cefuroxime in the treatment of uncomplicated gonorrhoea, it was argued that the inclusion of this indication is fully justified from a clinical and pharmacological point of view.
Vlagatelj je na podlagi originatorjevih povzetkov glavnih značilnosti zdravila za cefuroksim aksetil in priporočil iz literature o uporabi cefuroksima pri zdravljenju nezapletene gonoreje ugovarjal, da naj bi bila vključitev te indikacije popolnoma utemeljena iz kliničnega ter farmakološkega vidika.
Official guidance should be sought for its use and data on resistance just like for the other recommended antibiotics for this indication.
Treba bi bilo preučiti uradne smernice za uporabo zdravila in podatke o odpornosti, kot velja tudi za vse druge antibiotike, priporočene za to indikacijo.
In order to comply with the NfG on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections (CPMP/ EWP/ 558/ 95 rev.1), the applicant accepted that proposed SPC should be updated in due time to include EUCAST breakpoints.
1), se je vlagatelj strinjal s tem, da mora pravočasno posodobiti predlagani povzetek glavnih značilnosti zdravila, in sicer tako, da bo vključeval tudi prelomne točke po EUCAST.
The CHMP nonetheless considered that not sufficient evidence supported the optimal efficacy of cefuroxime axetil in treating uncomplicated gonorrhoea, restricted to urethritis and cervicitis.
CHMP je bil vseeno mnenja, da ni zadostnih dokazov, ki bi podpirali optimalno učinkovitost cefuroksim aksetila pri zdravljenju nezapletene gonoreje, ki je omejena na uretritis in cervicitis.
The efficacy of cefuroxime axetil on other anatomical locations, (which often remain asymptomatic), is highly questionable and consequently treatment with cefuroxime axetil might not curtail further transmission of the infection.
Učinkovitost cefuroksim aksetila na drugih anatomskih mestih (ki navadno ostanejo asimptomatična) je zelo vprašljiva, tako da zdravljenje s cefuroksim aksetilom posledično morda ne bo zmanjšalo prenosa okužbe.
Therefore, the inclusion of uncomplicated gonococcal disease is a matter of major concern from a public health perspective, both at individual and community level.
Zato predstavlja vključitev nezapletene gonokokne okužbe velik zadržek z vidika javnega zdravja tako na ravni posameznika kot na ravni skupnosti.
4 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
4 PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
CMD(h) referral agreed on all therapeutic indications, except uncomplicated gonorrhoea: urethritis and cervicitis.
V napotitvenem postopku v okviru CMD( h) je prišlo do strinjanja o vseh terapevtskih indikacijah z izjemo nezapletene gonoreje: uretritisa in cervicitisa.
The scope of the referral was to address the safety and efficacy of cefuroxime axetil in uncomplicated gonorrhoea (cervicitis and urethritis) and to conclude on the risk-benefit balance for this sought indication The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee. the CHMP has recommended by consensus that the indication pertaining uncomplicated gonorrhoea (cervicitis and urethritis) should not be included in the product information.
CHMP je soglasno priporočil, da indikacije, ki se nanaša na nezapleteno gonorejo (cervicitis in uretritis), ne bi smeli vključiti v informacije o zdravilu.
Consequently, the Summary of Product Characteristics and package leaflet should be amended as set out in Annex III.
Posledično bi bilo treba v skladu z določili, navedenimi v Dodatku III, popraviti povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications (see Annex I) should be granted to include these amendments.
Obstoječa dovoljenja za promet z zdravilom bi morali spremeniti, istočasno pa bi morali tudi vloge za dovoljenje za promet z zdravilom (glejte Dodatek I), ki so trenutno v postopku odobritve, odobriti pod pogojem, da vključujejo omenjene popravke.
5 ANNEX III
5 DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
6 SUMMARY OF PRODUCT CHARACTERISTICS
6 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Cefuroximaxetil 125, coated tablets 125 mg
Aksetilcefuroksimat 125, obložene tablete 125 mg
Cefuroximaxetil 125 contain 150.36 mg cefuroxime axetil which is equivalent to 125 mg cefuroxime per tablet
Aksetilcefuroksimat 125 vsebuje 150, 36 mg aksetilcefuroksimata, kar ustreza 125 mg cefuroksima na tableto
Cefuroxime axetil 125 mg coated tablets contain 0.2 mg aspartame.
Ena Aksetilcefuroksimat 125 mg obložena tableta vsebuje 0, 2 mg aspartama.
For a full list of excipients: see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Cefuroximaxetil 125:
Aksetilcefuroksimat 125:
white to slightly yellowish, biconvex, oblong tablets
bele do rahlo rumenkaste, bikonveksne, podolgovate tablete
Cefuroxime axetil is indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:
Aksetilcefuroksimat je indiciran za zdravljenje blagih do zmernih okužb, ki jih povzročajo mikroorganizmi, občutljivi za cefuroksim, in sicer za:
- upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
- okužbe zgornjih dihalnih poti: akutno vnetje srednjega ušesa, sinusitis, tonzilitis in faringitis
- treatment of early stage Lyme disease (stadium I) and subsequent prevention of late
- zdravljenje zgodnje oblike Lymske borelioze (1. stadij) in naknadno preprečevanje kasnejših
complications in adults and children above 12 years of age.
zapletov pri odraslih in otrocih nad 12 let starosti.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Bodite pozorni na uradne smernice glede ustrezne uporabe protibakterijskih sredstev.
Cefuroxime axetil tablets are coated to mask their taste: they should not be chewed.
Aksetilcefuroksimat tablete imajo oblogo, ki prekrije njihov okus, zato jih bolniki ne smejo žvečiti.
The usual duration of therapy is 7 days (ranging from 5 to 10 days).
Zdravljenje običajno traja 7 dni (od 5 do 10 dni).
In case of pharyngotonsillitis caused by Streptococcus pyogenes a therapy duration of at least 10 days is indicated.
V primeru faringotonzilitisa, ki ga povzroča Streptococcus pyogenes, se priporoča vsaj 10- dnevno zdravljenje.
The duration of treatment of early Lyme disease should be 20 days.
Zdravljenje zgodnje oblike Lymske borelioze traja 20 dni.
In order to achieve optimum absorption cefuroxime axetil tablets should be taken shortly after meals.
Da dosežemo optimalno absorpcijo, moramo aksetilcefuroksimat tablete jemati takoj po obroku.
The dosage depends on the severity of the infection.
Odmerjanje je odvisno od resnosti okužbe.
For severe infections parenteral forms of cefuroxime are recommended.
Za zdravljenje hudih okužb se priporočajo parenteralne oblike cefuroksima.
Where appropriate cefuroxime axetil is effective when used following initial parenteral cefuroxime sodium in the treatment of pneumonia and acute exacerbations of chronic bronchitis.
V ustreznih primerih je cefuroksim aksetil učinkovit, ko ga uporabljamo po začetnem zdravljenju pljučnice in akutnega poslabšanja kroničnega bronhitisa s parenteralnim natrijevim cefuroksimatom.
8 Dosage schedule for tablets:
8 Shema odmerjanja za tablete:
Adults and children over 12 years of age
Odrasli in otroci, starejši od 12 let
Upper respiratory tract infections
okužbe zgornjih dihalnih poti
250 (– 500) mg twice daily
250 (– 500) mg 2- krat/ dan
Lower respiratory tract infections
okužbe spodnjih dihalnih poti
500 mg twice daily
500 mg 2- krat/ dan
Lower uncomplicated urinary tract infections
nezapletene okužbe spodnjih sečil
125 – 250 mg twice daily
125 – 250 mg 2- krat/ dan
Skin and soft tissue infections
okužbe kože in mehkih tkiv
250 – 500 mg twice daily
250 – 500 mg 2- krat/ dan
Early Lyme disease
zgodnja oblika Lymske borelioze
500 mg twice daily during 20 days
500 mg 2- krat/ dan 20 dni
Children from 5 to 12 years of age
Otroci od 5 do 12 let
Above-mentioned indications, if relevant for this group of children
zgoraj navedene indikacije, če ustrezajo tej skupini otrok
Acute otitis media
akutno vnetje srednjega ušesa
250 mg twice daily
250 mg 2- krat/ dan
Children under 5 years of age:
Otroci do 5 let starosti:
Cefuroxime axetil tablets are not suitable for use in children under the age of 5.
Aksetilcefuroksimat tablete niso primerne za uporabo pri otrocih, mlajših od 5 let.
For patients in this age group it is advised to use an oral suspension.
Bolnikom te starostne skupine priporočamo peroralno suspenzijo.
There is no experience in children under 3 months of age.
Izkušenj z uporabo zdravila pri otrocih, mlajših od 3 mesecev, ni.
Dosage regimen in renal impairment, in dialysis patients and elderly:
Odmerjanje pri bolnikih z ledvično okvaro, bolnikih na hemodializi in starejših bolnikih:
No special precautions are necessary in patients with renal impairment, or in elderly patients if the daily dosage does not exceed 1 gram.
Pri bolnikih z ledvično okvaro in pri starejših bolnikih niso potrebni posebni previdnosti ukrepi, če dnevni odmerek ni večji od 1 grama.
In patients with renal impairment and creatinine clearance below 20 ml/ min cefuroxime axetil tablets should be dosed carefully.
Pri bolnikih z ledvično okvaro in očistkom kreatinina pod 20 ml/ min je treba aksetilcefuroksimat tablete odmerjati previdno.
Patients undergoing haemodialysis will require a supplementary dose of cefuroxime at the end of each dialysis treatment.
Bolniki na hemodializi prejmejo ob koncu vsake dialize dodaten odmerek cefuroksima.
Hypersensitivity to cefuroxime, other cephalosporins or to any of the excipients.
Preobčutljivost za cefuroksim, druge cefalosporine ali katerokoli pomožno snov.
Previous immediate and / or severe hypersensitivity reaction to a penicillin or to any other type of beta- lactammedicinal products.
Pretekla neposredna in/ ali huda preobčutljivostna reakcija na penicilin ali druge vrste betalaktamskih antibiotikov.
If after administration of cefuroxime axetil sensitivity reactions occur, the use should be discontinued immediately and an appropriate treatment should be established.
Če se po jemanju aksetilcefuroksimata pojavi preobčutljivostna reakcija, je treba zdravilo takoj ukiniti in uvesti ustrezno zdravljenje.
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
Posebna previdnost je potrebna pri bolnikih, ki so že doživeli anafilaktično reakcijo na peniciline ali druge betalaktame.
As with other broad spectrum antibiotics, prolonged use of cefuroxime axetil may result in the overgrowth of non-susceptible organisms (e. g., candida, enterococci and clostridium diffficile, which may require interruption of treatment.
Kot velja tudi za druge antibiotike širokega spektra, lahko dolgotrajna uporaba aksetilcefuroksimata povzroči prekomerno rast neobčutljivih organizmov (npr. kandide, enterokokov in clostridium diffficile, pri katerih je včasih potrebno zdravljenje prekiniti).
In patients who develop severe diarrhoea during or after use of cefuroxime axetil, the risk of life threatening pseudomembranous colitis should be taken into account.
Pri bolnikih, pri katerih se med uporabo aksetilcefuroksimata ali po njej pojavi huda driska, je treba upoštevati možnost tveganja nastanka smrtno nevarnega psevdomembranoznega kolitisa.
The use of cefuroxime axetil should be discontinued and the appropriate treatment established.
Zdravljenje z aksetilcefuroksimatom je treba prekiniti in uvesti ustrezno zdravljenje.
The use of preparations inhibiting the intestinal peristaltism is contra-indicated (see section 4.8).
Uporaba preparatov, ki zavirajo črevesno peristaltiko, je kontraindicirana (glejte poglavje 4. 8).
A 20-day treatment of Lyme disease may cause the frequency of developing diarrhoea to increase.
20- dnevno zdravljenje Lymske borelioze lahko povzroči pogostejše driske.
9 Long term use of cefuroxime axetil may lead to an excess of pathogens resistant to cefuroxime axetil.
9 Dolgoročna uporaba aksetilcefuroksimata lahko povzroči presežek povzročiteljev, odpornih na aksetilcefuroksimat.
It is of high importance that the patient is carefully checked.
Nadvse pomembno je skrbno spremljanje bolnika.
If a superinfection occurs during treatment, appropriate measures should be taken (see section 4.8).
Če med zdravljenjem pride do dodatne okužbe, je treba ustrezno ukrepati (glejte poglavje 4. 8).
The use of cefuroxime axetil is not recommended in patients with severe intestinal tract disorders accompanied by vomiting and diarrhoea, since in these situations a sufficient absorption can not be guaranteed.
Uporabe aksetilcefuroksimata pri bolnikih s hudimi motnjami prebavnega trakta, ki jih spremljata bruhanje in driska, ne priporočamo, saj v takih situacijah ni mogoče zagotoviti zadostne absorpcije zdravila.
Administration of a parenteral formulation of cefuroxime should be considered.
Treba je pretehtati možnost uporabe parenteralne oblike cefuroksima.
The Jarisch-Herxheimer reaction has been reported following cefuroxime axetil treatment of Lyme disease.
Po zdravljenju Lymske borelioze z aksetilcefuroksimatom so poročali o Jarisch- Herxheimerjevi reakciji.
The reaction results directly from the bactericidal activity of cefuroxime axetil on the spirochaete Borrelia burgdorferi.
Reakcija je neposredna posledica baktericidnega delovanja aksetilcefuroksimata na spiroheto Borrelia burgdorferi.