natgillin/translations-raw huggingface dataset:
Since it is proposed that the loading dose should be administered 3 to 5 times, it has been stated in the SmPC that trough serum concentrations should be monitored on completion of the loading dose regimen.
Ker je predlagano dajanje polnilnega odmerka od 3- do 5-krat, je bilo v povzetku glavnih značilnosti zdravila navedeno, da je treba najmanjše serumske koncentracije spremljati ob zaključku režima polnilnega odmerka.
Most of the patients included in study EG-87-42 (which was the larger of the two non-comparative studies) had suspected gram-positive infections from different sites, with the majority of them having skin and soft tissues infections (SSTIs), septicaemia and bone and joint infections.
Pri večini bolnikov, ki so bili vključeni v študijo EG-87-42 (ki je bila večja od dveh neprimerjalnih študij), so sumili na po Gramu pozitivne okužbe z različnih mest, večina pa je imela okužbo kože in mehkih tkiv (OKMT), septikemijo ter okužbe kosti in sklepov.
Recent time-kill studies confirm that in vitro bactericidal activity of teicoplanin is optimally tested according to CLSI guidelines, with tolerance defined at 24 hours.
Nedavne študije časovne mikrobne inhibicije so pokazale, da je bakterijska aktivnost teikoplanina in vitro optimalno preverjena v skladu s smernicami CLSI s toleranco pri 24 urah.
• Skin and soft tissue infections (SSTI)
• Okužbe kože in mehkih tkiv (OKMT)
Prophylaxis of infections caused by Gram-positive microorganisms Four prophylaxis comparative studies were conducted.
Profilaksa okužb zaradi po Gramu pozitivnih mikroorganizmov Izvedene so bile štiri primerjalne študije profilaktične uporabe zdravila.
This indication was considered to be acceptable by the CHMP as it appears that teicoplanin is not absorbed to a great extent from the gastro-intestinal tract .
Ta indikacija je bila za odbor CHMP sprejemljiva, saj se zdi, da se teikoplanin ne absorbira v veliki meri iz prebavnega trakta.
Treatment of infections caused by Gram-positive microorganisms The following infections caused by Gram-positive microorganisms were discussed by the CHMP:
Zdravljenje okužb zaradi po Gramu pozitivnih mikroorganizmov Odbor CHMP je razpravljal o naslednjih okužbah zaradi po Gramu pozitivnih mikroorganizmov:
Additionally, as mentioned above, the MAH has been requested to perform an appropriate PASS to evaluate the safety of this higher dosage.
Imetnik dovoljenja za promet z zdravilom je bil prav tako pozvan, kot je navedeno zgoraj, da izvede ustrezno študijo o varnosti zdravila po pridobitvi dovoljenja za promet, da oceni varnost tega višjega odmerka.
• The Committee reviewed the available data on submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the SmPC.
• Odbor je pregledal razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom iz obstoječih kliničnih študij, farmakovigilančnih podatkov in objavljene literature, ki utemeljujejo predlagano uskladitev povzetka glavnih značilnosti zdravila;
Teicoplanin is a glycopeptide antibiotic produced by fermentation of Actinoplanes teichomyceticus with in-vitro bactericidal activity against aerobic and anaerobic gram-positive bacteria.
Teikoplanin je antibiotik iz skupine glikopeptidov, ki nastane s fermentacijo bakterije Actinoplanes teichomyceticus z bakterijsko aktivnostjo in-vitro proti aerobnim in anaerobnim po Gramu pozitivnim bakterijam.
No specific study has been conducted by the MAH in support of this indication.
Imetnik dovoljenja za promet z zdravilom ni izvedel nobene posebne študije v podporo tej indikaciji.
The frequencies of all listed adverse reactions have been calculated using data from in-house clinical trials results used for the original submission, and these were incorporated into the CSP during the PSUR work-sharing procedure number GR/H/PSUR/0001/001, which was accepted by the member states.
Pogostnost vseh navedenih neželenih učinkov je bila izračunana z uporabo podatkov iz rezultatov internih kliničnih preskušanj, uporabljenih za prvotno vlogo, ti pa so bili vključeni v CSP med postopkom za delitev dela PSUR številka GR/H/PSUR/0001/001, kar so države članice sprejele.
In Study EG-87-42, the European multi-centre study, approximately 9% of the subjects enrolled had lower respiratory tract infections.
V študiji EG-87-42, tj. evropski multicentrični študiji, je imelo približno 9 % vključenih preiskovancev okužbe spodnjih dihalnih poti.
The studies provided in support of prophylactic use in cardiac surgery suggest that teicoplanin was not effective in preventing post-operative infections.
Študije, predložene v podporo profilaktični uporabi v srčni kirurgiji, nakazujejo, da teikoplanin ni učinkovit pri preprečevanju pooperativnih okužb.
No supportive data for the inclusion of the statement “convulsions after intraventricular administration” was retrieved.
Pridobljeni niso bili nobeni podporni podatki za vključitev izjave „konvulzije po intraventrikularnem dajanju“.
The loading dose of 12mg/kg bid is in line with what is currently recommended in the SmPCs in France and Finland.
Polnilni odmerek 12 mg/kg dvakrat na dan je v skladu s trenutnim priporočilom v povzetku glavnih značilnosti zdravila v Franciji in na Finskem.
The efficacy of teicoplanin in the treatment of Gram-positive infections has been investigated in a number of clinical studies that were submitted in the initial authorisation along with literature references.
Učinkovitost teikoplanina pri zdravljenju po Gramu pozitivnih okužb je bila preučena v številnih kliničnih študijah, ki so bile predložene v osnovni vlogi za pridobitev dovoljenja za promet z zdravilom skupaj z referencami iz literature.
• The Committee considered the identified divergences in the product information for Targocid and associated names with respect to the therapeutic indications, posology and method of administration sections, contraindications and special warnings and precautions for use, as well as the remaining sections of the SmPC.
• Odbor je upošteval prepoznane razlike v podatkih o zdravilu Targocid in povezanih imenih glede poglavij o terapevtskih indikacijah, odmerjanju in načinu uporabe, kontraindikacijah ter posebnih opozoril in previdnostnih ukrepov, kakor tudi preostala poglavja povzetka glavnih značilnosti zdravila;
Peptidoglycan synthesis is blocked by specific binding to D-alanyl-D-alanine residues.
Sintezo peptidoglikana zavira posebna vezava na ostanke D-alanil-D-alanina.
The microbiological spectrum of teicoplanin covers staphylococci including Staphylococcus aureus susceptible or resistant to methicillin, Streptococcus pneumoniae and other streptococci mainly including Streptococcus pyogenes, streptococci in the Viridans group and Enterococcus faecalis.
Mikrobiološki spekter teikoplanina obsega stafilokoke, vključno z bakterijo Staphylococcus aureus, ki je dovzetna ali odporna na meticilin, bakterijo Streptococcus pneumoniae in drugimi streptokoki, v glavnem streptokokni pirogeni, streptokoki skupine viridians in Enterococcus faecalis.
In the four published studies of the initial dossier, the teicoplanin dose regimens across studies ranged from 6 mg/kg unit dose to a loading dose of 10 mg/kg every 12 hours for 3 doses followed by 10 mg/kg daily maintenance dose.
V štirih objavljenih študijah v začetni dokumentaciji so režimi odmerjanja teikoplanina po študijah nihali od 6 mg/kg enote odmerka do polnilnega odmerka 10 mg/kg vsakih 12 ur za 3 odmerke, ki jim je sledil vzdrževalni odmerek 10 mg/kg na dan.
The CHMP agreed that teicoplanin can be indicated for the treatment of pneumonia (hospital acquired and community acquired pneumonia) without restricting its use according to the pathogen.
Odbor CHMP se je strinjal, da je teikoplanin lahko indiciran za zdravljenje pljučnice (bolnišnična in zunajbolnišnična okužba) brez omejitve uporabe glede na patogen.
Regarding dental surgery prophylaxis, the results suggested that teicoplanin could be useful.
Glede profilaktične uporabe v zobni kirurgiji so rezultati pokazali, da je teikoplanin lahko uporaben.
The information on the measurement of teicoplanin trough serum concentrations by High Performance Liquid Chromatography (HPLC) and Fluorescence Polarization Immunoassay (FPIA) method was considered to be acceptable by the CHMP.
Podatki o merjenju najmanjših serumskih koncentracij teikoplanina z metodo tekočinske kromatografije visoke ločljivosti (HPLC) in imunskih testov s fluorescenčno polarizacijo (FPIA) so bili za odbor CHMP sprejemljivi.
The proposed wording was considered to be acceptable by the CHMP.
Predlagano besedilo je bilo za odbor CHMP sprejemljivo.
The CHMP concluded that teicoplanin should be indicated in complicated SSTIs i.e. severe cases, but not for the treatment of minor SSTIs in line with the British Society for Antimicrobial Chemotherapy (BSAC) guideline, which does not recommend systemic antibiotics for the treatment of minor SSTIs.
Odbor CHMP je zaključil, da mora biti teikoplanin indiciran pri zapletenih okužbah kože in mehkih tkiv, tj. resnih primerih, vendar ne za zdravljenje manjših okužb kože in mehkih tkiv skladno s smernicami Britanskega združenja za protimikrobno zdravljenje (BSAC), ki ne priporočajo sistemskih antibiotikov za zdravljenje manjših okužb kože in mehkih tkiv.
Regarding interactions with teicoplanin, it is known that due to the potential for increased adverse effects, teicoplanin should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs, such as aminoglycosides, amphotericin B, ciclosporin, and furosemide.
Glede medsebojnega delovanja s teikoplaninom je znano, da je treba teikoplanin zaradi možnosti za povečane neželene učinke uporabljati previdno pri bolnikih, ki sočasno prejemajo nefrotoksična ali ototoksična zdravila, kot so na primer aminoglikozidi, amfotericin B, ciklosporin in furosemid.
The MAH took the opportunity to harmonise the Quality dossier for Targocid and associated names as part of the referral procedure.
Imetnik dovoljenja za promet z zdravilom je izkoristil priložnost za uskladitev dokumentacije o kakovosti za zdravilo Targocit in povezana imena kot del napotitvenega postopka.
The MAH has amended section 4.3 only including hypersensitivity to teicoplanin (or to any of the excipients).
Imetnik dovoljenja za promet z zdravilom je dopolnil poglavje 4.3, tako da ta vključuje samo preobčutljivost na teikoplanin (ali na katero koli od pomožnih snovi).
The clinical and bacteriological efficacy of teicoplanin was shown in SSTIs (37.4% of all infection sites) in Study EG-87-42 (European Multicentre Study).
Klinična in bakteriološka učinkovitost teikoplanina je bila ugotovljena pri okužbah kože in mehkih tkiv (37,4 % vseh mest okužb) v študiji EG-87-42 (evropska multicentrična študija).
The indication was therefore restricted to complicated urinary tract infections, which was accepted by the CHMP.
Indikacija je bila zato omejena na zapletene okužbe sečil, in jo je odbor CHMP sprejel.
In Study EG-87-42 (European Multicentre Study), the clinical and bacteriological efficacy of teicoplanin has been shown in UTI (8% of all infection sites).
V študiji EG-87-42 (evropski multicentrični študiji) je bila klinična in bakteriološka učinkovitost teikoplanina ugotovljena pri okužbah sečil (8 % vseh mest okužb).
Section 4.6 - Fertility, pregnancy and lactation The MAH has aligned the text so that it is in line with the CSP and the CHMP Guideline on risk assessment of medicinal products on human reproduction and lactation: From Data to labelling (EMEA/CHMP/203927/2005).
Imetnik dovoljenja za promet z zdravilom je uredil besedilo, tako da je v skladu s smernicami CSP in CHMP za oceno tveganja zdravil na človeško reprodukcijo in dojenje: Od podatkov do označevanja (EMEA/CHMP/203927/2005).
However a few cases of endocarditis were included in the open-label studies (EG-87-42 and N-86-04) conducted in support of the initial marketing authorisation.
Kljub temu je bilo v odprte študije (EG-87-42 in N-86-04), ki so bile izvedene v podporo začetnemu dovoljenju za promet, vključenih nekaj primerov endokarditisa.
In the current version of EUCAST MIC breakpoints, the resistance breakpoint for Staphylococcus aureus has been reduced to >2 mg/ml to avoid reporting of glycopeptide intermediate resistant Staphylococcus aureus (GISA) isolates, as serious infections with GISA isolates are not treatable with increased doses of vancomycin or teicoplanin.
V trenutni različici mejnih vrednosti MIK EUCAST je bila mejna vrednost odpornosti na bakterijo Staphylococcus aureus znižana na > 2 mg/ml, da bi se izognili poročanju o za glikopeptide intermediarno občutljivih izolatih Staphylococcus aureus (GISA), saj resnih okužb z izolati GISA ni mogoče zdraviti s povečanimi odmerki vankomicina ali teikoplanina.
The harmonised dossier was provided for the active substance (teicoplanin) and for products containing this substance: Targocid 100, 200 mg and 400 mg powder for solution for injection/infusion and Targocid 100, 200 mg and 400 mg powder and solvent for solution for injection/infusion.
Usklajena dokumentacija je bila predložena za zdravilno učinkovino (teikoplanin) in zdravila, ki vsebujejo to zdravilno učinkovino: Targocid 100 mg, 200 mg in 400 mg prašek za raztopino za injiciranje/infundiranje in Targocid 100 mg, 200 mg in 400 mg prašek in vehikel za raztopino za injiciranje/infundiranje.
The final PL wording was agreed by the CHMP.
Končno besedilo navodil za uporabo je potrdil odbor CHMP.
Section 4.5- Interaction with other medicinal products and other forms of interaction The lack of interaction between teicoplanin and other antibiotics, antihypertensives, cardiotropic, antidiabetic agents and anaesthetic agents has been included in the proposed harmonised SmPC.
Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij V predlagani usklajeni povzetek glavnih značilnosti zdravila je bila dodana odsotnost medsebojnega delovanja med teikoplaninom in drugimi antibiotiki, antihipertenzivi, kartiotropnimi zdravili, antidiabetiki in anestetiki.
• Pneumonia and respiratory tract infections
• Pljučnica in okužbe dihalnih poti
This PASS is imposed as a condition to the Marketing Authorisation.
Ta študija o varnosti zdravila po pridobitvi dovoljenja za promet je bila sprejeta kot pogoj dovoljenja za promet z zdravilom.
In line with the CHMP Guideline on the Evaluation of Medicinal Products indicated for Treatment of Bacterial Infections (CPMP/EWP/558/95 rev 2), it was considered acceptable to further qualify the indications.
V skladu s smernicami za vrednotenje zdravil odbora CHMP, indiciranih za zdravljenje bakterijskih okužb (CPMP/EWP/558/95 rev 2), je bilo sprejeto za nadaljnjo opredelitev indikacij.
Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site different from that affected by beta-lactam antibiotics.
Teikoplanin zavira rast dovzetnih organizmov, tako da posreduje pri biosintezi celične stene na mestu, ki je drugačno od mesta, na katerega so delovali betalaktamski antibiotiki.
No pharmacokinetic drug-drug interaction with teicoplanin has been carried out by the MAH, and no published data have been retrieved from the literature.
Imetnik dovoljenja za promet z zdravilom ni izvedel nobenega farmakokinetičnega medsebojnega delovanja med zdravili, predstavljeni pa niso bili nobeni objavljeni podatki iz literature.
The MAH has provided evidence from publications in support of the use of teicoplanin in combination with other anti-microbial agents such as aminoglycosides.
Imetnik dovoljenja za promet z zdravilom je predložil dokaze iz publikacij v podporo uporabi teikoplanina v kombinaciji z drugimi protimikrobnimi sredstvi, na primer aminoglikozidi.
The harmonization of the pharmacokinetic section in the teicoplanin SmPC is based on the data first provided in the initial marketing authorisation application, and more recent data retrieved from a literature research.
Uskladitev poglavja s farmakokinetiko v povzetku glavnih značilnosti teikoplanina temelji na podatkih, ki so bili predloženi v osnovni vlogi za pridobitev dovoljenja za promet z zdravilom, in novejših podatkih iz raziskav v literaturi.
The effect of the higher loading dose (as proposed in section 4.2) on the possible occurrence of adverse drug reactions has also been addressed by the MAH.
Imetnik dovoljenja za promet z zdravilom je obravnaval tudi vpliv višjega polnilnega odmerka (kot je predlagan v poglavju 4.2) na možni pojav neželenih učinkov zdravila.
Indeed, in a Cochrane meta-analysis of randomised controlled trials (RCT) in adults and children with CAPD-associated peritonitis, although the primary response and relapse rates did not differ between intraperitoneal (IP) glycopeptide-based regimens compared to first generation cephalosporin regimens, glycopeptide regimens were more likely to achieve a complete cure, and primary treatment failure was less likely to occur with teicoplanin than vancomycin (Wiggins et al. 2008)1.
V Cochranovi metaanalizi randomiziranih kontroliranih preskušanj pri odraslih in otrocih s peritonitisom, nastalim zaradi kontinuirane ambulantne peritonealne dialize, čeprav se delež primarnega odziva in relapsa med intraperitonealnimi (IP) režimi na podlagi glikopeptida in režimi cefalosporina prve generacije ni razlikoval, so glikopeptidni režimi verjetneje dosegli popolno ozdravitev, do neuspeha primernega zdravljenja pa je manj verjetneje prišlo pri teikoplaninu kot pri vankomicinu (Wiggins in sod.
Section 5.2 - Pharmacokinetic properties
Poglavje 5.2 - Farmakodinamične lastnosti
However the available data suggest that teicoplanin administered IV or IM at dosages of 10 mg/kg every 12 hours for 1 to 5 doses (loading dosage), then 6 to 10 mg/kg once daily, is effective in the treatment of Gram-positive infections such as septicaemia, skin and soft tissue infections, bone and joint infections, lower respiratory tract infections, and in neutropenia and fever, in children.
Kljub temu razpoložljivi podatki nakazujejo, da je teikoplanin, če se daje intravensko ali intramuskularno v odmerkih po 10 mg/kg vsakih 12 ur po 1 do 5 odmerkov (polnitveni odmerek), nato pa po 6 do 10 mg/kg enkrat na dan, učinkovit pri zdravljenju po Gramu pozitivnih okužb, kot so septikemija, okužbe kože in mehkih tkiv, okužbe kosti in sklepov, okužbe spodnjih dihalnih poti ter nevtropenije in povišane telesne temperature pri otrocih.
Information on the active substance was submitted in an ASMF.
Informacije o zdravilni učinkovini so bile predložene v glavni dokumentaciji o zdravilni učinkovini (ASMF).
The results from the various studies discussed by the MAH suggest that teicoplanin has a place in the management of pneumonia.
Rezultati različnih študij, o katerih je razpravljal imetnik dovoljenja za promet z zdravilom, so pokazali, da teikoplanin sodeluje pri zdravljenju pljučnice.
A modified warning regarding hypersensitivity reactions to address the fatal cases that have been reported and to strengthen the possibility of cross hypersensitivity to vancomycin was proposed by the MAH, and accepted by the CHMP.
Imetnik dovoljenja za promet z zdravilom je predlagal spremenjeno opozorilo glede preobčutljivostnih reakcij, ki se nanašajo na smrtne primere, o katerih so poročali, in na okrepitev možnosti navzkrižne preobčutljivosti na vankomicin, kar je odbor CHMP sprejel.
The product information was therefore updated to declare the qualitative and quantitative details of the active substance in terms of mass and IU: each vial contains 200mg (or 400) mg teicoplanin equivalent to 200,000 IU (or 400,000 IU).
Podatki o zdravilu so bili zato posodobljeni, tako da določajo kvalitativne in kvantitativne podrobnosti zdravilne učinkovine glede na maso in i. e.: ena viala vsebuje 200 mg (ali 400 mg) teikoplanina, kar je enakovredno 200.000 i. e. (ali 400.000 i. e.).
The subcomponents are separated by HPLC according to their polarity.
Podkomponente so ločene s tekočinsko kromatografijo visoke ločljivosti (HPLC) glede na polarnost.
The MAH has proposed that a trough plasma concentration of 10mg/l (when measured by high performance liquid chromatography) should be maintained for most infections, and that higher concentrations of 15 to 30mg/l for endocarditis, septic arthritis and osteomyelitis should be considered for severe infections.
Imetnik dovoljenja za promet z zdravilom je predlagal, da je treba za večino okužb vzdrževati najmanjšo koncentracijo 10 mg/l (izmerjeno s tekočinsko kromatografijo visoke ločljivosti) in da je treba pri resnih okužbah razmisliti o višjih koncentracijah od 15 do 30 mg/l za endokarditis, septični artritis in osteomielitis.
The wording of the CSP agreed during the PSUR work-sharing procedure (number GR/H/PSUR/0001/001) was considered to be acceptable by the CHMP.
Besedilo CSP, o katerem so se dogovorili med postopkom za delitev dela PSUR (GR/H/PSUR/0001/001), je bilo za odbor CHMP sprejemljivo.
Overall, the undesirable effects listed in the CSP agreed during the PSUR work-sharing procedure number GR/H/PSUR/0001/001 have been included in section 4.8 of the proposed harmonised SmPC using the MedDRA Preferred Terms (PTs), and classified by System Organ Class (SOC).
Neželeni učinki, navedeni v CSP, o katerih so se dogovorili med postopkom za delitev dela PSUR številka GR/H/PSUR/0001/001, so bili vključeni v poglavje 4.8 predlaganega usklajenega povzetka glavnih značilnosti zdravila z uporabo priporočenih izrazov po MedDRA in razvrščeni glede na organske sisteme.
In conclusion, based on the assessment of the proposals submitted by the MAH and the discussions of the Committee, the CHMP adopted the harmonised product information consisting of the summary of product characteristics (SmPC), labelling and package leaflets, for Targocid and associated names.
Na podlagi ocene predlogov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, in razprav odbora, je CHMP sprejel usklajene podatke o zdravilu Targocid in povezanih imenih, ki jih sestavljajo povzetek glavnih značilnosti zdravila (SmPC), označevanje in navodila za uporabo.
As is the current practice in some member states, the maintenance dose of 6-12mg/kg od depending on the type of infection was maintained: 6mg/kg od for complicated skin, soft tissue and urinary tract infections and pneumonia and 12mg/kg od for bone and joint infections and endocarditis.
Kot je trenutna praksa v nekaterih državah članicah, je vzdrževalni odmerek 6 do 12 mg/kg enkrat na dan odvisen od vrste okužbe: 6 mg/kg enkrat na dan za zapletene okužbe kože, mehkih tkiv in sečil ter pljučnico in 12 mg/kg za okužbe kosti in sklepov ter endokarditis.
Therefore the indication for the prophylactic use of teicoplanin was not considered to be acceptable by the CHMP.
Indikacija za profilaktično uporabo teikoplanina za odbor CHMP zato ni bila sprejemljiva.
The CHMP has requested the MAH to submit a RMP within 6 months of the Commission Decision to adequately address the important potential risks, in particular, the increased frequency of nephrotoxicity and other serious reactions with loading doses of 12mg/kg bid (24mg/kg/day).
Odbor CHMP je zahteval, da imetnik dovoljenja za promet z zdravilom predloži RMP v šestih mesecih po sklepu Komisije, da ustrezno pojasni pomen potencialnih tveganj, zlasti povečano pogostnost nefrotoksičnosti in drugih resnih reakcij s polnilnimi odmerki 12 mg/kg dvakrat na dan (24 mg/kg/dan).
The strengths of teicoplanin finished product are conventionally declared and prescribed in terms of mass (e.g. 200 mg and 400 mg), but given the variability of the active substance, it is the potency of the finished product, as determined by microbiological assay and declared in IU (e.g. 200,000 IU or 400,000 IU), that determines the quantitative amount of active substance in the finished product.
Jakosti končnega zdravila teikoplanina so konvencionalno določene in predpisane glede na maso (npr. 200 mg in 400 mg), vendar je zaradi variabilnosti zdravilne učinkovine učinkovitost končnega zdravila, kot je bila določena z mikrobiološkim določanjem in prijavljena v i. e. (npr. 200 000 i. e. ali 400 000 i. e.), tista, ki določa kvantitativno količino zdravilne učinkovine v končnem zdravilu.