natgillin/translations-raw huggingface dataset:
A study in 410 patients with advanced well- or moderately differentiated neuroendocrine tumours of pancreatic origin compared Afinitor with placebo.
V študiji, v katero je bilo vključenih 410 bolnikov z napredovalim ali zmerno diferenciranim nevroendokrinim tumorjem pankreatičnega izvora, so zdravilo Afinitor primerjali s placebom.
• advanced renal cell carcinoma (a kidney cancer), when the cancer has worsened despite treatment with a ‘VEGF-targeted' medicine (a type of medicine that blocks the effects of vascular endothelial growth factor proteins).
• napredovalega raka ledvičnih celic (ledvičnega raka), kadar se je rak poslabšal kljub zdravljenju s tarčnim zdravilom, ki je usmerjeno proti žilnemu endotelijskemu rastnemu dejavniku (VEGF) (vrsti zdravila, ki zavira učinke beljakovin žilnega endotelijskega rastnega dejavnika).
• pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) when the cancer cells are well- or moderately differentiated (which means that they can be distinguished from normal pancreas cells).
• nevroendokrinega tumorja pankreatičnega izvora (tumorja celic trebušne slinavke, ki tvorijo hormone), kadar so rakaste celice zelo ali zmerno diferencirane (kar pomeni, da so razpoznavno drugačne od normalnih celic trebušne slinavke).
The active substance in Afinitor, everolimus, blocks an enzyme called ‘mammalian target of rapamycin' (mTOR).
Učinkovina zdravila Afinitor, everolimus, deluje z zaviranjem beljakovine, imenovane „tarča rapamicina pri sesalcih“ (mTOR).
The Agency also concluded that the 7-month delay in disease progression for patients with neuroendocrine tumours originating in the lungs or gut was valuable, despite the known side effects of Afinitor.
Agencija je poleg tega zaključila, da je sedemmesečno podaljšanje časa brez napredovanja bolezni pri bolnikih z nevroendokrinim tumorjem pljučnega ali črevesnega izvora pomembno, kljub znanim neželenim učnikom zdravila Afinitor.
How is Afinitor used?
Kako se zdravilo Afinitor uporablja?
This complex then blocks mTOR.
Ta skupek nato zavira beljakovino mTOR.
Pancreatic neuroendocrine tumours
Nevroendokrini tumor pankreatičnega izvora
Patients who received Afinitor and best supportive treatments lived for an average of 11 months without the disease getting worse compared with around 4 months for patients who received placebo and best supportive treatments to relieve disease symptoms.
Bolniki, ki so prejeli zdravilo Afinitor in najboljše podporno zdravljenje, so v povprečju živeli 11 mesecev brez poslabšanja bolezni v primerjavi s štirimi meseci pri tistih, ki so prejemali placebo in najboljše podporno zdravljenje za lajšanje simptomov bolezni.
Afinitor in combination with exemestane has been studied in 724 patients with hormone receptorpositive and HER2/neu-negative advanced breast cancer which had got worse after treatment with letrozole and anastrazole (non-steroidal aromatase inhibitors).
V študijo, v kateri so uporabili zdravilo Afinitor in eksemestan, je bilo vključenih 724 bolnic z napredovalim rakom dojke, pozitivnim na hormonske receptorje in negativnim na HER2/neu, ki se je poslabšal po zdravljenju z letrozolom in anatrazolom (nesteroidnima zaviralcema aromataze).
Afinitor was studied in 416 patients with advanced renal cell carcinoma that had got worse despite treatment with VEGF-targeted medicines (sunitinib, sorafenib or both).
Tretja študija je vključevala 416 bolnikov z napredovalim rakom ledvičnih celic, ki se je poslabšal kljub zdravljenju z zdravili, ki so usmerjena proti žilnemu endotelijskemu rastnemu dejavniku (sunitinibom, sorafenibom ali kombinacijo obeh).
Afinitor was studied in 302 patients with advanced neuroendocrine tumours of lung or gut origin.
Zdravilo Afinitor so proučevali v študiji, v katero sta bila vključena 302 bolnika z nevroendokrinim tumorjem pljučnega ali črevesnega izvora.
For the full list of side effects of Afinitor, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Afinitor, glejte navodilo za uporabo.
Patients who took Afinitor lived for an average of 4.9 months without the disease getting worse, compared with 1.9 months for the patients who took placebo.
Bolniki, ki so prejemali zdravilo Afinitor, so v povprečju brez poslabšanja bolezni živeli 4,9 meseca v primerjavi z 1,9 meseca pri tistih, ki so prejemali placebo.
Patients who took Afinitor lived for an average of 7.8 months without their disease getting worse, compared with 3.2 months for the patients who took placebo (a dummy treatment).
Bolnice, ki so prejemale zdravilo Afinitor, so v povprečju 7,8 meseca živele brez poslabšanja bolezni v primerjavi s 3,2 meseca pri tistih, ki so prejemale placebo (zdravilo brez učinkovine).
Neuroendocrine tumours originating in the lung or gut
Nevroendokrini tumor pljučnega ali črevesnega izvora
Patients who took Afinitor lived for an average of 11.0 months without the disease getting worse, compared with 4.6 months for the patients who took placebo.
Bolniki, ki so prejemali zdravilo Afinitor, so v povprečju brez poslabšanja bolezni živeli 11,0 meseca v primerjavi s 4,6 meseca pri tistih, ki so prejemali placebo.
MA (EU) Number
Številka (EU)
400 mg / 100 mg Film-coated tablet
400 mg/100 mg Filmsko obložena tableta Peroralna uporaba Steklenička (HDPE) 28 tablet
This is more likely if:
To je verjetneje:
Treatment should not exceed 4 months.
Zdravljenje ne sme trajati več kot 4 mesece.
After the fourth day of treatment:
Po 4. dnevu zdravljenja:
This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Luxemburg, Malta, Netherlands, Poland, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom: Targocid
To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: Avstrija, Belgija, Bolgarija, Češka, Danska, Francija, Nemčija, Grčija, Madžarska, Irska, Luksemburg, Malta, Nizozemska, Poljska, Romunija, Slovaška, Slovenija, Španija, Švedska, Velika Britanija: Targocid Italija, Portugalska: Targosid
No specific interaction studies have been performed.
Specifičnih študij medsebojnega delovanja niso izvedli.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6.
The highest values of Vss are observed in the recent studies where the sampling period was superior to 8 days.
Najvišjo vrednost Vss so ugotovili v novejših študijah, v katerih je obdobje vzorčenja presegalo 8 dni.
The duration of treatment should be decided based on the clinical response.
Trajanje zdravljenja je treba določiti glede na klinični odziv.
The MICs breakpoints according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST), version 3.1, February 11, 2013 are displayed in the following table:
Mejne vrednosti MIC po EUCAST (European Committee on Antimicrobial Susceptibility Testing), verzija 3.1, 11. februar 2013, so prikazane v naslednji preglednici:
• Paediatric population
• Pediatrična populacija
If the solution does become foamy, then it should be left to stand for about 15 minutes.
Če raztopina postane penasta, jo je treba pustiti stati približno 15 minut.
Paediatric population The dose recommendations are the same in adults and children above 12 years of age.
Pediatrična populacija Priporočila za odmerjanje so pri odraslih in otrocih po 12. letu enaka.
After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Po izdaji Sklepa komisije kompetentni urad države članice skupaj z refernčno državo članico posodobi informacije o zdravilu kot zahtevano.
Targocid is an antibiotic.
Zdravilo Targocid je antibiotik.
For infective endocarditis a minimum of 21 days is usually considered appropriate.
Za infekcijski endokarditis po navadi velja za primerno uporaba vsaj 21 dni.
c IE indicates that there is insufficient evidence that the species in question is a good target for therapy with the drug.
c ND pomeni, da ni dovolj dokazov, da je zadevna vrsta dober cilj za zdravljenje s tem zdravilom.
• hearing loss, ringing in the ears or a feeling that you, or things around you are moving
• poslabšanje sluha, zvonjenje v ušesih ali občutek, da se gibljete vi ali stvari okrog vas
From a microbiological point of view, the medicine should be used immediately.
Z mikrobiološkega stališča je zdravilo treba uporabiti takoj.
• Modified target structure: this form of resistance has occurred particularly in Enterococcus faecium.
• Spremenjena zgradba cilja: Ta oblika odpornosti se je pojavila zlasti pri Enterococcus faecium.
Mechanism of resistance Resistance to teicoplanin can be based on the following mechanisms:
Mehanizem odpornosti Odpornost proti teikoplaninu lahko temelji na naslednjih mehanizmih:
<Detailed information on this medicinal product is available on the website of {name of MS/Agency}>
<Podrobne informacije o zdravilu so objavljene na spletni strani {ime DČ/agencije}>
It works by killing the bacteria that cause infections in your body.
Deluje tako, da uniči bakterije, ki povzročajo okužbe v telesu.
Shelf life of powder as packaged for sale: 3 years
Rok uporabnosti praška, kot je pakiran za prodajo: 3 leta.
• getting more infections than usual - these could be signs of a decrease in your blood cell count
• več okužb kot po navadi - to je lahko znak zmanjšanega števila krvnih celic
Targeted trough concentrations at day 3 to 5
Ciljna najnižja koncentracija od 3. do 5. dne
The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory.
Identifikacijo in preiskave antimikrobne občutljivosti je na takšnih izolatih treba ponoviti; če je rezultat potrjen, je treba izolat poslati v referenčni laboratorij.
It is unlikely that your doctor or nurse will give you too much medicine.
Ni verjetno, da bi vam zdravnik ali medicinska sestra dala preveč zdravila.
Patients experiencing these undesirable effects should not drive or use machines.
Bolniki, ki se jim pojavijo takšni neželeni učinki, ne smejo voziti in upravljati s stroji.
What Targocid is and what it is used for 2.
Kaj je zdravilo Targocid in za kaj ga uporabljamo 2.
Therefore, teicoplanin should not be used during pregnancy unless clearly necessary.
Zato se teikoplanina med nosečnostjo ne sme uporabljati, če ni nedvomno potrebno.
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 of types of infections is questionable.
Glede na potrebe je treba poiskati nasvet strokovnjaka, če je lokalna prevalenca odpornosti takšna, da je uporabnost tega zdravila vsaj pri nekaterih vrstah okužb vprašljiva.
Adults and elderly patients with normal renal function
Odrasli in starejši bolniki z normalnim delovanjem ledvic
Do not use Targocid if: • you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Targocid: • če ste alergični na teikoplanin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Not known (cannot be estimated from available data)
Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Upoštevati je treba uradne smernice za ustrezno uporabo protibakterijskih zdravil.
Your doctor or nurse will have instructions about when to give you Targocid.
Zdravnik ali medicinska sestra imata navodila, kdaj vam morata dati zdravilo Targocid.
Practical information for healthcare professionals on preparation and handling of Targocid.
Praktične informacije za zdravstvene delavce o pripravi in ravnanju z zdravilom Targocid.
Teicoplanin is mainly bound to human serum albumin.
Teikoplanin je v glavnem vezan na človeški serumski albumin.
• you are allergic to an antibiotic called ‘vancomycin'
• če ste alergični na antibiotik, ki se imenuje "vankomicin",
The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Prevalenca odpornosti za izbrane vrste se lahko razlikuje geografsko in v času, zato so zaželene lokalne informacije o odpornosti, zlasti pri zdravljenju hudih okužb.
Information about storage and the time to use Targocid, after it has been reconstituted and is ready to use, are described in the ‘Practical information for healthcare professionals on preparation and handling of Targocid'.
Informacije o shranjevanju in času za uporabo zdravila Targocid, potem ko je že pripravljeno za uporabo, so navedene v poglavju "Praktične informacije za zdravstvene delavce o pripravi in ravnanju z zdravilom Targocid".
Teicoplanin can cause dizziness and headache.
Teikoplanin lahko povzroči omotico in glavobol.
• your treatment will last for a long time
• če bo vaše zdravljenje dolgotrajno,
Teicoplanin antimicrobial activity depends essentially on the duration of time during which the substance level is higher than the minimum inhibitory concentration (MIC) of the pathogen.
Antimikrobna aktivnost teikoplanina je ključno odvisna od trajanja časa, med katerim je koncentracija snovi višja od minimalne inhibitorne koncentracije (MIC) patogena.
Spectrum of antibacterial activity
Spekter protibakterijskega delovanja
Treatment of teicoplanin overdose should be symptomatic.
Zdravljenje prevelikega odmerjanja teikoplanina mora biti simptomatsko.
Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
Dokler ni dokazov o kliničnem odzivu za potrjene izolate z MIC nad trenutnimi mejnimi vrednostmi odpornosti, jih je treba prijaviti kot odporne.
The binding to human serum proteins ranges from 87.6 to 90.8% without any variation in function of the teicoplanin concentrations.
Vezava na beljakovine v serumu pri človeku je od 87,6 do 90,8 %, brez variabilnosti v odvisnosti od koncentracije teikoplanina.
This medicine is for single use only.
To zdravilo je samo za enkratno uporabo.
• Aminoglycosides as they must not be mixed together with Targocid in the same injection.
• aminoglikozide, ker se jih ne sme mešati z zdravilom Targocid v isti injekciji.
Powder as packaged for sale: This medicinal product does not require any special storage condition.
Prašek, kot je pakiran za prodajo: Za shranjevanje zdravila niso potrebni posebni pogoji.
Not known (frequency cannot be estimated from the available data)
Ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
A potential risk of inner ear and renal damage to the foetus cannot be excluded (see section 4.4).
Možnega tveganja za okvaro notranjega ušesa in okvaro ledvic pri plodu ni mogoče izključiti (glejte poglavje 4.4).
If you forget to have Targocid
Če ste pozabili prejeti Targocid
In people who are given Targocid for a long time, bacteria that are not affected by the antibiotic may grow more than normal - your doctor will check for this.
Pri osebah, ki dolgo časa prejemajo zdravilo Targocid, se lahko prekomerno razmnožijo bakterije, na katere ta antibiotik ne vpliva - vaš zdravnik bo to preveril.
You may have regular tests to check if your blood, kidneys and/or liver are working properly (see ‘Other medicines and Targocid').
Zdravnik bo morda naročil redne preiskave, s katerimi bo preveril, ali vam kri, ledvice in/ali jetra delujejo ustrezno (glejte "Druga zdravila in zdravilo Targocid").
Studies in animals have shown reproductive toxicity at high doses (see section 5.3): in rats there was an increased incidence of stillbirths and neonatal mortality.
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri velikih odmerkih (glejte poglavje 5.3): pri podganah so ugotovili večjo incidenco mrtvorojenosti in neonatalne umrljivosti.
This is because Targocid can affect the way some other medicines work.
Zdravilo Targocid namreč lahko vpliva na delovanje nekaterih drugih zdravil.
Not known (frequency cannot be estimated from the available data) • problems where the injection was given - such as reddening of the skin, pain or swelling
Ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) • težave na mestu injiciranja zdravila - na primer pordelost kože, bolečina ali oteklost
The medicine will normally be given to you by a doctor or nurse.
To zdravilo vam bo praviloma dal zdravnik ali medicinska sestra.
The powder is packaged:
Prašek je pakiran:
However, there is no evidence of synergistic toxicity in combinations with teicoplanin.
Vendar ni dokazov o sinergistični toksičnosti v kombinacijah s teikoplaninom.
Targocid and associated names (see Annex I) is indicated in adults and in children from birth for the parenteral treatment of the following infections (see sections 4.2, 4.4 and 5.1):
Zdravilo Targocid in povezana imena (glejte Prilogo I) je indicirano pri odraslih in otrocih od rojstva za parenteralno zdravljenje naslednjih okužb (glejte poglavja 4.2, 4.4 in 5.1):
Solvent: water for injections.
Vehikel: voda za injekcije.
• It will be given by injection into a vein (intravenous use) or muscle (intramuscular use).
• Dobili ga boste z injekcijo v veno (intravenska uporaba) ali v mišico (intramuskularna uporaba).
On this basis it is expected that in most instances teicoplanin will be used to treat severe infections in patients for whom standard antibacterial activity is considered to be unsuitable.
Na tej podlagi je mogoče pričakovati, da bo teikoplanin večinoma uporabljen za zdravljenje hudih okužb pri bolnikih, za katere je standardno protibakterijsko delovanje ocenjeno kot neprimerno.
Other medicines and Targocid
Druga zdravila in zdravilo Targocid
Microorganism
Mikroorganizem
In one case agitation occurred in a 29-day-old newborn who had been administered 400 mg intravenously (95 mg/kg).
V enem primeru se je pojavila agitacija pri 29 dni starem novorojenčku, ki je prejel 400 mg intravensko (95 mg/kg).
Measurement of serum concentrations
Merjenje koncentracije v serumu
Teicoplanin did not show any potential to cause antigenicity (in mice, guinea-pigs or rabbits), genotoxicity or local irritancy.
Teikoplanin ni pokazal potenciala za antigenost (pri miših, morskih prašičkih ali kuncih), genotoksičnost ali lokalno draženje.
If an allergic reaction to teicoplanin occurs, treatment should be discontinued immediately and appropriate emergency measures should be initiated.
Če se pojavi alergijska reakcija na teikoplanin, je treba zdravljenje nemudoma prekiniti in uvesti ustrezne nujne ukrepe.
b Isolates with MIC values above the susceptible breakpoint are very rare or not yet reported.
b Izolati z MIC nad mejno vrednostjo občutljivosti so zelo redki ali še niso opisani.
What you need to know before you are given Targocid 3.
Kaj morate vedeti, preden boste dobili zdravilo Targocid 3.
The final solution is isotonic with plasma and has a pH of 7.2-7.8.
Končna raztopina je izotonična s plazmo in ima pH od 7,2 do 7,8.
a Glycopeptide MICs are method dependent and should be determined by broth microdilution (reference ISO 20776).
Odporni a MIC za glikopeptide so odvisne od metode in jih je treba določati z mikrodilucijo bujona (referenca ISO 20776).
When administered by oral route at 250 or 500 mg single dose to healthy subjects, teicoplanin is not detected in serum or urine but only recovered in feces (about 45% of the administered dose) as unchanged medicinal product.
Po peroralni uporabi enkratnega odmerka 250 ali 500 mg pri zdravih osebah se teikoplanin ni pojavil v serumu ali urinu, temveč le v blatu (približno 45 % uporabljenega odmerka) kot nespremenjeno zdravilo.
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
The modification is based on exchange of the terminal D-alanine-D-alanine function of the aminoacid chain in a murein precursor with D-Ala-D-lactate, thus reducing the affinity to vancomycin.
Sprememba temelji na zamenjavi terminalnega D-alanin-D-alaninskega dela aminokislinske verige v mureinskem predhodniku z D-Ala-D-laktatom; to zmanjša afiniteto za vankomicin.
The rational use of teicoplanin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient.
Za racionalno uporabo teikoplanina je treba upoštevati bakterijski spekter delovanja, varnostne značilnosti in primernost standardnega protibakterijskega zdravljenja za zdravljenje posameznega bolnika.
After intramuscular administration, the bioavailability of teicoplanin (as compared to intravenous administration) is almost complete (90%).
Po intramuskularni uporabi je biološka uporabnost teikoplanina (v primerjavi z intravensko uporabo) skoraj popolna (90 %).
a No current data were available when the tables were published.
a Ob objavi preglednic ni bilo na voljo trenutnih podatkov.
Also, some medicines can affect the way Targocid works.
Prav tako lahko nekatera zdravila vplivajo na delovanje zdravila Targocid.
The total and renal clearances of teicoplanin depends on the creatinine clearance.
Celotni in ledvični očistek teikoplanina sta odvisna od očistka kreatinina.
Under this regimen blood creatinine values should be monitored in addition to the recommended periodic haematological examination.
Med uporabo te sheme je treba poleg priporočenih rednih hematoloških pregledov kontrolirati tudi kreatinin v krvi.
Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2 to 8°C.
Kemična in fizikalna stabilnost v skladu s priporočili pripravljene raztopine med uporabo sta dokazani za 24 ur pri temperaturi od 2 do 8 °C.
Pharmacotherapeutic group: Glycopeptide Antibacterials, ATC code: J01XA 02
Farmakoterapevtska skupina: glikopeptidni antibiotiki, oznaka ATC: J01XA 02
However, a prior history of "red man syndrome" with vancomycin is not a contraindication to the use of teicoplanin.
Anamneza "sindroma rdečega moža" med uporabo vankomicina ni kontraindikacija za uporabo teikoplanina.
• Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.
• raztopina za peritonealno dializo, ki vsebuje 1,36 % ali 3,86 % raztopine glukoze.
Adults and elderly patients with impaired renal function Dose adjustment is not required until the fourth day of treatment, at which time dosing should be adjusted to maintain a serum trough concentration of at least 10 mg/L.
Odrasli in starejši bolniki z okvarjenim delovanjem ledvic Odmerka ni treba prilagoditi do četrtega dne zdravljenja; tedaj je treba odmerjanje prilagoditi tako, da je vzdrževana najnižja koncentracija v serumu vsaj 10 mg/l.
S. aureus with vancomycin MIC values of 2 mg/mL are on the border of the wild type MIC distribution and there may be an impaired clinical response.
S. aureus z vrednostjo MIC za vankomicin 2 mg/ml je na meji porazdelitve MIC divjega tipa in klinični odziv je lahko okrnjen.
12 hours, by injection into a vein.
na 12 ur z injekcijo v veno ali mišico.
Unchanged teicoplanin is mainly excreted by urinary route (80% within 16 days) while 2.7% of the administered dose is recovered in feces (via bile excretion) within 8 days following administration.
Nespremenjeni teikoplanin se v glavnem izloči v urinu (80 % v 16 dneh), 2,7 % uporabljenega odmerka pa se pojavi v blatu (preko izločanja v žolč) v 8 dneh po aplikaciji.
If teicoplanin is administered in combination therapy with other antibiotics, the preparation must be administered separately.
Če je teikoplanin uporabljen v kombiniranem zdravljenju z drugimi antibiotiki, je pripravek treba aplicirati ločeno.
Resistance rate can vary depending on the actual streptococcus species
Delež odpornosti se lahko razlikuje glede na dejansko vrsto streptokoka.