natgillin/translations-raw huggingface dataset:
Signifor 20 mg is available in unit packs containing one vial of powder with 20 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Zdravilo Signifor 20 mg je na voljo v posamičnih pakiranjih, ki vsebujejo po eno vialo s praškom z 20 mg pasireotida in eno napolnjeno injekcijsko brizgo z 2 ml vehikla.
Solution for injection
Priprava na injiciranje
Signifor 10 mg: each vial contains 10 mg pasireotide (as pasireotide pamoate).
Signifor 10 mg: ena viala vsebuje 10 mg pasireotida (v obliki pasireotidijevega pamoata).
If you have any questions, contact your doctor, nurse or pharmacist.
Če imate kakršnakoli vprašanja, se obrnite na zdravnika, medicinsko sestro ali farmacevta.
It is used to treat Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed.
Uporabljamo ga za zdravljenje tistih odraslih bolnikov s Cushingovo boleznijo, za katere kirurški poseg ni primeren oziroma pri katerih kirurški poseg ni bil uspešen.
Signifor 40 mg: each vial contains 40 mg pasireotide (as pasireotide pamoate).
Signifor 40 mg: ena viala vsebuje 40 mg pasireotida (v obliki pasireotidijevega pamoata).
The injection site
raztopina za injiciranje
Signifor 30 mg: each vial contains 30 mg pasireotide (as pasireotide pamoate).
Signifor 30 mg: ena viala vsebuje 30 mg pasireotida (v obliki pasireotidijevega pamoata).
The study enrolled 162 patients with a baseline UFC >1.5 x ULN who were randomised in a 1:1 ratio to receive a subcutaneous dose of either 0.6 mg or 0.9 mg Signifor twice daily.
Bolnike so randomizirali v razmerju 1:1, in sicer tako, da so prejemali subkutane odmerke zdravila Signifor bodisi 0,6 mg ali 0,9 mg dvakrat na dan.
Signifor 40 mg powder and solvent for suspension for injection EU/1/12/753/014-015
Signifor 40 mg prašek in vehikel za suspenzijo za injiciranje EU/1/12/753/014-015
Signifor 60 mg powder and solvent for suspension for injection One vial contains 60 mg pasireotide (as pasireotide pamoate).
Signifor 60 mg prašek in vehikel za suspenzijo za injiciranje Ena viala vsebuje 60 mg pasireotida (v obliki pasireotidijevega pamoata).
Treatment should not be restarted if the liver function abnormalities are suspected to be related to pasireotide.
Če obstaja domneva, da je nepravilno delovanje jeter povezano s pasireotidom, se zdravljenja ne sme ponovno uvesti.
One vial contains 20 mg pasireotide (as pasireotide pamoate).
Ena viala vsebuje 20 mg pasireotida (v obliki pasireotidijevega pamoata).
NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Signifor 10 mg is available in unit packs containing one vial of powder with 10 mg pasireotide and one pre filled syringe with 2 ml solvent.
Zdravilo Signifor 10 mg je na voljo v posamičnih pakiranjih, ki vsebujejo po eno vialo s praškom z 10 mg pasireotida in eno napolnjeno injekcijsko brizgo z 2 ml vehikla.
Signifor 30 mg is available in unit packs containing one vial of powder with 30 mg pasireotide and one pre filled syringe with 2 ml solvent.
Zdravilo Signifor 30 mg je na voljo v posamičnih pakiranjih, ki vsebujejo po eno vialo s praškom s 30 mg pasireotida in eno napolnjeno injekcijsko brizgo z 2 ml vehikla.
Signifor 0.9 mg injection pasireotide
Signifor 0,9 mg raztopina za injiciranje pasireotid
One vial contains 60 mg pasireotide (as pasireotide pamoate).
Ena viala vsebuje 60 mg pasireotida (v obliki pasireotidijevega pamoata).
Signifor 10 mg powder and solvent for suspension for injection One vial contains 10 mg pasireotide (as pasireotide pamoate).
Signifor 10 mg prašek in vehikel za suspenzijo za injiciranje Ena viala vsebuje 10 mg pasireotida (v obliki pasireotidijevega pamoata).
Signifor 60 mg is available in unit packs containing one vial of powder with 60 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Zdravilo Signifor 60 mg je na voljo v posamičnih pakiranjih, ki vsebujejo po eno vialo s praškom s 60 mg pasireotida in eno napolnjeno injekcijsko brizgo z 2 ml vehikla.
Signifor 10 mg powder and solvent for suspension for injection EU/1/12/753/018
Signifor 10 mg prašek in vehikel za suspenzijo za injiciranje EU/1/12/753/018
Signifor 40 mg powder and solvent for suspension for injection One vial contains 40 mg pasireotide (as pasireotide pamoate).
Signifor 40 mg prašek in vehikel za suspenzijo za injiciranje Ena viala vsebuje 40 mg pasireotida (v obliki pasireotidijevega pamoata).
Age has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Pri analizi populacijske farmakokinetike pri bolnikih s Cushingovo boleznijo so ugotovili, da ima starost vlogo sospremenljivke.
Signifor 0.9 mg: One ampoule of 1 ml solution contains 0.9 mg pasireotide (as pasireotide diaspartate).
Signifor 0,9 mg: Ena ampula z 1 ml raztopine vsebuje 0,9 mg pasireotida (v obliki pasireotidijevega diaspartata).
Asymptomatic elevations in lipase and amylase were observed in patients receiving pasireotide in clinical studies.
Pri bolnikih, ki so v kliničnih študijah prejemali pasireotid, so opažali asimptomatsko zvišanje vrednosti lipaze in amilaze.
Signifor 30 mg powder and solvent for suspension for injection One vial contains 30 mg pasireotide (as pasireotide pamoate).
Signifor 30 mg prašek in vehikel za suspenzijo za injiciranje Ena viala vsebuje 30 mg pasireotida (v obliki pasireotidijevega pamoata).
PRE-FILLED SYRINGE LABEL
Encimi trebušne slinavke
1 ml solution for injection contains 0.9 mg pasireotide (as pasireotide diaspartate).
1 ml raztopine za injiciranje vsebuje 0,9 mg pasireotida (v obliki pasireotidijevega diaspartata).
IM
po
One vial contains 10 mg pasireotide (as pasireotide pamoate).
Ena viala vsebuje 10 mg pasireotida (v obliki pasireotidijevega pamoata).
Ampoules of Signifor of different strengths (0.3 mg, 0.6 mg and 0.9 mg) are available to match the specific dose prescribed by your doctor.
Da bi lahko ustrezno odmerjali določen odmerek, ki vam ga predpiše zdravnik, so na voljo ampule zdravila Signifor različnih jakosti (0,3 mg, 0,6 mg in 0,9 mg).
Table 4 Key results at month 12 - phase III study in acromegaly patients
Preglednica 4 Glavni rezultati po 12 mesecih - študija faze III pri bolnikih z akromegalijo pasireotid intramuskularna uporaba n (%) N=176
Signifor 20 mg powder and solvent for suspension for injection EU/1/12/753/013
Signifor 20 mg prašek in vehikel za suspenzijo za injiciranje EU/1/12/753/013
Signifor 40 mg is available in unit packs containing one vial of powder with 40 mg pasireotide and one pre-filled syringe with 2 ml solvent.
Zdravilo Signifor 40 mg je na voljo v posamičnih pakiranjih, ki vsebujejo po eno vialo s praškom s 40 mg pasireotida in eno napolnjeno injekcijsko brizgo z 2 ml vehikla.
Signifor 0.3 mg: One ampoule of 1 ml solution contains 0.3 mg pasireotide (as pasireotide diaspartate).
Signifor 0,3 mg: Ena ampula z 1 ml raztopine vsebuje 0,3 mg pasireotida (v obliki pasireotidijevega diaspartata).
Signifor 0.3 mg injection pasireotide
Signifor 0,3 mg raztopina za injiciranje pasireotid
One vial contains 40 mg pasireotide (as pasireotide pamoate).
Ena viala vsebuje 40 mg pasireotida (v obliki pasireotidijevega pamoata).
Signifor 0.6 mg injection pasireotide
Signifor 0,6 mg raztopina za injiciranje pasireotid
Doses should not be doubled to make up for a missed dose.
Bolnik si ne sme injicirati dvojnega odmerka, če si je pozabil injicirati prejšnji odmerek.
Powder: poly(D,L-lactide-co-glycolide) (50-60:40-50), poly(D,L-lactide-co-glycolide) (50:50).
Vsebuje še: prašek: poli(D,L-laktid-ko-glikolid) (50-60:40-50), poli(D,L-laktid-ko-glikolid) (50:50) vehikel: natrijev karmelozat, manitol, poloksamer 188, voda za injekcije
Pasireotide
Odmerjanje
Diarrhoea, abdominal pain, nausea
Bolezni živčevja glavobol, omotičnost
Signifor 0.6 mg: One ampoule of 1 ml solution contains 0.6 mg pasireotide (as pasireotide diaspartate).
Signifor 0,6 mg: Ena ampula z 1 ml raztopine vsebuje 0,6 mg pasireotida (v obliki pasireotidijevega diaspartata).
1 ml solution for injection contains 0.6 mg pasireotide (as pasireotide diaspartate).
1 ml raztopine za injiciranje vsebuje 0,6 mg pasireotida (v obliki pasireotidijevega diaspartata).
1 ml solution for injection contains 0.3 mg pasireotide (as pasireotide diaspartate).
1 ml raztopine za injiciranje vsebuje 0,3 mg pasireotida (v obliki pasireotidijevega diaspartata).
Multipack: 3 packs of 1 injection kit
prašek in vehikel za suspenzijo za injiciranje skupno pakiranje: 3 pakiranja s po 1 kompletom za injiciranje
Keeping your thumbs together above and below the neck, break off the top of the ampoule at the breaking point.
Odlomite vrhnji del ampule pri lomilni zarezi tako, da imate palca nameščena skupaj nad in pod vratom.
Mild transient elevations in aminotransferases are commonly observed in patients treated with pasireotide.
Pri bolnikih, ki so prejemali pasireotid, so pogosto opažali blago prehodno zvišanje vrednosti aminotransferaz.
One vial contains 30 mg pasireotide (as pasireotide pamoate).
Ena viala vsebuje 30 mg pasireotida (v obliki pasireotidijevega pamoata).
Signifor 0.3 mg solution for injection One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide diaspartate).
Signifor 0,3 mg raztopina za injiciranje Ena 1-mililitrska ampula vsebuje 0,3 mg pasireotida (v obliki pasireotidijevega diaspartata).
Signifor 30 mg powder and solvent for suspension for injection EU/1/12/753/019
Signifor 30 mg prašek in vehikel za suspenzijo za injiciranje EU/1/12/753/019
Signifor 0.9 mg solution for injection One ampoule of 1 ml contains 0.9 mg pasireotide (as pasireotide diaspartate).
Signifor 0,9 mg raztopina za injiciranje Ena 1-mililitrska ampula vsebuje 0,9 mg pasireotida (v obliki pasireotidijevega diaspartata).
Powder and solvent for suspension for injection (powder for injection).
prašek in vehikel za suspenzijo za injiciranje (prašek za injiciranje) Prašek: nekoliko rumenkast do rumenkast prašek.
Signifor 60 mg powder and solvent for suspension for injection pasireotide
Signifor 60 mg prašek in vehikel za suspenzijo za injiciranje pasireotid
Signifor 20 mg powder and solvent for suspension for injection pasireotide
Signifor 20 mg prašek in vehikel za suspenzijo za injiciranje pasireotid
Do not use Signifor if you notice the solution is not clear or contains particles.
Če opazite, da raztopina ni bistra ali vsebuje delce, ne uporabite zdravila Signifor.
Signifor 0.6 mg solution for injection One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide diaspartate).
Signifor 0,6 mg raztopina za injiciranje Ena 1-mililitrska ampula vsebuje 0,6 mg pasireotida (v obliki pasireotidijevega diaspartata).
Signifor 10 mg powder and solvent for suspension for injection pasireotide
Signifor 10 mg prašek in vehikel za suspenzijo za injiciranje pasireotid
Especially, tell your doctor if you are using: - medicines used in organ transplantation to reduce the activity of the immune system
Obvestite svojega zdravnika zlasti če uporabljate: - zdravila, ki jih uporabljamo pri presaditvi organa za zaviranje imunskega sistema (ciklosporin); - zdravila za uravnavanje ravni sladkorja v krvi, kadar je ta previsoka (kot pri sladkorni bolezni)
Signifor 40 mg powder and solvent for suspension for injection pasireotide
Signifor 40 mg prašek in vehikel za suspenzijo za injiciranje pasireotid
Compound hsst1
učinkovina hsst1
Signifor 30 mg powder and solvent for suspension for injection pasireotide
Signifor 30 mg prašek in vehikel za suspenzijo za injiciranje pasireotid
Signifor 20 mg powder for injection pasireotide
Signifor 20 mg prašek za injiciranje pasireotid i.m.
Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies performed with the subcutaneous formulation.
V dveh študijah, namenjenih ugotavljanju vpliva na interval QT pri zdravih prostovoljcih, pri katerih so uporabljali obliko zdravila za subkutano uporabo, se je pri preiskavi EKG pokazalo, da pasireotid podaljšuje interval QT.
One long thick blunt sterile needle for drawing up the solution (your doctor or nurse will tell you if this is needed)
Za samoinjiciranje zdravila potrebujete: eno ampulo zdravila Signifor alkoholne blazinice ali kaj podobnega eno sterilno injekcijsko brizgo eno dolgo, debelo, topo sterilno iglo za vnos raztopine v brizgo (vaš zdravnik ali medicinska sestra vam bosta povedala, če je to potrebno) eno kratko, tanko sterilno iglo vsebnik za ostre predmete ali drug trden zabojnik za odpadke z dobrim zapiranjem
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije utrujenost*
Repeat moderate shaking for another 30 seconds if the powder is not completely suspended.
Če prašek še ni povsem dispergiran, vialo še enkrat zmerno stresajte 30 sekund.
- Inflammation of the gallbladder (cholecystitis).
Bolezni jeter, žolčnika in žolčevodov holelitiaza holecistitis*, holestaza
Signifor 40 mg powder for injection pasireotide
Signifor 40 mg prašek za injiciranje pasireotid i.m.
- Low blood pressure.
Motnje strjevanja krvi
Check the expiry date and the dose
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Signifor is to be administered subcutaneously by self injection.
Zdravilo Signifor je namenjeno subkutanemu samoinjiciranju.
Signifor 30 mg powder for injection pasireotide
Signifor 30 mg prašek za injiciranje pasireotid i.m.
Signifor 60 mg powder for injection pasireotide
Signifor 60 mg prašek za injiciranje pasireotid i.m.
How to store Signifor
Shranjevanje zdravila Signifor
Signifor 10 mg powder for injection pasireotide
Signifor 10 mg prašek za injiciranje pasireotid i.m.
Multipack: 30 (5 packs of 6) ampoules.
raztopina za injiciranje skupno pakiranje: 18 ampul (3 pakiranja po 6 ampul) skupno pakiranje: 30 ampul (5 pakiranj po 6 ampul) skupno pakiranje: 60 ampul (10 pakiranj po 6 ampul)
4 vials + 8 swabs
4 viale + 8 alkoholnih blazinic
25 mg Powder for solution for injection
25 mg prašek za raztopino za injiciranje viala (steklo)
24 vials + 24 prefilled syringes + 24 needles + 24 vial adaptors + 48 swabs
4 napolnjene injekcijske brizge + 4 igle +
Section 4.8.
Poglavje 4.8.
Adopted at the 11-14 April 2016 PRAC
Sprejeto na seji odbora PRAC med 11. in 14. aprilom 2016
Olanzapine - Drug reaction with eosinophilia and systemic symptoms (DRESS)(EPITT no 18534)
Olanzapin - Reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)(EPITT št. 18534)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (frequency unknown)
Reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (neznana pogostnost)
The PRAC adopted a recommendation on 16 October 2018 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 16. oktobra 2018 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnaval odbor CHMP.
The PRAC also reviewed all data submitted by different stakeholders, both before and after, the public hearing.
Pregledal je tudi vse podatke, ki so jih predložile različne zainteresirane strani pred javnim zaslišanjem in po njem.
Thus, the indication septicaemia should be deleted.
Posledično je treba indikacijo septikemije izbrisati.
Therefore these broad indications need to be amended.
Zato je treba te široke indikacije spremeniti;
They shall be removed or replaced by accurate medical terms.
Indikacije se odstranijo ali nadomestijo z natančnimi medicinskimi izrazi.
Overall, septicaemia is non-specific and is generally a secondary condition (a consequence) to a primary infection.
Na splošno je septikemija neznačilna in je na splošno sekundarno stanje (posledica) primarne okužbe.
Details of the amendments/ rewording of category 4 indications mentioned in tables 4 and 5 above are provided in Annex III of the CHMP opinion.
Podrobnosti o spremembah/preoblikovanju indikacij kategorije 4, navedenih v preglednicah 4 in 5 zgoraj, so navedene v Prilogi III k mnenju odbora CHMP.
• The PRAC concluded that in case of milder infections, other treatment options should be considered.
• Odbor PRAC je sklenil, da je treba v primeru blažjih okužb razmisliti o drugih možnostih zdravljenja.
This included the responses submitted by the marketing authorisation holders in writing as well as the outcomes of consultations with the Infectious Disease Working Party.
To je vključevalo odzive, ki so jih pisno predložili imetniki dovoljenja za promet z zdravilom, ter zaključke posvetovanj z delovno skupino s področja nalezljivih bolezni.
In addition, the PRAC considered the views of patient organisations, patients, families and carers, and the views of healthcare professionals in a public hearing.
Poleg tega je odbor upošteval tudi stališča organizacij bolnikov, bolnikov, družin in skrbnikov ter stališča zdravstvenih delavcev, izražena v javni obravnavi.
• Category 4: The Indications are considered too broad in view of the evidence available and related to some (sub) indications mentioned in categories 1, 2 or 3 above.
• Kategorija 4: indikacije se štejejo za preširoke glede na razpoložljive dokaze in so povezane z nekaterimi (pod)indikacijami, navedenimi v zgornjih kategorijah 1, 2 ali 3.
Indications in this category are amended (please refer to Annex III) as they are either:
Indikacije v tej kategoriji so spremenjene (glejte Prilogo III), ker so:
According to the current evidence and in line with the European guidelines (Woodhead et al. 2005, 2011), there is a modest benefit in using antibiotics for acute bronchitis in otherwise healthy individuals.
Glede na trenutne dokaze in v skladu z evropskimi smernicami (Woodhead et al., 2005, 2011) obstaja skromna korist uporabe antibiotikov pri akutnem bronhitisu pri drugače zdravih osebah.
Most cases of travellers' diarrhoea are self-limiting and resolve spontaneously within 3-5 days.
Večina primerov potovalne driske izzveni sama od sebe v 3-5 dneh.
ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
ABS je na splošno manj huda okužba, povezana z visokimi stopnjami spontane ozdravitve (90 %).
Therefore, PRAC concluded that these indications should be maintained.
Zato je odbor PRAC sklenil, da je treba te indikacije ohraniti.
After review of the available data, mainly based on animal models (Giamarellou H et al. 1989), efficacy of pefloxacin cannot be established.
Po pregledu razpoložljivih podatkov, ki temeljijo predvsem na živalskih modelih (Giamarellou H et al., 1989), ni mogoče ugotoviti učinkovitosti pefloksacina.
Drugs.
Zdravila.
Prostatitis, epididymo-orchitis
Prostatitis, epididimo-orhitis
A review of its antibacterial activity, pharmacokinetic properties and therapeutic use.
Pregled protibakterijske dejavnosti, farmakokinetičnih lastnosti in terapevtske uporabe.
Therefore, septicaemia is not acceptable as a stand-alone indication as per the Note for Guidance (CPMP/EWP/558/95 rev 2).
Zato septikemija ni nesprejemljiva kot samostojna indikacija v skladu z navodilom Note for Guidance (CPMP/EWP/558/95, rev 2).
Other indications were found to be incorrectly formulated in medical terms.
Ugotovljeno je bilo, da so bile druge indikacije nepravilno opisane z vidika medicinskih izrazov.
Category 4: rewording of indications according to the current medical knowledge
Kategorija 4: preoblikovanje besedila indikacij v skladu s trenutnim zdravstvenim znanjem
Antimicrobial prophylaxis can be given only after counselling and behavioural modification has been attempted and when nonantimicrobial measures have been unsuccessful.
Protimikrobna profilaksa se lahko predpiše šele po poskusu svetovanja in vedenjskih sprememb in kadar ukrepi, ki ne vključujejo protimikrobnega delovanja, niso bili uspešni.
(Fluoro)quinolones have been approved in the EU for a diversity of indications - over one hundred indications of various granularities.
(Fluoro)kinoloni so bili odobreni v EU za različne indikacije: več kot sto indikacij, ki so različno podrobno opredeljene.
The recent study by Gágyor et al (2015) showed that two thirds of women with uncomplicated urinary tract infection treated with ibuprofen recovered without any antibiotics.
Nedavna študija Gágyorja in sodelavcev (2015) je pokazala, da sta dve tretjini žensk z nezapleteno okužbo sečil, ki so se zdravile z ibuprofenom, okrevali brez antibiotikov.
It is also noted that these substances are not mentioned in any clinical guidelines and their place in the therapeutic armamentarium of urinary / genital / gastro-intestinal infections is not justified anymore.
Prav tako je treba opozoriti, da te snovi niso navedene v nobenih kliničnih smernicah, njihovo mesto v naboru terapevtskih sredstev za zdravljenje okužb sečil/spolovil/prebavil pa ni več upravičeno.
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for medicinal products containing substances related to quinolones and fluoroquinolones for systemic and inhaled use.
• Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES, ki je posledica farmakovigilančnih podatkov za zdravila, ki vsebujejo kinolonom in fluorokinolonom sorodne snovi za sistemsko uporabo in inhaliranje.
Indication heading
Naslov indikacije
(2) or the terminology is incorrect from a medical perspective.
(2) oziroma je izrazoslovje z zdravstvenega vidika napačno.
Based on the review of available scientific data, cases of uncomplicated cystitis have been often described as self-limiting.
Na podlagi pregleda razpoložljivih znanstvenih podatkov je bilo pogosto opisano, da so primeri nezapletenega cistitisa izzveneli sami od sebe.
About 80% cases of rhinosinusitis occurring in clinical practice are of viral origin and only a negligible proportion of these cases (i.e. 0,5-2%) develop to bacterial infection (Gwaltney 1996).
Približno 80 % primerov rinosinuzitisa, ki se pojavljajo v klinični praksi, povzročijo virusi in le zanemarljiv delež primerov (tj. 0,5-2 %) se razvije v bakterijsko okužbo (Gwaltney, 1996).
Indication
Oznaka
Therefore fluoroquinolones should be reserved as a last line treatment in patients where other therapeutic options are not effective or not tolerated.
Zato je treba fluorokinolone ohraniti kot zdravljenje zadnje možnosti pri bolnikih, pri katerih druge terapevtske možnosti niso učinkovite ali teh ne prenašajo.
• Chronic sinusitis (CRS)
• Kronični sinuzitis (CRS)
Inappropriate use of (fluoro)quinolones is associated with rapidly increasing bacterial resistance to these agents (Committee on Infectious Diseases 2006; Murray and Baltimore 2007).
Neustrezna uporaba (fluoro)kinolonov je povezana s hitro naraščajočo odpornostjo bakterij proti tem zdravilom (Committee on Infectious Diseases 2006; Murray in Baltimore, 2007).
Indeed, due to their chemical structure and the related pharmacodynamic and pharmacokinetic profile (very narrow range of antibacterial activity, high minimal inhibitory concentrations) their benefit is limited based on the current available data.
Dejansko je zaradi njihove kemijske zgradbe in s tem povezanega farmakodinamičnega in farmakokinetičnega profila (zelo ozek razpon protibakterijskega delovanja, visoka najnižja inhibitorna koncentracija) na podlagi trenutnih razpoložljivih podatkov njihova korist omejena.
Boader-spectrum antibiotics should not be used for peri-procedural prophylaxis or only cautiously in very selective cases (The 2015 European Association of Urology (EAU) guidelines on Urological infections).
Antibiotikov širokega spektra ne smemo uporabljati za profilakso pred posegom oziroma samo previdno v zelo izbranih primerih (Smernice o uroloških okužbah Evropskega združenja za urologijo (EAU) iz leta 2015).
Based on the evaluation of available guidelines and position papers, the prophylaxis of travellers´ diarrhoea should be limited to high-risk short-term travellers only.
Na podlagi ocene razpoložljivih smernic in dokumentov o stališčih moramo profilakso potovalne driske omejiti le na potnike z visokim tveganjem na kratkih potovanjih.
Risk factors associated with appearance of the assessed ADRs remain one of the main uncertainties and further examination of the risk factors should be further explored.
Dejavniki tveganja, povezani s pojavom ovrednotenih neželenih učinkov, ostajajo ena od glavnih negotovosti, zato jih je treba podrobneje raziskati.