Iskalni niz je ali predolg ali pa vsebuje preveč besed.
Prevodi: en > sl
51–65/65
clinical guidelines
51 Prevajalska redakcija
RS
EMEA
Reduction of hypercalcaemia in patients with: • parathyroid carcinoma. • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Zmanjšanje hiperkalciemije pri bolnikih s: • paratiroidnim karcinomom. • primarnim hiperparatiroidizmom, pri katerih bi bila glede na koncentracijo kalcija v serumu indicirana paratiroidektomija (kot je opredeljeno v ustreznih smernicah za zdravljenje), a ta pri njih ni klinično primerna ali je kontraindicirana.
52 Prevajalska redakcija
RS
EMEA
The total safety database derived from clinical studies now consists of 3293 infants vaccinated with Menitorix either as a primary course or as a booster and 578 infants vaccinated with 1713 doses of closely related Hib-MenC formulations and therefore exceeds that suggested by the CHMP Guideline for truly new vaccines.
5 Celotna baza podatkov o varnosti, ki je bila dobljena iz kliničnih študij, trenutno vključuje 3. 293 dojenčkov, ki so jih cepili z zdravilom Menitorix bodisi kot osnovno cepivo ali kot poživitveno cepivo, in 578 dojenčkov, ki so jih cepili s 1. 713 odmerki sorodnih formulacij Hib- MenC, in zato presega količino, ki jo predlaga smernica odbora CHMP za povsem nova cepiva.
53 Prevajalska redakcija
RS
EMEA
General considerations The recommended initial dosages presented below are intended to act solely as a guideline.< Invented name > dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below for recommended target whole blood trough concentrations).
Splošne opombe Spodaj navedeni priporočeni začetni odmerki so namenjeni le kot smernice. Odmerjanje < (Lastniško) ime zdravila > mora temeljiti predvsem na klinični oceni zavrnitve in prenašanja pri vsakem bolniku posebej; v dodatno pomoč je spremljanje koncentracije v krvi (za priporočene ciljne najnižje koncentracije v polni krvi glejte v nadaljevanju).
54 Prevajalska redakcija
RS
EMEA
Prophylaxis of invasive infections of adults due to Neisseria meningitides Ciprofloxacin is used in clinical practice in prophylaxis of invasive infections of adults due to Neisseria meningitidis when rifampicin is contra-indicated or after microbiologically documentation when Neisseria meningitidis is resistant to rifampicin, in line with some therapeutic guidelines.
Profilaksa invazivnih okužb pri odraslih zaradi bakterije Neisseria meningitides Ciprofloksacin se uporablja v klinični praksi, v profilaksi invazivnih okužb pri odraslih zaradi bakterije Neisseria meningitidis v primeru, kadar je rifampicin kontraindiciran ali po mikrobiološki dokumentaciji, ko je bakterija Neisseria meningitidis odporna na rifampicin v skladu z nekaterimi terapevtskimi smernicami.
55 Prevajalska redakcija
RS
EMEA
Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1). In rare and exceptional cases, subcutaneous infusion of 250-350 IU/ kg was able to produce therapeutic protein C plasma levels in patients with no intravenous access.
Na podlagi omejenih kliničnih izkušenj pri otrocih ter poročil in študij, opravljenih pri 83 bolnikih, so smernice za odmerjanje zdravila pri odraslih bolnikih veljavne tudi za novorojenčke in druge pediatrične bolnike (glejte poglavje 5. 1). V redkih in izjemnih primerih so s subkutano infuzijo 250 - 350 i. e. / kg dosegli terapevtske koncentracije proteina C v plazmi pri bolnikih brez intravenskega dostopa.
56 Prevajalska redakcija
RS
EMEA
It results in increased mean endometrial thickness. • Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs. • References to authoritative international guidelines relevant for uterine surveillance. • The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs.
Posledica je povečana povprečna debelina endometrija. • Na osnovi kliničnih preskušanj so morfološke spremembe, ki jih povzroči zdravilo FABLYN, benigne in ne zahtevajo nadaljnjih preiskav, razen pri pojavu krvavitev iz nožnice. • Navedba verodostojnih mednarodnih smernic, ki se nanašajo na spremljanje stanja maternice, kot reference. • Potreba po prekinitvi zdravljenja z zdravilom FABLYN in raziskavi vzrokov za pojav nepojasnjene krvavitve iz maternice.
57 Prevajalska redakcija
RS
EMEA
The Applicant addressed the concern that no comparator study was provided by arguing that a controlled clinical trial using an active comparator such as systemic doxycycline was not required, as the development program was in line with a number of ICH guidelines CPMP/ ICH/ 291/ 95 and CPMP/ ICH/ 135/ 95 which do not require an active comparator and with the E10 Guidance for the choice of control group in clinical trials (CPMP/ ICH/ 364/ 96), which supports the use of a placebo control group as the most appropriate design where ethically and practically feasible. The Applicant
Predlagatelj je odgovoril na zadržek, da ni predložil študije s komparatorjem, z argumentom, da nadzorovano klinično preskušanje z aktivnim komparatorjem, kot je sistemski doksiciklin, ni potrebno, saj je bil razvojni program v skladu z več priporočili ICH, CPMP/ ICH/ 291/ 95 in CPMP/ ICH/ 135/ 95, ki ne zahtevajo uporabe aktivnega komparatorja, ter s priporočilom E10 za izbiro kontrolnih skupin v kliničnih preskušanjih (CPMP/ ICH/ 364/ 96), ki podpira uporabo kontrolne skupine 5 s placebom, kot najprimernejšo zasnovo v primerih, ko je to etično in praktično izvedljivo.
58 Prevajalska redakcija
RS
EMEA
According to several international guidelines, doxycycline is also commonly recommended for the treatment of rosacea but is only approved in a few EU countries; consequently the off-label use of doxycycline is widely prescribed in clinical practice for long-term treatment (months to up to several years) of acne vulgaris, with dosages generally higher (100 mg daily) than the proposed dosage for Oracea (40 mg daily).
V skladu z več mednarodnimi priporočili se doksiciklin tudi pogosto priporoča za zdravljenje rozacee, vendar je odobren le v nekaj državah EU; zato se v klinični praksi pogosto predpisuje uporaba doksiciklina mimo indikacij za dolgoročno zdravljenje (več mesecev do več let) acne vulgaris, pri čemer so odmerki na splošno višji (100 mg na dan) od priporočenega odmerka zdravila Oracea (40 mg na dan).
59 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
Article 13(3) of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(4) requires that detailed guidance be drawn up, in accordance with the guidelines on good manufacturing practice, on the elements to be taken into account when evaluating investigational medicinal products for human use with the object of releasing batches within the Community.
Člen 13(3) Direktive 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi [4] v skladu s smernicami dobre proizvodne prakse zahteva sestavo podrobnih navodil glede elementov, ki jih je treba upoštevati pri ocenjevanju zdravil za ljudi v preskušanju z namenom sproščanja serij znotraj Skupnosti.
60 Prevajalska redakcija
RS
EMEA
The applicant has presented a number of publications from the literature in order to discuss the rational for deviation from the ICH Guideline on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ ICH/ 2711/ 99) and the basis of differentiation of 0-14 and 15-28 days instead of the more general definition of neonates as ‘ up to 28 days after birth’, as well as the different dosing regimens used.
Vlagatelj je v obrazložitev zakaj odstopanja od smernic ICH za klinične preiskave zdravil za pediatrično populacijo (CPMP/ ICH/ 2711/ 99) in zakaj razlikovanje med novorojenci, starimi od 0 do 14 ter od 15 do 28 dni, namesto bolj splošne opredelitve novorojencev kot " do 28 dni po rojstvu ", predložil številne objavljene članke in različne uporabljene režime odmerjanja.
61 Prevajalska redakcija
RS
EMEA
The treatment regimens that have been shown to satisfy the criteria required above were following: Standard dose proton pump inhibitor, twice daily, and: • metronidazole, 400 mg (tinidazole, 500 mg) twice daily, + clarithromycin, 250 mg twice daily; • amoxicillin, 1000 mg twice daily, + clarithomycin, 500 mg twice daily (advisable when metronidazole resistance is likely); • amoxicillin, 500 mg three times daily, + metronidazole, 400 mg three times daily (advisable when clarithomycin resistance is likely) Since then new data became available that necessitated an update of the original guidelines in order to provide practical management guidelines that would be acceptable across clinical practice, both in primary care and the specialist level.
Sheme zdravljenja, ki so ustrezale gornjim merilom, so bile naslednje: standardni odmerek zaviralca protonske črpalke, dvakrat dnevno, ter: • metronidazol, 400 mg (tinidazol, 500 mg) dvakrat dnevno, + klaritromicin, 250 mg dvakrat dnevno • amoksicilin, 1000 mg dvakrat dnevno, + klaritromicin, 500 mg dvakrat dnevno (priporočeno, kadar je možna odpornost na metronidazol); • amoksicilin, 500 mg trikrat dnevno, + metronidazol, 400 mg trikrat dnevno (priporočeno, kadar je verjetna odpornost na klaritromicin); Od takrat so bili na razpolago dani novi podatki zaradi katerih je bilo potrebno smernice posodobiti, da bi tako zagotovili praktična priporočila za obvladovanje, ki bi bila sprejemljiva po vsej klinični praksi, tako v osnovnem zdravstvu kot na specialistični ravni.
62 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
Whereas the principles and guidelines envisaged by this Directive are in conformity with the opinion of the Committee for Adaptation of Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector created by Article 2b of Directive 81/852/EEC of 28 September 1981 concerning the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), as last amended by Directive 87/20/EEC (5),
ker so načela in smernice, predvidene s to direktivo, v skladu z mnenjem Odbora za prilagoditev tehničnega napredka direktiv o odstranitvi tehničnih ovir v trgovini v sektorju zdravil za uporabo v veterinarski medicini, ustanovljenega s členom 2b Direktive 81/852/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic v zvezi z analitskimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli pri testiranju zdravil za uporabo v veterinarski medicini [4], kakor je bila nazadnje spremenjena z Direktivo 87/20/EGS [5],
63 Prevajalska redakcija
RS
EMEA
• To submit a Risk Management Plan, according to the current guideline, including: o Detailed strategies for educating physicians including appropriate injection techniques, dosing and lack of interchangeability between products as well as programmes for continued and improved monitoring of spread reactions in clinical use and in clinical trials. o Information on usage patterns and on types of prescribers/ users of Xeomin in order to identify if and at what type of clinics off-label cosmetic use is taking place, especially in the EU. o Steps to be taken to ensure that patients are adequately informed of the safety issues associated with these products, e. g. adequate labelling and patient brochures. Specifically this information should include advice to seek immediate medical help in the event of swallowing, speech or respiratory difficulties arise. o Specifically include toxin spread events in their sentinel list of events for active monitoring. o Evaluation of the spread reactions, specifically as part of future studies. o Commitment to alert the National Competent Authorities if there is a significant change in reporting rate.
• Predložitev načrta za obvladovanje tveganj v skladu z veljavno smernico, vključno s: podrobno strategijo za izobraževanje zdravnikov, ki vključuje ustrezno tehniko injiciranja, o odmerjanje in neobstoj medsebojne zamenljivosti med izdelki, kakor tudi programe za kontinuiran in izboljšan nadzor širjenja pri klinični uporabi in kliničnih preizkušanjih; informacijami o vzorcih uporabe in tipih predpisovalcev/ uporabnikov zdravila Xeomin, da o bi tako identificirali ali in v kakšnem tipu klinik prihaja do " off- label " uporabe (za namene, ki niso navedeni v registraciji zdravila) za kozmetične namene, zlasti v EU; potrebnimi koraki, da bi zagotovili, da so bolniki ustrezno informirani o vidikih varnosti o pri teh izdelkih, npr. ustrezno označevanje in brošure za bolnike; te informacije morajo vključevati izrecen napotek, naj bolniki takoj poiščejo zdravniško pomoč v primeru nastopa težav s požiranjem, govorom ali dihanjem; dogodke, povezane s širjenjem toksina, je treba izrecno vključiti v seznam dogodkov za o aktivno spremljanje; ovrednotenjem reakcij, povezanih s širjenjem, specifično kot del prihodnjih študij; o zavezo k opozorilu pristojnih nacionalnih organov v primeru pomembne spremembe v o pogostosti poročil.
64 Prevajalska redakcija
RS
EMEA
1) Description of post injection syndrome – Education about the 2 intramuscular formulations of olanzapine, including packaging differences – Description of reconstitution and proper administration technique – Recommendation for a 3-hour on-site observation period post injection – Recommendation that prior to giving the injection, the HCP should determine that the patient will not travel alone to their destination – Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed – Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events – Recommendation for appropriate monitoring until the event resolves if an event should occur 2) Recommendations for monitoring of patients for glucose, lipids, and weight. – Promote awareness of appropriate metabolic monitoring by distributing utilized published antipsychotic guidelines.
1) Opis sindroma po injiciranju Izobraževanje glede 2 intramuskularnih oblik olanzapina, vključno z različnimi pakiranji – Opis rekonstitucije in pravilnih tehnik injiciranja – Priporočilo za 3- urno opazovanje na mestu po injiciranju – Priporočilo, da pred dajanjem injekcije zdravstveno osebje zagotovi, da bolnik ne bo sam odšel – do svojega doma Priporočilo o obvestilu bolnikom, da preostanek dneva po injiciranju ne vozijo in ne upravljajo s – stroji, da morajo biti pozorni na znake in simptome sindroma po injiciranju ter da morajo imeti možnost po potrebi poiskati pomoč Opis najpogostejših simptomov, ki so jih poročali pri prevelikem odmerjanju olanzapina in – predstavljajo klinično izražene učinke pri sindromu po injiciranju Priporočilo za ustrezno spremljanje bolnikov, dokler se, v primeru pojava učinkov, učinki ne – izboljšajo 2) Priporočila za spremljanje bolnikov glede glukoze, lipidov in telesne mase.
65 Prevod
gospodarstvo
CELEX: 32002D0106
(a) provides guidelines and minimum requirements on diagnostic procedures, sampling methods and criteria for the evaluation of the results of clinical and post-mortem examinations and laboratory tests for a proper diagnosis of classical swine fever(1);
daje smernice in minimalne zahteve glede diagnostičnih postopkov, metod vzorčenja in meril za ocenjevanje rezultatov kliničnih, patoanatomskih preiskav in laboratorijskih preiskav za zanesljivo ugotavljanje klasične prašičje kuge [3];
Prevodi: en > sl
51–65/65
clinical guidelines