Iskalni niz je ali predolg ali pa vsebuje preveč besed.
Prevodi: sl > en
201–222/222
EA
201 Prevajalska redakcija
RS
EMEA
Študija obnovitvenega cepljenja je pokazala, da je cepivo Quintanrix enako učinkovito kot dve ločeni cepivi, saj je imelo 42 dni po obnovitvenem cepljenju od 92 do 100 % otrok zaščitne ravni protiteles. eā
The study of booster vaccination also showed Quintanrix was as effective as the two separate vaccines, with between 92 and 100 % of the infants having protective levels of antibodies 42 days after t uc
202 Prevajalska redakcija
RS
EMEA
Rezultati obsežnejše študije (VIII) pri 315 bolnikih so pri bolnikih, ki so dobivali Trudexo, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s eā
In the larger study (VIII) with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Trudexa compared to placebo.
203 Prevajalska redakcija
RS
EMEA
kg/ m², ali • imajo čezmerno telesno maso (BMI večji ali enak 27 kg/ m²) in pri katerih obstajajo dodatni dejavniki tveganja, kot so na primer diabetes tipa 2 ali dislipidemija (nenormalne ravni maščobe eā
ZIMULTI is used together with diet and exercise to treat adult patients: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/ m², • who are overweight (with a BMI greater than or equal to 27 kg/ m²) and also have other risk factors, such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in their blood).
204 Prevajalska redakcija
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EMEA
zdravljenim z nekim drugim zaviralcem TNF, so poročali o rakih, ki niso bili limfomi. Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNF za vas primerno. eā
If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you. t uc
205 Prevajalska redakcija
RS
EMEA
zelo pogosti: bolečina, rdečina in oteklina, zvišana telesna temperatura (aksilarna ≥ 37, 5 ºC; rektalna ≥ 38 ºC) pogosti: induracija, zvišana telesna temperatura (aksilarna > 39 ºC; rektalna > 39, 5 ºC) eā
r ge Gastrointestinal disorders: very common: loss of appetite rare: vomiting lon General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C) no
206 Prevajalska redakcija
RS
EMEA
Quixidar vsebuje sintetično učinkovino, imenovano natrijev fondaparinuks, ki zavre delovanje faktorja strjevanja krvi Xa (“ deset- A ”) v krvi in tako prepreči razvoj neželenih krvnih strdkov (trombozo) v krvnih žilah. eā
Quixidar contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa (“ ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels. ct
207 Prevajalska redakcija
RS
EMEA
Preiskovanci (n = 215, 54, 7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa eā
Subjects (n = 215, 54.7 %) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses. t uc
208 Prevajalska redakcija
RS
EMEA
• zvišani lipidi, motnje apetita; • tesnobnost, depresija, zaspanost in težave s spanjem; • bolezni živčevja (npr. multipla skleroza in vnetje očesnega živca), motnje okusa, motnje vida; • neprijeten občutek v ušesu; eā
• sensation of heart beating rapidly, high blood pressure; • asthma, shortness of breath; • abdominal symptoms (such as vomiting, indigestion, constipation), rectal bleeding; • skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing; t
209 Prevajalska redakcija
RS
EMEA
aktiviranega parcialnega tromboplastinskega časa (aPTT), aktiviranega časa nastanka strdka (ACT) ali razmerja protrombinski čas (PT) / internacionalno normalizirano razmerje (INR), niti na čas krvavitve ali fibrinolitično aktivnost. eā
At the 2.5 mg dose, fondaparinux does not affect routine coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/ International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
210 Prevajalska redakcija
RS
EMEA
Prašek in suspenzija za pripravo suspenzije za injiciranje Komponente cepiva proti davici (D), tetanusu (T), oslovskemu kašlju (celotna celica; Pw) in hepatitisu B (HBV) (DTPw- HBV) so v tekočem stanju in sicer v obliki motne bele suspenzije. eā
Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension. t
211 Prevajalska redakcija
RS
EMEA
V istem času je imelo 99, 9 % oseb titer specifičnih protiteles proti tetanusu ≥ 0, 1 i. e. / ml. En mesec po zaključku osnovnega cepljenja je imelo > 99 % otrok titer proti- PRP ≥ 0, 15 µg/ ml in 97, 3 % otrok titer protiteles proti- HBs eā
At this time, the percentage of infants with anti-PRP titres ≥ 0.15 µg/ ml was > 99 % and the percentage with anti-HBs titres ≥ 10 lon mIU/ ml was 97.3 %.
212 Prevajalska redakcija
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EMEA
karbamazepin (za epilepsijo), rifampicin (antibiotik), fenobarbital ali šentjanževko, zdravila, kot so takrolimus, ciklosporin in sirolimus (za presaditev organa), ali metoprolol (proti določenim srčnim motnjam) ali zdravilo proti HIV, ritonavir. eā
like tacrolimus, cyclosporin and sirolimus (for organ transplantation), or metoprolol (against heart disorder) or the anti HIV medicine ritonavir. t
213 Prevajalska redakcija
RS
EMEA
♦ če je v 48 urah po cepljenju vztrajno in neutolažljivo jokal 3 ure ali dlje, ♦ epileptične napade/ krče z ali brez zvišane telesne temperature v 3 dneh po cepljenju, • če ima vaš otrok težave s krvavitvami ali hitrim nastankom modric; eā
♦ Seizures/ fits with or without a high temperature within 3 days of vaccination • if your child has a bleeding problem or bruises easily • if your child has a tendency to seizures/ fits due to a fever, or if there is a history in the family of this t
214 Prevajalska redakcija
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EMEA
V vseh treh raziskavah (raziskave I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti. eā
A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (Studies lP
215 Prevajalska redakcija
izobraževanje
CELEX: 31979L0622
E'i se meri kot seštevek površine, ki se nahaja znotraj diagrama sila/deformacija prvotne obremenitve do točke, v kateri se obremenitev umakne (Ea), in celotne površine v diagramu sila/deformacija preskusa preobremenitve (E"i) (glej sliko 4c v Prilogi IV).
E'i is measured as the sum of the area contained within the force/deflection diagram of the original loading up to the point where the load is removed (Ea), and the total area under the force/deflection diagram of the overload test (E''i) (see figure 4c of Annex IV).
216 Prevajalska redakcija
RS
EMEA
Preprečevanje venskih trombemboličnih dogodkov (VTE) po kirurških posegih v trebušni votlini pri bolnikih, pri katerih obstaja povečano tveganje za pojav trombemboličnih zapletov, npr. bolniki po resekciji tumorja v trebušni votlini (glejte poglavje 5. 1). eā
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic lo surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. no
217 Prevajalska redakcija
RS
EMEA
Izhodiščni HbA1c je bil v obeh skupinah (skupini z rimonabantom in skupini s placebom) 7, 9 %. Absolutna sprememba HbA1c po šestih mesecih je bila v skupini, ki je prejemala 20 mg rimonabanta, – 0, 8 in v skupini, ki je prejemala placebo, – 0, 3 (razlika – eā
d In a second trial in treatment naïve type 2 diabetic obese patients (Serenade), the absolute change in HbA1c (with a baseline of 7.9 % for both groups) at six months was -0.8 for rimonabant 20 mg and
218 Prevajalska redakcija
RS
EMEA
rimonabanta, niso ugotovili neželenih učinkov na plodnost in cikličnost estrusa. Kar zadeva reproduktivne parametre pri 30 mg/ kg niso ugotovili razlik med zdravljenimi in kontrolnimi živalmi, pri 60 mg/ kg so bili učinki še vedno opazni (zmanjšano število rumenih telesc, skupno število eā
differences were observed between treated animals and controls, at 60 mg/ kg effects were still observed (decreased number of corpora lutea, implantations, total and viable fetuses).
219 Prevajalska redakcija
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EMEA
nja Neželeni učinki, o katerih so poročali raziskovalci in za katere je možna vsaj majhna povezava s fondaparinuksom, so navedeni v skupinah glede na pogostnost (zelo pogosti ≥ 1/ 10; pogosti ≥ 1/ 100 do < 1/ 10; občasni ≥ 1/ 1. 000 do < 1/ 100; redki ≥ 1/ 10. 000 do < 1/ 1. 000; zelo redki ≤ 1/ 10. 000) in lje organski sistem v padajočem vrstnem redu po resnosti. vo do eā av nim ilo rav Zd
ho The adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (very common ≥ 1/ 10; common: ≥ 1/ 100 to < 1/ 10; uncommon: ≥ 1/ 1,000 to ≤ 1/ 100; rare: ≥ 1/ 10,000 to ≤ 1/ 1,000; very rare ≤ 1/ 10,000) and system organ
220 Prevajalska redakcija
RS
EMEA
Incidenca mrtvorojenosti, carskega reza in poroda z zadnjično vstavo je bila v kontrolni in zdravljeni skupini živali primerljiva. do V isti predklinični študiji reproduktivne toksičnosti z daclizumabom so štiri od sedmih opic Cynomolgus v laktaciji, ki so prejele 5 - do 10- kratni (10 mg/ kg) običajni odmerek za ljudi, v mleko izločale zelo majhne vrednosti daclizumaba (0, 17 do 0, 28 % maternalnih serumskih vrednosti). eā
The incidence of stillbirth, caesarean section and breech delivery were comparable between the control and treatment groups. ge In the same non-clinical reproduction toxicity study with daclizumab, four out of seven lactating lon cynomolgus monkeys given a 5 – 10 fold multiple (10 mg/ kg) of the normal human dose were found to secrete very low levels of daclizumab (0.17 – 0.28 % of maternal serum levels) in breast milk. no
221 Prevod
promet
CELEX: 21997A1218(02)
Količine kmetijskih sestavin (EA), za katere lahko velja najvišja carina, so določene v Skupni carinski tarifi (Uredba (EGS) št. 2658/87 z dne 23. julija 1987, kakor je bila spremenjena).
The amounts of the agricultural components (EA) which may be subject to a maximum duty are set out in the Common Customs Tariff (Regulation (EEC) No 2658/87 of 23 July 1987 as amended).
222 Prevod
promet
CELEX: 21999A0429(01)
Znižana kmetijska komponenta (EAR) se uporablja v okviru količinskih omejitev iz preglednice 1. Za uvoz, ki presega te količine, se uporabljajo kmetijske komponente (EA), navedene v skupni carinski tarifi (Uredba (EGS) št. 2658/87 za dne 23. julija 1987, kot je bila spremenjena).
The reduced agricultural components (EAR) apply within the quantitative limits set out in Table 1. Imports exceeding these quantities are subject to the agricultural components (EA) set out in the Common Customs Tariff (Regulation (EEC) No 2658/87 of 23 July 1987 as amended).
Prevodi: sl > en
201–222/222
EA