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ASA
1 Objavljeno
delo in sociala
Ur. l. RS, št. MP 29-2009
Norveški inštitut za zavarovanje izvoznih kreditov, Eksportfinans ASA in
the Norwegian Guarantee Institute for Export Credits; Eksportfinans ASA; and
2 Končna redakcija
CELEX: 32004R0398
Elkem ASA, Oslo, Norveška
Elkem ASA, Oslo, Norway
3 Končna redakcija
CELEX: 32004R0398
Fesil ASA, Trondheim, Norveška
Fesil ASA, Trondheim, Norway
4 Pravna redakcija
DRUGO
EëëÜäá
ĹëëÜäá
5 Pravna redakcija
promet
CELEX: 32004R0398
Elkem ASA, Oslo, Norveška
Elkem ASA, Oslo, Norway
6 Pravna redakcija
promet
CELEX: 32004R0398
Fesil ASA, Trondheim, Norveška
Fesil ASA, Trondheim, Norway
7 Pravna redakcija
DRUGO
M asa plinastih onesnaževal v vsaki vreči
Mass of gaseous pollutants contained in each bag
8 Pravna redakcija
DRUGO
ĐáôÜôá ĘÜôů ĂŤÄşĹ`ńďęďÄ`ßďĹ` (ZGO)
ĐáôÜôá ĘÜôů ĂŤÄşĹ`ńďęďÄ`ßďĹ` (PGI)
9 Pravna redakcija
DRUGO
áíţíĹ`ěç ĺôáéńßá,
áíţíĹ`ěç ĺôáéńßá
10 Prevajalska redakcija
RS
EMEA
ASA ni spremenila s klopidogrelom dosežene inhibicije z ADP- jem sprožene agregacije trombocitov, vendar klopidogrel ojača učinek ASA na s kolagenom sproženo agregacijo trombocitov.
ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
11 Pravna redakcija
DRUGO
ĺôáéńßá Ä`ĺńéďńéďěÝíçň ÄşĹ`äýíçň
ĺôáéńßá Ä`ĺńéďńéóěÝíçň ÄşĹ`čýíçň
12 Pravna redakcija
DRUGO
ŐÄ`ÄŹĹ`ńăĺßď Ăĺůńăßáň ÄéĺýčĹ`íóç Ăĺůńăéęţí Ĺöáńěďăţí
ŐÄ`ÄŹĹ`ńăĺßď Ăĺůńăßáň ÄéĺýčĹ`íóç Ăĺůńăéęţí Ĺöáńěďăţí
13 Pravna redakcija
DRUGO
Éíóôéôďýôď ÁöčţäďĹ`ň ĐĹ`ńĺôďý, Áăßá ĐáńáóęĺĹ`Ţ ÁôôéęŢň.
Éíóôéôďýôď ÁöčţäďĹ`ň ĐĹ`ńĺôďý, Áăßá ĐáńáóęĺĹ`Ţ ÁôôéęŢň.
14 Prevajalska redakcija
RS
EMEA
Acetilsalicilna kislina (ASA):
Acetylsalicylic acid (ASA):
15 Prevajalska redakcija
RS
EMEA
V CURE je bil delež dogodkov z velikimi krvavitvami za klopidogrel in ASA odvisen od odmerka ASA (< 100 mg:
In CURE, the major bleeding event rate for clopidogrel+ASA was dose-dependent on ASA (< 100mg:
16 Prevajalska redakcija
RS
EMEA
odmerkom v kombinaciji z ASA ter z/ brez uporabe trombolitikov.
should be initiated without a loading dose.
17 Prevajalska redakcija
RS
EMEA
Ker so bili visoki odmerki ASA povezani s povišanim tveganjem za krvavitve, se priporoča, da odmerek ASA ni večji od 100 mg.
Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
18 Prevajalska redakcija
RS
EMEA
Ne kopajte se v vro i vodi dalj asa, saj se lahko obliž odlepi.
Avoid soaking in a hot bath for a long period of time, which can make the patch come off.
19 Prevajalska redakcija
RS
EMEA
4, 9 %), kakor tudi delež velikih krvavitev za placebo in ASA (< 100 mg:
4.9 %) as was the major bleeding event rate for placebo+ASA (< 100mg:
20 Prevajalska redakcija
RS
EMEA
Incidenca hujših primerov je bila 1, 4 % za klopidogrel in 1, 6 % za ASA.
The incidence of severe cases was 1.4 % for clopidogrel and 1.6 % for ASA.
21 Prevajalska redakcija
RS
EMEA
V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev (17, 4 %) v primerjavi s skupino s placebom in ASA (12, 9 %). Incidenca večjih krvavitev je bila v obeh skupinah podobna (1, 3 % v skupini s klopidogrelom in ASA ter 1, 1 % v skupini s placebom in ASA).
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4 %) vs. the placebo + ASA group (12.9 %). The incidence of major bleeding was similar between groups (1.3 % versus 1.1 % for the clopidogrel + ASA and the placebo + ASA groups, respectively).
22 Prevajalska redakcija
RS
EMEA
16 V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev (17, 4 %) v primerjavi s skupino s placebom in ASA (12, 9 %). Incidenca večjih krvavitev je bila v obeh skupinah podobna (1, 3 % v skupini s klopidogrelom in ASA ter 1, 1 % v skupini s placebom in ASA).
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%).The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
23 Prevajalska redakcija
RS
EMEA
17 V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev (17, 4 %) v primerjavi s skupino s placebom in ASA (12, 9 %). Incidenca večjih krvavitev je bila v obeh skupinah podobna (1, 3 % v skupini s klopidogrelom in ASA ter 1, 1 % v skupini s placebom in ASA).
In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%).The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).This was
24 Prevajalska redakcija
RS
EMEA
Pri bolnikih, ki so ostali na zdravljenju do 5 dni pred koronarno premostitveno operacijo, je bil delež dogodkov 9, 6 % za klopidogrel in ASA in 6, 3 % za placebo in ASA.
In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6 % for clopidogrel+ASA, and 6.3 % for placebo+ASA.
25 Prevajalska redakcija
RS
EMEA
Število velikih krvavitev s klopidogrelom in ASA ni bilo prekoračeno v 7 dneh po koronarni premostitveni operaciji pri bolnikih, ki so prenehali z zdravljenjem več kot 5 dni pred kirurškim posegom (4, 4 % klopidogrel in ASA proti 5, 3 % placebo in ASA).
There was no excess in major bleeds with clopidogrel + ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery (4.4 % clopidogrel+ASA vs. 5.3 % placebo+ASA).
26 Prevajalska redakcija
RS
EMEA
Študije drugih operacijskih posegov, razen postopke CABG, so vključevale le bolnike s kliničnim statusom ASA (ASA - American Society of Anaesthesiology), razreda I- III.
Studies in other surgeries than CABG procedures included patients with ASA (American Society of Anaesthesiology) Physical Status Class I-III only.
27 Prevajalska redakcija
RS
EMEA
- V skupini z ASA v majhnih odmerkih je bila incidenca APTC dogodkov 24/ 2167 bolnikov
- In the low-dose ASA group, the incidence of APTC events was 24/ 2167 patients (1.11 %) for
28 Prevajalska redakcija
RS
EMEA
- V skupini z ASA v majhnih odmerkih je bila incidenca POB 15/ 2167 bolnikov (0, 69 %) za
- In the low dose ASA group the incidence of POBs was 15/ 2167 patients (0.69 %) for
29 Prevajalska redakcija
RS
EMEA
Vendar pa so klopidogrel in ASA uporabljali sočasno do enega leta (glejte poglavje 5. 1).
However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
30 Prevajalska redakcija
RS
EMEA
Učinkovitost klopidogrela so opazili neodvisno od odmerka ASA (75- 325 mg enkrat na dan).
The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
31 Prevajalska redakcija
RS
EMEA
- V skupini z ASA v majhnih odmerkih je bila incidenca MI dogodkov 9/ 2167 bolnikov (0, 42 %)
- In the low-dose ASA group, the incidence of MI events was 9/ 2167 patients (0.42 %) for
32 Prevajalska redakcija
RS
EMEA
Do tega lahko pride bodisi takoj bodisi nekaj asa po tem, ko ste zaužili zdravilo ZYPREXA VELOTAB.
This may occur immediately or some time after you take ZYPREXA VELOTAB.
33 Prevajalska redakcija
RS
EMEA
V študiji COMMIT je bil skupni delež večjih necerebralnih krvavitev ali cerebralne krvavitve nizek in podoben v obeh skupinah (0, 6 % v skupini s klopidogrelom in ASA ter 0, 5 % v skupini s placebom in ASA).
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups (0.6 % versus 0.5 % in the clopidogrel + ASA and the placebo + ASA groups, respectively).
34 Prevajalska redakcija
RS
EMEA
5 V študiji COMMIT je bil skupni delež večjih necerebralnih krvavitev ali cerebralne krvavitve nizek in podoben v obeh skupinah (0, 6 % v skupini s klopidogrelom in ASA ter 0, 5 % v skupini s placebom in ASA).
5 In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups (0.6 % versus 0.5 % in the clopidogrel + ASA and the placebo + ASA groups, respectively).
35 Prevajalska redakcija
RS
EMEA
Pri prehodu z drugih insulinov na zdravilo NovoMix 70 utegne biti potrebna prilagoditev odmerka in asa uporabe.
Transfer to NovoMix 70 from other insulin preparations may require adjustment of dose and timing of administration.
36 Prevajalska redakcija
RS
EMEA
V podskupini z miokardnim infarktom je večina bolnikov prejemala ASA prvih nekaj dni po akutnem miokardnem infarktu.
In the myocardial infarction subgroup, most of the patients received ASA for the first few days following the acute myocardial infarction.
37 Prevajalska redakcija
RS
EMEA
insulinsko rpalko, ogroža hiter nastanek ketoacidoze, e je stalno subkutano infundiranje insulina dalj asa prekinjeno. do
an insulin pump are at risk of fast development of ketoacidosis in case of prolonged interruption of continuous subcutaneous insulin infusion. no
38 Prevajalska redakcija
RS
EMEA
12 urna površina pod krivuljo plazemske koncentracije v odvisnosti od asa v stanju dinami nega ravnovesja je 92, 5 ng h/ ml.
The steady state 12-hour area under the plasma concentration versus time curve was 92.5 ng. hr/ ml.
39 Prevajalska redakcija
RS
EMEA
V CAPRIE je bila pri bolnikih, zdravljenih bodisi s klopidogrelom ali ASA, celokupna incidenca kakršnihkoli krvavitev 9, 3 %.
In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding was 9.3 %.
40 Prevajalska redakcija
RS
EMEA
Varnost sistema IONSYS še ni bila ugotovljena pri bolnikih s fizikalnim statusom IV po ASA (American Society of Anesthesiologists).
The safety of IONSYS has not been established in patients with American Society of Anesthesiologists (ASA) physical status classification IV.
41 Prevajalska redakcija
RS
EMEA
Randomizacija je bila stratificirana po uporabi ASA v majhnih odmerkih (24 % bolnikov v celotni populaciji študije) in po starosti.
Randomization was stratified by low-dose ASA use (24 % of patients in the overall study population) and age.
42 Prevajalska redakcija
RS
EMEA
Analiza skupne umrljivosti kot sekundarnega opazovanega dogodka ni pokazala pomembne razlike med klopidogrelom (5, 8 %) in ASA (6, 0 %).
Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8 %) and ASA (6.0 %).
43 Prevajalska redakcija
RS
EMEA
Bolniki so bili naključno razdeljeni v skupine, ki so prejemale klopidogrel 75 mg/ dan ali ASA 325 mg/ dan, spremljali so jih od 1 do 3 let.
Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
44 Prevajalska redakcija
RS
EMEA
TARGET je zajel bolnike, ki so jemali ASA v majhnih odmerkih (75- 100 mg na dan) za primarno ali sekundarno preventivo koronarne bolezni srca.
TARGET included patients taking low-dose ASA (75-100 mg daily) for primary or secondary prevention of coronary heart disease.
45 Prevajalska redakcija
RS
EMEA
V celoti je bil klopidogrel v odmerku 75 mg/ dan v študiji CAPRIE, primerljiv z ASA v odmerku 325 mg/ dan, ne glede na starost, spol ali raso.
Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
46 Prevajalska redakcija
RS
EMEA
8, 9 do 36, 2), in šibkejšo (ni bila pomembno različna od ASA) pri bolnikih s kapjo (zmanjšanje RT=7, 3 %; IZ: - 5, 7 do 18, 7 (p=0, 258)).
8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
47 Prevajalska redakcija
RS
EMEA
Bolniki so 28 dni oziroma do odpusta dobivali klopidogrel (75 mg na dan, n=22. 961) ali placebo (n=22. 891) v kombinaciji z ASA (162 mg na dan).
Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
48 Prevajalska redakcija
RS
EMEA
8, 9 do 36, 2), in šibkejšo (ni bila pomembno različna od ASA) pri bolnikih s kapjo (zmanjšanje RT=7, 3 %; IZ: - 5, 7 do 18, 7 [ p=0, 258 ]).
8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3 %; CI: -5.7 to 18.7 [ p=0.258 ]).
49 Prevajalska redakcija
RS
EMEA
Vendar pa sočasna uporaba 500 mg ASA dvakrat dnevno en dan ni pomembno povečala podaljšanja časa krvavitve, sprožene z jemanjem klopidogrela.
However, concomitant administration of 500 mg of ASA twice a day for one day did not significantly increase the prolongation of bleeding time induced by clopidogrel intake.
50 Prevajalska redakcija
RS
EMEA
Koristnosti zdravljenja s kombinacijo klopidrogela in ASA, ki bi bilo daljše od štirih tednov, v tem okviru niso preučevali (glejte poglavje 5. 1).
The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
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ASA