natgillin/translations-raw huggingface dataset:
Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular motion.
Ko se očiščeni predel kože posuši, ga z eno roko nežno stisnite in ga trdno primite.
DO NOT touch this area again before giving the injection.
Z drugo roko kot svinčnik držite brizgo.
Pick up the pre-filled syringe from the flat work surface.
Ko je igla v celoti v koži, spustite kožo, ki ste jo držali.
Remove the needle cover by firmly pulling it straight off the syringe (see Diagram 2).
Shema 4
Do not rub the injection site.
Na mesto injiciranja lahko za 10 sekund pritisnete kos vate ali gazo, vendar pa mesta injiciranja ne smete masirati.
NEVER recap a needle.
Igle NIKOLI ponovno ne pokrivajte.
362
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Enviage is a medicine containing the active substance aliskiren.
Enviage je zdravilo, ki vsebuje zdravilno učinkovino aliskiren.
It is available as tablets (pink, round:
Na voljo je v obliki tablet (rožnate in okrogle:
150 mg; red, oval:
150 mg; rdeče in ovalne:
Enviage is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Zdravilo Enviage se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka).
The medicine can only be obtained with a prescription.
Izraz „ esencialna “ pomeni, da natančnega vzroka za hipertenzijo ni mogoče odkriti.
The recommended dose of Enviage is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Priporočeni odmerek zdravila Enviage znaša 150 mg enkrat dnevno, bodisi samostojno ali v kombinaciji z drugimi zdravili za zdravljenje hipertenzije.
It should be taken with a light meal preferably at the same time each day.
Vzeti ga je treba z lahkim obrokom, najbolje vsak dan ob istem času.
The dose may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Zdravnik lahko pri bolnikih, katerih krvni tlak ni primerno nadzorovan, odmerek poveča na 300 mg enkrat dnevno.
Enviage is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Zdravilo Enviage ni priporočeno za otroke, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej skupini.
It blocks the activity of a human enzyme called renin, which is involved in the production of a substance, angiotensin I, in the body.
Zavira aktivnost človeškega encima, imenovanega renin, ki v telesu sodeluje pri tvorjenju spojine, imenovane angiotenzin.
Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (it narrows blood vessels).
Angiotenzin I se pretvori v hormon angiotenzin II, ki deluje kot močan vazokonstriktor (učinkovina, ki oži žile).
By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Zdravilna učinkovina z zaviranjem tvorjenja angiotenzina I zniža tako raven angiotenzina I kot tudi angiotenzina II.
This causes vasodilation (widening of the blood vessels), so that the blood pressure drops and the potential risk of damage caused by high blood pressure may be reduced.
To povzroči vazodilatacijo (razširjenje žil), zaradi česar krvni tlak pade, s tem pa se zniža tudi morebitno tveganje poškodb zaradi visokega krvnega tlaka.
Enviage was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Zdravilo Enviage so raziskali v 14 glavnih študijah, ki so vključevale preko 10. 000 bolnikov z esencialno hipertenzijo.
Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension.
Trinajst študij je zajemalo bolnike z blago do zmerno hipertenzijo, ena pa je vključevala bolnike s hudo hipertenzijo.
In five of the studies, the effects of Enviage taken alone were compared with those of placebo (a dummy treatment).
V petih študijah so učinke jemanja zdravila Enviage, uporabljenega kot samostojno zdravilo, primerjali s placebom (zdravilom brez zdravilne učinkovine).
Enviage, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Zdravilo Enviage so, bodisi kot samostojno zdravilo ali v kombinaciji z drugimi zdravili, primerjali tudi z drugimi zdravili za zdravljenje hipertenzije.
Combination studies looked at Enviage used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V študijah kombinacij zdravil so raziskovali 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged diuretic (hydrochlorothiazide).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged zdravilo Enviage v kombinaciji z zaviralcem angiotenzinske konvertaze (ramipril), zaviralcem angiotenzinskih receptorjev (valsartan), zaviralcem receptorjev beta (atenolol), zaviralcem kalcijevih kanalčkov (amlodipin) in diuretikom (hidroklorotiazid).
The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (diastolic) or when the chambers of the heart are contracting (systolic).
Študije so trajale od šest do 52 tednov, glavno merilo učinkovitosti pa je bila sprememba krvnega tlaka med mirovalno fazo srčnega utripa (diastolični tlak) ali med krčenjem komor srca (sistolični tlak).
Enviage on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Zdravilo Enviage kot samostojno zdravilo je bilo pri zdravljenju visokega krvnega tlaka bolj učinkovito kot placebo in enako učinkovito kot zdravljenja s primerljivimi zdravili.
When the results of the five studies comparing Enviage taken alone with placebo were looked at together, patients aged under 65 had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Enviage, from an average of 99.4 mmHg at the start of the study.
Ko so primerjali skupaj rezultate petih študij, v katerih so zdravilo Enviage kot samostojno zdravilo primerjali s placebom, se je pri bolnikih pod 65 leti starosti po osmih tednih jemanja 150 mg zdravila Enviage povprečni diastolični tlak, ki je na začetku znašal 99, 4 mmHg, v povprečju znižal za 9, 0 mmHg.
This was compared with a fall of 5.8 mmHg from 99.3 mmHg in those taking placebo.
Rezultate so primerjali z znižanjem za 5, 8 mmHg od vrednosti 99, 3 mmHg pri tistih, ki so jemali placebo.
Larger falls were seen in patients aged 65 or over and those taking higher doses of Enviage.
Pri bolnikih, starih 65 let ali več, in tistih, ki so jemali večje odmerke zdravila Enviage, so opazili večja znižanja tlaka.
Enviage also reduced blood pressure in patients with diabetes, patients who were overweight, and those who were over 65 years of age.
Zdravilo Enviage je krvni tlak znižalo tudi pri bolnikih s sladkorno boleznijo, prekomerno težkih bolnikih in tistih, ki so bili starejši od 65 let.
The medicine’ s effects were maintained for up to 52 weeks in two of the studies.
V dveh študijah so učinkovanje zdravila vzdrževali do 52 tednov.
The studies also showed that Enviage, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with those produced by these medicines taken without Enviage.
Študije so pokazale tudi, da lahko zdravilo Enviage v kombinaciji z drugimi zdravili (še posebej hidroklorotiazidom) povzroči še dodatna znižanja krvnega tlaka v primerjavi z znižanji tlaka, ki jih imajo ta zdravila brez kombiniranja z zdravilom Enviage.
The most common side effect with Enviage (seen in between 1 and 10 patients in 100) is diarrhoea.
Najpogostejši neželeni učinek zdravila Enviage (opažen med 1 in 10 bolniki od 100) je driska.
For the full list of all side effects reported with Enviage, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Enviage, glejte Navodilo za uporabo.
It must also not be used during the second or third trimesters of pregnancy (from around the fourth month of pregnancy).
Zdravila prav tako ne smejo uporabljati nosečnice v drugem ali tretjem tromesečju nosečnosti (od približno četrtega meseca nosečnosti dalje).
Its use during the first trimester of pregnancy and in women planning to become pregnant is not recommended.
Zdravilo ni priporočeno niti za ženske v prvem tromesečju nosečnosti in za tiste, ki načrtujejo zanositev.
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Enviage are greater than its risks for the treatment of essential hypertension.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristi zdravila Enviage pri zdravljenju esencialne hipertenzije večje od z njim povezanih tveganj.
The Committee recommended that Enviage be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Enviage.
The European Commission granted a marketing authorisation valid throughout the European Union for Enviage to Novartis Europharm Limited on 22 August 2007.
Evropska Komisija je dovoljenje za promet z zdravilom Enviage, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 22. avgusta 2007.
The full EPAR for Enviage can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Enviage je na voljo tukaj.
This summary was last updated in 07-2007.
Ta povzetek je bil nazadnje posodobljen 07- 2007.
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Izmišljeno ime Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage Enviage
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farmacevtska oblika filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta
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ovojnina pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC) pretisni omot (PA/ Alu/ PVC)
7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 (3x28) tablets 90 tablets 98 (2x49) tablets 280 (20x14) tablets 7 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 (3x28) tablets 90 (3x30) tablets 98 (2x49) tablets 280 (20x14) tablets
velikost pakiranja 7 tablet 14 tablet 28 tablet 30 tablet 50 tablet 56 tablet 84 (3x28) tablet 90 tablet 98 (2x49) tablet 280 (20x14) tablet 7 tablet 14 tablet 28 tablet 30 tablet 50 tablet 56 tablet 84 (3x28) tablet 90 (3x30) tablet 98 (2x49) tablet 280 (20x14) tablet
Light-pink, biconvex, round tablet, imprinted “ IL ” on one side and “ NVR” on the other side.
Bikonveksna okrogla tableta svetlo roza barve, z vtisnjeno oznako ‘ IL ’ na eni strani in ‘ NVR ’ na drugi.
The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily.
Antihipertenzivni učinek se v precejšnji meri izrazi v dveh tednih (85 - 90%) po začetku zdravljenja z odmerkom 150 mg enkrat dnevno.
Enviage may be used alone or in combination with other antihypertensive agents (see sections 4.4 and 5.1).
Enviage se lahko jemlje samostojno ali v kombinaciji z drugimi učinkovinami za zniževanje krvnega tlaka (glejte poglavji 4. 4 in 5. 1).
Renal impairment No adjustment of the initial dose is required for patients with mild to severe renal impairment (see sections 4.4 and 5.2).
Okvara ledvic Bolnikom z blago do hudo okvaro ledvic ni potrebno prilagajati začetnega odmerka (glejte poglavji 4. 4 in 5. 2).
Hepatic impairment No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2).
Okvara jeter Bolnikom z blago do hudo okvaro jeter ni potrebno prilagajati začetnega odmerka (glejte poglavje 5. 2).
Paediatric patients (below 18 years) Enviage is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Pediatrični bolniki (mlajši od 18 let) Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Enviage pri otrocih in mladostnikih pod 18 let ni priporočljiva (glejte poglavje 5. 2).
4.3 Contraindications
2 4. 3 Kontraindikacije
2 Second and third trimesters of pregnancy (see section 4.6).
Drugo in tretje trimesečje nosečnosti (glejte poglavje 4. 6).
The concomitant use of aliskiren with ciclosporin, a highly potent P-gp inhibitor, and other potent P- gp inhibitors (quinidine, verapamil), is contraindicated (see section 4.5).
Sočasna uporaba aliskirena in ciklosporina, ki je zelo močan zaviralec P- gp, oziroma drugih močnih zaviralcev P- gp (kinidina, verapamila) je kontraindicirana (glejte poglavje 4. 5).
Patients receiving other medicinal products inhibiting the renin-angiotensin system (RAS), and/ or those with reduced kidney function and/ or diabetes mellitus are at an increased risk of hyperkalaemia during aliskiren therapy.
Pri bolnikih, ki prejemajo druga zdravila, ki zavirajo sistem renin- angiotenzin (RAS), in/ ali pri bolnikih z zmanjšanim delovanjem ledvic in/ ali s sladkorno boleznijo je v času zdravljenja z aliskirenom zvečano tveganje za hiperkaliemijo.
Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV).
Previdnost je potrebna pri uporabi aliskirena pri bolnikih z resnim kongestivnim srčnim popuščanjem (funkcijskih razredov III- IV po klasifikaciji Newyorškega združenja za srce (New York Heart Association [NYHA])).
Sodium and/ or volume depleted patients In patients with marked volume- and/ or salt-depletion (e. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Enviage.
Bolniki s pomanjkanjem natrija in/ ali hipovolemijo Pri bolnikih s hudim pomanjkanjem natrija in/ ali hipovolemijo (na primer pri tistih, ki prejemajo velike odmerke diuretikov) lahko po uvedbi zdravljenja z zdravilom Enviage pride do simptomatske hipotenzije.
This condition should be corrected prior to administration of Enviage, or the treatment should start under close medical supervision.
Pomanjkanje natrija in/ ali hipovolemijo je treba odpraviti pred aplikacijo zdravila Enviage ali pa je treba zdravljenje uvajati pod strogim zdravniškim nadzorom.
Renal impairment In clinical studies Enviage has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μ mol/ l or 1.70 mg/ dl in women and ≥ 177 μ mol/ l or 2.00 mg/ dl in men and/ or estimated glomerular filtration rate (GFR) < 30 ml/ min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Okvara ledvic V kliničnih študijah zdravila Enviage niso raziskovali pri hipertenzivnih bolnikih s hudo okvaro ledvic (kreatinin v serumu ≥ 150 μmol/ l oziroma 1, 70 mg/ dl pri ženskah in ≥ 177 μmol/ l oziroma 2, 00 mg/ dl pri moških in/ ali ocenjeno hitrostjo glomerulne filtracije (GFR) < 30 ml/ min), pri bolnikih, ki so se že zdravili z dializo, pri bolnikih z nefrotskim sindromom ali z renovaskularno hipertenzijo.
Renal artery stenosis No data are available on the use of Enviage in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Stenoza ledvične arterije Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oziroma bolnikih s stenozo ledvične arterije v primeru solitarne ledvice o uporabi zdravila Enviage ni podatkov.
Moderate P-gp inhibitors Co-administration of aliskiren 300 mg with ketoconazole 200 mg resulted in a 76% increase in aliskiren AUC but P-gp inhibitors such as ketoconazole are expected to increase tissue concentrations more than plasma concentrations.
Zmerni zaviralci P- gp Sočasna uporaba 300 mg aliskirena in 200 mg ketokonazola je povzročila 76% zvečanje AUC aliskirena v plazmi, vendar je od zaviralcev P- gp, kot je ketokonazol, mogoče pričakovati, da bodo zvišali koncentracije v tkivih bolj kot koncentracije v plazmi.
Therefore caution should be exercised when aliskiren is administered with moderate P-gp inhibitors such as ketoconazole (see section 4.5).
Zato je pri sočasni uporabi z zmernimi zaviralci P- gp, kot je ketokonazol, potrebna previdnost (glejte poglavje 4. 5).
Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate, ramipril and hydrochlorothiazide.
Med učinkovinami, ki so jih raziskovali v kliničnih farmakokinetičnih študijah, so acenokumarol, atenolol, celekoksib, pioglitazon, alopurinol, izosorbid- 5- mononitrat, ramipril in hidroklorotiazid.
Co-administration of aliskiren with either valsartan (↓ 28%), metformin (↓ 28%), amlodipine (↑ 29%) or cimetidine (↑ 19%) resulted in between 20% and 30% change in Cmax or AUC of Enviage.
Zaradi
When administered with atorvastatin, steady-state Enviage AUC and Cmax increased by 50%.
3 sočasne uporabe z atorvastatinom sta se AUC in Cmax zdravila Enviage v stanju dinamičnega ravnovesja zvišala za 50%.
3 Preliminary data suggest that irbesartan may decrease Enviage AUC and Cmax.
Predhodni podatki nakazujejo, da irbesartan lahko zmanjša AUC in Cmax zdravila Enviage.
In experimental animals, it has been shown that P-gp is a major determinant of Enviage bioavailability.
Na poskusnih živalih se je pokazalo, da je P- gp glavna determinanta biološke uporabnosti zdravila Enviage.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Enviage.
Zato lahko induktorji P- gp (šentjanževka, rifampin) zmanjšajo biološko uporabnost zdravila Enviage.
CYP450 interactions Aliskiren does not inhibit the CYP450 isoenzymes (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A).
Medsebojno delovanje s CYP450 Aliskiren ne zavira izoencimov CYP450 (CYP1A2, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A).
However, CYP3A4 inhibitors often also affect P-gp.
Vendar zaviralci CYP3A4 pogosto vplivajo tudi na P- gp.
Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see P-glycoprotein interactions below).
Zato je mogoče pričakovati povečano izpostavljenost aliskirenu v času sočasne uporabe tistih zaviralcev CYP3A4, ki zavirajo tudi P- gp (glejte spodaj Medsebojno delovanje s P- glikoproteinom).
P-glycoprotein interactions MDR1/ Mdr1a/ 1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies.
Medsebojno delovanje s P- glikoproteinom V predkliničnih študijah so ugotovili, da predstavlja MDR1/ Mdr1a/ 1b (P- gp) najpomembnejši izlivni sistem pri absorpciji aliskirena v črevesju in njegovem izločanju z žolčem.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Enviage.
Zato bi lahko induktorji P- gp (šentjanževka, rifampicin) zmanjšali biološko uporabnost zdravila Enviage.
Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Čeprav tega niso proučevali pri aliskirenu, je znano, da P- gp tudi uravnava privzem različnih snovi v tkiva in da zaviralci P- gp lahko povečajo razmerje koncentracij med tkivi in plazmo.
Therefore, P-gp inhibitors may increase tissue levels more than plasma levels.
Zato lahko zaviralci P- gp povišajo koncentracije v tkivih bolj kot koncentracije v plazmi.
The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Možnost interakcij na mestu P- gp je verjetno odvisna od stopnje zaviranja tega prenašalca.
P-gp substrates or weak inhibitors No relevant interactions with atenolol, digoxin, amlodipine or cimetidine have been observed.
Substrati P- gp ali šibki zaviralci P- gp Z atenololom, z digoksinom, z amlodipinom in s cimetidinom niso opažali pomembnega medsebojnega delovanja.
When administered with atorvastatin (80 mg), steady-state aliskiren (300 mg) AUC and Cmax increased by 50%.
Pri sočasni uporabi atorvastatina (80 mg) in aliskirena (300 mg) sta se AUC in Cmax aliskirena v stanju dinamičnega ravnovesja zvečali za 50%.
Moderate P-gp inhibitors Co-administration of ketoconazole (200 mg) with aliskiren (300 mg) resulted in an 80% increase in plasma levels of aliskiren (AUC and Cmax).
Zmerni zaviralci P- gp Sočasna uporaba ketokonazola (200 mg) in aliskirena (300 mg) je povzročila 80% zvečanje koncentracij aliskirena v plazmi (AUC in Cmax).