natgillin/translations-raw huggingface dataset:
If you use more Omnitrope than you should
90 Če ste vzeli večji odmerek zdravila Omnitrope, kot bi smeli
How to inject Omnitrope 6.7 mg/ ml
Kako si je treba injicirati zdravilo Omnitrope 6, 7 mg/ ml
The following instructions explain how to inject Omnitrope 6.7 mg/ ml yourself.
Navodila v nadaljevanju pojasnjujejo, kako si lahko sami injicirate zdravilo Omnitrope 6, 7 mg/ ml.
- a cartridge with Omnitrope 6.7 mg/ ml solution for injection.
- vložek z raztopino za injiciranje zdravila Omnitrope 6, 7 mg/ ml
- the Omnitrope Pen 10, an injection device specifically developed
- Omnitrope Pen 10, pripravo za injiciranje, narejeno posebej za
for use with Omnitrope 6.7 mg/ ml solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope Pen 10).
uporabo raztopine za injiciranje zdravila Omnitrope 6, 7 mg/ ml (ki je ni v ovojnini; glejte Navodila za uporabo, priložena napravi Omnitrope Pen 10).
After injecting
91 Po injiciranju
93 General disorders and reactions at the injection site
92 zelo redko redko občasno pogosto (pojavljajo se pri (pojavljajo se pri (pojavljajo se pri (pojavljajo se pri manj kot vsaj 1 bolniku od vsaj 1 bolniku od vsaj 1 bolniku od 1 bolniku od 10. 000, vendar 1. 000, vendar 100, vendar manj 10. 000) manj kot pri 1 od manj kot pri 1 od kot pri 1 od 10) 1. 000) 100) pri splošne težave in
94 Nervous system
93 Živčevje
The active substance of Omnitrope is somatropin (6.7 mg/ ml) in a cartridge.
Zdravilna učinkovina v zdravilu Omnitrope je somatropin (6, 7 mg/ ml) v vložku.
One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
En vložek vsebuje 10, 0 mg (ustreza 30 i. e.) somatropina v 1, 5 ml.
The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine
94 Pomožne snovi so: natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat glicin poloksamer 188 fenol voda za injekcije
96 Eesti Österreich Sandoz d. d.
Österreich
Eesti filiaal Pärnu mnt 105 EE - 11312 Tallinn Tel: +372 665 2400
95
Sandoz GmbH Biochemiestr.
Sandoz GmbH Sandoz d. d.
Ireland Rowex Ltd Bantry Co.
Rowex Ltd Bantry Co.
Slovenija Lek farmacevtska druž ba d. d.
Lek farmacevtska družba d. d.
97 Latvija Sandoz d. d.
96 United Kingdom Latvija Sandoz Limited Sandoz d. d.
This is a genetic disease that causes ‘ adenomatous intestinal polyps’, growths that project from the lining of the large intestine or rectum.
To je genetska bolezen, pri kateri nastajajo „ adenomatozni intestinalni polipi ”, izrastki na sluznici debelega črevesa ali danke.
Onsenal is used in addition to surgery (to remove the polyps) and endoscopic monitoring (to check if polyps are developing, using an endoscope, a thin tube that allows a doctor to look inside the gut).
Zdravilo Onsenal se uporablja kot dodatek k operaciji (za odstranitev polipov) in endoskopskemu nadzoru (preiskavam za preverjanje, ali nastajajo polipi, ki se opravijo z endoskopom – tanko cevko, s pomočjo katere zdravnik opazuje črevesje).
Because the number of patients with FAP is low, the disease is considered ‘ rare’, and Onsenal was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 20 November 2001.
Ker je število bolnikov s familiarno adenomatozno polipozo majhno, velja ta bolezen za „ redko ”, zato je bilo zdravilo Onsenal dne 20. novembra 2001 določeno kot „ zdravilo sirota ” (zdravilo, ki se uporablja pri redkih boleznih).
In patients with moderate liver disease, the dose of Onsenal should be halved, and it should be used with caution in patients with mild or moderate kidney problems.
Pri bolnikih z zmerno okvaro jeter je treba odmerek zdravila Onsenal zmanjšati za polovico, zdravilo pa uporabljati previdno pri bolnikih z blagimi do zmernimi ledvičnimi obolenji.
Onsenal must not be given to patients with severe liver or kidney problems.
Zdravilo Onsenal se ne sme uporabljati pri bolnikih s hudimi boleznimi jeter ali ledvic.
It should be used with caution, possibly with a lower starting dose, in patients whose bodies may break Onsenal down slowly.
Zdravilo Onsenal je treba uporabljati previdno, po možnosti z najnižjim začetnim odmerkom, pri bolnikih, pri katerih utegne telo zdravilo počasneje presnavljati.
Special care should be taken when it is used in the elderly.
Pri starostnikih je potrebna posebna previdnost.
The active substance in Onsenal, celecoxib, is a ‘ non-steroidal anti-inflammatory drug’ (NSAID) that belongs to the group ‘ cyclo-oxygenase-2 (COX-2) inhibitors’.
Zdravilna učinkovina zdravila Onsenal, celekoksib, je nesteroidno protivnetno zdravilo (NSAID), ki spada v skupino „ zaviralcev ciklooksigenaze2 (COX- 2) ”.
It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in processes such as inflammation and the activity of smooth muscle (muscle that performs automatic tasks such as the opening and closing of blood vessels).
Celekoksib zavira encim COX- 2, kar povzroči zmanjšanje nastajanja prostaglandinov – snovi, ki sodelujejo pri procesih, kot so vnetja in aktivnosti gladkih mišic (mišic, ki opravljajo samodejne dejavnosti, kot so odpiranje in zapiranje žil).
Onsenal has been studied in one main study involving 83 adults with FAP, in which the effectiveness of two doses of Onsenal was compared with that of placebo (a dummy treatment).
Zdravilo Onsenal so proučili v eni glavni študiji, v katero je bilo vključenih 83 odraslih s familiarno adenomatozno polipozo in v kateri so učinkovitost dveh odmerkov zdravila Onsenal primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine).
In the study, 25 patients had an intact colon (lower gut), but the remainder had had some or all of their colon removed through surgery.
V študiji je imelo 25 bolnikov nespremenjen kolon (eden od končnih delov debelega črevesa), drugi pa so imeli v celoti ali delno kirurško odstranjen kolon.
The main measure of effectiveness was the reduction in the number of polyps in a defined area of the colon or rectum wall after six months of treatment.
Glavno merilo učinkovitosti je bilo zmanjšanje števila polipov v določenem področju kolona ali rektuma po šestih mesecih zdravljenja.
An additional study looked at the effects of Onsenal in 18 children with FAP.
V dodatni študiji so proučevali učinke zdravila Onsenal pri 18 otrocih s familiarno adenomatozno polipozo.
In adults, Onsenal had reduced the average number of polyps by 28% after six months, while the number fell by 5% in the patients taking placebo.
Po šestih mesecih je zdravilo Onsenal zmanjšalo povprečno število polipov za 28%, pri bolnikih, ki so prejemali placebo, pa se je to število zmanjšalo za 5%.
Onsenal also reduced the number of polyps in children with FAP.
Zdravilo Onsenal je prav tako zmanjšalo število polipov pri otrocih s familiarno adenomatozno polipozo.
The most common side effects with Onsenal (seen in more than 1 patient in 10) are hypertension (high blood pressure) and diarrhoea.
Najpogostejši neželeni učinki zdravila Onsenal (opaženi pri več kot 1 bolniku od 10) so hipertenzija (povišani krvni tlak) in driska.
Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Zdravila Onsenal ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) celekoksib, katero koli drugo sestavino zdravila ali sulfonamide (določene antibiotike).
It must not be used in patients who have an active ulcer or bleeding in the stomach or gut, or in patients who have had allergic-type reactions after taking aspirin or an NSAID, including another COX-2 inhibitor.
Zdravila Onsenal ne smejo uporabljati tudi osebe, ki imajo aktivno razjedo ali krvavitev v želodcu ali črevesju, in osebe, ki so kadar koli imele alergijsko reakcijo po uporabi aspirina ali nesteroidnega protivnetnega zdravila, vključno z drugimi zaviralci COX- 2.
The Committee for Medicinal Products for Human Use (CHMP) decided that Onsenal’ s benefits are greater than its risks for the reduction of the number of adenomatous intestinal polyps in FAP as an adjunct to surgery and further endoscopic surveillance.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Onsenal za zmanjšanje števila adenomatoznih intestinalnih polipov pri familiarni adenomatozni polipozi kot dodatka h kirurškemu zdravljenju in nadaljnjemu endoskopskemu spremljanju večje od z njim povezanih tveganj.
The Committee noted that no effect of the reduced number of polyps caused by Onsenal on the risk of developing cancer of the intestine had been shown.
Odbor ugotavlja, da vpliv zmanjšanja števila polipov, ki ga povzroči zdravilo Onsenal, na tveganje za raka črevesja ni bil dokazan.
Onsenal has been authorised under ‘ Exceptional Circumstances’.
Zdravilo Onsenal je bilo odobreno v „ izjemnih okoliščinah “.
This means that because the disease is rare, it has not been possible to obtain complete information about Onsenal.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu Onsenal.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto pregledala vse razpoložljive nove podatke in po potrebi posodobila ta povzetek.
The company that makes Onsenal will carry out a study in patients with FAP, in order to collect more information on the medicine ’ s safety and effectiveness.
Družba, ki izdeluje zdravilo Onsenal, bo opravila študijo pri bolnikih s familiarno adenomatozno polipozo, da bi zbrala več podatkov o varnosti in učinkovitosti zdravila.
The marketing authorisation was renewed on 17 October 2008.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 17. oktobra 2008.
The summary of opinion of the Committee for Orphan Medicinal Products for Onsenal is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Onsenal je na volju tukaj.
Excipients:
Pomožne snovi: laktoza monohidrat 49, 8 mg.
Lactose Monohydrate 49.8 mgFor a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).
Onsenal je indiciran za zmanjšanje števila adenomatoznih intestinalnih polipov pri familiarni adenomatozni polipozi (FAP) kot dodatek operaciji in nadaljnjemu endoskopskemu nadzoru (glejte poglavje 4. 4).
The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
Ni dokazano, da zmanjšanje števila polipov, doseženo z Onsenalom, vpliva na tveganje za karcinom na črevesu (glejte poglavji 4. 4 in 5. 1).
The recommended oral dose is two 200 mg capsules twice per day, taken with food (see section 5.2).
Priporočeni peroralni odmerek je dve 200 mg kapsuli dvakrat na dan, zaužiti s hrano (glejte poglavje 5. 2).
In patients with moderate hepatic impairment (serum albumin of 25-35 g/ l), the daily recommended dose of celecoxib should be reduced by 50% (see sections 4.3 and 5.2).
Pri bolnikih z zmerno jetrno okvaro (albumin v serumu od 25 do 35 g/ l) je treba dnevni priporočeni odmerek celekoksiba zmanjšati za 50% (glejte poglavji 4. 3 in 5. 2).
Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see sections 4.3, 4.4 and 5.2).
Izkušnje s celekoksibom pri bolnikih z blago ali zmerno ledvično okvaro so omejene, zato je treba takšne bolnike zdraviti previdno (glejte točke 4. 3, 4. 4 in 5. 2).
Experience with celecoxib in FAP patients below the age of 18 years is limited to a single pilot study in a very small population, in which patients were treated with celecoxib at doses up to 16 mg/ kg daily, which corresponds to the recommended adult FAP dose of 800 mg daily (see section 5.1).
V tej študiji so bolniki dobivali celekoksib v odmerkih do 16 mg na dan, kar ustreza priporočenemu odmerku 800 mg na dan za odrasle s FAP (glejte poglavje 5. 1).
CYP2C9 Poor Metabolizers:
Bolniki, ki slabo presnavljajo s CYP2C9:
Patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/ experience with other CYP2C9 substrates should be administered celecoxib with caution, as the risk of dose-dependent adverse effects is increased.
Takšni bolniki imajo namreč večje tveganje za neželene učinke, odvisne od odmerka.
Consider starting treatment at a reduced dose (see section 5.2).
V poštev pride uvedba zdravljenja z manjšim odmerkom (glejte poglavje 5. 2).
The dose for elderly FAP patients has not been established.
Odmerek za starejše bolnike s FAP ni ugotovljen.
Special care should be used in such patients (see section 5.2).
Pri takšnih bolnikih je potrebna posebna previdnost (glejte poglavje 5. 2).
2 • Hypersensitivity to the active substance or to any of the excipients (see section 6.1). • Known hypersensitivity to sulphonamides. • Active peptic ulceration or gastrointestinal (GI) bleeding. • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti-inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors. • In pregnancy and in women who can become pregnant unless using an effective method of contraception (see sections 4.5, 4.6 and 5.3) • Breast feeding (see sections 4.6 and 5.3) • Severe hepatic dysfunction (serum albumin< 25 g/l or Child-Pugh score > 10) (Class C). • Patients with renal insufficiency with estimated creatinine clearance < 30 ml/ min. • Inflammatory bowel disease. • Congestive heart failure (NYHA II-IV). • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6. 1). • Znana preobčutljivost za sulfonamide. • Aktiven peptični ulkus ali krvavitev v prebavilih. • Bolniki, ki so po jemanju acetilsalicilne kisline ali nesteroidnih protivnetnih zdravil (NSAID – „ non steroidal antiinflammatory drugs “), vključno s selektivnimi zaviralci COX- 2 (ciklooksigenaze- 2), kdaj imeli astmo, akutni rinitis, nosne polipe, angionevrotični edem, urtikarijo ali kakšno drugo alergijsko reakcijo. • V nosečnosti in pri ženskah, ki lahko zanosijo, če ne uporabljajo učinkovite kontracepcijske zaščite (glejte poglavja 4. 5, 4. 6 in 5. 3) • Dojenje (glejte poglavji 4. 6 in 5. 3). • Hudo poslabšano delovanje jeter (albumin v serumu < 25 g/ l ali ocena po Child- Pughu > 10) (stopnja C) • Bolniki z ledvično insuficienco z ocenjenim očistkom kreatinina < 30 ml / min. • Vnetna črevesna bolezen. • Kongestivno srčno popuščanje (NYHA II- IV). • Potrjena ishemična bolezen srca, bolezen perifernih arterij in/ ali cerebrovaskularna bolezen
Gastro-intestinal disorder Upper gastrointestinal complications [perforations, ulcers or bleeds (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Bolezni prebavil Pri bolnikih, zdravljenih s celekoksibom, so se pojavljali zapleti na zgornjih prebavilih [perforacije, ulkusi in krvavitve], ki so bili v nekaterih primerih smrtni.
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
Glede varnosti za prebavila v dolgoročnih kliničnih preskušanjih niso ugotovili pomembne razlike med uporabo selektivnih zaviralcev COX- 2 in acetilsalicilne kisline v primerjavi z uporabo nesteroidnih protivnetnih zdravil in acetilsalicilne kisline (glejte poglavje 5. 1).
NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see 5.1). The concomitant use of celecoxib and a non-aspirin NSAID should be avoided.
Celekoksiba ne uporabljajte sočasno z ne- aspirinskimi nesteroidnimi protivnetnimi zdravili.
Blood and lymphatic system disorder / Cardio-vascular disorder Increased number of serious cardiovascular events, mainly myocardial infarction, has been found in a long- term placebo-controlled study in subjects with sporadic adenomatous polyps treated with celecoxib at doses of 200 mg BID and 400 mg BID compared to placebo (see section 5.1).
Bolezni krvi in limfatičnega sistema / Srčne in žilne bolezni V dolgotrajni, s placebom nadzorovani študiji, so odkrili povečano število nevarnih srčnožilnih dogodkov, v glavnem miokardni infarkt, pri osebah s sporadičnimi adenomatoznimi polipi, zdravljenih s celekoksibom, v odmerkih po 200 mg dvakrat na dan in 400 mg dvakrat na dan v primerjavi s placebom (glejte poglavje 5. 1).
As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1)
Zato je treba odziv bolnikov s FAP na celekoksib redno preverjati, da bi preprečili nepotrebno izpostavljanje zdravilu pri bolnikih s FAP, pri katerih celekoksib ni učinkovit (glejte poglavja 4. 2, 4. 3, 4. 8 in 5. 1).
Patients with significant risk factors for cardiovascular events (e. g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see section 5.1).
Bolnike s pomembnimi dejavniki tveganja za srčnožilne dogodke (npr. hipertenzija, hiperlipidemija, diabetes mellitus, kajenje) lahko s celekoksibom zdravimo le po skrbnem premisleku (glejte poglavje 5. 1).
3 COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect.
Ker selektivni zaviralci COX- 2 nimajo antiagregacijskega delovanja, niso nadomestilo za acetilsalicilno kislino v profilaksi kardiovaskularnih trombemboličnih bolezni.
Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained.
Te bolnike je zato treba stalno ustrezno zdravstveno nadzirati.
Renal and hepatic disorders NSAIDs, including celecoxib, may cause renal toxicity.
Bolezni ledvic in jeter Nesteroidna protivnetna zdravila imajo lahko toksične učinke na ledvice; to velja tudi za celekoksib.
Experience with celecoxib in patients with mild or moderate renal or hepatic impairment is limited, therefore such patients should be treated with caution (see sections 4.2 and 5.2).
(glejte poglavji 4. 2 in 5. 2).
Skin Reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib (see section 4.8).
Kožne reakcije Pri uporabi celekoksiba so zelo redko poročali o resnih kožnih reakcijah, nekatere od njih so bile smrtne, vključno z, eksfoliacijskim dermatitisom, Stevens- Johnsonovim sindromom in toksično epidermalno nekrolizo (glejte poglavje 4. 8).
Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see section 4.8).
Pri bolnikih, ki so dobivali celekoksib, so bile opisane resne preobčutljivostne reakcije (anafilaksija in angioedem) (glejte poglavje 4. 8).
Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see section 4.3).
Resne kožne reakcije ali preobčutljivostne reakcije lahko bolj ogrožajo bolnike z anamnezo alergije na sulfonamide ali alergije na kakršnakoli zdravila (glejte poglavje 4. 3).
Other Patients known to be CYP2C9 poor metabolisers should be treated with caution (see section 5.2).
Drugo Bolnike, za katere je znano, da slabo presnavljajo s CYP2C9, je treba zdraviti previdno (glejte poglavje 5. 2).
Celecoxib may mask fever and other signs of inflammation.
4 Celekoksib lahko prikrije zvišano telesno temperaturo in druge znake vnetja.
Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (see section 4.5).
Previdnost je potrebna, kadar se celekoksib kombinira z varfarinom in drugimi peroralnimi antikoagulanti (glejte poglavje 4. 5).
Onsenal 200 mg capsules contain lactose (49.8 mg).
Kapsule Onsenal 200 mg vsebujejo laktozo (49, 8 mg).
A more pronounced effect at 400 mg BID therefore cannot be excluded.
Farmakodinamične interakcije Večina študij interakcij je bila opravljena s celekoksibom v odmerkih 200 mg dvakrat na dan (to je odmerkih, ki se uporabljajo pri osteoartritisu/ revmatoidnem artritisu), zato ni mogoče izključiti, da ima odmerek 400 mg dvakrat na dan izrazitejše učinke.
Anticoagulant activity should be monitored in patients taking warfarin or other anticoagulants, particularly in the first few days after initiating or changing the dose of celecoxib, since these patients have an increased risk of bleeding complications.
Te bolnike namreč bolj ogrožajo zapleti s krvavitvami.
Bleeding events in association with increases in prothrombin time have been reported in arthritis patients (mainly elderly) receiving celecoxib concurrently with warfarin, some of them fatal (see section 4.4).
Pri bolnikih z artritisom (predvsem starejših), ki so dobivali celekoksib sočasno z varfarinom, so bile opisane krvavitve, povezane s podaljšanjem protrombinskega časa; nekatere od teh krvavitev so bile smrtne (glejte poglavje 4. 4).
NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
NSAID- i lahko zmanjšajo učinek diuretikov in antihipertenzivov.
As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e. g. dehydrated patients or elderly patients) when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
Za NSAID- e velja, da se tveganje akutne ledvične insuficience, ki je običajno reverzibilna, lahko pri nekaterih bolnikih s prizadeto funkcijo ledvic (npr. dehidrirani ali starejši bolniki) poveča v primeru, da kombiniramo zaviralce ACE ali antagoniste receptorjev angiotenzina II z NSAID- i, vključno s celekoksibom.
In a 28-day clinical study in patients with lisinopril-controlled Stage I and II hypertension, administration of celecoxib 200 mg BID resulted in no clinically significant increases, when compared to placebo treatment, in mean daily systolic or diastolic blood pressure as determined using 24-hour ambulatory blood pressure monitoring.
V 28- dnevni klinični študiji bolnikov s hipertenzijo I. in II. stopnje, urejeno z lizinoprilom, uporaba 200 mg celekoksiba dvakrat na dan v primerjavi s placebom ni klinično pomembno zvišala povprečnega sistoličnega ali diastoličnega krvnega tlaka med stalnim 24- urnim merjenjem.
Among patients treated with celecoxib 200 mg BID, 48% were considered unresponsive to lisinopril at the final clinic visit (defined as either cuff diastolic blood pressure > 90 mmHg or cuff diastolic blood pressure increased > 10% compared to baseline), compared to 27% of patients treated with placebo; this difference was statistically significant.
Razlika je statistično značilna.
As with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1).
Tako kot pri drugih NSAID je tudi sočasno uporabo celekoksiba in majhnih odmerkov acetilsalicilne kisline spremljalo večje tveganje za ulkuse in druge zaplete na prebavilih kot pri uporabi celekoksiba samega (glejte poglavje 5. 1).
Effects of celecoxib on other medicinal products Celecoxib is a weak inhibitor of CYP2D6.
Vplivi celekoksiba na druga zdravila Celekoksib je šibek zaviralec CYP2D6.
During celecoxib treatment, the mean plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
Povprečna plazemska koncentracija dekstrometorfana, substrata CYP2D6, se je med zdravljenjem s celekoksibom zvečala za 136%.