natgillin/translations-raw huggingface dataset:
You will need to use effective contraception during and for at least six months after receiving this treatment.
Med zdravljenjem in še najmanj 6 mesecev po njem boste morali uporabljati učinkovito kontracepcijo.
Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild to severe renal impairment (see section 5.2).
Glede na analizo populacijske farmakokinetike se za bolnike z blago do hudo okvaro ledvic ne priporoča prilagoditev odmerjanja (glejte poglavje 5.2).
Citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Citronska kislina monohidrat, glicin, polisorbat 80, natrijev hidroksid, klorovodikova kislina, voda za injekcije.
- Each vial contains 20 mg of mogamulizumab in 5 mL of concentrate, corresponding to 4 mg/mL.
- Ena viala vsebuje 20 mg mogamulizumaba v 5 ml koncentrata, kar ustreza 4 mg/ml.
P value
Vrednost Pa
The effect of hepatic impairment on the clearance of mogamulizumab was evaluated by a population PK analysis in patients with mild hepatic impairment (total bilirubin [TB] less than or equal to the upper limit of normal [ULN] and AST greater than ULN or TB less than 1 to 1.5 times ULN and any AST; n= 80) or moderate (TB greater than 1.5 to 3 times ULN and any AST; n=3) hepatic impairment.
Učinek okvare jeter na očistek mogamulizumaba je bil ocenjen z analizo populacijske FK pri bolnikih z blago okvaro jeter (raven skupnega bilirubina [TB], nižja ali enaka kot zgornja meja normalne vrednosti [ULN] in vrednost AST, višja od ULN, ali vrednost TB, nižja od 1- do 1,5-kratne ULN, in kakršna koli vrednost AST, n = 80) ali zmerno okvaro jeter (vrednost TB, višja od 1,5- do 3-kratne ULN, in kakršna koli vrednost AST; n = 3).
The Kaplan-Meier curve for PFS is shown Figure 1.
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni je prikazana na Slika 1.
Nodal (n) Response Rate (n, %) 95% CIa M=mogamulizumab.
Bezgavke (n) Stopnja odziva (n, %) 95-odstotni IZa M = mogamulizumab, V = vorinostat
Reporting suspected adverse reactions
Poročanje o domnevnih neželenih učinkih
There is no information on overdose with mogamulizumab.
Informacij o prevelikem odmerjanju mogamulizumaba ni.
A small percentage of patients receiving POTELIGEO tested positive for treatment emergent (treatment induced or treatment boosted) anti mogamulizumab antibodies.
Majhen odstotek bolnikov, ki so prejemali zdravilo POTELIGEO, je imel pozitiven rezultat testa protiteles proti mogamulizumabu kot učinka, sproženega ali povečanega zaradi zdravljenja.
Mix diluted solution by gentle inversion.
Razredčeno raztopino premešajte z nežnim preobračanjem.
The efficacy of mogamulizumab in the treatment of patients with mycosis fungoides (MF) or Sézary syndrome (SS) was established in a Phase 3, multicentre, open-label, study (0761-010) of 372 adult patients randomised 1:1 to treatment with either mogamulizumab or vorinostat.
Učinkovitost mogamulizumaba pri zdravljenju bolnikov s fungoidno mikozo (FM) ali Sézaryjevim sindromom (SS) je bila ugotovljena v multicentrični odprti študiji 3. faze (0761-010), ki je vključevala
Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL.
Ena viala vsebuje 20 mg mogamulizumaba v 5 ml, kar ustreza 4 mg/ml.
Each vial of 5 mL contains 20 mg of mogamulizumab.
Ena 5-ml viala vsebuje 20 mg mogamulizumaba.
No trend in latency to event onset was identified for drug eruptions and rashes; both early and late-onset events occurred.
Pri kožnih reakcijah/izpuščaju niso opazili nobenega trenda v zakasnitvi nastopa reakcij; nekatere so se pojavile zgodaj in druge pozno.
POTELIGEO is unlikely to affect your ability to drive and use machines.
Malo verjetno je, da bo zdravilo POTELIGEO vplivalo na vašo sposobnost vožnje ali upravljanja strojev.
POTELIGEO is for intravenous use.
Zdravilo POTELIGEO je namenjeno za intravensko uporabo.
No mogamulizumab-related toxic effects in the male and female reproductive organs were observed in repeat-dose toxicology studies in sexually mature monkeys up to 26 weeks.
V toksikoloških študijah s ponavljajočimi se odmerki pri spolno zrelih opicah, ki so trajale do 26 tednov, niso opazili nobenih toksičnih učinkov, povezanih z mogamulizumabom, na reproduktivne organe samcev ali samic.
- The other excipients are citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections.
- Pomožne snovi so citronska kislina monohidrat, glicin, polisorbat 80, natrijev hidroksid, klorovodikova kislina in voda za injekcije.
The incidence of infusion related reactions was highest after the first infusion (28.8% of subjects),
Pojavnost reakcij, povezanih z infundiranjem, je bila največja po prvi infuziji (28,8 % bolnikov) in se je po dveh ali več infuzijah zmanjšala na ≤ 3,8 % bolnikov.
The number of infusions of mogamulizumab administered to crossover patients ranged from 1 to 94 (up to 46 months of treatment) as of the December 2016 datacut.
Po podatkih, zbranih do decembra 2016, so bolniki, ki so zamenjali zdravilo, prejeli od 1 do 94 infuzij mogamulizumaba (do 46 mesecev zdravljenja).
There are no clinical data available on the effect of mogamulizumab on human fertility.
O vplivu mogamulizumaba na plodnost pri ljudeh ni na voljo nobenih kliničnih podatkov.
Uncommon side effects (may affect up to 1 in 100 people)
- premalo aktivna ščitnica Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
Fatigue may occur following administration of mogamulizumab (see section 4.8).
Po prejemu mogamulizumaba se lahko pojavi utrujenost (glejte poglavje 4.8).
- chest pain, shortness of breath, fast or slow heartbeat, sweating, dizziness, nausea or vomiting, weakness, feeling faint and feeling unwell.
- bolečina v prsih, zasoplost, hiter ali počasen srčni utrip, znojenje, omotica, siljenje na bruhanje ali bruhanje, šibkost, občutek, da boste omedleli, in splošno slabo počutje.
POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab
POTELIGEO 4 mg/ml koncentrat za raztopino za infundiranje mogamulizumab
Very common Drug eruption (including skin rash) a Folliculitis, Cellulitis, Candidiasis, Pneumonia, Sepsis, Skin infection, Otitis externa, Herpes zoster, Staphylococcal skin infection, Urinary tract infection, Herpes simplex and cytomegalovirus
a folikulitis, celulitis, kandidiaza, pljučnica, sepsa, okužba kože, vnetje sluhovoda, herpes zoster, stafilokokna okužba kože, okužba sečil, herpes simpleks in citomegalovirus
Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Okvara jeter Glede na analizo populacijske farmakokinetike se za bolnike z blago ali zmerno okvaro jeter ne priporoča prilagoditev odmerjanja.
Risk Diff (M vs. V)
Razlika v tveganju (M v prim.
Tumour lysis syndrome (TLS) has been observed in patients receiving mogamulizumab.
Pri bolnikih, ki so prejemali mogamulizumab, so opazili sindrom tumorske lize (TLS).
When mogamulizumab has been administered to patients with T-cell lymphomas other than MF or SS, serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in less than 1% of patients during clinical trials, and also reported during the post-marketing period; some of these cases were reported with fatal outcomes.
Pri uporabi mogamulizumaba pri bolnikih s T-celičnimi limfomi razen FM ali SS v kliničnih preskušanjih so pri manj kot 1 % bolnikov poročali o pojavu resnih kožnih reakcij, vključno s StevensJohnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN).
See section 4.2 for premedication and dose modification information.
Informacije o predhodnem zdravljenju in prilagoditvah odmerjanja so v poglavju 4.2.
Pre-medication with anti-pyretic and anti-histamine is recommended for the first POTELIGEO infusion.
Pri prvi infuziji zdravila POTELIGEO se priporoča predhodno zdravljenje z antipiretikom in antihistaminikom.
What POTELIGEO looks like and contents of the pack
Izgled zdravila POTELIGEO in vsebina pakiranja
In general, IgG molecules are known to cross the placental barrier and mogamulizumab concentrations in foetus plasma were detected.
Na splošno je znano, da molekule IgG prehajajo skozi placentarno pregrado.
Based on a population PK analysis, the geometric mean [% coefficient of variation (CV%)] central volume of distribution (Vc) was 3.57 L (20.1%).
osrednjega volumna porazdelitve (Vc) 3,57 l (20,1 %).
Tell the person giving you the infusion or get medical help straight away if you experience a reaction during or after any POTELIGEO infusion.
Če med infuzijo zdravila POTELIGEO ali po njej doživite reakcijo, to povejte zdravstvenemu delavcu, ki vam je dal infuzijo, oziroma takoj poiščite zdravniško pomoč.
Key secondary endpoints were overall response rate (ORR), ORR after crossover, duration of response (DOR), and changes from baseline of the Skindex-29 Symptoms and Functional Scales, and Functional Assessment of Cancer Therapy-General (FACT-G) Physical and Functional Well-being domains.
Ključni sekundarni opazovani dogodki so bili skupna stopnja odziva (SSO), SSO po zamenjavi zdravila, trajanje odziva (TO) ter spremembe od izhodišča v simptomih in na funkcionalni lestvici
Very common Constipation, diarrhoea, nausea, stomatitis
Bolezni prebavil zelo pogosti zaprtost, driska, navzea, stomatitis pogosti bruhanje
Administration is weekly on days 1, 8, 15 and 22 of the first 28-day cycle, followed by infusions every two weeks on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.
V prvem 28-dnevnem krogu zdravljenja se zdravilo daje v tedenskih presledkih 1., 8., 15. in 22. dan, temu pa sledijo infuzije v dvotedenskih presledkih 1. in 15. dan vsakega nadaljnjega
PFS, months ITT Population IB/II III/IV ITT=intent to treat Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with mogamulizumab in all subsets of the paediatric population in cutaneous T-cell lymphoma (CTCL) (MF and SS are subtypes of CTCL).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z mogamulizumabom za vse podskupine pediatrične populacije s kožnim T-celičnim limfomom (CTCL) (FM in SS sta podtipa CTCL).
Mogamulizumab infusion was administered at a dose of 1 mg/kg once weekly for the first 28-day cycle (on Days 1, 8, 15 and 22), and on days 1 and 15 of subsequent 28-day cycles.
V prvem 28-dnevnem krogu zdravljenja so bolniki dobivali infuzije mogamulizumaba v odmerku 1 mg/kg enkrat na teden (1., 8., 15. in 22. dan) in v nadaljnjih
Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious.
Pri bolnikih, ki so prejemali mogamulizumab, se je pojavil medikamentozni izpuščaj (kožna reakcija na zdravilo); nekateri primeri so bili hudi in/ali resni.
• POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) infusion-related reaction (see section 4.4).
• Ob pojavu življenjsko nevarne reakcije, povezane z infundiranjem (stopnja 4), je treba zdravljenje z zdravilom POTELIGEO trajno opustiti (glejte poglavje 4.4).
Uncommon Hepatitis acute, hepatitis
Bolezni jeter, žolčnika in žolčevodov občasni akutni hepatitis, hepatitis
Response Rate (n, %) 95% CIa
Stopnja odziva (n, %) 95-odstotni IZa
POTELIGEO 4 mg/mL concentrate for solution for infusion.
POTELIGEO 4 mg/ml koncentrat za raztopino za infundiranje
Overall response rate (confirmed CR + PR, %) 95% CI
Skupna stopnja odziva (potrjen CR + PR, %) 95-odstotni IZ
If you are breast-feeding, you should discuss with your doctor whether you can breast-feed during or after treatment with POTELIGEO.
ali smete dojiti med zdravljenjem z zdravilom POTELIGEO ali po njem.
• The infusion of POTELIGEO should be temporarily interrupted for mild to severe (Grades 1-3) infusion-related reactions and symptoms treated.
• Če se pojavijo blage do hude reakcije (stopnje 1-3), povezane z infundiranjem, je treba infundiranje zdravila POTELIGEO začasno prekiniti in zdraviti simptome.
How POTELIGEO is given
Kako se daje zdravilo POTELIGEO
Response in the viscera could not be evaluated due to limited efficacy data in subjects with visceral involvement; the benefit-risk of mogamulizumab in subjects with visceral involvement is currently undetermined due to lack of data.
Razmerje med koristmi in tveganji mogamulizumaba pri bolnikih s prizadetim drobovjem je trenutno nejasno zaradi pomanjkanja podatkov.
Crossover patients received up to 46 months of mogamulizumab therapy, as of December 2016 data cut.
Po podatkih, zbranih do decembra 2016, so se bolniki, ki so zamenjali zdravilo, zdravili z mogamulizumabom največ 46 mesecev.
POTELIGEO is a clear to slightly opalescent, colourless solution.
POTELIGEO je bistra do rahlo opalescentna brezbarvna raztopina.
The effects of various covariates on the PK s of mogamulizumab were assessed in population PK analyses.
V analizah populacijske farmakokinetike so ocenili učinke različnih kovariatov na farmakokinetiko mogamulizumaba.
Patients receiving POTELIGEO have experienced drug rash (drug eruption), some of which were severe and/or serious.
Pri bolnikih, ki so prejemali zdravilo POTELIGEO, se je pojavil medikamentozni izpuščaj (kožna reakcija na zdravilo); nekateri primeri so bili hudi in/ali resni.
POTELIGEO contains sodium
OVOJNINAH NALEPKA NA VIALI
No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
V študijah toksičnosti ponavljajočih se odmerkov, ki so jih opravili na opicah pasme Macaca fascicularis, niso ugotovili neželenih učinkov na reproduktivne organe samcev in samic (glejte poglavje 5.3).
For patients who test positive for current/previous hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended for advice concerning appropriate measures against hepatitis B reactivation.
Bolnike je treba pred začetkom zdravljenja z mogamulizumabom testirati za okužbo z virusom hepatitisa B. Bolnikom s pozitivnim testom za sedanjo/preteklo okužbo s hepatitisom B se priporoča, da se posvetujejo z zdravnikom, ki ima strokovno znanje o zdravljenju hepatitisa B, glede ustreznih ukrepov za preprečevanje ponovne aktivacije hepatitisa B. Zapleti pri alogenski presaditvi hematopoetskih matičnih celic (HSCT) po zdravljenju z mogamulizumabom Pri bolnikih s T-celičnimi limfomi, razen FM ali SS, pri katerih so po zdravljenju z mogamulizumabom opravili presaditev hematopoetskih matičnih celic (HSCT), so poročali o zapletih,
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi citronska kislina monohidrat glicin polisorbat 80 natrijev hidroksid (za prilagoditev vrednosti pH) klorovodikova kislina (za prilagoditev vrednosti pH) voda za injekcije
Very common Headache
Bolezni živčevja zelo pogosti glavobol
Injury, poisoning and procedural complications
Poškodbe, zastrupitve in zapleti pri posegih zelo pogosti reakcija, povezana z infundiranjem
Anaemia, neutropenia, leukopenia, Thrombocytopenia
Bolezni krvi in limfatičnega sistema pogosti anemija, nevtropenija, levkopenija, trombocitopenija
The majority of IRRs occur during or shortly after the first infusion (all within 24 hours of administration), with the incidence decreasing over subsequent treatments.
(v 24 urah po dajanju zdravila), nato pa se pojavnost pri nadaljnjih krogih zdravljenja zmanjšuje.
- fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness and/or muscle or joint pain.
epileptični napadi, neenakomeren srčni utrip, temen ali moten urin, nenavadna utrujenost in/ali bolečine v mišicah ali sklepih.
See section 4.2 for dose modification information.
Informacije o prilagoditvah odmerjanja so v poglavju 4.2.
Overall response rate (confirmed CR + PR, %) 95% CI P-valuea Viscera n=6
Skupna stopnja odziva (potrjen CR + PR, %) 95-odstotni IZ Vrednost Pa Drobovje n = 6
Overall response rate (confirmed CR + PR, %)
Skupna stopnja odziva (potrjen PO + DO, %)
No clinically important differences in the clearance of mogamulizumab were found between patients with mild to severe renal impairment and patients with normal renal function.
Med bolniki z blago do hudo okvaro ledvic in bolniki z normalnim delovanjem ledvic ni bilo klinično pomembnih razlik v očistku mogamulizumaba.
No clinically important differences in the clearance of mogamulizumab were found between patients with mild to moderate hepatic impairment and patients with normal hepatic function.
Med bolniki z blago do zmerno okvaro jeter in bolniki z normalnim delovanjem jeter niso ugotovili klinično pomembnih razlik v očistku mogamulizumaba.
Of the patients randomised to vorinostat, 136 patients (73.1%) crossed over to mogamulizumab during the study.
Med bolniki, ki so bili naključno razvrščeni v skupino z vorinostatom, je med študijo 136 bolnikov
Warnings and precautions Talk to your doctor or nurse before using POTELIGEO if you:
Pred začetkom uporabe zdravila POTELIGEO se posvetujte z zdravnikom ali medicinsko sestro:
Overall response rate (confirmed CR + PR, %) 95% CI P-valuea Lymph nodes n=136
Skupna stopnja odziva (potrjen PO + DO, %) 95-odstotni IZ Vrednost Pa Bezgavke n = 136
- signs of infection, which may include a fever, sweats or chills, flu-like symptoms, sore throat or difficulty swallowing, cough, shortness of breath, stomach pain, nausea or vomiting, diarrhoea and feeling very unwell.
Zdravnik lahko ukine vaše zdravljenje z zdravilom POTELIGEO, če imate hudo reakcijo nanj; - znaki okužbe, ki lahko vključujejo zvišano telesno temperaturo, znojenje ali mrazenje, gripi podobne simptome, vneto grlo ali težave pri požiranju, kašelj, zasoplost, bolečine v želodcu, siljenje na bruhanje ali bruhanje, drisko in zelo slabo počutje; - kožne bolečine, srbenje, mehurji na koži, kožni izpuščaj ali bolečina v ustih, ki so morda znaki,
POTELIGEO should be administered within 2 days of the scheduled day.
Dajanje zdravila POTELIGEO sme odstopati od načrtovanega dneva za največ dva dni.
• Visually inspect the medicinal product for particulate matter and discolouration prior to administration.
• Pred uporabo raztopino preverite ter se prepričajte, da ne vsebuje delcev in ni obarvana.
Acute infusion-related reactions (IRRs) have been observed in patients treated with mogamulizumab.
Pri bolnikih, zdravljenih z mogamulizumabom, so opazili akutne reakcije, povezane z infundiranjem.
Less than 1% of patients treated in Study 0761-010 discontinued treatment due to infusion-related reactions.
Zaradi reakcij, povezanih z infundiranjem, se je prenehalo zdraviti manj kot 1 % bolnikov v študiji
- chills, nausea or vomiting, headache, wheezing, itching, flushing, rash, dizziness or feeling faint, difficulty breathing and fever, which may be signs of an infusion reaction.
omotica ali občutek, da boste omedleli, oteženo dihanje in zvišana telesna temperatura, ki so lahko znaki reakcije na infuzijo.
- skin pain, itching, skin blisters, skin rash or sore mouth, which are possible signs that you may be developing a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
da se razvija huda kožna reakcija, kot sta Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza;
• POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) rash (see section 4.4).
POTELIGEO trajno opustiti (glejte poglavje 4.4).
Polysorbate 80
Bloemlaan 2
Clear to slightly opalescent, colourless solution.
POTELIGEO je bistra brezbarvna raztopina.
Endocrine disorders
Organski sistem
Uncommon Tumour lysis syndrome
Presnovne in prehranske motnje občasni sindrom tumorske lize
- ever had an infusion reaction with this medicine (possible symptoms of an infusion reaction are listed in section 4).
- če ste kdaj imeli hudo kožno reakcijo na to zdravilo; - če ste kdaj imeli reakcijo na infuzijo tega zdravila (možni simptomi reakcije, povezane z infuzijo, so navedeni v poglavju 4); - če imate virus humane imunske pomanjkljivosti (HIV), herpes, citomegalovirus (CMV), okužbo s hepatitisom B ali C ali drugo okužbo, ki se še ni pozdravila;
Blood and lymphatic system disorders
Bolezni endokrinega sistema pogosti hipotiroidizem
• If you have any questions, speak with your doctor or pharmacist.
• Če imate kakršna koli vprašanja, se posvetujte z zdravnikom ali farmacevtom.
It is currently available in the European Union (EU) in a number of different formulations.
Trenutno je v Evropski uniji (EU) na voljo v več različnih farmacevtskih oblikah.
The review of systemic diclofenac was initiated on 31 October 2012 at the request of the United Kingdom medicines agency, under Article 31 of Directive 2001/83/EC.
Pregled sistemskega diklofenaka se je začel dne 31. oktobra 2012 na zahtevo agencije Združenega kraljestva za zdravila v skladu s členom 31 Direktive 2001/83/ES.
• You should not stop taking your treatment without talking to your doctor.
• Zdravila ne smete prenehati jemati, ne da bi se prej posvetovali z zdravnikom.
Limitations in the data had made it hard to quantify the risk initially, but a consistent picture was emerging by the time of the 2012 review.
Zaradi pomanjkljivosti podatkov je bilo najprej težko kvantificirati tveganje, vendar se je do pregleda leta 2012 že pojavila dosledna slika.
The product information will be amended and healthcare professionals prescribing or dispensing systemic diclofenac will receive further appropriate communication at a national level.
Informacije o zdravilu bodo spremenjene, zdravstveni delavci, ki predpisujejo ali izdajajo sistemski diklofenak, pa bodo prejeli dodatna ustrezna obvestila na nacionalni ravni.
The safety of NSAIDs has been closely monitored by regulatory authorities in the EU.
Varnost teh zdravil podrobno spremljajo regulativni organi v EU.
New measures aim to minimise cardiovascular risks
Novi ukrepi so namenjeni zmanjšanju srčno-žilnih tveganj
The latter found that, compared with placebo, the risk of major vascular events was increased by about one third by a COX-2 inhibitor (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.312.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032).
V tej analizi so ugotovili, da se je v primerjavi s placebom tveganje za večje vaskularne dogodke povečalo za približno eno tretjino pri uporabi zaviralca COX-2 (razmerje stopnje [RS] 1,37, 95-odstotni interval zaupanja [IZ] 1,14-1,66; p = 0,0009) ali diklofenaka (1,41, 1,12-1,78; p = 0,0036), v glavnem zaradi povečanja števila večjih koronarnih dogodkov (koksibi: 1,76, 1,31-2,37; p = 0,0001; diklofenak: 1,70, 1,19-2,41; p = 0,0032).
Diclofenac-containing medicines have been authorised by national approval procedures in the EU Member States and have been available for many years under a wide range of trade names.
Zdravila, ki vsebujejo diklofenak, so bila v državah članicah EU odobrena po nacionalnih postopkih in so že več let na voljo pod vrsto različnih trgovskih imen.
This applies particularly when diclofenac is used at a high dose and for long-term treatment.
To velja predvsem, kadar se diklofenak uporablja pri velikih odmerkih za dolgoročno zdravljenje.
About 8 people in 1,000 at moderate risk of heart disease are likely to have a heart attack over one year.
Približno 8 od 1.000 ljudi, pri katerih obstaja zmerno tveganje za bolezen srca, utegne utrpeti možgansko kap v obdobju enega leta.
• The effectiveness of diclofenac is well established.
• Učinkovitost diklofenaka je bila dokazana.
As diclofenac-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Ker so vsa zdravila, ki vsebujejo diklofenak, odobrena na nacionalni ravni, so bila priporočila odbora PRAC posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.