FrancophonIA/ELRC3.0 huggingface dataset:
English: If you stop taking Copalia
Slovenian: Če ste prenehali jemati zdravilo Copalia
English: The rate and extent of absorption of Copalia are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Slovenian: Hitrost in obseg absorpcije zdravila Copalia sta enakovredna biološki uporabnosti valsartana in amlodipina, uporabljenih v ločenih tabletah.
English: If hypotension occurs with Copalia, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Slovenian: Če se med uporabo zdravila Copalia pojavi hipotenzija, je treba bolnika poleči in mu, če je potrebno, dati intravensko infuzijo fiziološke raztopine.
English: Copalia was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Slovenian: Zdravilo Copalia so raziskali tudi v študiji, kontrolirani z učinkovino, pri 130 bolnikih s hipertenzijo, ki so imeli srednji diastolični krvni tlak sede ≥110 mm Hg in <120 mm Hg.
English: Copalia combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Slovenian: Zdravilo Copalia vsebuje dve antihipertenzivni učinkovini s komplementarnima mehanizmoma delovanja za obvladanje krvnega tlaka pri bolnikih z esencialno hipertenzijo: amlodipin spada med zaviralce kalcijevih kanalčkov, valsartan pa med antagoniste angiotenzina II.
English: If you get these symptoms, stop taking Copalia and contact your doctor straight away.
Slovenian: Če opazite navedene simptome, takoj prenehajte jemati zdravilo Copalia in obvestite svojega zdravnika.
English: Slovenská republika Novartis Slovakia r.o.
Slovenian: Slovenská republika Novartis s.Slovakia r.o.
English: Correction of this condition prior to administration of Copalia or close medical supervision at the start of treatment is recommended.
Slovenian: Priporočljivo je, da pred začetkom uporabe zdravila Copalia, popravite to stanje ali bolniku zagotovite natančen zdravniški nadzor na začetku zdravljenja.
English: There are no clinical studies on fertility with Copalia.
Slovenian: Kliničnih študij glede plodnosti pri uporabi zdravila Copalia ni.
English: Clinically significant hypotension due to Copalia overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Slovenian: Klinično značilna hipotenzija zaradi prevelikega odmerka zdravila Copalia zahteva srčnožilno podporo, vključno s pogostim nadziranjem delovanja srca in dihal, dviganjem udov ter kontrolo krožečega volumna tekočine in izločanja urina.
English: If any of these apply to you, tell your doctor before taking Copalia.
Slovenian: Če kaj od naštetega velja za vas, morate to povedati zdravniku, preden vzamete zdravilo Copalia.
English: Particular caution should be exercised when administering Copalia to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Slovenian: Posebna previdnost je potrebna v primeru uporabe zdravila Copalia pri bolnikih z blago do zmerno okvaro jeter ali z obstruktivnimi biliarnimi boleznimi.
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovine, na dihidropiridinske derivate ali katero koli pomožno snov,
English: Over 1,400 hypertensive patients received Copalia once daily in two placebo-controlled trials.
Slovenian: V dveh s placebom kontroliranih preskušanjih je zdravilo Copalia enkrat na dan dobivalo več kot 1.400 bolnikov s hipertenzijo.
English: This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Copalia.
Slovenian: Grenivka in grenivkin sok lahko namreč povzročita zvišanje koncentracije zdravilne učinkovine amlodipina v krvi, kar lahko pripelje do nepredvidljivega povečanja učinka zdravila Copalia pri zniževanju krvnega tlaka.
English: There is no experience of overdose with Copalia.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila Copalia ni.
English: Side effects reported with amlodipine or valsartan alone and either not observed with Copalia or observed with a higher frequency than with Copalia:
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi amlodipina ali valsartana samega, ki jih bodisi niso opažali pri uporabi zdravila Copalia ali pa so jih opažali z večjo pogostnostjo kot pri uporabi zdravila Copalia:
English: Caution should be exercised when administering Copalia to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Slovenian: Previdnost je potrebna pri uporabi zdravila Copalia pri bolnikih z okvaro jeter ali obstruktivno biliarno boleznijo (glejte poglavje 4.4).
English: Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Copalia as well, even if not observed in clinical trials or during the post-marketing period.
Slovenian: Dodatne informacije o posameznih zdravilnih učinkovinah Neželeni učinki, opisani za katero od obeh zdravilnih učinkovin (za amlodipin ali valsartan), so lahko tudi neželeni učinki zdravila Copalia, tudi če niso bili ugotovljeni v kliničnih preskušanjih ali v obdobju po prihodu zdravila na trg.
English: Talk to your doctor before taking Copalia: if you have been sick (vomiting or diarrhoea).
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Copalia se posvetujte z zdravnikom: če vam je bilo slabo (bruhanje ali driska).
English: In this study (baseline blood pressure 171/113 mmHg), a Copalia regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Slovenian: V tej študiji (izhodiščni krvni tlak 171/113 mm Hg) je shema odmerjanja zdravila Copalia 5 mg/160 mg, titrirana do 10 mg/160 mg, znižala krvni tlak sede za 36/29 mm Hg; v primerjavi s tem je shema odmerjanja lizinoprila/hidroklorotiazida 10 mg/12,5 mg, titrirana do 20 mg/12,5 mg, znižala krvni tlak za 32/28 mm Hg.
English: Copalia tablets contain two substances called amlodipine and valsartan.
Slovenian: Tablete zdravila Copalia vsebujejo dve učinkovini: amlodipin in valsartan.
English: How to take Copalia
Slovenian: Kako jemati zdravilo Copalia
English: Copalia is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Slovenian: Če želite dojiti, bo zdravnik za vas izbral drugo zdravilo, še posebno če je vaš otrok še novorojenček ali je bil rojen prezgodaj.
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Copalia in placebo-controlled studies.
Slovenian: V študijah, kontroliranih s placebom, so čezmerno hipotenzijo opažali pri 0,4 % bolnikov z nezapleteno hipertenzijo, ki so dobivali zdravilo Copalia.
English: If any of the above applies to you, do not take Copalia and talk to your doctor.
Slovenian: Če kaj od naštetega velja za vas, ne vzemite zdravila Copalia, temveč povejte zdravniku.
English: Following oral administration of Copalia, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Slovenian: Po peroralni uporabi zdravila Copalia doseže valsartan največjo koncentracijo v plazmi v 3 urah, amlodipin pa v 6 do 8 urah.
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or Copalia, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Slovenian: Pri prehodu ustreznih bolnikov s hipertezijo (glejte poglavje 4.1) z jetrno okvaro na amlodipin ali zdravilo Copalia, je potrebno uporabiti najnižji razpoložljivi odmerek amlodipina v monoterapiji ali kot komponento.
English: ACE inhibitors or aliskiren (see also information under the headings “Do not take Copalia” and “Warnings and precautions”); diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce); lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Slovenian: To še posebej velja za naslednja zdravila: zaviralci ACE ali aliskiren (glejte tudi informacije pod naslovoma “Ne jemljite zdravila Copalia” in “Opozorila in previdnostni ukrepi”); diuretike (vrsto zdravil, ki jim pravimo tudi "tablete za odvajanje vode" in povečajo nastajanje urina v telesu); litij (zdravilo, ki se uporablja za zdravljenje nekaterih vrst depresij); diuretike, ki varčujejo s kalijem, kalijeve dodatke, nadomestke soli, ki vsebujejo kalij, in druge učinkovine, ki lahko zvišajo koncentracijo kalija; določena zdravila proti bolečinam, ki jih imenujemo nesteroidna protivnetna zdravila (NSAID) ali selektivni zaviralci ciklooksigenaze-2 (zaviralci COX-2).
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Copalia, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Slovenian: Pri prehodu ustreznih starejših bolnikov s hipertezijo (glejte poglavje 4.1) na amlodipin ali zdravilo Copalia, je potrebno uporabiti najnižji razpoložljivi odmerek amlodipina v monoterapiji ali kot komponento.
English: Copalia is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Slovenian: Zdravilo Copalia je indicirano pri odraslih, pri katerih krvni tlak ni ustrezno urejen ob monoterapiji z amlodipinom ali valsartanom.
English: The active substances of Copalia are amlodipine (as amlodipine besylate) and valsartan.
Slovenian: Učinkovini v zdravilu Copalia sta amlodipin (v obliki amlodipinijevega besilata) in valsartan.
English: Copalia should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Slovenian: Pri bolnikih z enostransko ali obojestransko stenozo ledvične arterije oz. s stenozo v primeru solitarne ledvice je pri zdravljenju hipertenzije z zdravilom Copalia potrebna previdnost, saj pri takih bolnikih lahko pride do zvišanja koncentracij sečnine v krvi in kreatinina v serumu.
English: Copalia is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Slovenian: Zdravilo Copalia uporabljamo za zdravljenje visokega krvnega tlaka pri odraslih, pri katerih krvni tlak ni dovolj dobro urejen samo z amlodipinom ali samo z valsartanom.
English: Do not use any Copalia pack that is damaged or shows signs of tampering.
Slovenian: Zdravila Copalia ne uporabljajte, če je ovojnina poškodovana ali opazite, da je bila že odprta.
English: No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (GFR >30 ml/min/1,73 m2) odmerka zdravila Copalia ni treba prilagajati.
English: Hepatic impairment Copalia is contraindicated in patients with severe hepatic impairment (see section 4.3).
Slovenian: Okvara jeter Pri bolnikih s hudo okvaro jeter je zdravilo Copalia kontraindicirano (glejte poglavje 4.3).
English: What Copalia contains
Slovenian: Kaj vsebuje zdravilo Copalia
English: Copalia 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Slovenian: Zdravilo Copalia 5 mg/80 mg lahko uporabite pri bolnikih, pri katerih krvni tlak ni ustrezno urejen samo s 5 mg amlodipina ali z 80 mg valsartana.
English: Copalia should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Slovenian: Bolnikom, pri katerih pride do angioedema, je treba zdravilo Copalia takoj ukiniti.
English: Copalia 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Copalia 5 mg/160 mg.
Slovenian: Zdravilo Copalia 10 mg/160 mg lahko uporabite pri bolnikih, pri katerih krvni tlak ni ustrezno urejen samo z 10 mg amlodipina ali s 160 mg valsartana ali s kombinacijo zdravila Copalia 5 mg/160 mg.
English: No information is available regarding the use of Copalia during breast-feeding, therefore Copalia is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Za uporabo med dojenjem je bolje izbrati drugo zdravilo z dokazanim varnostnim profilom, še posebno če gre za dojenje novorojenčka ali nedonošenčka.
English: Copalia 5 mg/80 mg film-coated tablets Copalia 5 mg/160 mg film-coated tablets Copalia 10 mg/160 mg film-coated tablets
Slovenian: Copalia 5 mg/80 mg filmsko obložene tablete Copalia 5 mg/160 mg filmsko obložene tablete Copalia 10 mg/160 mg filmsko obložene tablete
English: Copalia 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Slovenian: Tablete zdravila Copalia 10 mg/160 mg so ovalne in svetlorumene; na eni strani imajo oznako “NVR” in na drugi “UIC”.
English: Grapefruit and grapefruit juice should not be consumed by people who are taking Copalia.
Slovenian: Ljudje, ki jemljejo zdravilo Copalia, ne smejo uživati grenivk in grenivkinega soka.
English: Copalia 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Slovenian: Zdravilo Copalia 5 mg/160 mg lahko uporabite pri bolnikih, pri katerih krvni tlak ni ustrezno urejen samo s 5 mg amlodipina ali 160 mg valsartana.
English: Copalia 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Slovenian: Tablete zdravila Copalia 5 mg/160 mg so ovalne in temnorumene; na eni strani imajo oznako “NVR” in na drugi “ECE”.
English: Copalia 5 mg/80 mg film-coated tablets
Slovenian: Copalia 5 mg/80 mg filmsko obložene tablete
English: Copalia 5 mg/80 mg film-coated tablets Copalia 5 mg/160 mg film-coated tablets Copalia 10 mg/160 mg film-coated tablets amlodipine/valsartan
Slovenian: Copalia 5 mg/80 mg filmsko obložene tablete Copalia 5 mg/160 mg filmsko obložene tablete Copalia 10 mg/160 mg filmsko obložene tablete amlodipin/valsartan
English: Copalia 10 mg/160 mg film-coated tablets
Slovenian: Copalia 10 mg/160 mg filmsko obložene tablete
English: Uncommon Insomnia, mood changes (including anxiety), depression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance (including diplopia), tinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.
Slovenian: Amlodipin pogosti somnolenca, omotica, palpitacije, bolečine v trebuhu, navzea, otekanje gležnjev nespečnost, spremembe razpoloženja (vključno z anksioznostjo), depresija, tremor, motnje v zaznavanju okusa, sinkopa, hipestezija, motnje vida (vključno z diplopijo), tinitus, hipotenzija, dispneja, rinitis, bruhanje, dispepsija, alopecija, purpura, obarvanje kože, hiperhidroza, srbenje, eksantem, mialgija, mišični krči, bolečine, motnje uriniranja, zvečana pogostnost uriniranja, impotenca, ginekomastija, bolečine v prsih, slabo počutje, zvečanje ali zmanjšanje telesne mase redki zmedenost zelo redki levkopenija, trombocitopenija, alergijske reakcije, hiperglikemija, hipertonija, periferna nevropatija, miokardni infarkt, aritmija (vključno z bradikardijo, ventrikularno tahikardijo in atrijsko fibrilacijo), vaskulitis, pankreatitis, gastritis, hiperplazija dlesni, hepatitis, zlatenica, zvišanje ravni jetrnih encimov*, angioedem, multiformni eritem, urtikarija, eksfoliativni dermatitis, Stevens-Johnsonov sindrom, Quinckejev edem, fotosenzitivnost * o tem so najpogosteje poročali v povezavi s holestazo
English: Copalia 10 mg/160 mg film-coated tablets amlodipine/valsartan
Slovenian: Copalia 10 mg/160 mg filmsko obložene tablete amlodipin/valsartan
English: EU/1/06/372/035 280 film-coated tablets (4x70) EU/1/06/372/038 280 film-coated tablets (20x14)
Slovenian: EU/1/06/372/035 280 filmsko obloženih tablet (4x70) EU/1/06/372/038 280 filmsko obloženih tablet (20x14)
English: Copalia 5 mg/160 mg film-coated tablets
Slovenian: Copalia 5 mg/160 mg filmsko obložene tablete
English: EU/1/06/372/036 280 film-coated tablets (4x70) EU/1/06/372/039 280 film-coated tablets (20x14)
Slovenian: EU/1/06/372/036 280 filmsko obloženih tablet (4x70) EU/1/06/372/039 280 filmsko obloženih tablet (20x14)
English: EU/1/06/372/034 280 film-coated tablets (4x70) EU/1/06/372/037 280 film-coated tablets (20x14)
Slovenian: EU/1/06/372/034 280 filmsko obloženih tablet (4x70) EU/1/06/372/037 280 filmsko obloženih tablet (20x14)
English: What Copalia looks like and contents of the pack Copalia 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Slovenian: Tablete zdravila Copalia 5 mg/80 mg so okrogle in temnorumene; na eni strani imajo oznako “NVR” in na drugi “NV”.
English: How to store Copalia
Slovenian: Shranjevanje zdravila Copalia
English: Copalia 5 mg/80 mg film-coated tablets amlodipine/valsartan
Slovenian: Copalia 5 mg/80 mg filmsko obložene tablete amlodipin/valsartan
English: Copalia 5 mg/160 mg film-coated tablets amlodipine/valsartan
Slovenian: Copalia 5 mg/160 mg filmsko obložene tablete amlodipin/valsartan
English: EU/1/06/372/001 7 film-coated tablets EU/1/06/372/002 14 film-coated tablets EU/1/06/372/003 28 film-coated tablets EU/1/06/372/004 30 film-coated tablets EU/1/06/372/005 56 film-coated tablets EU/1/06/372/006 90 film-coated tablets EU/1/06/372/007 98 film-coated tablets EU/1/06/372/008 280 film-coated tablets EU/1/06/372/025 56x1 film-coated tablet (unit dose) EU/1/06/372/026 98x1 film-coated tablet (unit dose) EU/1/06/372/027 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/372/001 7 filmsko obloženih tablet EU/1/06/372/002 14 filmsko obloženih tablet EU/1/06/372/003 28 filmsko obloženih tablet EU/1/06/372/004 30 filmsko obloženih tablet EU/1/06/372/005 56 filmsko obloženih tablet EU/1/06/372/006 90 filmsko obloženih tablet EU/1/06/372/007 98 filmsko obloženih tablet EU/1/06/372/008 280 filmsko obloženih tablet EU/1/06/372/025 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/372/026 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/372/027 280x1 filmsko obložena tableta (za enkratni odmerek)
English: EU/1/06/372/017 7 film-coated tablets EU/1/06/372/018 14 film-coated tablets EU/1/06/372/019 28 film-coated tablets EU/1/06/372/020 30 film-coated tablets EU/1/06/372/021 56 film-coated tablets EU/1/06/372/022 90 film-coated tablets EU/1/06/372/023 98 film-coated tablets EU/1/06/372/024 280 film-coated tablets EU/1/06/372/031 56x1 film-coated tablet (unit dose) EU/1/06/372/032 98x1 film-coated tablet (unit dose) EU/1/06/372/033 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/372/017 7 filmsko obloženih tablet EU/1/06/372/018 14 filmsko obloženih tablet EU/1/06/372/019 28 filmsko obloženih tablet EU/1/06/372/020 30 filmsko obloženih tablet EU/1/06/372/021 56 filmsko obloženih tablet EU/1/06/372/022 90 filmsko obloženih tablet EU/1/06/372/023 98 filmsko obloženih tablet EU/1/06/372/024 280 filmsko obloženih tablet EU/1/06/372/031 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/372/032 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/372/033 280x1 filmsko obložena tableta (za enkratni odmerek)
English: EU/1/06/372/009 7 film-coated tablets EU/1/06/372/010 14 film-coated tablets EU/1/06/372/011 28 film-coated tablets EU/1/06/372/012 30 film-coated tablets EU/1/06/372/013 56 film-coated tablets EU/1/06/372/014 90 film-coated tablets EU/1/06/372/015 98 film-coated tablets EU/1/06/372/016 280 film-coated tablets EU/1/06/372/028 56x1 film-coated tablet (unit dose) EU/1/06/372/029 98x1 film-coated tablet (unit dose) EU/1/06/372/030 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/372/009 7 filmsko obloženih tablet EU/1/06/372/010 14 filmsko obloženih tablet EU/1/06/372/011 28 filmsko obloženih tablet EU/1/06/372/012 30 filmsko obloženih tablet EU/1/06/372/013 56 filmsko obloženih tablet EU/1/06/372/014 90 filmsko obloženih tablet EU/1/06/372/015 98 filmsko obloženih tablet EU/1/06/372/016 280 filmsko obloženih tablet EU/1/06/372/028 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/372/029 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/372/030 280x1 filmsko obložena tableta (za enkratni odmerek)
English: No dosage adjustment is required for patients with mild to moderate renal impairment.
Slovenian: CopaliaBolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: This compared with around a quarter of the patients receiving placebo.
Slovenian: To so primerjali s približno četrtino vseh bolnikov, ki so prejemali placebo.
English: The full EPAR for Lifmior can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lifmior je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Lifmior?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lifmior?
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Slovenian: V njem je pojasnjeno, kako je agencija ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
English: In rheumatoid arthritis, five studies have been carried out involving around 2,200 patients.
Slovenian: Za revmatoidni artritis je bilo izvedenih pet študij, v katere je bilo vključenih približno 2 200 bolnikov.
English: This is a summary of the European public assessment report (EPAR) for Lifmior.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lifmior.
English: Lifmior is identical to Enbrel, which has been authorised in the EU since 3 February 2000.
Slovenian: Zdravilo Lifmior je enako zdravilu Enbrel, za katerega je bilo dovoljenje za promet v EU izdano 3. februarja 2000.
English: The patient or carer can give the injection if they have been trained appropriately.
Slovenian: Bolnik ali negovalec lahko zdravilo injicira, če je za to ustrezno usposobljen.
English: Lifmior is an anti-inflammatory medicine for treating the following diseases:
Slovenian: Lifmior je protivnetno zdravilo za zdravljenje naslednjih bolezni:
English: Other information about Lifmior
Slovenian: Druge informacije o zdravilu Lifmior
English: The CHMP therefore concluded that Lifmior's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini je zato zaključil, da so koristi zdravila Lifmior večje od z njim povezanih tveganj, in priporočil, naj se zanj izda dovoljenje za promet.
English: What benefits of Lifmior have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Lifmior izkazalo v študijah?