natgillin/translations-raw huggingface dataset:
Solymbic must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Zdravilo Solymbic se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali pri bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
Because Solymbic is a biosimilar medicine, the studies on effectiveness and safety carried out for Humira do not all need to be repeated for Solymbic.
Zdravilo Solymbic je „podobno biološko zdravilo“, zato vseh študij o učinkovitosti in varnosti, izvedenih za zdravilo Humira, za zdravilo Solymbic ni treba ponavljati.
The company that markets Solymbic must provide educational packs for doctors who will prescribe the medicine.
Družba, ki trži zdravilo Solymbic, mora pripraviti izobraževalno gradivo za zdravnike, ki ga bodo predpisovali.
Solymbic is a medicine that acts on the immune system and is used to treat the following conditions:
Zdravilo Solymbic učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
Solymbic and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Zdravilo Solymbic in druga zdravila iz istega razreda lahko vplivajo tudi na obrambno sposobnost imunskega sistema proti okužbam in raku, saj so bili pri bolnikih, ki prejemajo adalimumab, zabeleženi nekateri primeri resnih okužb in krvnega raka.
This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Solymbic is used to treat.
Ta prenašalec sodeluje pri povzročanju vnetja in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, ki se zdravijo z zdravilom Solymbic.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Solymbic have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Solymbic upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Other rare serious side effects (seen in between 1 in 10,000 and 1 in 1,000 patients) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Drugi redki resni neželeni učinki (opaženi pri od 1 bolniku od 10 000 do 1 bolniku od 1 000) vključujejo nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podoben sindrom (obolenje, pri katerem imunski sistem napada bolnikova lastna tkiva, kar povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (hudo kožno obolenje).
Solymbic can only be obtained with a prescription and treatment should be started and supervised by specialist doctors experienced in the diagnosis and treatment of the conditions for which it is authorised.
Predpisovanje in izdaja zdravila Solymbic je le na recept, zdravljenje z njim pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere je zdravilo odobreno.
In addition, studies in rheumatoid arthritis and psoriasis have shown that the effects of the medicine are equivalent to those of Humira in these conditions.
Poleg tega sta študiji pri revmatoidnem artritisu in psoriazi dokazali, da so učinki zdravila Solymbic pri teh boleznih enakovredni učinkom zdravila Humira.
The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Najpogostejši neželeni učinki zdravilne učinkovine adalimumab (opaženi pri več kot 1 bolniku od 10) so okužbe nosu in grla, sinusov in zgornjih dihal, reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
The dose depends on the condition to be treated and in children is usually calculated according to the child's weight and height.
Odmerek je odvisen od bolezni, ki se zdravi, pri otrocih pa se odmerek izračuna na podlagi telesne mase in višine otroka.
Why is Solymbic approved?
Zakaj je bilo zdravilo Solymbic odobreno?
The active substance in Solymbic, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a chemical messenger in the body called tumour necrosis factor (TNF).
Zdravilna učinkovina zdravila Solymbic, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna kemičnega prenašalca, imenovanega tumorje nekrotizirajoči faktor (TNF), in se veže nanj.
In the psoriasis study, which looked at the degree of improvement after 16 weeks, there was an 81% improvement in symptom score with Solymbic compared with an 83% improvement with Humira.
V študiji psoriaze, v kateri so preučevali stopnjo izboljšanja po 16 tednih, je bilo izboljšanje na lestvici simptomov pri bolnikih, ki so prejemali zdravilo Solymbic, 81-odstotno, pri bolnikih, ki so prejemali zdravilo Humira, pa 83-odstotno.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Solymbic has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Solymbic po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Humira in da se po telesu enako prenaša.
For more information about treatment with Solymbic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Solymbic preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Doctors treating uveitis should also take advice from doctors who have experience of using Solymbic.
Zdravniki, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo zdravila Solymbic.
For practical information about using Solymbic, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Solymbic naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Solymbic contains the active substance adalimumab and is a ‘biosimilar medicine'.
Zdravilo Solymbic vsebuje zdravilno učinkovino adalimumab in je „podobno biološko zdravilo“.
• axial spondyloarthritis (inflammation of spine causing back pain), including ankylosing spondylitis and when there is no damage on X-ray but clear signs of inflammation
• aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), vključno ankilozirajočega spondilitisa in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
For information on the doses to be used for each condition and other information on the use of Solymbic, see the package leaflet.
Za več informacij o odmerjanju pri posameznih boleznih in druge podatke o uporabi zdravila Solymbic glejte navodilo za uporabo.
The medicine has been shown to have similar effects to Humira in one main study involving 526 patients with moderate to severe rheumatoid arthritis that had not responded adequately to methotrexate, and in another study in 350 patients with moderate to severe psoriasis.
V eni glavni študiji, ki je vključevala 526 bolnikov z zmernim do hudim revmatoidnim artritisom, ki se niso ustrezno odzvali na metotreksat, in v drugi študiji s 350 bolniki z zmerno do hudo psoriazo so dokazali, da ima zdravilo Solymbic podobne učinke kot zdravilo Humira.
For the full list of restrictions with Solymbic, see the package leaflet.
Za celoten seznam omejitev pri uporabi zdravila Solymbic glejte navodilo za uporabo.
Extensive laboratory studies comparing Solymbic with Humira have shown that adalimumab in Solymbic is highly similar to adalimumab in Humira in terms of chemical structure, purity and biological activity.
Obsežne laboratorijske študije, v katerih so zdravilo Solymbic primerjali z zdravilom Humira, so pokazale, da je zdravilna učinkovina adalimumab v zdravilu Solymbic po zgradbi, čistosti in biološkem delovanju zelo podobna adalimumabu v zdravilu Humira.
• active enthesitis-related arthritis (a rare disease causing inflammation in the joints)
• aktivnega artritisa, povezanega z entezitisom (redke bolezni, ki povzroča vnetje sklepov);
How is Solymbic used?
Kako se zdravilo Solymbic uporablja?
How does Solymbic work?
Kako zdravilo Solymbic deluje?
In the rheumatoid arthritis study, response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 75% of those given Solymbic responded, compared with 72% of those given Humira.
V študiji revmatoidnega artritisa so po 24 tednih zdravljenja odziv opredelili kot vsaj 20-odstotno izboljšanje simptomov.
400 mg / 100 mg / 100 mg Film-coated tablet Oral use bottle (HDPE)
400 mg / 100 mg / 100 mg filmsko obložena tableta peroralna uporaba plastenka (HDPE) 28 tablet
EU Number
Številka postopka pri EU-i
Pharmaceutical Form Route of Administration Packaging
Način uporabe Pakiranje
The dose may later be increased to
Odmerek se lahko kasneje poveča na
The safety and efficacy of Karvea in children aged 0 to 18 has not been established.
Varnost in učinkovitost zdravila Karvea pri otrocih, starih od 0 do 18 let, nista bili dokazani.
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Absorpcija Irbesartan se po peroralni uporabi dobro absorbira: študije absolutne biološke razpoložljivosti so dale vrednosti približno 60-80%.
See also information under the heading “Do not take Karvea”.
Glejte tudi informacije pod naslovom “Ne jemljite zdravila Karvea”.
It is important that you continue to take Karvea until your doctor tells you otherwise.
Pomembno je, da zdravilo Karvea jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
Karvea is indicated in adults for the treatment of essential hypertension.
Zdravilo Karvea je indicirano pri odraslih za zdravljenje esencialne hipertenzije.
Other medicines and Karvea
Druga zdravila in zdravilo Karvea
What Karvea is and what it is used for What you need to know before you take Karvea How to take Karvea
Kaj je zdravilo Karvea in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Karvea Kako jemati zdravilo Karvea
If you take more Karvea than you should
Če ste vzeli večji odmerek zdravila Karvea, kot bi smeli
You can take Karvea with or without food.
Zdravilo Karvea lahko jemljete s hrano ali brez nje.
No specific information is available on the treatment of overdose with Karvea.
Specifični podatki o zdravljenju prevelikega odmerjanja z zdravilom Karvea niso na voljo.
Therefore, the use of Karvea is not recommended.
Zato uporaba zdravila Karvea ni priporočljiva.
If you forget to take Karvea
Če ste pozabili vzeti zdravilo Karvea
Karvea at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Na splošno zagotavlja odmerek 150 mg zdravila Karvea enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
Please see section 2 “Karvea contains lactose”.
Prosimo glejte poglavje 2 »Zdravilo Karvea vsebuje laktozo«.
If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.
Če opazite kateregakoli od teh simptomov ali se pojavi občutek težkega dihanja, zdravilo Karvea takoj prenehajte uporabljati in nemudoma poiščite zdravniško pomoč.
Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists.
Zdravilo Karvea spada v skupino zdravil, ki so znana kot antagonisti angiotenzina-II.
Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18 - 40 years).
Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18-40 let).
Such conditions should be corrected before the administration of Karvea.
Ta stanja se mora korigirati, preden se uporabi zdravilo Karvea.
Renal impairment and kidney transplantation: when Karvea is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Ledvična okvara in presaditev ledvic: pri dajanju zdravila Karvea bolnikom s prizadeto ledvično funkcijo se priporoča redno nadzorovanje ravni kalija in kreatinina v serumu.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Karvea, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Karvea od 75 mg do vzdrževalnega odmerka 300 mg, odmerek amlodipina od 2,5 do 10 mg, oziroma placeba, kot so ga prenesli.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Karvea (see section 4.4).
Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Karvea (glejte poglavje 4.4).
(It is also better to avoid Karvea in early pregnancysee pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
(Jemanju zdravila Karvea se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all cause mortality.
Irbesartan je pomembno znižal tveganje za primarno povezan izid podvojitve serumskega kreatinina, zadnje faze ledvične bolezni (ESRD) in celokupne smrtnosti.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KARVEADo not take Karvea  if you are allergicto irbesartan or any other ingredients of this medicine (listed in section 6)  if you are more than 3 months pregnant.
Kaj morate vedeti, preden boste vzeli zdravilo Karvea Ne jemljite zdravila Karvea če ste alergični na irbesartan ali katerokoli sestavino tega zdravila (navedeno v poglavju 6) če ste noseči dlje kot tri mesece.
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Karvea 300 mg group (34%) than in the placebo group (21%).
V skupini s 300 mg zdravila Karvea je bila pogostejša (34%) regresija na normoalbuminurijo (<30 mg/dan), kot v placebo skupini (21%).
What Karvea is and what it is used for
KAJ JE ZDRAVILO KARVEA IN ZA KAJ GA UPORABLJAMO
The study examined the long-term effects (2 years) of Karvea on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila Karvea na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom -“urinary albumin excretion rate”-UAER >300 mg/dan in povečanje UAER-a najmanj za 30% začetne vrednosti).
Lithium: the combination of lithium and Karvea is not recommended (see section 4.5).
Litij: sočasna uporaba zdravila Karvea in litija ni priporočljiva (glejte poglavje 4.5).
Karvea contains lactose.
Zdravilo Karvea vsebuje laktozo.
While this is not documented with Karvea, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Čeprav to za zdravilo Karvea ni dokazano, je treba podobne učinke pričakovati pri antagonistih receptorjev za angiotenzin
Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Zdravilo Karvea preprečuje vezavo angiotenzina-II na te receptorje in tako sprošča krvne žile ter znižuje krvni tlak.
Side effects reported in clinical studies for patients treated with Karvea were:
V kliničnih preskušanjih so pri bolnikih, ki so se zdravili z zdravilom Karvea, poročali o naslednjih neželenih učinkih:
The concomitant use of Karvea with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73m2) (see sections 4.5 and 5.1).
Sočasna uporaba zdravila Karvea in zdravil, ki vsebujejo aliskiren, je kontraindicirana pri bolnikih s sladkorno boleznijo ali z okvaro ledvic (hitrost glomerularne filtracije < 60 ml/min/1,73 m2) (glejte poglavji 4.5 in 5.1).
300 mg (four tablets a day) once daily depending on blood pressure response.
300 mg (štiri tablete) enkrat na dan, odvisno od odziva krvnega tlaka.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Karvea has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Diuretiki in drugi antihipertenzivi: drugi antihipertenzivi lahko povečajo hipotenzivni učinek irbesartana; vendar pa so zdravilo Karvea varno uporabljali z drugimi antihipertenzivi, kot so zaviralci adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov z dolgotrajnim delovanjem in tiazidnimi diuretiki.
impaired renal function including cases of renal failure in patients at risk (see section 4.4)
motnje v delovanju ledvic, vključno s primeri odpovedi ledvic pri ogroženih bolnikih (glejte poglavje 4.4)
How to take Karvea
Kako jemati zdravilo Karvea
Approximately 33% of patients in the irbesartan group reached the primary renalcomposite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
Približno 33% bolnikov v skupini z irbesartanom je doseglo primarno povezan ledvični izid v primerjavi s 39% pri placebu in 41% v skupini z amlodipinom [20% relativno zmanjšanje tveganja v primerjavi s placebom (p = 0,024) in 23% relativno zmanjšanje tveganja v primerjavi z amlodipinom (p = 0,006)].
Patients with high blood pressure and type 2 diabetes with kidney disease
Bolniki z visokim krvnim tlakom in sladkorno boleznijo tipa 2 z boleznijo ledvic
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Karvea (see section 4.5).
In sicer, se je pri dodatni uvedbi diuretika, kot je hidroklorotiazid, pokazal sinergistični učinek z zdravilom Karvea (glejte poglavje 4.5).
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): če imate visok krvni tlak in sladkorno bolezen tipa 2 z boleznijo ledvic lahko krvne preiskave pokažejo zvišanje vrednosti kalija v krvi.
Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Zdravila Karvea ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Karvea, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Hiperkaliemija: kot pri drugih zdravilih, ki vplivajo na sistem renin-angiotenzin-aldosteron, se lahko tudi med zdravljenjem z zdravilom Karvea pojavi hiperkaliemija, zlasti ob prisotnosti ledvične okvare, izrazite proteinurije zaradi diabetične ledvične bolezni in/ali odpovedi srca.
Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea.
Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Karvea prekinete, še preden zanosite ali takoj, ko se izkaže, da ste zanosili, in vam predpisal zdravljenje z drugim zdravilom.
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).
Zdravnik vam bo morda moral spremeniti odmerek in/ali uporabiti druge previdnostne ukrepe: Če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Karvea" in "Opozorila in previdnostni ukrepi").
The efficacy of Karvea is not influenced by age or gender.
Spol in starost ne vplivata na učinkovitost zdravila Karvea.
The frequency of the side effects listed below is defined using the following convention: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
V nadaljevanju so neželeni učinki navedeni po pogostnosti v skladu z naslednjim dogovorom: zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov pogosti: pojavijo se lahko pri največ 1 od
Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Zdravila Karvea ne smete jemati, če ste noseči dlje kot 3 mesece, saj lahko zdravilo v tem obdobju resno škoduje vašemu otroku (glejte poglavje o nosečnosti).
At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
(≥500 mg/kg/dan) so pri podganah in makako opicah sprožili degenerativne spremembe v ledvicah (kot so intersticijski nefritis, razširitev tubulov, bazofilni tubuli, povečana plazemska koncentracija sečnine in kreatinina), za katere domnevajo, da so sekundarne hipotenzivnim učinkom zdravila, ki vodi do zmanjšanega pretoka v ledvicah.
There is no experience regarding the administration of Karvea in patients with a recent kidney transplantation.
Glede uporabe zdravila Karvea pri bolnikih po nedavni presaditvi ledvic ni nobenih izkušenj.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of Karvea on the progression of renal disease and all-cause mortality were examined.
Pri 1.715 bolnikih z visokim krvnim tlakom z diabetesom tipa 2, proteinurijo ≥900 mg/dan in serumskim kreatininom 1,03,0 mg/dl, so raziskovali dolgotrajne učinke zdravila Karvea (povprečje 2,6 let) na napredovanje ledvične bolezni in na celokupno smrtnost.
In patients insufficiently controlled with 150 mg once daily, the dose of Karvea can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Pri bolnikih, kjer enkratni dnevni odmerek 150 mg zdravila Karvea ne zadošča za nadzor krvnega tlaka, se lahko odmerek poveča na 300 mg ali uvede dodatni antihipertenziv (glejte poglavja 4.3, 4.4, 4.5 in 5.1).