FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Slovenian: Bolniki so nadaljevali zdravljenje s stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ali prednizona (< 0,2 mg/kg/dan ali največ 10 mg).
English: (frequency rare).
Slovenian: Organski sistem Zelo pogosti
English: Cartons contain 4, 8 or 24 pre-filled syringes of LIFMIOR and 4, 8 or 24 alcohol swabs.
Slovenian: Škatle vsebujejo 4, 8 ali 24 napolnjenih injekcijskih brizg zdravila LIFMIOR in 4, 8 ali 24 alkoholnih blazinic.
English: Inspection window will have turned purple
Slovenian: Okence za pregledovanje se obarva vijolično.
English: Contact your doctor before using LIFMIOR if the needle cover will be handled by, or LIFMIOR will be given to, someone with a known or possible hypersensitivity (allergy) to latex.
Slovenian: Če bo s pokrovčkom igle rokovala ali zdravilo LIFMIOR dobivala oseba z znano ali možno preobčutljivostjo (alergijo) na lateks, se pred uporabo zdravila LIFMIOR posvetujte z zdravnikom.
English: n = 46 wk 12
Slovenian: teden n = 46
English: • Chickenpox: Tell your doctor if the child is exposed to chickenpox when using LIFMIOR.
Slovenian: Norice: Povejte zdravniku, če je bil otrok med zdravljenjem z zdravilom LIFMIOR izpostavljen noricam.
English: Pairwise comparison p-values: * = p < 0.05 for comparisons of LIFMIOR vs. methotrexate, † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. LIFMIOR.
Slovenian: Vrednosti p za primerjavo po parih: * = p < 0,05 za primerjavo zdravila LIFMIOR z metotreksatom, † = p < 0,05 za primerjavo kombinacije zdravilo LIFMIOR + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravilo LIFMIOR + metotreksat z zdravilom LIFMIOR.
English: Plaque psoriasis
Slovenian: Psoriaza v plakih
English: See section 5 for instructions on how to store LIFMIOR.
Slovenian: Za navodila o shranjevanju zdravila LIFMIOR glejte poglavje 5.
English: The dose should be 25 mg twice weekly or 50 mg once weekly.
Slovenian: Odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
English: LIFMIOR is reconstituted with 1 ml water for injections before use, and administered by subcutaneous injection.
Slovenian: Pred uporabo in subkutanim injiciranjem zdravilo LIFMIOR rekonstituirajte v 1 ml vode za injekcije.
English: n = 96 wk 12
Slovenian: teden n = 96
English: Serious adverse reactions have also been reported for LIFMIOR.
Slovenian: Pri uporabi zdravila LIFMIOR so poročali tudi o pojavu resnih neželenih učinkov.
English: In a fourth study, the safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly vs 25 mg LIFMIOR administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Slovenian: V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja zdravila LIFMIOR v odmerku 50 mg enkrat na teden (dve 25 mg subkutani injekciji) v primerjavi z dajanjem zdravila LIFMIOR v odmerku 25 mg dvakrat na teden.
English: The 10 mg presentation is for paediatric patients prescribed a dose of 10 mg or less.
Slovenian: 10 mg viala je namenjena za uporabo pri otrocih, ki potrebujejo odmerek 10 mg ali manj.
English: CARTON TEXT - (50 mg Pre-filled Pen) - EU/1/16/1165/011-013
Slovenian: BESEDILO NA ŠKATLI - (50 mg napolnjeni injekcijski peresnik) - EU/1/16/1165/011-013
English: These include the alcohol swab from the LIFMIOR carton and a cotton ball or gauze.
Slovenian: Pripravite si še druge stvari, ki jih boste potrebovali pri injiciranju, to sta alkoholna blazinica iz škatle z zdravilom LIFMIOR in košček vate ali gaze.
English: • Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Slovenian: Alergijske reakcije: Če se pri vas ali otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
English: LIFMIOR 25 mg powder and solvent for solution for injection etanercept
Slovenian: LIFMIOR 25 mg prašek in vehikel za raztopino za injiciranje etanercept
English: CARTON TEXT - (50 mg Pre-filled Syringe) - EU/1/16/1165/008-010
Slovenian: BESEDILO NA ŠKATLI - (50 mg napolnjena injekcijska brizga) - EU/1/16/1165/008-010
English: The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Slovenian: Domnevajo, da je mehanizem delovanja etanercepta kompetitivna inhibicija vezave TNF na receptorje za TNF na površini celice.
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject LIFMIOR."
Slovenian: Izčrpna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila LIFMIOR".
English: New onset cardiac failure congestive (see section 4.4)
Slovenian: nastanek kongestivnega srčnega popuščanja (glejte poglavje 4.4)
English: Remissionc
Slovenian: Odziv
English: The presence of hepatic impairment should not require a change in dosage.
Slovenian: Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
English: 25 mg LIFMIOR administered twice weekly is the recommended dose.
Slovenian: Priporočeni odmerek je 25 mg zdravila LIFMIOR dvakrat na teden.
English: • Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Slovenian: Alergijske reakcije: Če se pri otroku pojavijo alergijske reakcije, na primer tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
English: Tell your doctor if the child develops any change in the appearance of the skin or growths on the skin.
Slovenian: Pri nekaterih bolnikih, ki so prejemali zdravilo LIFMIOR, se je pojavil kožni rak. Povejte zdravniku, če se pri otroku razvije kakšna sprememba videza kože ali rašče na koži.
English: These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin
Slovenian: Znaki lahko vključujejo zmanjšanje telesne mase, vročino, pojav otekline (z bolečino ali brez nje), trdovratnega kašlja, zatrdlin ali izrastkov na koži;
English: Do not inject into tender, bruised or hard skin.
Slovenian: Ne injicirajte v predelih, kjer je koža občutljiva, poškodovana ali trda.
English: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Slovenian: Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
English: Cardiac disorders
Slovenian: Kongestivno srčno popuščanje
English: LIFMIOR 25 mg powder and solvent for solution for injection.
Slovenian: LIFMIOR 25 mg prašek in vehikel za raztopino za injiciranje
English: Each pre-filled syringe of LIFMIOR contains 25 mg etanercept.
Slovenian: Ena napolnjena injekcijska brizga zdravila LIFMIOR vsebuje 25 mg etanercepta.
English: A 25 mg strength of LIFMIOR is available for doses of 25 mg.
Slovenian: Predpisali so vam zdravilo LIFMIOR v jakosti 50 mg. Za 25 mg odmerek je na voljo zdravilo LIFMIOR jakosti 25 mg.
English: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Slovenian: Če se pri otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo LIFMIOR in nemudoma obvestite zdravnika.
English: • This medicine has been prescribed for you or a child in your care.
Slovenian: Zdravilo je bilo predpisano vam ali otroku, za katerega skrbite, osebno in ga ne smete dajati drugim.
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. LIFMIOR.
Slovenian: Vrednosti p za primerjavo po parih: † = p < 0,05 za primerjavo kombinacije zdravila LIFMIOR + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravila LIFMIOR + metotreksat z zdravilom LIFMIOR.
English: The recommended dose is 25 mg LIFMIOR administered twice weekly, or 50 mg administered once weekly.
Slovenian: Priporočeni odmerek je 25 mg zdravila LIFMIOR dvakrat na teden ali 50 mg enkrat na teden.
English: LIFMIOR 25 mg solution for injection in pre-filled syringe etanercept
Slovenian: LIFMIOR 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept
English: The solution should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein.
Slovenian: Raztopina mora biti bistra ali rahlo svetlikajoča, brezbarvna do bledo rumena oziroma bledo rjava in lahko vsebuje majhne bele ali skoraj prozorne delce beljakovine.
English: Each MYCLIC pre-filled pen contains 50 mg of etanercept.
Slovenian: En napolnjeni injekcijski peresnik MYCLIC vsebuje 50 mg etanercepta.
English: The needle cover should not be removed while allowing the prefilled syringe to reach room temperature.
Slovenian: Med čakanjem, da se napolnjeni injekcijski peresnik segreje na sobno temperaturo, pokrovčka igle ne smete odstraniti.
English: Detailed instructions on how to inject LIFMIOR are provided in section 7, “Instructions for preparing and giving an injection of LIFMIOR”.
Slovenian: Podrobna navodila o injiciranju zdravila LIFMIOR so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila LIFMIOR”.
English: Always use this medicine exactly as the doctor has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
English: Detailed instructions on how to prepare and inject LIFMIOR are provided in section 7, “Instructions for preparing and giving an injection of LIFMIOR”.
Slovenian: Podrobna navodila o pripravi in injiciranju zdravila LIFMIOR so v poglavju 7 “Navodila za pripravo in dajanje injekcije zdravila LIFMIOR”.
English: In this study most psoriatic arthritis patients receiving LIFMIOR were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower and few patients had two-fold rises in titres compared to patients not receiving LIFMIOR.
Slovenian: Večina bolnikov s psoriatičnim artritisom, ki so dobivali zdravilo LIFMIOR, je v tej študiji zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
English: Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8).
Slovenian: Čvrste in hematopoetične maligne bolezni (razen kožnega raka) V obdobju trženja zdravila so prejeli več poročil o raznih malignih boleznih (vključno z rakom dojke in pljuč ter limfomi) (glejte poglavje 4.8).
English: Each vial of LIFMIOR contains 25 mg etanercept.
Slovenian: Ena viala zdravila LIFMIOR vsebuje 25 mg etanercepta.
English: If this is the case, start again with another vial.
Slovenian: V tem primeru si pripravite nov podstavek za odmerjanje.
English: • Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Slovenian: Bolezni krvi: Če se pri vas ali otroku pojavi katerikoli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte z zdravnikom.
English: Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or 12 alcohol swabs.
Slovenian: Eno pakiranje vsebuje 2, 4 ali 12 injekcijskih peresnikov in 2, 4 ali 12 alkoholnih blazinic.
English: The 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Slovenian: Pri otrocih z juvenilnim idiopatskim artritisom, ki imajo telesno maso manjšo od 25 kg, bo morda primernejša uporaba 10 mg viale.
English: and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Slovenian: Etanercept je fuzijska beljakovina receptorja p75 Fc za humani tumorje nekrotizirajoči faktor.
English: Each pre-filled syringe of LIFMIOR contains 50 mg etanercept.
Slovenian: Ena napolnjena injekcijska brizga zdravila LIFMIOR vsebuje 50 mg etanercepta.
English: • Blood disorders: Seek medical advice immediately if the child has any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
Slovenian: Bolezni krvi: Če se pri otroku pojavi katerikoli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte z zdravnikom.
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of LIFMIOR”.
Slovenian: Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA LIFMIOR".
English: Comprehensive instructions for the preparation and administration of the reconstituted LIFMIOR vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of LIFMIOR."
Slovenian: Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila LIFMIOR so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA LIFMIOR".
English: Comprehensive instructions for the preparation and administration of the reconstituted LIFMIOR vial are given in the package leaflet, section 7, “INSTRUCTIONS FOR PREPARATION AND GIVING AN INJECTION OF LIFMIOR”.
Slovenian: Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila LIFMIOR so navedena v navodilu za uporabo, poglavje 7 "Navodila za pripravo in dajanje injekcije zdravila LIFMIOR".
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use Etanercept
Slovenian: LIFMIOR 10 mg prašek za raztopino za injiciranje etanercept subkutana uporaba
English: No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients.
Slovenian: V kliničnih preskušanjih pri bolnikih z revmatoidnim artritisom niso opazili take vrste toksičnosti, ki bi omejevala odmerjanje.
English: LIFMIOR did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Slovenian: Tudi pri opicah cynomolgus, ki so subkutano prejemale odmerek 15 mg/kg 2-krat tedensko 4 ali 26 tednov zapored, zdravilo LIFMIOR ni povzročilo toksičnosti, ki bi omejevala višino odmerka, niti toksičnosti za tarčne organe.
English: (If not, don't use the dose tray and consult your pharmacist).
Slovenian: Podstavek z zdravilom mora vsebovati vse spodaj navedene pripomočke (če jih ne, ne uporabite zdravila in se posvetujte s farmacevtom).
English: How to store LIFMIOR
Slovenian: Shranjevanje zdravila LIFMIOR
English: It should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein.
Slovenian: Raztopina mora biti bistra ali rahlo svetlikajoča, brezbarvna do bledorumena oziroma bledo rjava in lahko vsebuje majhne bele ali skoraj prozorne delce beljakovine.
English: The solution should be clear to slightly opalescent, colourless to pale yellow or pale brown, and may contain small translucent or white particles of protein.
Slovenian: Raztopina mora biti bistra do rahlo opalescentna, brezbarvna do bledo rumena oziroma bledo rjava ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
English: LIFMIOR 50 mg solution for injection in pre-filled syringe.
Slovenian: LIFMIOR 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Cartons contain 2, 4 or 12 pre-filled syringes of LIFMIOR with 2, 4 or 12 alcohol swabs.
Slovenian: Škatle vsebujejo 2, 4 ali 12 napolnjenih injekcijskih brizg zdravila LIFMIOR in 2, 4 ali 12 alkoholnih blazinic.
English: LIFMIOR 50 mg solution for injection in pre-filled syringe etanercept
Slovenian: LIFMIOR 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept
English: Each pre-filled pen contains 50 mg of etanercept.
Slovenian: En napolnjen injekcijski peresnik vsebuje 50 mg etanercepta.
English: 2 pre-filled syringes2 alcohol swabs
Slovenian: 2 napolnjeni injekcijski brizgi 2 alkoholni blazinici
English: Do not use this medicine after the expiry date which is stated on the carton and pre-filled syringe after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in napolnjeni injekcijski brizgi poleg oznake ''EXP''.
English: The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes, or particles.
Slovenian: Raztopina mora biti bistra in brezbarvna do bledo rumena ali bledo rjava in ne sme vsebovati kepic, kosmičev ali delcev.
English: • Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with LIFMIOR.
Slovenian: Hepatitis B: Če ste vi ali vaš otrok kdaj imeli hepatitis B, o tem obvestite zdravnika.
English: With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 19).
Slovenian: Nato potisnite bat tako, da počasi in enakomerno injicirate vso raztopino (glejte sliko 19).
English: With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly, or with great force.
Slovenian: Z izkušnjami boste našli kot, ki je za vas ali otroka najustreznejši.
English: Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
Slovenian: 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Injekcijska brizga iz prozornega stekla (steklo tipa I) z iglo iz nerjavečega jekla, gumijastim pokrovčkom igle in plastičnim batom.
English: LIFMIOR is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown, solution for injection (solution for injection).
Slovenian: 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo LIFMIOR je na voljo v napolnjeni injekcijski brizgi, ki vsebuje bistro, brezbarvno do bledo rumeno oziroma bledo rjavo raztopino za injiciranje (raztopino za injiciranje).
English: • This medicine has been prescribed for a child in your care.
Slovenian: Zdravilo je bilo predpisano otroku, za katerega skrbite, osebno in ga ne smete dajati drugim.
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use.
Slovenian: LIFMIOR 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih
English: The solution should be clear, colourless to pale yellow or pale brown, with no lumps or flakes or particles.
Slovenian: Raztopina mora biti bistra, brezbarvna do bledo rumena oziroma bledo rjava in ne sme vsebovati kepic, kosmičev ali delcev.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - (For paediatric use) - EU/1/16/1165/001 1.
Slovenian: BESEDILO NA NALEPKI INJEKCIJSKE BRIZGE - (za uporabo pri otrocih)EU/1/16/1165/001
English: b. Setting up for an injection
Slovenian: Priprava na injiciranje
English: With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 4).
Slovenian: Nato potisnite bat tako, da počasi in enakomerno injicirate vso raztopino (glejte sliko 4).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR SYRINGE LABEL - EU/1/16/1165/002-004
Slovenian: BESEDILO NA NALEPKI INJEKCIJSKE BRIZGE - EU/1/16/1165/002-004
English: No treatment was given for the majority of injection site reactions in the LIFMIOR treatment groups, and the majority of patients who were given treatment received topical preparations such as corticosteroids, or oral antihistamines.
Slovenian: V skupinah, ki so prejemale zdravilo LIFMIOR, večine reakcij na mestu injiciranja ni bilo potrebno zdraviti.
English: Live vaccines should not be given concurrently with LIFMIOR.
Slovenian: Med zdravljenjem z zdravilom LIFMIOR bolnik ne sme prejeti živih cepiv.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - (25 mg Pre-filled Syringe) - EU/1/16/1165/005
Slovenian: BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - (25 mg napolnjena injekcijska brizga) - EU/1/16/1165/005-007
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR VIAL LABEL - (For paediatric use) - EU/1/16/1165/001 1.
Slovenian: BESEDILO NA NALEPKI VIALE - (za uporabo pri otrocih) - EU/1/16/1165/001
English: Paediatric plaque psoriasis
Slovenian: Otroška psoriaza v plakih
English: 1.0 ml (50 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Slovenian: 12 (3 x 4) napolnjen injekcijski peresniks (skupno pakiranje)
English: Immediate Packaging
Slovenian: 1 napolnjen injekcijski peresnik
English: Pack size bottle (HDPE)
Slovenian: Stična ovojnina Velikost pakiranja plastenka (HDPE)
English: The study was terminated early because of an increased risk of adverse outcomes.
Slovenian: Študija se je končala predčasno zaradi večjega tveganja za neželene izide.
English: Other medicines and X
Slovenian: Druga zdravila in zdravilo X
English: This combination apparently increases the risk for adverse events and is therefore not recommended.
Slovenian: Ta kombinacija očitno poveča tveganje neželenih učinkov, zato ni priporočljiva.
English: “Your doctor may need to change your dose and/or to take other precautions:
Slovenian: “Zdravnik vam bo morda moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe:
English: • “if you are taking any of the following medicines used to treat high blood pressure:
Slovenian: • “če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka:
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
English: I. Summary of Product Characteristics
Slovenian: I. Povzetek glavnih značilnosti zdravila
English: “Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Slovenian: “Dvojna blokada sistema renin-angiotenzin-aldosteron (RAAS)
English: These medicines are for the treatment of heart failure (see “Other medicines and X”).”
Slovenian: To so zdravila za zdravljenje srčnega popuščanja (glejte "Druga zdravila in zdravilo X")."
English: Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.
Slovenian: Obvestite <zdravnika> <ali> <farmacevta>, če <jemljete> <uporabljate>, ste pred kratkim <jemali> <uporabljali> ali pa boste morda začeli <jemati> <uporabljati> katero koli drugo zdravilo.
English: Caution should be observed when initiating therapy in patients with heart failure.
Slovenian: Previdnost je potrebna pri uvajanju zdravljenja bolnikom s srčnim popuščanjem.