FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin.
Slovenian: Najpogostejši neželeni učinki, o katerih poročajo in so povezani z leflunomidom so: blago zvišanje krvnega tlaka, levkopenija, parestezija, glavobol, omotica, driska, navzea, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu, zvečano izpadanje las, ekcem, izpuščaji (vključno makulopapularni izpuščaji), pruritus, suha koža, tendosinovitis, zvišan CPK, anoreksija, izguba telesne mase (ponavadi nepomembno), astenija, blage alergijske reakcije in zvišanje jetrnih parametrov (transaminaze (zlasti ALT), manj pogosto gama-GT, alkalne fosfataze, bilirubina).
English: After this the dose is: - For rheumatoid arthritis: 10 mg or 20 mg once daily depending on the severity of the disease.
Slovenian: • za zdravljenje revmatoidnega artritisa: 10 ali 20 mg zdravila Repso enkrat na dan, odvisno od resnosti obolenja,
English: 30 film-coated tablets 100 film-coated tablets
Slovenian: 30 filmsko obloženih tablet 100 filmsko obloženih tablet
English: Iron Oxide Yellow (E172) Polysorbate (E433)
Slovenian: Rumeni železov oksid (E172) Polisorbat (E433) Kinolinsko rumeno barvilo Indigotin (E132)
English: You will normally take Repso over long periods of time.
Slovenian: Običajno boste zdravilo Repso jemali dolgo časa.
English: diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain; colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis
Slovenian: driska, navzeja, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu; kolitis, vključno z mikroskopskim kolitisom, kot je na primer limfocitni kolitis ali kolagenski kolitis
English: Repso provided in tablet containers are available in pack sizes of 30 and 100 film-coated tablets.
Slovenian: Tablete Repso so dobavljene v vsebnikih za tablete, v pakiranjih po 30 in 100 filmsko obloženih tablet.
English: Repso provided in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets.
Slovenian: Tablete Repso so dobavljene v pretisnih omotih, v pakiranjih po 28, 30 in 100 filmsko obloženih tablet.
English: Repso contains lactose.
Slovenian: Zdravilo vsebuje laktozo.
English: Pack sizes of 30 and 100 film-coated tablets.
Slovenian: Pakiranja po 30 in 100 filmsko obloženih tablet.
English: - Cimetidine, medicine for the treatment of heartburn and peptic ulcers
Slovenian: ki jo telo absorbira, - cimetidin, zdravilo za zdravljenje pekoče bolečine za prsnico in peptičnih razjed.
English: HDPE tablet containers: 2 years
Slovenian: Repso 10 mg filmsko obložene tablete HDPE vsebniki za tablete: 2 leti Pretisni omoti: 2 leti
English: MARKETING AUTHORISATION HOLDER Teva B.V.
Slovenian: Imetnik dovoljenja za promet Teva B.V.
English: INFORMATION IN BRAILLE Repso 10 mg film-coated tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Repso 10 mg filmsko obložene tablete
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila Repso, se posvetujte z zdravnikom,s farmacevtom ali z medicinsko sestro.
English: Not known side effects (frequency cannot be estimated from the available data) Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS (see above and section 2) may also occur with an unknown frequency.
Slovenian: Z neznano pogostnostjo se lahko pojavijo neželeni učinki, kot je ledvična odpoved, zmanjšana koncentracija sečne kisline v krvi, pljučna hipertenzija, neplodnost pri moških (izgine po prenehanju uporabe tega zdravila), kožni lupus (značilen izpuščaj/eritem na predelih kože, ki so izpostavljeni svetlobi), luskavica (ki se pojavi na novo ali poslabšanje le te) in sindrom DRESS (glejte zgoraj in poglavje 2).
English: Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.
Slovenian: Tveganje za resne neželene učinke lahko poleg tega poveča tudi prehod z leflunomida na drugo imunomodulirajoče antirevmatično zdravilo brez postopka izpiranja (glejte poglavje 4.4), in to celo dalj časa po prehodu.
English: In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: < 20 kg, 20-40 kg, and > 40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥ 30 % (p = 0.02).
Slovenian: Po 16 tednih zdravljenja je bila razlika v deležu odziva statistično značilna v prid metotreksata po opredelitvi izboljšanja (DOI - Definition of Improvement) za JRA ≥ 30 % (p = 0,02).
English: LIST OF EXCIPIENTS Contains lactose (see leaflet for further information).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo (za dodatne informacije glejte navodilo za uporabo).
English: INFORMATION IN BRAILLE Repso 20 mg film-coated tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Repso 20 mg filmsko obložene tablete
English: Common: Rare:
Slovenian: Pogosti: Redki:
English: There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of A771726.
Slovenian: Po ponavljajočih se odmerkih A771726 se je povprečna Cmax etinilestradiola povečala za 1,58-krat in njegova povprečna AUC0-24 za 1,54-krat); povprečna Cmax levonorgestrela se je povečala za 1,33-krat in povprečna AUC0-24 za 1,41-krat).
English: Crospovidone type A Pregelatinized starch (maize) Talc
Slovenian: Krospovidon, vrsta A Predgelirani koruzni škrob Smukec
English: The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Slovenian: Uporaba nekaterih imunosupresivnih zdravil poveča nevarnost malignomov, zlasti limfoproliferativnih bolezni.
English: What Repso looks like and contents of the pack Repso 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Slovenian: Repso 20 mg filmsko obložene tablete so temno rjavkaste, trikotne filmsko obložene tablete, z vgravirano oznako »20« na eni strani in »L« na drugi strani tablete.
English: Teva Pharma, S.L.U Tél: +34 91 387 32 80
Slovenian: Tél: +34 91 387 32 80
English: What Repso looks like and contents of the pack Repso 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Slovenian: Repso 10 mg filmsko obložene tablete so bele, okrogle filmsko obložene tablete, z vgravirano oznako »10« na eni strani in »L« na drugi strani.
English: Repso 10 mg film-coated tablets
Slovenian: Repso 10 mg filmsko obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/674/006 30 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/674/006 30 filmsko obloženih tablet
English: Repso 20 mg film-coated tablets
Slovenian: Repso 20 mg filmsko obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/674/001 30 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/674/001 30 filmsko obloženih tablet
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Repso.
Slovenian: Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Repso je treba upoštevati dolg razpolovni čas leflunomida.
English: EU/1/11/674/007 100 film-coated tablets
Slovenian: EU/1/11/674/007 100 filmsko obloženih tablet
English: Drinking alcohol while taking Repso may increase the chance of liver damage.
Slovenian: Zdravila Repso skupaj s hrano, pijačo in alkoholom Pitje alkohola med jemanjem zdravila Repso lahko poveča možnost poškodbe jeter.
English: Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Slovenian: Temno bež, trikotna filmsko obložena tableta, z vgravirano oznako »20« na eni strani in »L« na drugi strani tablete.
English: urticaria
Slovenian: Kolitis
English: Tel: +44 1977 628500
Slovenian: United Kingdom Teva UK Limited Tel: +44 1977 628500
English: There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo.
Slovenian: Po večkratnih odmerkih A771726 so ugotovili povečanje povprečne Cmax cefaklorja za 1,43-krat in njegove povprečne AUC za 1,54-krat; to kaže, da A771726 in vivo zavira OAT3.
English: red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis).
Slovenian: Ne jemljite zdravila Repso - če ste kdaj doživeli alergijsko reakcijo na leflunomid (zlasti resno kožno reakcijo, ki jo pogosto spremljajo povišana telesna temperatura, bolečine v sklepih, rdeči madeži na koži ali mehurji, kot je Stevens-Johnsonov sindrom) ali katero koli sestavino tega zdravila (navedeno v poglavju 6) ali če ste alergični na teriflunomid (ki se uporablja za zdravljenje multiple skleroze).
English: EU/1/11/674/002 100 film-coated tablets
Slovenian: EU/1/11/674/002 100 filmsko obloženih tablet
English: Repso 20 mg film-coated tablets leflunomide
Slovenian: Repso 20 mg filmsko obložene tablete leflunomid
English: Each film-coated tablet contains 20 mg of leflunomide.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg leflunomida.
English: • Each film-coated tablet contains 20 mg of leflunomide.
Slovenian: • Ena filmsko obložena tableta vsebuje 20 mg leflunomida.
English: Repso 10 mg film-coated tablets leflunomide
Slovenian: Repso 10 mg filmsko obložene tablete leflunomid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Repso 10 mg film-coated tablets Each film-coated tablet contains 10 mg of leflunomide.
Slovenian: Repso 10 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 10 mg leflunomida.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet 30 tablets 100 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 30 filmsko obloženih tablet 100 filmsko obloženih tablet
English: • Each film-coated tablet contains 10 mg of leflunomide.
Slovenian: • Ena filmsko obložena tableta vsebuje 10 mg leflunomida.
English: Each film-coated tablet contains 10 mg of leflunomide.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg leflunomida.
English: EU/1/11/674/008 28 film-coated tablets EU/1/11/674/009 30 film-coated tablets EU/1/11/674/010 100 film-coated tablets
Slovenian: EU/1/11/674/008 28 filmsko obloženih tablet EU/1/11/674/009 30 filmsko obloženih tablet EU/1/11/674/010 100 filmsko obloženih tablet
English: This may affect your ability to concentrate or react properly.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Repso lahko povzroči omotičnost, kar lahko prizadene sposobnost za koncentracijo in pravilno reagiranje.
English: - Alosetron for the management of severe diarrhoea - Theophylline for asthma - Tizanidine, a muscle relaxant - Oral contraceptives (containing ethinylestradiol and levonorgestrel) - Cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - Indomethacin, ketoprofen for pain or inflammation - Furosemide for heart disease (diuretic, water pill) - Zidovudine for HIV infection - Rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - Sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of Repso absorbed by your body.
Slovenian: - varfarin in druga peroralna zdravila, ki se uporabljajo za redčenje krvi, ker so potrebne kontrole, da bi zmanjšali tveganje neželenih učinkov tega zdravila, - teriflunomid za multiplo sklerozo, - repaglinid, pioglitazon, nateglinid, ali rosiglitazon za sladkorno bolezen, - daunorubicin, doksorubicin, paklitaksel, ali topotekan za raka, - duloksetin za depresijo, inkontinenco urina ali bolezen ledvic pri sladkornih bolnikih, - alosetron za obvladovanje hude driske, - teofilin za astmo, - tizanidin, mišični relaksant, - peroralni kontraceptivi (vključno z etinilestradiolom and levonorgestrelom), - cefaklor, benzilpenicillin (penicillin G), ciprofloksacin za okužbe, - indometacin, ketoprofen za bolečino ali vnetje, - furosemid za bolezni srca (diuretik, tableta za odvajanje vode), - zidovudin za HIV okužbe, - rosuvastatin, simvastatin, atorvastatin, pravastatin za hiperholesterolemijo (zvišane vrednosti holesterola), - sulfasalazin za vnetno bolezen črevesa ali revmatoidni artritis, - holestiramin (uporablja se za zniževanje zvišanega holesterola in za zdravljenje serbečice v povezavi z zlatenico) ali aktivno oglje, saj ti dve zdravili lahko znižata količino zdravila Repso,
English: - Ruptured tendons.
Slovenian: pretrganje tetive
English: Very rare side effects (may affect up to 1 in 10,000 people) - An infection characterised by high fever, sore throat, skin lesions and an extreme reduction of white blood cells (agranulocytosis).
Slovenian: Redki neželeni učinki (prizadanejo lahko največ 1 od 1.000 ljudi) - resno zvišanje krvnega tlaka - zmanjšanje števila vseh krvnih celic (pancitopenija), - izrazito zmanjšanje števila belih krvnih celic, kar lahko poveča možnosti infekcij (levkopenija), - zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija),
English: - If you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.
Slovenian: Nemudoma obvestite svojega zdravnika in prenehajte jemati zdravilo Repso - če se počutite oslabeli, če občutite vrtoglavost ali omotičnost ali težko dihate, saj so to lahko znaki resne alergijske reakcije, - če se vam razvijejo kožni izpuščaji ali razjede v ustih, je to lahko znak smrtno nevarnih reakcij (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem, neželena reakcija z eozinofilijo in sistemskimi simptomi [sindrom DRESS]), glejte poglavje 2.
English: NAME OF THE MEDICINAL PRODUCT Repso 10 mg film-coated tablets Repso 20 mg film-coated tablets
Slovenian: Repso 10 mg filmsko obložene tablete Repso 20 mg filmsko obložene tablete
English: OUTER CARTON/BLISTER PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA/PLASTENKA
English: Especially if you are taking any of the following: - Other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable - Warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - Teriflunomide for multiple sclerosis - Repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - Daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - Duloxetine for depression, urinary incontinence or in kidney disease in diabetics - Alosetron for the management of severe diarrhoea
Slovenian: intramuskularno ali peroralno zlato, D-penicilamin, azatioprin in druga imunosupresivna zdravila (npr. metotreksat), ker te kombinacije niso priporočljive, - varfarin in druga peroralna zdravila, ki se uporabljajo za redčenje krvi, ker so potrebne kontrole, da bi zmanjšali tveganje neželenih učinkov tega zdravila, - teriflunomid za multiplo sklerozo, - repaglinid, pioglitazon, nateglinid, ali rosiglitazon za sladkorno bolezen, - daunorubicin, doksorubicin, paklitaksel, ali topotekan za raka, - duloksetin za depresijo, inkontinenco urina ali bolezen ledvic pri sladkornih bolnikih, - alosetron za obvladovanje hude driske, - teofilin za astmo, - tizanidin, mišični relaksant, - peroralni kontraceptivi (vključno z etinilestradiolom and levonorgestrelom), - cefaklor, benzilpenicillin (penicillin G), ciprofloksacin za okužbe, - indometacin, ketoprofen za bolečino ali vnetje, - furosemid za bolezni srca (diuretik, tableta za odvajanje vode), - zidovudin za HIV okužbe, - rosuvastatin, simvastatin, atorvastatin, pravastatin za hiperholesterolemijo (zvišane vrednosti holesterola), - sulfasalazin za vnetno bolezen črevesa ali revmatoidni artritis, - holestiramin (uporablja se za zniževanje zvišanega holesterola in za zdravljenje serbečice v povezavi z zlatenico) ali aktivno oglje, saj ti dve zdravili lahko znižata količino zdravila Repso,
English: Magyarország Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
Slovenian: Tel.: +36 1 288 64 00
English: EU/1/11/674/001 30 film-coated tablets EU/1/11/674/002 100 film-coated tablets
Slovenian: EU/1/11/674/001 30 filmsko obloženih tablet EU/1/11/674/002 100 filmsko obloženih tablet
English: EU/1/11/674/003 28 film-coated tablets EU/1/11/674/004 30film-coated tablets EU/1/11/674/005 100 film-coated tablets
Slovenian: EU/1/11/674/003 28 filmsko obloženih tablet EU/1/11/674/004 30 filmsko obloženih tablet EU/1/11/674/005 100 filmsko obloženih tablet
English: EU/1/11/674/006 30 film-coated tablets EU/1/11/674/007 100 film-coated tablets
Slovenian: EU/1/11/674/006 30 filmsko obloženih tablet EU/1/11/674/007 100 filmsko obloženih tablet
English: - Decrease in the number of all blood cells (pancytopenia) - A pronounced reduction in the number of white blood cells, which makes infections more likely
Slovenian: Redki neželeni učinki (prizadanejo lahko največ 1 od 100 ljudi) - resno zvišanje krvnega tlaka, - zmanjšanje števila vseh krvnih celic (pancitopenija), - izrazito zmanjšanje števila belih krvnih celic, kar lahko poveča možnosti infekcij (levkopenija), - zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija),
English: NAME OF THE MEDICINAL PRODUCT Repso 20 mg film-coated tablets leflunomide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Repso 20 mg filmsko obložene tablete leflunomid
English: NAME OF THE MEDICINAL PRODUCT Repso 10 mg film-coated tablets leflunomide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Repso 10 mg filmsko obložene tablete leflunomid
English: - An increase in the levels of fat in the blood (cholesterol and triglycerides).
Slovenian: - druga zdravila za revmatoidni artritis, kot so antimalariki (npr. klorokin in hidroksiklorokin),
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/674/001-010
Slovenian: EU/1/11/674/001-010
English: OUTER CARTON/BOTTLE PACK
Slovenian: ZUNANJA OVOJNINA/PRETISNI OMOT
English: pulmonary hypertension
Slovenian: Pogostost ni znana: pljučna hipertenzija
English: 76 ml
Slovenian: 76 ml plastenko
English: Cutaneous use Bottle (PET)
Slovenian: Plastenko (PET)
English: Cutaneous spray, solution
Slovenian: Dermalno pršilo, raztopina
English: A risk to the child cannot be excluded.
Slovenian: Tveganja za otroka ne moremo izključiti.
English: The plunger may rise up by itself again - this is normal.
Slovenian: Bat se lahko ponovno dvigne sam od sebe - to je normalno.
English: Date removed from refrigerator: ________________________
Slovenian: Datum odvzema iz hladilnika: ________________________
English: *Bleeding events: see below
Slovenian: *dogodki krvavitve: glejte spodaj
English: The recommended treatment is
Slovenian: Priporočeno zdravljenje je
English: Never expose to temperatures above 30 °C.
Slovenian: Zdravila nikoli ne izpostavljajte temperaturam nad 30 °C.
English: Do not warm them up in any other way.
Slovenian: Ne ogrevajte ju na noben drug način.
English: • Go to step 8 immediately after these 5 minutes.
Slovenian: • Po teh 5 minutah takoj preidite na 8. korak.
English: Patient age ranged from 18 to 79 years, with a mean of 46 years.
Slovenian: Starostni razpon bolnikov je bil 18 do 79 let, s povprečjem 46 let.
English: Patients were followed for 1 month after discontinuation of treatment.
Slovenian: Bolnike so 1 mesec po prenehanju zdravljenja spremljali.
English: Differences in the different subpopulations were investigated.
Slovenian: Preučili so razlike v različnih podpopulacijah.
English: Tell your doctor if you:
Slovenian: Zdravniku povejte, če:
English: Total volume of plasma used (liter)
Slovenian: Celokupni volumen uporabljene plazme (liter)
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Slovenian: Kemična in fizična stabilnost med uporabo je bila dokazana za 4 ure pri temperaturi 25 °C.
English: Length of hospitalization (days)
Slovenian: Dolžina hospitalizacije (dnevi)
English: Study ALX0681-C301
Slovenian: Študija ALX0681-C301
English: Although in some cases these events were serious and required medical attention, most were self-limited and all resolved.
Slovenian: Čeprav so bili ti dogodki v nekaterih primerih resni in so potrebovali zdravniško oskrbo, jih je večina minila sama od sebe in vsi so izzveneli.
English: Unopened vial 4 years.
Slovenian: Neodprte viale 4 leta.
English: Children and adolescents Cablivi is not recommended for children under 18 years.
Slovenian: Otroci in mladostniki Zdravilo Cablivi ni priporočljivo za otroke, stare manj kot 18 let.
English: Do not use the vial if the green plastic cap is missing.
Slovenian: Viale ne uporabite, če zelena plastična zaporka manjka.
English: N: number of patients evaluated; SE: Standard Error; ICU: Intensive Care Unit
Slovenian: N: število ocenjenih bolnikov; SE: standardna napaka
English: In clinical studies, bleeding events occurred in different body systems, independent of treatment duration.
Slovenian: V kliničnih študijah so se dogodki krvavitve pojavili v različnih telesnih sistemih, neodvisno od trajanja zdravljenja.
English: Characteristics in specific groups
Slovenian: Značilnosti za specifične skupine
English: The line can be flushed with 0.9% sodium chloride.
Slovenian: Linija se lahko izpere z 0,9-% natrijevim kloridom.
English: Half of the patients were experiencing their first episode of aTTP.
Slovenian: Polovica bolnikov je imela svojo prvo epizodo aTTP.
English: Contact your doctor immediately if any of the following serious side effects occur.
Slovenian: Takoj se obrnite na zdravnika, če se pojavi kateri od naslednjih resnih neželenih učinkov.
English: Side effects in a clinical study were reported with the following frequencies:
Slovenian: Neželene učinke v klinični študiji so poročali z naslednjimi pogostnostmi:
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1000), zelo redki (<1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: In patients with aTTP the central volume of distribution was estimated at 6.33 L.
Slovenian: Pri bolnikih z aTTP je ocenjen centralni volumen porazdelitve 6,33 l.