FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of deaths, n (%) Median OS in months [95% CI]a Hazard ratio [95% CI]c p-valued
Slovenian: število smrti, n (%) mediano OS v mesecih [95 % IZ] razmerje ogroženosti [95 % IZ] vrednost p
English: In patients with hyperleukocytic (leukocyte count ≥ 30,000/mm3) AML, cytoreduction is recommended either with leukapheresis, oral hydroxyurea or AraC with or without hydroxyurea to reduce the peripheral white blood cell (WBC) count 48 hours prior to administration of MYLOTARG.
Slovenian: 3) je 48 ur pred uporabo zdravila MYLOTARG priporočljiva citoredukcija z levkaferezo, peroralno hidroksisečnino ali citarabinom s hidroksisečnino ali brez nje, da zmanjšate število levkocitov v periferni krvi.
English: Risk difference [95% CI]f p-valueg
Slovenian: CRp razlika v tveganju [95 % IZ] vrednost p
English: y. Fatigue includes the following reported PTs: Fatigue, Asthenia, Lethargy, and Malaise.
Slovenian: Utrujenost vključuje naslednje PT, o katerih so poročali: utrujenost, astenija, letargija in splošno slabo počutje.
English: • Fatigue
Slovenian: • driska
English: Non-fractionated dosing refers to MYLOTARG (total dose ranging 1.8 mg/m2 - 9 mg/m2) 2 times during a cycle at least 14 days apart.
Slovenian: b: Frakcionirano odmerjanje se nanaša na odmerek zdravila MYLOTARG 3 mg/m2 na 1., 4. in 7. dan. Nefrakcionirano odmerjanje se nanaša na dajanje zdravila MYLOTARG (skupni odmerek v razponu 1,8 mg/m 2 - 9 mg/m 2) 2-krat v ciklu z vsaj 14-dnevnim presledkom.
English: MYLOTARG + daunorubicin + cytarabine (N=131)
Slovenian: Organski sistem Pogostnost Priporočeni izraz zdravilo MYLOTARG + daunorubicin + citarabin (n = 131)
English: Dose modifications for non-haematological toxicities Non-haematological toxicities Dose modifications VOD/SOS
Slovenian: Prilagoditve odmerkov za nehematološke toksičnosti Nehematološke toksičnosti
English: o. Abdominal pain includes the following reported PTs: Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal discomfort, and Abdominal tenderness.
Slovenian: Bolečina v trebuhu vključuje naslednje PT, o katerih so poročali: bolečina v trebuhu, bolečina v spodnjem delu trebuha, bolečina v zgornjem delu trebuha, nelagodje v trebuhu in občutljivost trebuha.
English: The median times to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 were 21 and 25 days, respectively.
Slovenian: Mediani čas do povečanja ANC na 500/mm 3 oziroma 1.000/mm 3 je bil 21 dni oziroma 25 dni.
English: ≤ 2.5 × ULN prior to each dose (see Table 4, sections 4.4 and 5.2).
Slovenian: Odložite zdravljenje z zdravilom MYLOTARG, dokler se celokupni bilirubin pred vsakim odmerkom ne izboljša na ≤ 2 × ZMN, vrednosti AST in ALT pa na ≤ 2,5 × ZMN (glejte preglednico 4 ter poglavji 4.4 in 5.2).
English: Effects on female reproductive organs and the eye in monkeys were adverse in the 12-week study (approximately 193 and 322 times, respectively, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Slovenian: V 12-tedenski študiji so bili učinki na ženske reprodukcijske organe in oči pri opicah neželeni (približno 193-kratnik klinične izpostavljenosti pri ljudeh za ženske reprodukcijske organe in približno 322-kratnik klinične izpostavljenosti pri ljudeh za oči po tretjem odmerku 3 mg/m za človeka na podlagi vrednosti
English: e: Where analysed, median recovery (defined as 20 x 109/L or 50 x 109/L for platelets and 0.5 x 109/L for neutrophils) ranged from 42-48 days for platelets and 30-37 days for neutrophils.
Slovenian: 9/l za nevtrofilce) v razponu 42-48 dni za trombocite in 30-37 dni za nevtrofilce.
English: For patients experiencing a complete remission (CR) following induction, defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count (ANC) of more than 1.0 × 109 cells/L with a platelet count of 100 × 109/L or more in the peripheral blood in the absence of transfusion, up to 2 consolidation courses of intravenous DNR (60 mg/m2 for 1 day [first course] or 2 days [second course]) in combination with intravenous AraC (1 g/m2 per 12 hours, infused over 2 hours on Day 1 to Day 4) with intravenous MYLOTARG (3 mg/m2/dose infused over 2 hours up to a maximum dose of one 5 mg vial on Day 1) are recommended.
Slovenian: 9 celic/l, pri čemer je število trombocitov v periferni krvi 100 × 10 9/l ali več ob odsotnosti transfuzije, sta priporočljiva največ 2 konsolidacijska cikla intravenskega dajanja daunorubicina (60 mg/m 2 1 dan [prvi cikel] ali 2 dneva
English: d. Anaemia includes the following reported PTs: Anaemia and Haemoglobin decreased.
Slovenian: Anemija vključuje naslednja PT, o katerih so poročali: anemija in zmanjšanje vrednosti hemoglobina.
English: u. Rash includes the following reported PTs: Rash, Dermatitis#, Dermatitis allergic#, Dermatitis bullous, Dermatitis contact, Dermatitis exfoliative#, Drug eruption, Pruritus allergic# and Rash erythematous#, Rash macular#, Rash maculo papular, Rash papular, Rash pruritic, Rash vesicular#.
Slovenian: kontaktni dermatitis, eksfoliativni dermatitis #, erupcija zaradi zdravila, alergijski pruritus # in eritematozni izpuščaj makulozni izpuščaj
English: In patients with hyperleukocytic AML, leukoreduction should be considered with hydroxyurea or leukapheresis to reduce the peripheral WBC count to below 30,000/mm3 prior to administration of MYLOTARG to reduce the risk of inducing TLS (see section 4.2).
Slovenian: Za zmanjšanje tveganja za pojav TLS je treba pri bolnikih z AML s hiperlevkocitozo pred uporabo zdravila MYLOTARG razmisliti o levkoredukciji s hidroksisečnino ali levkaferezo za zmanjšanje števila belih krvnih celic v periferni krvi na manj kot 30.000/mm
English: Premedication with a corticosteroid, antihistamine and acetaminophen (or paracetamol) is recommended 1 hour prior to MYLOTARG dosing (see section 4.2).
Slovenian: Eno uro pred odmerjanjem zdravila MYLOTARG je priporočljiva premedikacija s kortikosteroidi, antihistaminiki in paracetamolom (oziroma acetaminofenom) (glejte poglavje 4.2).
English: i. Hyperglycaemia includes the following reported PTs: Hyperglycaemia and Blood glucose increased#.
Slovenian: Hiperglikemija vključuje naslednja PT, o katerih so poročali: hiperglikemija in zvečanje koncentracije glukoze v krvi j.
English: In toxicity studies, rats developed preneoplastic lesions (minimal to slight oval cell hyperplasia) in the liver approximately 54 times, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Slovenian: V študijah toksičnosti so se pri podganah pri približno 54-kratniku klinične izpostavljenosti pri ljudeh po tretjem odmerku 3 mg/m2 za človeka na podlagi vrednosti AUC168 pojavile preneoplastične lezije (minimalna do blaga hiperplazija ovalnih celic) v jetrih.
English: After reconstitution each vial contains 1 mg/mL gemtuzumab ozogamicin.
Slovenian: Po rekonstituciji ena viala vsebuje 1 mg/ml gemtuzumab ozogamicina.
English: • Rapid heartbeat
Slovenian: • kratka sapa
English: The PK of gemtuzumab ozogamicin has not been studied in patients with severe renal impairment.
Slovenian: Farmakokinetike gemtuzumab ozogamicina pri bolnikih s hudo ledvično okvaro niso preučevali.
English: e. Leukopenia includes the following reported PTs: Leukopenia and White blood cell count decreased.
Slovenian: Levkopenija vključuje naslednja PT, o katerih so poročali: levkopenija in zmanjšanje števila levkocitov.
English: fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia*; and bacterial infections including Stenotrophomonas infection were also reported.
Slovenian: *, ter o bakterijskih okužbah, med drugim o okužbi z rodom Stenotrophomonas.
English: • Itchy skin
Slovenian: • srbeča koža
English: Effect of gemtuzumab ozogamicin on other medicinal products Effect on CYP substrates
Slovenian: Učinek gemtuzumab ozogamicina na druga zdravila
English: Keep out of the sight and reach of children.
Slovenian: Izogibajte se zanositvi ali spočetju otroka.
English: 35 mg/m2/day on Day 1 to Day 2
Slovenian: 35 mg/m 2/dan od 1. do
English: Neutrophils decreased Hyperglycaemia Aspartate aminotransferase (AST) increas ed Prothrombin time increased Activated partial thromboplastin time prolonged Alkaline phosphatase increased
Slovenian: Preiskave *** zelo pogosti zmanjšanje vrednosti hemoglobina zmanjšanje števila trombocitov zmanjšanje števila levkocitov zmanjšanje (absolutnega) števila limfocitov zmanjšanje števila nevtrofilcev hiperglikemija zvečanje vrednosti aspartat-aminotransferaze (AST) podaljšanje protrombinskega časa podaljšan aktivirani parcialni tromboplastinski čas zvečanje vrednosti alkalne fosfataze zvečanje vrednosti alanin-aminotransferaze (ALT) zvečanje vrednosti bilirubina v krvi hiperurikemija
English: During the consolidation 2 phase, 80 (97.6%) and 70 (85.4%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Slovenian: Med 2. konsolidacijsko fazo se je pri 80 bolnikih (97,6 %) število trombocitov povečalo na 50.000/mm 3, pri 70 bolnikih (85,4 %) pa na 100.000/mm 3.
English: Schedule modification for the treatment of hyperleukocytosis with cytarabine
Slovenian: Prilagajanje sheme za zdravljenje hiperlevkocitoze s citarabinom Potek zdravljenja zdravilo MYLOTARG daunorubicin citarabin hidroksisečnina
English: Gemtuzumab ozogamicin was found to be clastogenic.
Slovenian: Ugotovili so, da je gemtuzumab ozogamicin klastogen.
English: There were no preneoplastic or neoplastic lesions observed in monkeys up to approximately 115 times the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Slovenian: Pri opicah pri približno 115-kratniku klinične izpostavljenosti pri ljudeh po tretjem odmerku 3 mg/m2 za človeka na podlagi vrednosti AUC168 niso opazili preneoplastičnih ali neoplastičnih lezij.
English: h. Infusion related reaction includes the following reported PTs: Infusion related reaction, Urticaria, Hypersensitivity,
Slovenian: Z infuzijo povezana reakcija vključuje naslednje PT, o katerih so poročali: z infuzijo povezana reakcija, urtikarija, preobčutljivost, bronhospazem, preobčutljivost na zdravilo in urtikarija na mestu injiciranja i.
English: ELN (favourable/intermediate), N Number of deaths, n (%) Median OS in months [95% CI]a
Slovenian: ELN (ugodno/zmerno), n število smrti, n (%) mediano OS v mesecih [95 % IZ]
English: ELN (favourable/intermediate), N Number of events, n (%) Median EFS in months [95% CI]a
Slovenian: ELN (ugodno/zmerno), n število dogodkov, n (%) mediano EFS v mesecih [95 % IZ]
English: No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with hepatic impairment.
Slovenian: Formalnih farmakokinetičnih študij z gemtuzumab ozogamicinom pri bolnikih z okvaro jeter niso izvedli.
English: Ratec
Slovenian: Redčenje
English: No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with renal impairment.
Slovenian: Formalnih farmakokinetičnih študij z gemtuzumab ozogamicinom pri bolnikih z okvaro ledvic niso izvedli.
English: • Bleeding
Slovenian: • krvavitev
English: • If platelet count recovery remains < 50,000/mm3 for greater than 14 days consolidation therapy should be re-evaluated and a BMA should be performed to re-assess the patients' status.
Slovenian: 14 dni, je treba ponovno ovrednotiti konsolidacijsko zdravljenje in opraviti aspiracijo kostnega mozga za ponovno oceno bolnikovega stanja.
English: Hepatobiliary disorders Very common Transaminases increasedq Hyperbilirubinaemiar
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo pogosti zvečanje vrednosti transaminaz hiperbilirubinemija
English: Cytogenetics (favourable/intermediate), N Number of events, n (%) Median EFS in months [95% CI]a
Slovenian: Citogenetika (ugodno/zmerno), n število dogodkov, n (%) mediano EFS v mesecih [95 % IZ]
English: Cytogenetics (favourable/intermediate), N Number of deaths, n (%) Median OS in months [95% CI]a
Slovenian: Citogenetika (ugodno/zmerno), n število smrti, n (%) mediano OS v mesecih [95 % IZ]
English: Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate anhydrous
Slovenian: 6.1 Seznam pomožnih snovi dekstran 40 saharoza natrijev klorid natrijev dihidrogenfosfat monohidrat brezvodni dinatrijev hidrogenfosfat
English: During the consolidation 1 phase, 92 (94.8%) and 71 (73.2%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Slovenian: Med 1. konsolidacijsko fazo se je pri 92 bolnikih (94,8 %) število trombocitov povečalo na 50.000/mm 3, pri 71 bolnikih (73,2 %) pa na
English: g. Lymphopenia includes the following reported PTs: Lymphopenia and Lymphocyte count decreased.
Slovenian: Limfopenija vključuje naslednja PT, o katerih so poročali: limfopenija in zmanjšanje števila limfocitov.
English: You must avoid becoming pregnant or fathering a child. Women must use 2 methods of effective contraception during treatment and for at least 7 months after the last dose of treatment.
Slovenian: Ženske morajo med zdravljenjem in vsaj 7 mesecev po zadnjem odmerku zdravila uporabljati 2 metodi učinkovite kontracepcije.
English: During the induction phase, 109 (83.2%) and 99 (75.6%) patients had platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Slovenian: Med indukcijsko fazo se je pri 109 bolnikih (83,2 %) število trombocitov povečalo na 50.000/mm 3, pri
English: f. Pancytopenia includes the following reported PTs: Pancytopenia and Bone marrow failure.
Slovenian: Pancitopenija vključuje naslednja PT, o katerih so poročali: pancitopenija in odpoved kostnega mozga.
English: In monotherapy studies the most common adverse reactions (> 30%) included pyrexia, nausea, infection, chills, haemorrhage, vomiting, thrombocytopenia, fatigue, headache, stomatitis, diarrhoea, abdominal pain, and neutropenia.
Slovenian: navzeo, okužbo, mrzlico, krvavitev, bruhanje, trombocitopenijo, utrujenost, glavobol, stomatitis, diarejo, bolečino v trebuhu in nevtropenijo.
English: Hazard ratio [95% CI]c p-valued
Slovenian: razmerje ogroženosti [95 % IZ] vrednost p
English: All of these TEAEs were determined to be adverse drug reactions.
Slovenian: Vsi ti neželeni učinki, ki so se pojavili med zdravljenjem, veljajo za neželene učinke zdravila.
English: Cytogenetics (unfavourable), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Slovenian: Citogenetika (neugodno), n število dogodkov, n (%) mediano EFS v mesecih [95 % IZ] razmerje ogroženosti [95 % IZ] vrednost p
English: (5.3%), Bacterial infection (9.2%), Gastrointestinal infection (8.4%), Skin infection (2.3%), and Other infections b. Haemorrhage includes Central nervous system haemorrhage (3.1%), Upper gastrointestinal haemorrhage (33.6%), Lower gastrointestinal haemorrhage (17.6%), Subcutaneous haemorrhage (60.3%), Other haemorrhage (64.9%), and Epistaxis (62.6%).
Slovenian: Krvavitev vključuje krvavitev v centralnem živčnem sistemu (3,1 %), krvavitev v zgornjih prebavilih (33,6 %), krvavitev v spodnjih prebavilih (17,6 %), podkožno krvavitev (60,3 %), drugo krvavitev (64,9 %) in epistakso (62,6 %).
English: Cytogenetics (unfavourable), N Number of deaths, n (%) Median OS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Slovenian: Citogenetika (neugodno), n število smrti, n (%) mediano OS v mesecih [95 % IZ] razmerje ogroženosti [95 % IZ] vrednost p
English: In the consolidation 2 phase of therapy, 80 (97.6%) patients had neutrophil recovery to counts of 500/mm3, and 79 (96.3%) patients recovered to counts of 1,000/mm3.
Slovenian: V 2. konsolidacijski fazi zdravljenja se je pri 80 bolnikih (97,6 %) število nevtrofilcev povečalo na 500/mm 3, pri
English: Abbreviations: AML=acute myeloid leukaemia; CI=confidence interval; ELN=European LeukaemiaNet; mITT=modified intent-to-treat; n=number; N=number; NE=not estimable; OS=Overall Survival a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer and Crowley Method with log-log transformation.
Slovenian: Okrajšave: AML = akutna mieloična levkemija; IZ = interval zaupanja; ELN = European LeukaemiaNet; mITT = modificirana populacija, ki so jo nameravali zdraviti; n = število; NE = ni mogoče oceniti; OS = celokupno preživetje a.
English: Thrombocytopenia with platelet counts < 50,000/mm3 persisting 45 days after the start of therapy for responding patients (CR and incomplete platelet recovery [CRp]) occurred in 22 (20.4%) of patients.
Slovenian: 3, ki je trajala 45 dni od začetka zdravljenja pri bolnikih, ki so se na zdravilo odzivali, (CR in delno povečanje števila trombocitov [CRp - Complete Remission and incomplete platelet recovery]).
English: Number of studies
Slovenian: DRUGI PODATKI
English: 60 mg/m2/day on Day 1 to Day 2
Slovenian: 60 mg/m 2/dan na 1. dan
English: ELN (poor/adverse), N Number of deaths, n (%) Median OS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Slovenian: ELN (nizko/škodljivo), n število smrti, n (%) mediano OS v mesecih [95 % IZ] razmerje ogroženosti [95 % IZ] vrednost p
English: b. Thrombocytopenia includes the following reported PTs: Platelet count decreased and Thrombocytopenia*.
Slovenian: Trombocitopenija vključuje naslednja PT, o katerih so poročali: zmanjšanje števila trombocitov in trombocitopenija c.
English: The efficacy and safety of MYLOTARG were evaluated in a multicentre, randomised, open-label Phase 3 study comparing the addition of MYLOTARG to a standard chemotherapy induction regimen of daunorubicin and cytarabine (DA) versus DA alone.
Slovenian: Učinkovitost in varnost zdravila MYLOTARG so ocenili v multicentrični, randomizirani, odprti študiji
English: a. See Table 3 and Table 4 for additional dose modification information.
Slovenian: Za dodatne informacije o prilagajanju odmerkov glejte preglednico 3 in preglednico 4.
English: Budd-Chiari s yndrome#
Slovenian: • vnetje požiralnika
English: ELN (poor/adverse), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Slovenian: ELN (nizko/škodljivo), n število dogodkov, n (%) mediano EFS v mesecih [95 % IZ] razmerje ogroženosti [95 % IZ] vrednost p
English: For IV infusion after reconstitution and dilution
Slovenian: infundiranje po rekonstituciji in redčenju
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 34 and 35 days, respectively.
Slovenian: 50.000/mm 3 oziroma 100.000/mm 3 je bil 34 dni oziroma 35 dni.
English: Lower gastrointestinal haemorrhage (15.2%), Subcutaneous haemorrhage (28.5%), Other haemorrhage (32.9%), and
Slovenian: Krvavitve vključujejo krvavitev v centralnem živčnem sistemu (5,1 %), krvavitev v zgornjih prebavilih (21,3 %), krvavitev v spodnjih prebavilih (15,2 %), podkožno krvavitev (28,5 %), drugo krvavitev (32,9 %) in epistakso l.
English: 200 mg/m2/day on Day 1 to Day 7
Slovenian: 200 mg/m 2/dan od 1. do
English: Efficacy results from study ALFA-0701 (mITT population)
Slovenian: Podatki o učinkovitosti iz študije ALFA-0701 (modificirana populacija, ki so jo nameravali zdraviti (modified Intent-To-Treat [mITT] population)
English: Combinationa
Slovenian: Odmerjanje
English: a. Infection includes Sepsis and Bacteraemia (53.4%), Fungal infection (15.3%), Lower respiratory tract infection
Slovenian: Okužbe vključujejo sepso in bakteriemijo (53,4 %), glivično okužbo (15,3 %), okužbo spodnjih dihal (5,3 %), bakterijsko okužbo (9,2 %), okužbo prebavil (8,4 %), okužbo kože (2,3 %) in druge okužbe (28,4 %).
English: MYLOTARG daunorubicin cytarabine hydroxyurea
Slovenian: zdravilo MYLOTARG + daunorubicin + citarabin daunorubicin + citarabin
English: • Liver failure
Slovenian: • odpoved jeter
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: Vascular disorders Very common Haemorrhage*k Hypotensionl Hypertensionm
Slovenian: *k hipotenzija hipertenzija
English: ≤ 2.5 × ULN.
Slovenian: 9/l za trombocite in 0,5 x
English: Non-fractionatedb MYLO TARG
Slovenian: nefrakcionirano odmerjanje b zdravila MYLOTARG
English: S ys tem organ clas s Frequency
Slovenian: Organski sistem Pogostnost Priporočeni izraz
English: Nervous system disorders Very common Headache Cardiac disorders Very common Tachycardiaj
Slovenian: Bolezni prebavil zelo pogosti bruhanje diareja bolečina v trebuhu navzea stomatitis zaprtje pogosti ascites dispepsija ezofagitis neznana nevtropenični kolitis
English: a. See Table 3 and Table 4 for dose modification information.
Slovenian: Za informacije o prilagajanju odmerkov glejte preglednico 3 in preglednico 4.
English: VO D VO D post HSCT
Slovenian: VOD VOD po PKMC
English: Unknown Inters titial pneumonia*
Slovenian: pogosti venookluzivna bolezen jeter
English: It is essentially ‘sodium-free'.
Slovenian: vsebuje natrij”.
English: OTHER
Slovenian: delež
English: n. Dyspnoea includes the following reported PTs: Dyspnoea and Dyspnoea exertional.
Slovenian: Dispneja vključuje naslednja PT, o katerih so poročali: dispneja in dispneja med naporom.
English: • Mouth inflammation
Slovenian: • vnetje ust
English: Eligible patients were between 50 and 70 years of age with previously untreated de novo AML (Study ALFA-0701).
Slovenian: 3. faze, v kateri so primerjali dodajanje zdravila MYLOTARG standardnemu režimu indukcijske kemoterapije s kombinacijo daunorubicina in citarabina (DA) v primerjavi s samo DA. Za vključitev v študijo so bili primerni bolniki med 50. in 70. letom starosti s predhodno nezdravljeno AML de novo (Študija ALFA-0701).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MYLOTARG 5 mg powder for concentrate gemtuzumab ozogamicin
Slovenian: MYLOTARG 5 mg prašek za koncentrat gemtuzumab ozogamicin za i.v.
English: Fractionatedb MYLO TARG
Slovenian: frakcionirano odmerjanje b zdravila MYLOTARG
English: The marketing authorisation was renewed on 14 August 2002 and 14 August
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 14. avgusta 2002 in 14. avgusta 2007.
English: There are no known side effects of the test.
Slovenian: Ni znanih neželenih učinkov testa.
English: This means that it contains 13C, a rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.
Slovenian: To pomeni, da vsebuje 13C, redko obliko ogljikovega atoma, namesto ogljika-12 (12C), oblike, ki je v naravi najpogostejša.
English: In children aged three to 11 years, the ‘test meal' should be 100 ml of pure orange juice.
Slovenian: Pri otrocih, starih od treh do 11 let, je „testni obrok“ 100 ml čistega pomarančnega soka.
English: This labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Slovenian: Ta označeni ogljikov dioksid je mogoče izmeriti v specializiranih laboratorijih s tehniko, imenovano masna spektrometrija.
English: The powder is the active substance 13C-urea (45 mg for children or 75 mg for adults).
Slovenian: Prašek je zdravilna učinkovina 13C-sečnina (45 mg za otroke ali 75 mg za odrasle).
English: children under the age of 11 who received 45 mg. One of the studies in adults was carried out in patients after they had received antibiotics to treat their infection.
Slovenian: 204 otrok, mlajših od 11 let, ki so je prejeli 45 mg. Ena izmed študija z odraslimi je bila izvedena z bolniki, potem ko so le-ti prejeli antibiotike za zdravljenje okužbe.
English: However, if the patient vomits during the test, the test will need to be done again, but not until at least the following day.
Slovenian: V primeru, da bi bolnik med testom bruhal, je treba test ponoviti, vendar pa je treba s ponovitvijo počakati najmanj do naslednjega dne.
English: All received 75 mg of 13C-urea, except 204
Slovenian: Vsi so prejeli 75 mg 13C-sečnine, razen
English: The European Commission granted a marketing authorisation valid throughout the European Union for Helicobacter Test INFAI to INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH on 14 August 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Helicobacter Test INFAI, veljavno po vsej Evropski uniji, odobrila družbi INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH dne 14. avgusta 1997.
English: If there is no labelled carbon dioxide in the breath, this means there are no bacteria in the stomach or duodenum.
Slovenian: Če v izdihanem zraku ni označenega ogljikovega dioksida, to pomeni, da v želodcu ali dvanajstniku ni bakterij.